Actelsar HCT

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 40 mg/12.5 mg tablets 
Actelsar HCT 80 mg/12.5 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Actelsar HCT 40 mg/12.5 mg tablets 
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
Actelsar HCT 80 mg/12.5 mg tablets 
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet. 
 
Actelsar HCT 40 mg/12.5 mg tablets 
White or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets marked with “TH” on one 
side. 
 
Actelsar HCT 80 mg/12.5 mg tablets 
White or almost white, 9.0 x 17.0 mm capsule-shaped tablets marked with “TH 12.5” on both sides. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of essential hypertension. 
 
Actelsar HCT fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 
80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not 
adequately controlled on telmisartan alone. 
 
4.2 Posology and method of administration 
 
Posology 
 
Actelsar HCT should be taken in patients whose blood pressure is not adequately controlled by 
telmisartan alone. Individual dose titration with each of the two components is recommended before 
changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy 
to the fixed combination may be considered. 
 
- Actelsar HCT 40 mg/12.5 mg may be administered once daily in patients whose blood pressure 

is not adequately controlled by telmisartan 40 mg 
- Actelsar HCT 80 mg/12.5 mg may be administered once daily in patients whose blood pressure 

is not adequately controlled by telmisartan 80 mg 
 
Actelsar HCT is also available at the dose strength 80 mg/25 mg 
 



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Special populations: 
Patients with renal impairment 
 
Periodic monitoring of renal function is advised (see section 4.4). 
 
Patients with hepatic impairment 
 
In patients with mild to moderate hepatic impairment the posology should not exceed Actelsar HCT 
40 mg/12.5 mg once daily. Actelsar HCT is not indicated in patients with severe hepatic impairment. 
Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4). 
 
Elderly patients 
 
No dose adjustment is necessary. 
 
Paediatric population 
 
The safety and efficacy of Actelsar HCT in children and adolescents aged below 18 have not been 
established. No data are available. 
 
Method of administration 
 
Actelsar HCT tablets are for once-daily oral administration and should be taken with liquid, with or 
without food. 
 
4.3 Contraindications 
 
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
- Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a 

sulphonamide-derived medicinal product). 
- Second and third trimesters of pregnancy (see sections 4.4 and 4.6). 
- Cholestasis and biliary obstructive disorders. 
- Severe hepatic impairment. 
- Severe renal impairment (creatinine clearance <30 ml/min). 
- Refractory hypokalaemia, hypercalcaemia. 
 
The concomitant use of Actelsar HCT with aliskiren-containing products is contraindicated in patients 
with diabetes mellitus or renal impairment (GFR<60 ml/min/1.73 m2) (see sections 4.5 and 5.1). 
 
4.4 Special warnings and precautions for use 
 
Pregnancy 
 
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 
4.6). 
 
Hepatic impairment 
 
Actelsar HCT should not be given to patients with cholestasis, biliary obstructive disorders or severe 
hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile. These 
patients can be expected to have reduced hepatic clearance for telmisartan. 
 



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In addition, Actelsar HCT should be used with caution in patients with impaired hepatic function or 
progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate 
hepatic coma. There is no clinical experience with Actelsar HCT in patients with hepatic impairment. 
 
Renovascular hypertension 
 
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral 
renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal 
products that affect the renin-angiotensin-aldosterone system. 
 
Renal impairment and kidney transplantation 
 
Actelsar HCT must not be used in patients with severe renal impairment (creatinine clearance 
<30 ml/min) (see section 4.3). There is no experience regarding the administration of 
telmisartan/hydrochlorothiazide in patients with recent kidney transplantation. Experience with 
telmisartan/hydrochlorothiazide is modest in the patients with mild to moderate renal impairment, 
therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended. 
Thiazide diuretic associated azotaemia may occur in patients with impaired renal function. 
 
Intravascular hypovolaemia 
 
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or 
sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such 
conditions should be corrected before the administration of Actelsar HCT. 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
 
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or 
aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including 
acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin 
II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). 
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist 
supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. 
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with 
diabetic nephropathy. 
 
Other conditions with stimulation of the renin-angiotensin-aldosterone system 
 
In patients whose vascular tone and renal function depend predominantly on the activity of the renin-
angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal 
disease, including renal artery stenosis), treatment with medicinal products that affect this system has 
been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see 
section 4.8). 
 
Primary aldosteronism 
 
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 
acting through inhibition of the renin-angiotensin system. Therefore, the use of Actelsar HCT is not 
recommended. 
 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy 
 
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral 
stenosis, or obstructive hypertrophic cardiomyopathy. 
 



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Metabolic and endocrine effects 
 
Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients 
under insulin or antidiabetic therapy and telmisartan treatment. Therefore, in these patients blood 
glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be 
required, when indicated. Latent diabetes mellitus may become manifest during thiazide therapy. 
 
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; 
however, at the 12.5 mg dose contained in Actelsar HCT, minimal or no effects were reported. 
Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide 
therapy. 
 
Electrolyte imbalance 
 
As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be 
performed at appropriate intervals. 
 
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including 
hypokalaemia, hyponatraemia and hypochloraemic alkalosis). Warning signs of fluid or electrolyte 
imbalance are dryness of mouth, thirst, asthenia, lethargy, drowsiness, restlessness, muscle pain or 
cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as 
nausea or vomiting (see section 4.8). 
 
- Hypokalaemia 
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with 
telmisartan may reduce diuretic-induced hypokalaemia. The risk of hypokalaemia is greater in patients 
with cirrhosis of liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate 
oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or 
Adrenocorticotropic hormone (ACTH) (see section 4.5). 
 
- Hyperkalaemia 
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component 
of Actelsar HCT, hyperkalaemia might occur. Although clinically significant hyperkalaemia has not 
been documented with Actelsar HCT, risk factors for the development of hyperkalaemia include renal 
insufficiency and/or heart failure, and diabetes mellitus. Potassium-sparing diuretics, potassium 
supplements or potassium-containing salt substitutes should be co-administered cautiously with 
Actelsar HCT (see section 4.5). 
 
- Hyponatraemia and hypochloraemic alkalosis 
There is no evidence that Actelsar HCT would reduce or prevent diuretic-induced hyponatraemia. 
Chloride deficit is generally mild and usually does not require treatment. 
 
- Hypercalcaemia 
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of 
serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcaemia 
may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out 
tests for parathyroid function. 
 
- Hypomagnesaemia 
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in 
hypomagnesaemia (see section 4.5). 
 



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Ethnic differences 
 
As with all other angiotensin II receptor antagonists, telmisartan is apparently less effective in 
lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of 
low renin states in the black hypertensive population. 
 
Other 
 
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic 
cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. 
 
General 
 
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of 
allergy or bronchial asthma, but are more likely in patients with such a history. Exacerbation or 
activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, 
including hydrochlorothiazide. 
Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8). If a 
photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a 
re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to 
the sun or to artificial UVA. 
 
Choroidal effusion, acute Myopia and Angle-Closure Glaucoma 
 
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal 
effusion with visual field defect, acute transient myopia and acute angle-closure glaucoma. Symptoms 
include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks 
of telmisartan hydrochlorothiazide initiation. Untreated acute angle-closure glaucoma can lead to 
permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as 
possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure 
remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history 
of sulfonamide or penicillin allergy. 
 
Non-melanoma skin cancer 
 
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous 
cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has 
been observed in two epidemiological studies based on the Danish National Cancer Registry. 
Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC. 
Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their 
skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive 
measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate 
protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious 
skin lesions should be promptly examined potentially including histological examinations of biopsies. 
The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC 
(see also section 4.8). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 



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Lithium 
 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors. Rare cases have 
also been reported with angiotensin II receptor antagonists (including 
telmisartan/hydrochlorothiazide). Co-administration of lithium and Actelsar HCT is not recommended 
(see section 4.4). If this combination proves essential, careful monitoring of serum lithium level is 
recommended during concomitant use. 
 
Medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, 
laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and 
derivatives) 
 
If these substances are to be prescribed with the hydrochlorothiazide-telmisartan combination, 
monitoring of potassium plasma levels is advised. These medicinal products may potentiate the effect 
of hydrochlorothiazide on serum potassium (see section 4.4). 
 
Medicinal products that may increase potassium levels or induce hyperkalaemia (e.g. ACE inhibitors, 
potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin 
or other medicinal products such as heparin sodium). 
 
If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, 
monitoring of potassium plasma levels is advised. Based on the experience with the use of other 
medicinal products that blunt the renin-angiotensin system, concomitant use of the above medicinal 
products may lead to increases in serum potassium and is, therefore, not recommended (see section 
4.4). 
 
Medicinal products affected by serum potassium disturbances 
 
Periodic monitoring of serum potassium and ECG is recommended when Actelsar HCT is 
administered with medicinal products affected by serum potassium disturbances (e.g. digitalis 
glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which 
include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes. 
- class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) 
- class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) 
- some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, 

cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) 
- others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, 

pentamidine, sparfloxacine, terfenadine, vincamine IV) 
 
Digitalis glycosides 
 
Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced 
arrhythmia (see section 4.4). 
 
Digoxin 
 
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma 
concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and 
discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic 
range. 
 



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Other antihypertensive agents 
 
Telmisartan may increase the hypotensive effect of other antihypertensive agents. 
 
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) 
through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated 
with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal 
function (including acute renal failure) compared to the use of a single RAAS-acting agent (see 
sections 4.3, 4.4 and 5.1). 
 
Antidiabetic medicinal products (oral agents and insulin) 
 
Dose adjustment of the antidiabetic medicinal products may be required (see section 4.4). 
 
Metformin 
 
Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional 
renal failure linked to hydrochlorothiazide. 
 
Cholestyramine and colestipol resins 
 
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. 
 
Non-steroidal anti-inflammatory medicinal products (NSAIDs) 
 
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dose regimens, COX-2 inhibitors and 
non-selective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide 
diuretics and the antihypertensive effects of angiotensin II receptor antagonists. 
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with 
compromised renal function) the co-administration of angiotensin II receptor antagonists and agents 
that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible 
acute renal failure, which is usually reversible. Therefore the combination should be administered with 
caution, especially in the elderly. Patients should be adequately hydrated and consideration should be 
given to monitoring of renal function after initiation of concomitant therapy and periodically 
thereafter. 
 
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the 
AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known. 
 
Pressor amines (e.g. noradrenaline) 
 
The effect of pressor amines may be decreased. 
 
Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) 
 
The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide. 
 
Medicinal products used in the treatment for gout (e.g. probenecid, sulfinpyrazone and allopurinol) 
 
Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise 
the level of serum uric acid. Increase in dose of probenecid or sulfinpyrazone may be necessary. 
Co-administration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol. 
 



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Calcium salts 
 
Thiazide diuretics may increase serum calcium levels due to the decreased excretion. If calcium 
supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be prescribed, serum 
calcium levels should be monitored and calcium dose adjusted accordingly. 
 
Beta-blockers and diazoxide 
 
The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides. 
 
Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide-type 
diuretics by decreasing gastrointestinal motility and stomach emptying rate. 
 
Amantadine 
 
Thiazides may increase the risk of adverse events caused by amantadine. 
 
Cytotoxic agents (e.g. cyclophosphamide, methotrexate) 
 
Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their 
myelosuppressive effects. 
 
Based on their pharmacological properties it can be expected that the following medicinal products 
may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, 
amifostine. 
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
The use of angiotensin II receptor antagonists is not recommended during the first trimester of 
pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated during 
the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
 
There are no adequate data from the use of Actelsar HCT in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). 
 
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors 
during the first trimester of pregnancy has not been conclusive; however a small increase in risk 
cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II 
receptor antagonists, similar risks may exist for this class of medicinal products. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and if appropriate, alternative therapy should be started. 
 
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known 
to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification 
retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should 
exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, 
ultrasound check of renal function and skull is recommended. 
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for 
hypotension (see sections 4.3 and 4.4). 
 



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There is limited experience with hydrochlorothiazide during pregnancy, especially during the first 
trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the 
pharmacological mechanism of action of hydrochlorothiazide its use during the second and third 
trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like 
icterus, disturbance of electrolyte balance and thrombocytopenia. Hydrochlorothiazide should not be 
used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased 
plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease. 
Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare 
situations where no other treatment could be used. 
 
Breast-feeding 
 
Because no information is available regarding the use of telmisartan during breast-feeding, Actelsar 
HCT is not recommended and alternative treatments with better established safety profiles during 
breast-feeding are preferable, especially while nursing a newborn or preterm infant.  
 
Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing 
intense diuresis can inhibit the milk production. The use of hydrochlorothiazide during breast feeding 
is not recommended. If hydrochlorothiazide is used during breast-feeding, doses should be kept as low 
as possible. 
 
Fertility 
 
In preclinical studies, no effects of telmisartan and hydrochlorothiazide on male and female fertility 
were observed. 
 
4.7 Effects on ability to drive and use machines 
 
Actelsar HCT can have influence on the ability to drive and use machines. Dizziness or drowsiness 
may occasionally occur when taking Actelsar HCT. 
 
4.8 Undesirable effects 
 
 Summary of the safety profile 
 
The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely 
(≥1/10,000 to <1/1,000). 
 
The overall incidence of adverse reactions reported with telmisartan/hydrochlorothiazide was 
comparable to those reported with telmisartan alone in randomised controlled trials involving 
1,471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone 
(636). Dose-relationship of adverse reactions was not established and they showed no correlation with 
gender, age or race of the patients. 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported in all clinical trials and occurring more frequently (p≤0.05) with 
telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ 
class. Adverse reactions known to occur with each component given singly but which have not been 
seen in clinical trials may occur during treatment with Actelsar HCT. 
 
Adverse reactions have been ranked under headings of frequency using the following convention: very 
common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to 
<1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 



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Infections and infestations 
Rare: Bronchitis, pharyngitis, sinusitis 

 
Immune system disorders 

Rare: Exacerbation or activation of systemic lupus erythematosus1 
 
Metabolism and nutrition disorders 

Uncommon: Hypokalaemia 
Rare: Hyperuricaemia, hyponatraemia 

 
Psychiatric disorders 

Uncommon: Anxiety 
Rare: Depression 

 
Nervous system disorders 

Common: Dizziness 
Uncommon: Syncope, paraesthesia 
Rare: Insomnia, sleep disorders 

 
Eye disorders 

Rare: Visual disturbance, vision blurred 
 
Ear and labyrinth disorders 

Uncommon: Vertigo 
 
Cardiac disorders 

Uncommon: Tachycardia, arrhythmias 
 
Vascular disorders 

Uncommon: Hypotension, orthostatic hypotension 
 
Respiratory, thoracic and mediastinal disorders 

Uncommon: Dyspnoea 
Rare: Respiratory distress (including pneumonitis and pulmonary oedema) 

 
Gastrointestinal disorders 

Uncommon: Diarrhoea, dry mouth, flatulence 
Rare: Abdominal pain, constipation, dyspepsia, vomiting, gastritis 

 
Hepatobiliary disorders 

Rare: Abnormal hepatic function/liver disorder2 
 
Skin and subcutaneous tissue disorders 

Rare:  Angioedema (also with fatal outcome), erythema, pruritus, rash, 
hyperhidrosis, urticaria 

 
Musculoskeletal, connective tissue and bone disorders 

Uncommon: Back pain, muscle spasms, myalgia 
Rare: Arthralgia, muscle cramps, pain in limb 

 
Reproductive system and breast disorders 

Uncommon: Erectile dysfunction 
 
General disorders and administration site conditions 

Uncommon: Chest pain 
Rare: Influenza-like illness, pain 

 



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Investigations 
Uncommon: Blood uric acid increased 
Rare: Blood creatinine increased, blood creatine phosphokinase increased, 

hepatic enzyme increased 
 
1 Based on post-marketing experience 
2 For further description, please see sub-section “Description of selected adverse reactions” 
 
Additional information on individual components 
 
Adverse reactions previously reported with one of the individual components may be potential adverse 
reactions with Actelsar HCT, even if not observed in clinical trials with this product. 
 
Telmisartan 
Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients. 
 
The overall incidence of adverse reactions reported with telmisartan (41.4%) was usually comparable 
to placebo (43.9%) in placebo controlled trials. The following adverse reactions listed below have 
been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in 
patients 50 years or older at high risk of cardiovascular events. 
 
Infections and infestations 

Uncommon: Upper respiratory tract infection, urinary tract infection including 
cystitis 

Rare: Sepsis including fatal outcome3 
 
Blood and lymphatic system disorders 

Uncommon: Anaemia 
Rare: Eosinophilia, thrombocytopenia 

 
Immune system disorders 

Rare: Hypersensitivity, anaphylactic reactions 
 
Metabolism and nutrition disorders 

Uncommon: Hyperkalaemia 
Rare: Hypoglycaemia (in diabetic patients) 

 
Cardiac disorders 

Uncommon: Bradycardia 
 

Nervous system disorder 
Rare: Somnolence 

 
Respiratory, thoracic and mediastinal disorders 

Uncommon: Cough 
Very rare: Interstitial lung disease3 

 
Gastrointestinal disorders 

Rare: Stomach discomfort 
 
Skin and subcutaneous tissue disorders 

Rare: Eczema, drug eruption, toxic skin eruption 
 
Musculoskeletal, connective tissue and bone disorders 

Rare: Arthrosis, tendon pain 
 



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Renal and urinary disorders 
Uncommon: Renal impairment (including acute renal failure) 

 
General disorders and administration site conditions 

Uncommon: Asthenia 
 
Investigations 

Rare: Haemoglobin decreased 
 
3 For further description, please see sub-section “Description of selected adverse reactions”. 
 
Hydrochlorothiazide 
Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance 
(see section 4.4). 
 
Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include: 
 
Infections and infestations 

Not known: Sialadenitis 
 
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 

Not known Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell 
carcinoma) 

 
Blood and lymphatic system disorders 

Rare: Thrombocytopenia (sometimes with purpura) 
Not known: Aplastic anaemia, haemolytic anaemia, bone marrow failure, 

leukopenia, neutropenia, agranulocytosis,  
 
Immune system disorders 

Not known: Anaphylactic reactions, hypersensitivity 
 
Endocrine disorders 

Not known: Diabetes mellitus inadequate control 
 
Metabolism and nutrition disorders 

Common: Hypomagnesaemia 
Rare: Hypercalcaemia 
Very rare: Hypochloraemic alkalosis 
Not known: Anorexia, appetite decreased, electrolyte imbalance, 

hypercholesterolaemia, hyperglycaemia, hypovolaemia 
 
Psychiatric disorders 

Not known: Restlessness 
 
Nervous system disorders 

Rare: Headache 
Not known: Light-headedness 

 
Eye disorders 

Not known: Xanthopsia, choroidal effusion, acute myopia, acute angle-closure 
glaucoma 

 
Vascular disorders 

Not known: Vasculitis necrotizing 
 



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Gastrointestinal disorders 
Common: Nausea 
Not known: Pancreatitis, stomach discomfort 

 
Hepatobiliary disorders 

Not known: Jaundice hepatocellular, jaundice cholestatic 
 
Skin and subcutaneous tissue disorders 

Not known: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic 
epidermal necrolysis, erythema multiforme 

 
Musculoskeletal, connective tissue and bone disorders 

Not known: Weakness 
 
Renal and urinary disorders 

Not known: Nephritis interstitial, renal dysfunction, glycosuria 
 
General disorders and administration site conditions 

Not known: Pyrexia 
 
Investigations 

Not known: Triglycerides increased 
 
Description of selected adverse reactions 
 
Hepatic function abnormal / liver disorder 
Most cases of hepatic function abnormal/liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these 
adverse reactions. 
 
Sepsis 
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with 
placebo. The event may be a chance finding or related to a mechanism currently not known (see 
section 5.1). 
 
Interstitial lung disease 
Cases of interstitial lung disease have been reported from post-marketing experience in temporal 
association with the intake of telmisartan. However, a causal relationship has not been established. 
 
Non-melanoma skin cancer 
Based on available data from epidemiological studies, cumulative dose-dependent association between 
HCTZ and NMSC has been observed (see also sections 4.4 and 5.1). 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is limited information available for telmisartan with regard to overdose in humans. The degree 
to which hydrochlorothiazide is removed by haemodialysis has not been established. 
 
Symptoms 
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; 
bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


15 

reported. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, 
hypochloraemia) and hypovolaemia resulting from excessive diuresis. The most common signs and 
symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and/or 
accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain 
anti-arrhythmic medicinal products. 
 
Treatment 
Telmisartan is not removed by haemodialysis. The patient should be closely monitored, and the 
treatment should be symptomatic and supportive. Management depends on the time since ingestion 
and the severity of the symptoms. Suggested measures include induction of emesis and/or gastric 
lavage. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and 
creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a 
supine position, with salt and volume replacements given quickly. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists 
and diuretics, ATC code: C09DA07 
 
Actelsar HCT is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide 
diuretic, hydrochlorothiazide. The combination of these ingredients has an additive antihypertensive 
effect, reducing blood pressure to a greater degree than either component alone. Actelsar HCT once 
daily produces effective and smooth reductions in blood pressure across the therapeutic dose range. 
 
Mechanism of action 
Telmisartan is an orally effective and specific angiotensin II receptor subtype 1 (AT1) antagonist. 
Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor 
subtype, which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any 
partial agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The 
binding is long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and 
other less characterised AT receptors. The functional role of these receptors is not known, nor is the 
effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. 
Plasma aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma 
renin or block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), 
the enzyme which also degrades bradykinin. Therefore, it is not expected to potentiate 
bradykinin-mediated adverse events. 
An 80 mg dose of telmisartan administered to healthy volunteers almost completely inhibits the 
angiotensin II evoked blood pressure increase. The inhibitory effect is maintained over 24 hours and 
still measurable up to 48 hours. 
 
Hydrochlorothiazide is a thiazide diuretic. The mechanism of the antihypertensive effect of thiazide 
diuretics is not fully known. Thiazides have an effect on the renal tubular mechanisms of electrolyte 
reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent 
amounts. The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin 
activity, increases aldosterone secretion, with consequent increases in urinary potassium and 
bicarbonate loss, and decreases in serum potassium. Presumably through blockade of the renin-
angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss 
associated with these diuretics. With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak 
effect occurs at about 4 hours, while the action persists for approximately 6-12 hours. 
 
Clinical efficacy and safety 
 
Treatment of essential hypertension 



16 

After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 
3 hours. The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of 
treatment and is sustained during long-term therapy. The antihypertensive effect persists constantly 
over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory 
blood pressure measurements. This is confirmed by measurements made at the point of maximum 
effect and immediately prior to the next dose (through to peak ratios consistently above 80% after 
doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies). 
 
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without 
affecting pulse rate. The antihypertensive efficacy of telmisartan is comparable to that of agents 
representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials 
comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril). 
 
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment 
values over a period of several days without evidence of rebound hypertension. 
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those 
given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two 
antihypertensive treatments. 
 
Cardiovascular prevention 
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) 
compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on 
cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery 
disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence 
of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), 
which is a population at risk for cardiovascular events. 
 
Patients were randomized to one of the three following treatment groups: telmisartan 80 mg 
(n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg 
(n = 8502), and followed for a mean observation time of 4.5 years. 
 
Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of 
cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for 
congestive heart failure. The incidence of the primary endpoint was similar in the telmisartan (16.7 %) 
and ramipril (16.5 %) groups. The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.93 - 
1.10, p (non-inferiority) = 0.0019 at a margin of 1.13). The all-cause mortality rate was 11.6 % and 
11.8 % among telmisartan and ramipril treated patients, respectively. 
 
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of 
cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 - 
1.08), p (non-inferiority = 0.0004], the primary endpoint in the reference study HOPE (The Heart 
Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo. 
 
TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as 
ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care. 
The mean duration of follow up was 4 years and 8 months. No statistically significant difference in the 
incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, 
non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan 
and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p=0.22)]. There 
was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary 
composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke 
[0.87 (95 % CI 0.76 - 1.00, p = 0.048)]. There was no evidence for benefit on cardiovascular mortality 
(hazard ratio 1.03, 95 % CI 0.85 - 1.24). 
 
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in 
combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs 



17 

Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an 
angiotensin II receptor blocker. 
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular 
disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. For more detailed 
information see above under the heading “Cardiovascular prevention”. 
VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy. 
These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and 
mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as 
compared to monotherapy was observed. Given their similar pharmacodynamic properties, these 
results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers. 
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in 
patients with diabetic nephropathy. 
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) 
was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor 
or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney 
disease, cardiovascular disease, or both. The study was terminated early because of an increased risk 
of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the 
aliskiren group than in the placebo group and adverse events and serious adverse events of interest 
(hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren 
group than in the placebo group. 
 
Cough and angioedema were less frequently reported in patients treated with telmisartan than in 
patients treated with ramipril, whereas hypotension was more frequently reported with telmisartan. 
 
Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone. CV 
mortality and all cause mortality were numerically higher with the combination. In addition, there was 
a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the 
combination arm. Therefore the use of a combination of telmisartan and ramipril is not recommended 
in this population. 
 
In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 
50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for 
telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 
1.00-2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) 
vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14-3.76)]. The observed 
increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance 
finding or related to a mechanism not currently known. 
 
Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the 
risk of cardiovascular mortality and morbidity. 
 
The effects of fixed dose combination of telmisartan/HCT on mortality and cardiovascular morbidity 
are currently unknown. 
 
Non-melanoma skin cancer: 
Based on available data from epidemiological studies, cumulative dose-dependent association between 
HCTZ and NMSC has been observed. One study included a population comprised of 71,533 cases of 
BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively. 
High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23-
1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC. A clear cumulative dose response relationship 
was observed for both BCC and SCC. Another study showed a possible association between lip cancer 
(SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, 
using a risk-set sampling strategy. A cumulative dose-response relationship was demonstrated with an 
adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 
7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4). 
 



18 

Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
telmisartan hydrochlorothiazide in all subsets of the paediatric population in hypertension (see section 
4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Concomitant administration of hydrochlorothiazide and telmisartan does not appear to affect the 
pharmacokinetics of either substance in healthy subjects. 
 
Absorption 
Telmisartan: Following oral administration, peak concentrations of telmisartan are reached in 0.5-1.5 h 
after dosing. The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42% and 58%, 
respectively. Food slightly reduces the bioavailability of telmisartan with a reduction in the area under 
the plasma concentration time curve (AUC) of about 6% with the 40 mg tablet and about 19% after a 
160 mg dose. By 3 hours after administration plasma concentrations are similar whether telmisartan is 
taken fasting or with food. The small reduction in AUC is not expected to cause a reduction in the 
therapeutic efficacy. Telmisartan does not accumulate significantly in plasma on repeated 
administration. 
Hydrochlorothiazide: Following oral administration of telmisartan/hydrochlorothiazide, peak 
concentrations of hydrochlorothiazide are reached in approximately 1.0-3.0 hours after dosing. Based 
on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60%. 
 
Distribution 
Telmisartan is highly bound to plasma proteins (>99.5%) mainly albumin and alpha l-acid 
glycoprotein. The apparent volume of distribution for telmisartan is approximately 500 litres 
indicating additional tissue binding. 
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 
0.83-1.14 l/kg. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to form a pharmacologically inactive acylglucuronide. The 
glucuronide of the parent compound is the only metabolite that has been identified in humans. After a 
single dose of 14C-labelled telmisartan the glucuronide represents approximately 11% of the measured 
radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of 
telmisartan. 
Hydrochlorothiazide is not metabolised in man. 
 
Elimination 
Telmisartan: Following either intravenous or oral administration of 14C-labelled telmisartan most of 
the administered dose (>97%) was eliminated in faeces via biliary excretion. Only minute amounts 
were found in urine. Total plasma clearance of telmisartan after oral administration is >1500 ml/min. 
Terminal elimination half-life was >20 hours. 
 
Hydrochlorothiazide is excreted almost entirely as unchanged substance in urine. About 60% of the 
oral dose is eliminated within 48 hours. Renal clearance is about 250-300 ml/min. The terminal 
elimination half-life of hydrochlorothiazide is 10-15 hours. 
 
Linearity/non-linearity  
Telmisartan: The pharmacokinetics of orally administered telmisartan are non-linear over doses from 
20 – 160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with 
increasing doses. 
Hydrochlorothiazide exhibits linear pharmacokinetics.  
 
Elderly 
Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years. 
 



19 

Gender 
Plasma concentrations of telmisartan are generally 2-3 times higher in females than in males. In 
clinical trials however, no significant increases in blood pressure response or in the incidence of 
orthostatic hypotension were found in women. No dose adjustment is necessary. There was a trend 
towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects. This is 
not considered to be of clinical relevance. 
 
Renal impairment 
Renal excretion does not contribute to the clearance of telmisartan. Based on modest experience in 
patients with mild to moderate renal impairment (creatinine clearance of 30-60 ml/min, mean about 
50 ml/min) no dose adjustment is necessary in patients with decreased renal function. Telmisartan is 
not removed from blood by haemodialysis. In patients with impaired renal function the rate of 
hydrochlorothiazide elimination is reduced. In a typical study in patients with a mean creatinine 
clearance of 90 ml/min the elimination half-life of hydrochlorothiazide was increased. In functionally 
anephric patients the elimination half-life is about 34 hours. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute 
bioavailability up to nearly 100%. The elimination half-life is not changed in patients with hepatic 
impairment. 
 
5.3 Preclinical safety data 
 
In preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide 
in normotensive rats and dogs, doses producing exposure comparable to that in the clinical therapeutic 
range caused no additional findings not already observed with administration of either substance 
alone. The toxicological findings observed appear to have no relevance to human therapeutic use. 
 
Toxicological findings also well known from preclinical studies with angiotensin converting enzyme 
inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters 
(erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea 
nitrogen and creatinine), increased plasma renin activity, hypertrophy/hyperplasia of the 
juxtaglomerular cells and gastric mucosal injury. Gastric lesions could be prevented/ameliorated by 
oral sodium chloride solution supplementation and group housing of animals. In dogs renal tubular 
dilation and atrophy were observed. These findings are considered to be due to the pharmacological 
activity of telmisartan. 
 
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an 
effect on the postnatal development of the offsprings such as lower body weight and delayed eye 
opening was observed. 
Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies 
and no evidence of carcinogenicity in rats and mice. Studies with hydrochlorothiazide have shown 
equivocal evidence for a genotoxic or carcinogenic effect in some experimental models. However, the 
extensive human experience with hydrochlorothiazide has failed to show an association between its 
use and an increase in neoplasms. 
For the foetotoxic potential of the telmisartan/hydrochlorothiazide combination see section 4.6. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Magnesium stearate (E470b) 
Potassium hydroxide 
Meglumine 
Povidone 
Sodium starch glycolate (type A) 



20 

Microcrystalline cellulose 
Mannitol (E421) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
For Al/Al blisters and HDPE tablet container: 
2 years. 
 
For Al/PVC/PVDC blister: 
1 year. 
 
6.4 Special precautions for storage 
 
Al/Al blisters and HDPE tablet container: 
This medicinal product does not require any special storage conditions. 
 
Al/PVC/PVDC blister: 
Do not store above 30ºC. 
 
6.5 Nature and contents of container 
 
Al/Al blister, Al/PVC/PVDC blister and HDPE tablet container with LDPE cap and HDPE desiccant 
with silica filling. 
 
Al/Al blister: 14, 28, 30, 56, 84, 90 and 98 tablets 
 
Actelsar HCT 40 mg/12.5 mg tablets 
Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets 
 
Actelsar HCT 80 mg/12.5 mg tablets 
Al/PVC/PVDC blister: 14, 28, 56, 84, 90 and 98 tablets 
 
Tablet container: 30, 90 and 250 tablets 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78 
220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Actelsar HCT 40 mg/12.5 mg tablets 



21 

EU/1/13/817/043 
EU/1/13/817/001 
EU/1/13/817/042 
EU/1/13/817/002 
EU/1/13/817/003 
EU/1/13/817/004 
EU/1/13/817/005 
EU/1/13/817/006 
EU/1/13/817/007 
EU/1/13/817/008 
EU/1/13/817/009 
EU/1/13/817/010 
EU/1/13/817/011 
EU/1/13/817/012 
EU/1/13/817/013 
 
Actelsar HCT 80 mg/12.5 mg tablets 
EU/1/13/817/014 
EU/1/13/817/015 
EU/1/13/817/044 
EU/1/13/817/016 
EU/1/13/817/017 
EU/1/13/817/018 
EU/1/13/817/019 
EU/1/13/817/020 
EU/1/13/817/021 
EU/1/13/817/022 
EU/1/13/817/023 
EU/1/13/817/024 
EU/1/13/817/025 
EU/1/13/817/026 
EU/1/13/817/027 
EU/1/13/817/028 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 13 March 2013 
Date of latest renewal:  
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


22 

1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/25 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet. 
 
Actelsar HCT 80 mg/25 mg tablets are white or almost white, 9.0 x 17.0 mm oval-shaped and 
biconvex tablets marked with “TH” on one side and “25” on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of essential hypertension. 
 
Actelsar HCT fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in 
adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg/12.5 mg 
(80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on 
telmisartan and hydrochlorothiazide given separately. 
 
4.2 Posology and method of administration 
 
Posology 
 
Actelsar HCT should be taken in patients whose blood pressure is not adequately controlled by 
telmisartan alone. Individual dose titration with each of the two components is recommended before 
changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy 
to the fixed combination may be considered. 
 
- Actelsar HCT 80 mg/25 mg may be administered once daily in patients whose blood pressure is 

not adequately controlled by Actelsar HCT 80 mg/12.5 mg or in patients who have been 
previously stabilised on telmisartan and hydrochlorothiazide given separately. 

 
Actelsar HCT is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg 
 
Special populations: 
 
Patients with renal impairment 
 
Periodic monitoring of renal function is advised (see section 4.4). 
 



23 

Patients with hepatic impairment 
 
In patients with mild to moderate hepatic impairment the posology should not exceed Actelsar HCT 
40 mg/12.5 mg once daily. Actelsar HCT is not indicated in patients with severe hepatic impairment. 
Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4). 
 
Elderly patients 
 
No dose adjustment is necessary. 
 
Paediatric population 
 
The safety and efficacy of Actelsar HCT in children and adolescents aged below 18 have not been 
established. No data are available. 
 
Method of administration 
 
Actelsar HCT tablets are for once-daily oral administration and should be taken with liquid, with or 
without food. 
 
4.3 Contraindications 
 
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
- Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a 

sulphonamide-derived medicinal product). 
- Second and third trimesters of pregnancy (see sections 4.4 and 4.6). 
- Cholestasis and biliary obstructive disorders. 
- Severe hepatic impairment. 
- Severe renal impairment (creatinine clearance <30 ml/min). 
- Refractory hypokalaemia, hypercalcaemia. 
 
The concomitant use of Actelsar HCT with aliskiren-containing products is contraindicated in patients 
with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1). 
 
4.4 Special warnings and precautions for use 
 
Pregnancy 
 
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 
4.6). 
 
Hepatic impairment 
 
Actelsar HCT should not be given to patients with cholestasis, biliary obstructive disorders or severe 
hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile. These 
patients can be expected to have reduced hepatic clearance for telmisartan. 
 
In addition, Actelsar HCT should be used with caution in patients with impaired hepatic function or 
progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate 
hepatic coma. There is no clinical experience with Actelsar HCT in patients with hepatic impairment. 
 



24 

Renovascular hypertension 
 
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral 
renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal 
products that affect the renin-angiotensin-aldosterone system. 
 
Renal impairment and kidney transplantation 
 
Actelsar HCT must not be used in patients with severe renal impairment (creatinine clearance 
<30 ml/min) (see section 4.3). There is no experience regarding the administration of 
telmisartan/hydrochlorothiazide in patients with recent kidney transplantation. Experience with 
telmisartan/hydrochlorothiazide is modest in the patients with mild to moderate renal impairment, 
therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended. 
Thiazide diuretic associated azotaemia may occur in patients with impaired renal function. 
 
Intravascular hypovolaemia 
 
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or 
sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such 
conditions should be corrected before the administration of Actelsar HCT. 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
 
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or 
aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including 
acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin 
II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). 
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist 
supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. 
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with 
diabetic nephropathy. 
 
Other conditions with stimulation of the renin-angiotensin-aldosterone system 
 
In patients whose vascular tone and renal function depend predominantly on the activity of the renin-
angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal 
disease, including renal artery stenosis), treatment with medicinal products that affect this system has 
been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see 
section 4.8). 
 
Primary aldosteronism 
 
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 
acting through inhibition of the renin-angiotensin system. Therefore, the use of Actelsar HCT is not 
recommended. 
 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy 
 
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral 
stenosis, or obstructive hypertrophic cardiomyopathy. 
 
Metabolic and endocrine effects 
 
Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients 
under insulin or antidiabetic therapy and telmisartan treatment. Therefore, in these patients blood 
glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be 
required, when indicated. Latent diabetes mellitus may become manifest during thiazide therapy. 



25 

 
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; 
however, at the 12.5 mg dose contained in Actelsar HCT, minimal or no effects were reported. 
Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide 
therapy. 
 
Electrolyte imbalance 
 
As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be 
performed at appropriate intervals. 
 
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including 
hypokalaemia, hyponatraemia and hypochloraemic alkalosis). Warning signs of fluid or electrolyte 
imbalance are dryness of mouth, thirst, asthenia, lethargy, drowsiness, restlessness, muscle pain or 
cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as 
nausea or vomiting (see section 4.8). 
 
- Hypokalaemia 
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with 
telmisartan may reduce diuretic-induced hypokalaemia. The risk of hypokalaemia is greater in patients 
with cirrhosis of liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate 
oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or 
Adrenocorticotropic hormone (ACTH) (see section 4.5). 
 
- Hyperkalaemia 
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component 
of Actelsar HCT, hyperkalaemia might occur. Although clinically significant hyperkalaemia has not 
been documented with Actelsar HCT, risk factors for the development of hyperkalaemia include renal 
insufficiency and/or heart failure, and diabetes mellitus. Potassium-sparing diuretics, potassium 
supplements or potassium-containing salt substitutes should be co-administered cautiously with 
Actelsar HCT (see section 4.5). 
 
- Hyponatraemia and hypochloraemic alkalosis 
There is no evidence that Actelsar HCT would reduce or prevent diuretic-induced hyponatraemia. 
Chloride deficit is generally mild and usually does not require treatment. 
 
- Hypercalcaemia 
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of 
serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcaemia 
may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out 
tests for parathyroid function. 
 
- Hypomagnesaemia 
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in 
hypomagnesaemia (see section 4.5). 
 
Ethnic differences 
 
As with all other angiotensin II receptor antagonists, telmisartan is apparently less effective in 
lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of 
low renin states in the black hypertensive population. 
 
Other 
 
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic 
cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. 
 



26 

General 
 
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of 
allergy or bronchial asthma, but are more likely in patients with such a history. Exacerbation or 
activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, 
including hydrochlorothiazide. 
Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8). If a 
photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a 
re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to 
the sun or to artificial UVA. 
 
Choroidal effusion, acute Myopia and Angle-Closure Glaucoma 
 
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal 
effusion with visual field defect, acute transient myopia and acute angle-closure glaucoma. Symptoms 
include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks 
of telmisartan hydrochlorothiazide initiation. Untreated acute angle-closure glaucoma can lead to 
permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as 
possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure 
remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history 
of sulfonamide or penicillin allergy. 
 
Non-melanoma skin cancer 
 
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous 
cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has 
been observed in two epidemiological studies based on the Danish National Cancer Registry. 
Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC. 
Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their 
skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive 
measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate 
protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious 
skin lesions should be promptly examined potentially including histological examinations of biopsies. 
The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC 
(see also section 4.8). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Lithium 
 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors. Rare cases have 
also been reported with angiotensin II receptor antagonists (including 
telmisartan/hydrochlorothiazide). Co-administration of lithium and Actelsar HCT is not recommended 
(see section 4.4). If this combination proves essential, careful monitoring of serum lithium level is 
recommended during concomitant use. 
 
Medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, 
laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and 
derivatives) 
 
If these substances are to be prescribed with the hydrochlorothiazide-telmisartan combination, 
monitoring of potassium plasma levels is advised. These medicinal products may potentiate the effect 
of hydrochlorothiazide on serum potassium (see section 4.4). 
 



27 

Medicinal products that may increase potassium levels or induce hyperkalaemia (e.g. ACE inhibitors, 
potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin 
or other medicinal products such as heparin sodium). 
 
If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, 
monitoring of potassium plasma levels is advised. Based on the experience with the use of other 
medicinal products that blunt the renin-angiotensin system, concomitant use of the above medicinal 
products may lead to increases in serum potassium and is, therefore, not recommended (see section 
4.4). 
 
Medicinal products affected by serum potassium disturbances 
 
Periodic monitoring of serum potassium and ECG is recommended when Actelsar HCT is 
administered with medicinal products affected by serum potassium disturbances (e.g. digitalis 
glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which 
include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes. 
- class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) 
- class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) 
- some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, 

cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) 
- others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, 

pentamidine, sparfloxacine, terfenadine, vincamine IV) 
 
Digitalis glycosides 
 
Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced 
arrhythmia (see section 4.4). 
 
Digoxin 
 
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma 
concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and 
discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic 
range. 
 
Other antihypertensive agents 
 
Telmisartan may increase the hypotensive effect of other antihypertensive agents. 
 
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) 
through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated 
with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal 
function (including acute renal failure) compared to the use of a single RAAS-acting agent (see 
sections 4.3, 4.4 and 5.1). 
 
Antidiabetic medicinal products (oral agents and insulin) 
 
Dose adjustment of the antidiabetic medicinal products may be required (see section 4.4). 
 
Metformin 
 
Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional 
renal failure linked to hydrochlorothiazide. 
 



28 

Cholestyramine and colestipol resins 
 
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. 
 
Non-steroidal anti-inflammatory medicinal products (NSAIDs) 
 
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dose regimens, COX-2 inhibitors and 
non-selective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide 
diuretics and the antihypertensive effects of angiotensin II receptor antagonists. 
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with 
compromised renal function) the co-administration of angiotensin II receptor antagonists and agents 
that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible 
acute renal failure, which is usually reversible. Therefore the combination should be administered with 
caution, especially in the elderly. Patients should be adequately hydrated and consideration should be 
given to monitoring of renal function after initiation of concomitant therapy and periodically 
thereafter. 
 
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the 
AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known. 
 
Pressor amines (e.g. noradrenaline) 
 
The effect of pressor amines may be decreased. 
 
Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) 
 
The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide. 
 
Medicinal products used in the treatment for gout (e.g. probenecid, sulfinpyrazone and allopurinol) 
 
Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise 
the level of serum uric acid. Increase in dose of probenecid or sulfinpyrazone may be necessary. 
Co-administration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol. 
 
Calcium salts 
 
Thiazide diuretics may increase serum calcium levels due to the decreased excretion. If calcium 
supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be prescribed, serum 
calcium levels should be monitored and calcium dose adjusted accordingly. 
 
Beta-blockers and diazoxide 
 
The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides. 
 
Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide-type 
diuretics by decreasing gastrointestinal motility and stomach emptying rate. 
 
Amantadine 
 
Thiazides may increase the risk of adverse events caused by amantadine. 
 
Cytotoxic agents (e.g. cyclophosphamide, methotrexate) 
 
Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their 
myelosuppressive effects. 
 



29 

Based on their pharmacological properties it can be expected that the following medicinal products 
may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, 
amifostine. 
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
The use of angiotensin II receptor antagonists is not recommended during the first trimester of 
pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated during 
the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
 
There are no adequate data from the use of Actelsar HCT in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). 
 
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors 
during the first trimester of pregnancy has not been conclusive; however a small increase in risk 
cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II 
receptor antagonists, similar risks may exist for this class of medicinal products. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and if appropriate, alternative therapy should be started. 
 
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known 
to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification 
retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should 
exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, 
ultrasound check of renal function and skull is recommended. 
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for 
hypotension (see sections 4.3 and 4.4). 
 
There is limited experience with hydrochlorothiazide during pregnancy, especially during the first 
trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the 
pharmacological mechanism of action of hydrochlorothiazide its use during the second and third 
trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like 
icterus, disturbance of electrolyte balance and thrombocytopenia. Hydrochlorothiazide should not be 
used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased 
plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease. 
Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare 
situations where no other treatment could be used. 
 
Breast-feeding 
 
Because no information is available regarding the use of telmisartan during breast-feeding, Actelsar 
HCT is not recommended and alternative treatments with better established safety profiles during 
breast-feeding are preferable, especially while nursing a newborn or preterm infant.  
 
Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing 
intense diuresis can inhibit the milk production. The use of hydrochlorothiazide during breast feeding 
is not recommended. If hydrochlorothiazide is used during breast-feeding, doses should be kept as low 
as possible. 
 



30 

Fertility 
 
In preclinical studies, no effects of telmisartan and hydrochlorothiazide on male and female fertility 
were observed. 
 
4.7 Effects on ability to drive and use machines 
 
Actelsar HCT can have influence on the ability to drive and use machines. Dizziness or drowsiness 
may occasionally occur when taking Actelsar HCT. 
 
4.8 Undesirable effects 
 
 Summary of the safety profile 
 
The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely 
(≥1/10,000 to <1/1,000). 
 
The overall incidence and pattern of adverse reactions reported with telmisartan/hydrochlorothiazide 
80 mg/25 mg was comparable with telmisartan/hydrochlorothiazide 80 mg/12.5 mg. A dose-
relationship of adverse reaction was not established and they showed no correlation with gender, age 
or race of the patients. 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported in all clinical trials and occurring more frequently (p≤0.05) with 
telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ 
class. Adverse reactions known to occur with each component given singly but which have not been 
seen in clinical trials may occur during treatment with Actelsar HCT. 
 
Adverse reactions have been ranked under headings of frequency using the following convention: very 
common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to 
<1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Infections and infestations 

Rare: Bronchitis, pharyngitis, sinusitis 
 
Immune system disorders 

Rare: Exacerbation or activation of systemic lupus erythematosus1 
 
Metabolism and nutrition disorders 

Uncommon: Hypokalaemia 
Rare: Hyperuricaemia, hyponatraemia 

 
Psychiatric disorders 

Uncommon: Anxiety 
Rare: Depression 

 
Nervous system disorders 

Common: Dizziness 
Uncommon: Syncope, paraesthesia 
Rare: Insomnia, sleep disorders 

 
Eye disorders 

Rare: Visual disturbance, vision blurred 
 



31 

Ear and labyrinth disorders 
Uncommon: Vertigo 

 
Cardiac disorders 

Uncommon: Tachycardia, arrhythmias 
 
Vascular disorders 

Uncommon: Hypotension, orthostatic hypotension 
 
Respiratory, thoracic and mediastinal disorders 

Uncommon: Dyspnoea 
Rare: Respiratory distress (including pneumonitis and pulmonary oedema) 

 
Gastrointestinal disorders 

Uncommon: Diarrhoea, dry mouth, flatulence 
Rare: Abdominal pain, constipation, dyspepsia, vomiting, gastritis 

 
Hepatobiliary disorders 

Rare: Abnormal hepatic function/liver disorder2 
 
Skin and subcutaneous tissue disorders 

Rare:  Angioedema (also with fatal outcome), erythema, pruritus, rash, 
hyperhidrosis, urticaria 

 
Musculoskeletal, connective tissue and bone disorders 

Uncommon: Back pain, muscle spasms, myalgia 
Rare: Arthralgia, muscle cramps, pain in limb 

 
Reproductive system and breast disorders 

Uncommon: Erectile dysfunction 
 
General disorders and administration site conditions 

Uncommon: Chest pain 
Rare: Influenza-like illness, pain 

 
Investigations 

Uncommon: Blood uric acid increased 
Rare: Blood creatinine increased, blood creatine phosphokinase increased, 

hepatic enzyme increased 
 
1 Based on post-marketing experience 
2 For further description, please see sub-section “Description of selected adverse reactions” 
 
Additional information on individual components 
 
Adverse reactions previously reported with one of the individual components may be potential adverse 
reactions with Actelsar HCT, even if not observed in clinical trials with this product. 
 
Telmisartan 
Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients. 
 
The overall incidence of adverse reactions reported with telmisartan (41.4%) was usually comparable 
to placebo (43.9%) in placebo controlled trials. The following adverse reactions listed below have 
been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in 
patients 50 years or older at high risk of cardiovascular events. 
 



32 

Infections and infestations 
Uncommon: Upper respiratory tract infection, urinary tract infection including 

cystitis 
Rare: Sepsis including fatal outcome3 

 
Blood and lymphatic system disorders 

Uncommon: Anaemia 
Rare: Eosinophilia, thrombocytopenia 

 
Immune system disorders 

Rare: Hypersensitivity, anaphylactic reactions 
 
Metabolism and nutrition disorders 

Uncommon: Hyperkalaemia 
Rare: Hypoglycaemia (in diabetic patients) 

 
Cardiac disorders 

Uncommon: Bradycardia 
 

Nervous system disorder 
 Rare: Somnolence 
 
Respiratory, thoracic and mediastinal disorders 
 Uncommon: Cough 
 Very rare: Interstitial lung disease3 
 
Gastrointestinal disorders 

Rare: Stomach discomfort 
 
Skin and subcutaneous tissue disorders 

Rare: Eczema, drug eruption, toxic skin eruption 
 
Musculoskeletal, connective tissue and bone disorders 

Rare: Arthrosis, tendon pain 
 
Renal and urinary disorders 

Uncommon: Renal impairment (including acute renal failure) 
 
General disorders and administration site conditions 

Uncommon: Asthenia 
 
Investigations 

Rare: Haemoglobin decreased 
 
3 For further description, please see sub-section “Description of selected adverse reactions”. 
 
Hydrochlorothiazide 
Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance 
(see section 4.4). 
 
Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include: 
 
Infections and infestations 

Not known: Sialadenitis 
 



33 

Neoplasms benign, malignant and unspecified (incl cysts and polyps) 
Not known Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell 

carcinoma) 
 
Blood and lymphatic system disorders 

Rare: Thrombocytopenia (sometimes with purpura) 
Not known: Aplastic anaemia, haemolytic anaemia, bone marrow failure, 

leukopenia, neutropenia, agranulocytosis 
 
Immune system disorders 

Not known: Anaphylactic reactions, hypersensitivity 
 
Endocrine disorders 

Not known: Diabetes mellitus inadequate control 
 
Metabolism and nutrition disorders 

Common: Hypomagnesaemia 
Rare: Hypercalcaemia 
Very rare: Hypochloraemic alkalosis 
Not known: Anorexia, appetite decreased, electrolyte imbalance, 

hypercholesterolaemia, hyperglycaemia, hypovolaemia 
 
Psychiatric disorders 

Not known: Restlessness 
 
Nervous system disorders 

Rare: Headache 
Not known: Light-headedness 

 
Eye disorders 

Not known: Xanthopsia, choroidal effusion, acute myopia, acute angle-closure 
glaucoma 

 
Vascular disorders 

Not known: Vasculitis necrotizing 
 
Gastrointestinal disorders 

Common: Nausea 
Not known: Pancreatitis, stomach discomfort 

 
Hepatobiliary disorders 

Not known: Jaundice hepatocellular, jaundice cholestatic 
 
Skin and subcutaneous tissue disorders 

Not known: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic 
epidermal necrolysis, erythema multiforme 

 
Musculoskeletal, connective tissue and bone disorders 

Not known: Weakness 
 
Renal and urinary disorders 

Not known: Nephritis interstitial, renal dysfunction, glycosuria 
 
General disorders and administration site conditions 

Not known: Pyrexia 
 



34 

Investigations 
Not known: Triglycerides increased 

 
Description of selected adverse reactions 
 
Hepatic function abnormal/liver disorder 
Most cases of hepatic function abnormal/liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these 
adverse reactions. 
 
Sepsis 
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with 
placebo. The event may be a chance finding or related to a mechanism currently not known (see 
section 5.1). 
 
Interstitial lung disease 
Cases of interstitial lung disease have been reported from post-marketing experience in temporal 
association with the intake of telmisartan. However, a causal relationship has not been established. 
 
Non-melanoma skin cancer 
Based on available data from epidemiological studies, cumulative dose-dependent association between 
HCTZ and NMSC has been observed (see also sections 4.4 and 5.1). 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is limited information available for telmisartan with regard to overdose in humans. The degree 
to which hydrochlorothiazide is removed by haemodialysis has not been established. 
 
Symptoms 
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; 
bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been 
reported. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, 
hypochloraemia) and hypovolaemia resulting from excessive diuresis. The most common signs and 
symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and/or 
accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain 
anti-arrhythmic medicinal products. 
 
Treatment 
Telmisartan is not removed by haemodialysis. The patient should be closely monitored, and the 
treatment should be symptomatic and supportive. Management depends on the time since ingestion 
and the severity of the symptoms. Suggested measures include induction of emesis and/or gastric 
lavage. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and 
creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a 
supine position, with salt and volume replacements given quickly. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


35 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists 
and diuretics, ATC code: C09DA07 
 
Actelsar HCT is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide 
diuretic, hydrochlorothiazide. The combination of these ingredients has an additive antihypertensive 
effect, reducing blood pressure to a greater degree than either component alone. Actelsar HCT once 
daily produces effective and smooth reductions in blood pressure across the therapeutic dose range. 
 
Mechanism of action 
Telmisartan is an orally effective and specific angiotensin II receptor subtype 1 (AT1) antagonist. 
Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor 
subtype, which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any 
partial agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The 
binding is long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and 
other less characterised AT receptors. The functional role of these receptors is not known, nor is the 
effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. 
Plasma aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma 
renin or block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), 
the enzyme which also degrades bradykinin. Therefore, it is not expected to potentiate 
bradykinin-mediated adverse events. 
An 80 mg dose of telmisartan administered to healthy volunteers almost completely inhibits the 
angiotensin II evoked blood pressure increase. The inhibitory effect is maintained over 24 hours and 
still measurable up to 48 hours. 
 
Hydrochlorothiazide is a thiazide diuretic. The mechanism of the antihypertensive effect of thiazide 
diuretics is not fully known. Thiazides have an effect on the renal tubular mechanisms of electrolyte 
reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent 
amounts. The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin 
activity, increases aldosterone secretion, with consequent increases in urinary potassium and 
bicarbonate loss, and decreases in serum potassium. Presumably through blockade of the renin-
angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss 
associated with these diuretics. With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak 
effect occurs at about 4 hours, while the action persists for approximately 6-12 hours. 
 
Clinical efficacy and safety 
 
Treatment of essential hypertension 
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 
3 hours. The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of 
treatment and is sustained during long-term therapy. The antihypertensive effect persists constantly 
over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory 
blood pressure measurements. This is confirmed by measurements made at the point of maximum 
effect and immediately prior to the next dose (through to peak ratios consistently above 80% after 
doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies). 
 
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without 
affecting pulse rate. The antihypertensive efficacy of telmisartan is comparable to that of agents 
representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials 
comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril). 
 
In a double-blind controlled clinical trial (n=687 patients evaluated for efficacy) in non-responders to 
the 80 mg/12.5 mg combination, an incremental blood pressure lowering effect of the 80 mg/25 mg 
combination compared to continued treatment with the 80 mg/12.5 mg combination of 2.7/1.6 mm Hg 



36 

(SBP/DBP) was demonstrated (difference in adjusted mean changes from baseline). In a follow-up 
trial with the 80 mg/25 mg combination, blood pressure was further decreased (resulting in an overall 
reduction of 11.5/9.9 mm Hg (SBP/DBP). 
 
In a pooled analysis of two similar 8 week double-blind placebo-controlled clinical trials vs. 
valsartan/hydrochlorothiazide 160 mg/25 mg (n=2,121 patients evaluated for efficacy) a significantly 
greater blood pressure lowering effect of 2.2/1.2 mm Hg (SBP/DBP) was demonstrated (difference in 
adjusted mean changes from baseline, respectively) in favour of telmisartan/hydrochlorothiazide 
80 mg/25 mg combination. 
 
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment 
values over a period of several days without evidence of rebound hypertension. 
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those 
given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two 
antihypertensive treatments. 
 
Cardiovascular prevention 
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) 
compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on 
cardiovascular outcomes in 25,620 patients aged 55 years or older with a history of coronary artery 
disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence 
of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), 
which is a population at risk for cardiovascular events. 
 
Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n=8542), 
ramipril 10 mg (n=8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n=8502), and 
followed for a mean observation time of 4.5 years. 
 
Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of 
cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for 
congestive heart failure. The incidence of the primary endpoint was similar in the telmisartan (16.7%) 
and ramipril (16.5%) groups. The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5% CI 
0.93-1.10, p (non-inferiority)=0.0019 at a margin of 1.13). The all-cause mortality rate was 11.6% and 
11.8% among telmisartan and ramipril treated patients, respectively. 
 
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of 
cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.90-1.08), 
p (non-inferiority) =0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes 
Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo. 
 
TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as 
ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care. 
The mean duration of follow up was 4 years and 8 months. No statistically significant difference in the 
incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, 
non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7% in the telmisartan 
and 17.0% in the placebo groups with a hazard ratio of 0.92 (95% CI 0.81-1.05, p=0.22)]. There was 
evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite 
endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95% CI 
0.76-1.00, p=0.048)]. There was no evidence for benefit on cardiovascular mortality (hazard ratio 
1.03, 95% CI 0.85-1.24). 
 
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in 
combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs 
Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an 
angiotensin II receptor blocker. 



37 

ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular 
disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. For more detailed 
information see above under the heading “Cardiovascular prevention”. 
VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy. 
These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and 
mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as 
compared to monotherapy was observed. Given their similar pharmacodynamic properties, these 
results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers. 
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in 
patients with diabetic nephropathy. 
 
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) 
was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor 
or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney 
disease, cardiovascular disease, or both. The study was terminated early because of an increased risk 
of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the 
aliskiren group than in the placebo group and adverse events and serious adverse events of interest 
(hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren 
group than in the placebo group. 
 
Cough and angioedema were less frequently reported in patients treated with telmisartan than in 
patients treated with ramipril, whereas hypotension was more frequently reported with telmisartan. 
 
Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone. CV 
mortality and all cause mortality were numerically higher with the combination. In addition, there was 
a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the 
combination arm. Therefore the use of a combination of telmisartan and ramipril is not recommended 
in this population. 
 
In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 
50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for 
telmisartan compared with placebo, 0.70% vs. 0.49% [RR 1.43 (95% confidence interval 1.00-2.06)]; 
the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33%) vs. patients 
taking placebo (0.16%) [RR 2.07 (95% confidence interval 1.14-3.76)]. The observed increased 
occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or 
related to a mechanism not currently known. 
 
Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the 
risk of cardiovascular mortality and morbidity. 
 
The effects of fixed dose combination of telmisartan/HCT on mortality and cardiovascular morbidity 
are currently unknown. 
 
Non-melanoma skin cancer: 
Based on available data from epidemiological studies, cumulative dose-dependent association between 
HCTZ and NMSC has been observed. One study included a population comprised of 71,533 cases of 
BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively. 
High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23-
1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC. A clear cumulative dose response relationship 
was observed for both BCC and SCC. Another study showed a possible association between lip cancer 
(SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, 
using a risk-set sampling strategy. A cumulative dose-response relationship was demonstrated with an 
adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 
7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4). 



38 

 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
telmisartan hydrochlorothiazide in all subsets of the paediatric population in hypertension (see section 
4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Concomitant administration of hydrochlorothiazide and telmisartan does not appear to affect the 
pharmacokinetics of either substance in healthy subjects. 
 
Absorption 
Telmisartan: Following oral administration, peak concentrations of telmisartan are reached in 0.5-1.5 h 
after dosing. The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42% and 58%, 
respectively. Food slightly reduces the bioavailability of telmisartan with a reduction in the area under 
the plasma concentration time curve (AUC) of about 6% with the 40 mg tablet and about 19% after a 
160 mg dose. By 3 hours after administration plasma concentrations are similar whether telmisartan is 
taken fasting or with food. The small reduction in AUC is not expected to cause a reduction in the 
therapeutic efficacy. Telmisartan does not accumulate significantly in plasma on repeated 
administration. 
 
Hydrochlorothiazide: Following oral administration of telmisartan/hydrochlorothiazide, peak 
concentrations of hydrochlorothiazide are reached in approximately 1.0-3.0 hours after dosing. Based 
on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60%. 
 
Distribution 
Telmisartan is highly bound to plasma proteins (>99.5%) mainly albumin and alpha l-acid 
glycoprotein. The apparent volume of distribution for telmisartan is approximately 500 litres 
indicating additional tissue binding. 
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 
0.83-1.14 l/kg. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to form a pharmacologically inactive acylglucuronide. The 
glucuronide of the parent compound is the only metabolite that has been identified in humans. After a 
single dose of 14C-labelled telmisartan the glucuronide represents approximately 11% of the measured 
radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of 
telmisartan. 
Hydrochlorothiazide is not metabolised in man. 
 
Elimination 
Telmisartan: Following either intravenous or oral administration of 14C-labelled telmisartan most of 
the administered dose (>97%) was eliminated in faeces via biliary excretion. Only minute amounts 
were found in urine. Total plasma clearance of telmisartan after oral administration is >1500 ml/min. 
Terminal elimination half-life was >20 hours. 
 
Hydrochlorothiazide is excreted almost entirely as unchanged substance in urine. About 60% of the 
oral dose is eliminated within 48 hours. Renal clearance is about 250-300 ml/min. The terminal 
elimination half-life of hydrochlorothiazide is 10-15 hours. 
 
Linearity/non-linearity 
Telmisartan: The pharmacokinetics of orally administered telmisartan are non-linear over doses from 
20–160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with 
increasing doses. 
Hydrochlorothiazide exhibits linear pharmacokinetics. 



39 

 
Elderly 
Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years. 
 
Gender 
Plasma concentrations of telmisartan are generally 2-3 times higher in females than in males. In 
clinical trials however, no significant increases in blood pressure response or in the incidence of 
orthostatic hypotension were found in women. No dose adjustment is necessary. There was a trend 
towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects. This is 
not considered to be of clinical relevance. 
 
Renal impairment 
Renal excretion does not contribute to the clearance of telmisartan. Based on modest experience in 
patients with mild to moderate renal impairment (creatinine clearance of 30-60 ml/min, mean about 
50 ml/min) no dose adjustment is necessary in patients with decreased renal function. Telmisartan is 
not removed from blood by haemodialysis. In patients with impaired renal function the rate of 
hydrochlorothiazide elimination is reduced. In a typical study in patients with a mean creatinine 
clearance of 90 ml/min the elimination half-life of hydrochlorothiazide was increased. In functionally 
anephric patients the elimination half-life is about 34 hours. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute 
bioavailability up to nearly 100%. The elimination half-life is not changed in patients with hepatic 
impairment. 
 
5.3 Preclinical safety data 
 
In preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide 
in normotensive rats and dogs, doses producing exposure comparable to that in the clinical therapeutic 
range caused no additional findings not already observed with administration of either substance 
alone. The toxicological findings observed appear to have no relevance to human therapeutic use. 
 
No additional preclinical studies have been performed with the Fixed Dose Combination product 
80 mg/25 mg. Previous preclinical safety studies performed with co-administration of telmisartan and 
hydrochlorothiazide in normotensive rats and dogs, in doses producing exposure comparable to that in 
the clinical therapeutic range, caused no additional findings not already observed with administration 
of either substance alone. The toxicological findings observed appear to have no relevance to human 
therapeutic use. 
 
Toxicological findings also well known from preclinical studies with angiotensin converting enzyme 
inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters 
(erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea 
nitrogen and creatinine), increased plasma renin activity, hypertrophy/hyperplasia of the 
juxtaglomerular cells and gastric mucosal injury. Gastric lesions could be prevented/ameliorated by 
oral sodium chloride solution supplementation and group housing of animals. In dogs renal tubular 
dilation and atrophy were observed. These findings are considered to be due to the pharmacological 
activity of telmisartan. 
 
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an 
effect on the postnatal development of the offsprings such as lower body weight and delayed eye 
opening was observed. 
Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies 
and no evidence of carcinogenicity in rats and mice. Studies with hydrochlorothiazide have shown 
equivocal evidence for a genotoxic or carcinogenic effect in some experimental models. However, the 
extensive human experience with hydrochlorothiazide has failed to show an association between its 
use and an increase in neoplasms. 
For the foetotoxic potential of the telmisartan/hydrochlorothiazide combination see section 4.6. 



40 

 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Magnesium stearate (E470b) 
Potassium hydroxide 
Meglumine 
Povidone 
Sodium starch glycolate (type A) 
Microcrystalline cellulose 
Mannitol (E421) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
For Al/Al blisters and HDPE tablet container: 
2 years. 
 
For Al/PVC/PVDC blister: 
1 year. 
 
6.4 Special precautions for storage 
 
Al/Al blisters and HDPE tablet container: 
This medicinal product does not require any special storage conditions. 
 
Al/PVC/PVDC blister: 
Do not store above 30ºC. 
 
6.5 Nature and contents of container 
 
Al/Al blister, Al/PVC/PVDC blister and HDPE tablet container with LDPE cap and HDPE desiccant 
with silica filling. 
 
Al/Al blister: 14, 28, 30, 56, 84, 90 and 98 tablets 
Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets 
Tablet container: 30, 90 and 250 tablets 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78 
220 Hafnarfjörður 
Iceland 



41 

 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/045 
EU/1/13/817/029 
EU/1/13/817/046 
EU/1/13/817/030 
EU/1/13/817/031 
EU/1/13/817/032 
EU/1/13/817/033 
EU/1/13/817/034 
EU/1/13/817/035 
EU/1/13/817/036 
EU/1/13/817/037 
EU/1/13/817/038 
EU/1/13/817/039 
EU/1/13/817/040 
EU/1/13/817/041 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
  
Date of first authorisation: 13 March 2013 
Date of latest renewal:  
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/


42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

 A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



43 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Actavis hf. 
Reykjavikurvegur 78 
220 Hafnarfjörður 
Iceland 
 
Actavis Ltd. 
BLB016 
Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
Not applicable. 
  



44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
  



46 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Al/Al blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 40 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets 
28 tablets 
30 tablets 
56 tablets 
84 tablets 
90 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



47 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/043 
EU/1/13/817/001 
EU/1/13/817/042 
EU/1/13/817/002 
EU/1/13/817/003 
EU/1/13/817/004 
EU/1/13/817/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 40 mg/12.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Al/PVC/PVDC blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 40 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
28 tablets 
56 tablets 
84 tablets 
90 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30ºC 
 



49 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/006 
EU/1/13/817/007 
EU/1/13/817/008 
EU/1/13/817/009 
EU/1/13/817/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 40 mg/12.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



50 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 40 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for HDPE tablet container 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 40 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
90 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



52 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/011 
EU/1/13/817/012 
EU/1/13/817/013 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 40 mg/12.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



53 

PARTICULARS TO APPEAR ON THE INNER PACKAGING 
 
Label for HDPE tablet container 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 40 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
90 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



54 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/011 
EU/1/13/817/012 
EU/1/13/817/013 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 
  



55 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Al/Al blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets  
28 tablets 
30 tablets 
56 tablets 
84 tablets 
90 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



56 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/014 
EU/1/13/817/015 
EU/1/13/817/044 
EU/1/13/817/016 
EU/1/13/817/017 
EU/1/13/817/018 
EU/1/13/817/019 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 80 mg/12.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



57 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Al/PVC/PVDC blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets  
28 tablets 
56 tablets 
84 tablets 
90 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30ºC 



58 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/020 
EU/1/13/817/021 
EU/1/13/817/022 
EU/1/13/817/023 
EU/1/13/817/024 
EU/1/13/817/025 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 80 mg/12.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



59 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



60 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for HDPE tablet container 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
90 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



61 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/026 
EU/1/13/817/027 
EU/1/13/817/028 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 80 mg/12.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



62 

PARTICULARS TO APPEAR ON THE INNER PACKAGING 
 
Label for HDPE tablet container 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
90 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



63 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/817/026 
EU/1/13/817/027 
EU/1/13/817/028 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
  



64 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Al/Al blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/25 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
14 tablets 
28 tablets 
30 tablets 
56 tablets 
84 tablets 
90 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



65 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/045 
EU/1/13/817/029 
EU/1/13/817/046 
EU/1/13/817/030 
EU/1/13/817/031 
EU/1/13/817/032 
EU/1/13/817/033 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 80 mg/25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



66 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Al/PVC/PVDC blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/25 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
28 tablets 
56 tablets 
84 tablets 
90 tablets 
98 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30ºC 
 



67 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/034 
EU/1/13/817/035 
EU/1/13/817/036 
EU/1/13/817/037 
EU/1/13/817/038 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 80 mg/25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



68 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/25 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



69 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for HDPE tablet container 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/25 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
90 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



70 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/039 
EU/1/13/817/040 
EU/1/13/817/041 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Actelsar HCT 80 mg/25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



71 

PARTICULARS TO APPEAR ON THE INNER PACKAGING 
 
Label for HDPE tablet container 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Actelsar HCT 80 mg/25 mg tablets 
telmisartan/hydrochlorothiazide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
90 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



72 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/817/039 
EU/1/13/817/040 
EU/1/13/817/041 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 
  



73 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



74 

 
Package leaflet: Information for the user 

 
Actelsar HCT 40 mg/12.5 mg tablets 

telmisartan/hydrochlorothiazide 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Actelsar HCT is and what it is used for 
2. What you need to know before you take Actelsar HCT 
3. How to take Actelsar HCT 
4. Possible side effects 
5. How to store Actelsar HCT 
6. Contents of the pack and other information 
 
 
1. What Actelsar HCT is and what it is used for 
 
Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide in one 
tablet. Both of these substances help to control high blood pressure. 
 
- Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. 

Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow 
thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the 
blood vessels relax, and your blood pressure is lowered. 

- Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your 
urine output to increase, leading to a lowering of your blood pressure. 

 
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead 
sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms 
of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure 
to verify if it is within the normal range. 
 
Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood 
pressure is not controlled enough when telmisartan is used alone. 
 
 
2. What you need to know before you take Actelsar HCT 
 
Do not take Actelsar HCT 
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in 

section 6). 
- if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines. 
- if you are more than 3 months pregnant. (It is also better to avoid Actelsar HCT in early 

pregnancy – see pregnancy section). 
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with 

drainage of the bile from the liver and gall bladder) or any other severe liver disease. 
- if you have severe kidney disease. 



75 

- if your doctor determines that you have low potassium levels or high calcium levels in your 
blood that do not get better with treatment. 

- if you have diabetes or impaired kidney function and you are treated with a blood pressure 
lowering medicine containing aliskiren. 

 
If any of the above applies to you, tell your doctor or pharmacist before taking Actelsar HCT. 
 
Warnings and precautions  
Talk to your doctor before taking Actelsar HCT if you are suffering or have ever suffered from any of 
the following conditions or illnesses: 
 
- Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body 

water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, 
vomiting, or haemodialysis. 

- Kidney disease or kidney transplant. 
- Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). 
- Liver disease. 
- Heart trouble. 
- Diabetes. 
- Gout. 
- Raised aldosterone levels (water and salt retention in the body along with imbalance of various 

blood minerals). 
- Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body’s 

immune system attacks the body. 
- The active substance hydrochlorothiazide can cause an unusual reaction, resulting in a decrease 

in vision and eye pain. These could be symptoms of fluid accumulation in the vascular layer of 
the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours 
to weeks of taking Actelsar HCT. This can lead to permanent vision impairment, if not treated. 

- if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. 
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase 
the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin 
from sun exposure and UV rays while taking Actelsar HCT  

 
Talk to your doctor before taking Actelsar HCT, if you are taking: 
- any of the following medicines used to treat high blood pressure: 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have 
diabetes-related kidney problems. 

- aliskiren. 
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes 
(e.g. potassium) in your blood at regular intervals. See also information under the heading “Do 
not take Actelsar HCT”. 

- digoxin. 
 
You must tell your doctor if you think you are (or might become) pregnant. Actelsar HCT is not 
recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it 
may cause serious harm to your baby if used at that stage (see pregnancy section). 
 
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms 
of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, 
muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart 
rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor. 
 
You should also tell your doctor if you experience an increased sensitivity of the skin to the sun with 
symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than 
normal. 
 
In case of surgery or anaesthetics, you should tell your doctor that you are taking Actelsar HCT. 



76 

 
Actelsar HCT may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Actelsar HCT in children and adolescents up to the age of 18 years is not recommended. 
 
Other medicines and Actelsar HCT 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Your doctor may need to change the dose of these other medicines or take other 
precautions. In some cases you may have to stop taking one of the medicines. This applies especially 
to the medicines listed below taken at the same time with Actelsar HCT: 
 
- Lithium containing medicines to treat some types of depression. 
- Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, (“water 

tablets”), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), 
amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G 
sodium (an antibiotic), and salicylic acid and derivatives. 

- Medicines that may increase blood potassium levels such as potassium-sparing diuretics, 
potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an 
immunosuppressant drug) and other medicinal products such as heparin sodium (an 
anticoagulant). 

- Medicines that are affected by changes of the blood potassium level such as heart medicines 
(e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, 
amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, 
levomepromazine) and other medicines such as certain antibiotics (e.g. sparfloxacine, 
pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine). 

- Medicines for the treatment of diabetes (insulins or oral agents such as metformin). 
- Cholestyramine and colestipol, medicines for lowering blood fat levels. 
- Medicines to increase blood pressure, such as noradrenaline. 
- Muscle relaxing medicines, such as tubocurarine. 
- Calcium supplements and/or vitamin D supplements. 
- Anti-cholinergic medicines (medicines used to treat a variety of disorders such as 

gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, 
Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden. 

- Amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain 
illnesses caused by viruses). 

- Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-
steroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis. 

- If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not 
take Actelsar HCT” and “Warnings and precautions”). 

- Digoxin. 
 
Actelsar HCT may increase the blood pressure lowering effect of other medicines used to treat high 
blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). 
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. You may notice this as dizziness when standing up. You should consult with your 
doctor if you need to adjust the dose of your other medicine while taking Actelsar HCT. 
 
The effect of Actelsar HCT may be reduced when you take NSAIDs (non steroidal anti-inflammatory 
medicines, e.g. acetylsalicyl acid or ibuprofen). 
 
Actelsar HCT with food and alcohol 
 
You can take Actelsar HCT with or without food. 
Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall 
more and/or increase the risk of you becoming dizzy or feeling faint. 



77 

 
Pregnancy and breast-feeding 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Actelsar HCT before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Actelsar HCT. Actelsar HCT is not 
recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may 
cause serious harm to your baby if used after the third month of pregnancy. 
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding. Actelsar HCT is not 
recommended for mothers who are breast-feeding and your doctor may choose another treatment for 
you if you wish to breast-feed. 
 
Driving and using machines 
Some people feel dizzy or tired when taking Actelsar HCT. If you feel dizzy or tired, do not drive or 
operate machinery. 
 
 
3. How to take Actelsar HCT 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. You can 
take Actelsar HCT with or without food. The tablets should be swallowed with some water or other 
non-alcoholic drink. It is important that you take Actelsar HCT every day until your doctor tells you 
otherwise. 
 
If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day. 
 
If you take more Actelsar HCT than you should 
If you accidentally take too many tablets you may experience symptoms such as low blood pressure 
and rapid heartbeat. Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney 
failure, have also been reported. Due to the hydrochlorothiazide component, markedly low blood 
pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness 
and muscle cramps and/or irregular heartbeat associated with the concomitant use of drugs such as 
digitalis or certain anti-arrhythmic treatments. Contact your doctor, pharmacist, or your nearest 
hospital emergency department immediately. 
 
If you forget to take Actelsar HCT 
If you forget to take a dose, do not worry. Take it as soon as you remember, then carry on as before. If 
you do not take your tablet on one day, take your normal dose on the next day. Do not take a double 
dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious and need immediate medical attention: 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis* (often called “blood poisoning”), is a severe infection with whole-body inflammatory 
response, rapid swelling of the skin and mucosa (angioedema); blistering and peeling of the top layer 



78 

of skin (toxic epidermal necrolysis) these side effects are rare (may affect up to 1 in 1,000 people) or 
of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop 
taking the medicine and see their doctor immediately. If these effects are not treated they could be 
fatal. Increased incidence of sepsis has been observed with telmisartan only, however it can not be 
ruled out for Actelsar HCT. 
 
Possible side effects of Actelsar HCT: 
 
Common (may affect up to 1 in 10 people): 
Dizziness 
 
Uncommon (may affect up to 1 in 100 people): 
Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles 
(paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low 
blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), 
diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability 
to get or keep an erection), chest pain, increased blood uric acid levels. 
 
Rare (may affect up to 1 in 1000 people): 
Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a 
disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and 
fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), 
impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick 
(vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are 
more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as 
itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, 
muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic 
enzymes or creatine phosphokinase in the blood. 
 
Adverse reactions reported with one of the individual components may be potential adverse reactions 
with Actelsar HCT, even if not observed in clinical trials with this product. 
 
Telmisartan 
In patients taking telmisartan alone the following additional side effects have been reported: 
 
Uncommon (may affect up to 1 in 100 people): 
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract 
infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate 
(bradycardia), kidney impairment including acute kidney failure, weakness, cough. 
 
Rare (may affect up to 1 in 1000 people): 
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious 
allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in 
diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, 
decreased haemoglobin (a blood protein), somnolence. 
 
Very rare (may affect up to 1 in 10,000 people): 
Progressive scarring of lung tissue (interstitial lung disease)** 
 
*The event may have happened by chance or could be related to a mechanism currently not known. 
 
**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. 
However, it is not known whether telmisartan was the cause.  
 
Hydrochlorothiazide 
In patients taking hydrochlorothiazide alone the following additional side effects have been reported: 
 



79 

Common (may affect up to 1 in 10 people): 
Feeling sick (nausea), low blood magnesium level. 
 
Rare (may affect up to 1 in 1,000 people): 
Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in 
skin or other tissue caused by bleeding), high blood calcium level, headache. 
 
Very rare (may affect up to 1 in 10,000 people): 
Increased pH (disturbed acid-base balance) due to low blood chloride level. 
 
Side effects of unknown frequency (frequency cannot be estimated from the available data) 
Inflammation of the salivary gland, skin and lip cancer (Non-melanoma skin cancer), decreases in the 
number (or even lack) of cells in the blood, including low red and white blood cell count, serious 
allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, 
restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible 
signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute myopia or 
acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed 
pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition 
mimicking a disease called systemic lupus erythematosus where the body’s immune system attacks the 
body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, 
redness of the skin, blistering of the lips, eyes or mouth, skin peeling , fever (possible signs of 
erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the 
urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood 
volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in 
patients with a diagnosis of diabetes mellitus,or fat in the blood. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Actelsar HCT 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, blister or bottle label after 
“EXP”. The expiry date refers to the last day of that month. “Lot”, which is printed on the carton, 
refers to the batch number. 
 
For Al/Al blisters and HDPE tablet container 
This medicine does not require any special storage conditions. 
 
For Al/PVC/PVDC blister 
Do not store above 30ºC. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Actelsar HCT contains  
- The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg 

telmisartan and 12.5 mg hydrochlorothiazide. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


80 

- The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, 
povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421). 

 
What Actelsar HCT looks like and contents of the pack 
Actelsar HCT 40 mg/12.5 mg tablets are white or almost white, 6.55 x 13.6 mm oval-shaped and 
biconvex tablets marked with “TH” on one side. 
 
Pack sizes 
Al/Al blister packs: 14, 28, 30, 56, 84, 90 and 98 tablets  
Al/PVC/PVDC blister packs: 28, 56, 84, 90 and 98 tablets 
Tablet containers: 30, 90 and 250 tablets 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland 
 
Manufacturer 
Actavis hf. 
Reykjavíkurvegur 78, 220 Hafnarfjörður, Iceland 
 
Actavis Ltd. 
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland / Islande / Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande / Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 (0)35 542 99 33 
 

Eesti 
UAB Teva Baltics Eesti Filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 



81 

Ελλάδα 
Specifar A.B.E.E. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0 
 

España 
Aurovitas Spain, S.A.U. 
Tfno.: +34 91 630 86 45 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 22 345 93 00 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 (0) 20 180 5900 
 

Κύπρος 
Specifar A.B.E.E.  
Τηλ: +30 2118805000 
Ελλάδα 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1977628500 
 

 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/


82 

Package leaflet: Information for the user 
 

Actelsar HCT 80 mg/12.5 mg tablets 
telmisartan/hydrochlorothiazide 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Actelsar HCT is and what it is used for 
2. What you need to know before you take Actelsar HCT 
3. How to take Actelsar HCT 
4. Possible side effects 
5. How to store Actelsar HCT 
6. Contents of the pack and other information 
 
 
1. What Actelsar HCT is and what it is used for 
 
Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide in one 
tablet. Both of these substances help to control high blood pressure. 
 
- Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. 

Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow 
thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the 
blood vessels relax, and your blood pressure is lowered. 

- Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your 
urine output to increase, leading to a lowering of your blood pressure. 

 
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead 
sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms 
of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure 
to verify if it is within the normal range. 
 
Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood 
pressure is not controlled enough when telmisartan is used alone. 
 
 
2. What you need to know before you take Actelsar HCT 
 
Do not take Actelsar HCT 
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in 

section 6). 
- if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines. 
- if you are more than 3 months pregnant. (It is also better to avoid Actelsar HCT in early 

pregnancy – see pregnancy section). 
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with 

drainage of the bile from the liver and gall bladder) or any other severe liver disease. 
- if you have severe kidney disease. 



83 

- if your doctor determines that you have low potassium levels or high calcium levels in your 
blood that do not get better with treatment. 

- if you have diabetes or impaired kidney function and you are treated with a blood pressure 
lowering medicine containing aliskiren. 

 
If any of the above applies to you, tell your doctor or pharmacist before taking Actelsar HCT. 
 
Warnings and precautions  
Talk to your doctor before taking Actelsar HCT if you are suffering or have ever suffered from any of 
the following conditions or illnesses: 
 
- Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body 

water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, 
vomiting, or haemodialysis. 

- Kidney disease or kidney transplant. 
- Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). 
- Liver disease. 
- Heart trouble. 
- Diabetes. 
- Gout. 
- Raised aldosterone levels (water and salt retention in the body along with imbalance of various 

blood minerals). 
- Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body’s 

immune system attacks the body. 
- The active substance hydrochlorothiazide can cause an unusual reaction, resulting in a decrease 

in vision and eye pain. These could be symptoms of fluid accumulation in the vascular layer of 
the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours 
to weeks of taking Actelsar HCT. This can lead to permanent vision impairment, if not treated. 

- if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. 
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase 
the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin 
from sun exposure and UV rays while taking Actelsar HCT  

 
Talk to your doctor before taking Actelsar HCT if you are taking: 
- any of the following medicines used to treat high blood pressure: 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have 
diabetes-related kidney problems. 

- aliskiren. 
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes 
(e.g. potassium) in your blood at regular intervals. See also information under the heading “Do 
not take Actelsar HCT”. 

- digoxin. 
 
You must tell your doctor if you think you are (or might become) pregnant. Actelsar HCT is not 
recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it 
may cause serious harm to your baby if used at that stage (see pregnancy section). 
 
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms 
of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, 
muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart 
rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor. 
 
You should also tell your doctor if you experience an increased sensitivity of the skin to the sun with 
symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than 
normal. 
 
In case of surgery or anaesthetics, you should tell your doctor that you are taking Actelsar HCT. 



84 

 
Actelsar HCT may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Actelsar HCT in children and adolescents up to the age of 18 years is not recommended. 
 
Other medicines and Actelsar HCT 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Your doctor may need to change the dose of these other medicines or take other 
precautions. In some cases you may have to stop taking one of the medicines. This applies especially 
to the medicines listed below taken at the same time with Actelsar HCT: 
 
- Lithium containing medicines to treat some types of depression. 
- Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, (“water 

tablets”), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), 
amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G 
sodium (an antibiotic), and salicylic acid and derivatives. 

- Medicines that may increase blood potassium levels such as potassium-sparing diuretics, 
potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an 
immunosuppressant drug) and other medicinal products such as heparin sodium (an 
anticoagulant). 

- Medicines that are affected by changes of the blood potassium level such as heart medicines 
(e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, 
amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, 
levomepromazine) and other medicines such as certain antibiotics (e.g. sparfloxacine, 
pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine). 

- Medicines for the treatment of diabetes (insulins or oral agents such as metformin). 
- Cholestyramine and colestipol, medicines for lowering blood fat levels. 
- Medicines to increase blood pressure, such as noradrenaline. 
- Muscle relaxing medicines, such as tubocurarine. 
- Calcium supplements and/or vitamin D supplements. 
- Anti-cholinergic medicines (medicines used to treat a variety of disorders such as 

gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, 
Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden. 

- Amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain 
illnesses caused by viruses). 

- Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-
steroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis. 

- If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not 
take Actelsar HCT” and “Warnings and precautions”). 

- Digoxin. 
 
Actelsar HCT may increase the blood pressure lowering effect of other medicines used to treat high 
blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). 
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. You may notice this as dizziness when standing up. You should consult with your 
doctor if you need to adjust the dose of your other medicine while taking Actelsar HCT. 
 
The effect of Actelsar HCT may be reduced when you take NSAIDs (non steroidal anti-inflammatory 
medicines, e.g. acetylsalicyl acid or ibuprofen). 
 
Actelsar HCT with food and alcohol 
 
You can take Actelsar HCT with or without food. 
Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall 
more and/or increase the risk of you becoming dizzy or feeling faint. 



85 

 
Pregnancy and breast-feeding 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Actelsar HCT before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Actelsar HCT. Actelsar HCT is not 
recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may 
cause serious harm to your baby if used after the third month of pregnancy. 
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding. Actelsar HCT is not 
recommended for mothers who are breast-feeding and your doctor may choose another treatment for 
you if you wish to breast-feed. 
 
Driving and using machines 
Some people feel dizzy or tired when taking Actelsar HCT. If you feel dizzy or tired, do not drive or 
operate machinery. 
 
 
3. How to take Actelsar HCT 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. You can 
take Actelsar HCT with or without food. The tablets should be swallowed with some water or other 
non-alcoholic drink. It is important that you take Actelsar HCT every day until your doctor tells you 
otherwise. 
 
If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day. 
 
If you take more Actelsar HCT than you should 
If you accidentally take too many tablets you may experience symptoms such as low blood pressure 
and rapid heartbeat. Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney 
failure, have also been reported. Due to the hydrochlorothiazide component, markedly low blood 
pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness 
and muscle cramps and/or irregular heartbeat associated with the concomitant use of medicinal 
products such as digitalis or certain anti-arrhythmic treatments. Contact your doctor, pharmacist, or 
your nearest hospital emergency department immediately.  
 
If you forget to take Actelsar HCT 
If you forget to take a dose, do not worry. Take it as soon as you remember, then carry on as before. If 
you do not take your tablet on one day, take your normal dose on the next day. Do not take a double 
dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious and need immediate medical attention: 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis* (often called “blood poisoning”), is a severe infection with whole-body inflammatory 
response, rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer 



86 

of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or 
of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop 
taking the medicine and see their doctor immediately. If these effects are not treated they could be 
fatal. Increased incidence of sepsis has been observed with telmisartan only, however it can not be 
ruled out for Actelsar HCT. 
 
Possible side effects of Actelsar HCT: 
 
Common (may affect up to 1 in 10 people): 
Dizziness 
 
Uncommon (may affect up to 1 in 100 people): 
Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles 
(paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low 
blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), 
diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability 
to get or keep an erection), chest pain, increased blood uric acid levels. 
 
Rare (may affect up to 1 in 1000 people): 
Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a 
disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and 
fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), 
impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick 
(vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are 
more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as 
itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, 
muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic 
enzymes or creatine phosphokinase in the blood. 
 
Adverse reactions reported with one of the individual components may be potential adverse reactions 
with Actelsar HCT, even if not observed in clinical trials with this product. 
 
Telmisartan 
In patients taking telmisartan alone the following additional side effects have been reported: 
 
Uncommon (may affect up to 1 in 100 people): 
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract 
infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate 
(bradycardia), kidney impairment including acute kidney failure, weakness, cough. 
 
Rare (may affect up to 1 in 1000 people): 
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious 
allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in 
diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, 
decreased haemoglobin (a blood protein), somnolence. 
 
Very rare (may affect up to 1 in 10,000 people): 
Progressive scarring of lung tissue (interstitial lung disease)** 
 
*The event may have happened by chance or could be related to a mechanism currently not known. 
 
**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. 
However, it is not known whether telmisartan was the cause.  
 
Hydrochlorothiazide 
In patients taking hydrochlorothiazide alone the following additional side effects have been reported: 
 



87 

Common (may affect up to 1 in 10 people): 
Feeling sick (nausea), low blood magnesium level. 
 
Rare (may affect up to 1 in 1,000 people): 
Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in 
skin or other tissue caused by bleeding), high blood calcium level, headache. 
 
Very rare (may affect up to 1 in 10,000 people): 
Increased pH (disturbed acid-base balance) due to low blood chloride level. 
 
Side effects of unknown frequency (frequency cannot be estimated from the available data) 
Inflammation of the salivary gland, skin and lip cancer (Non-melanoma skin cancer), decreases in the 
number (or even lack) of cells in the blood, including low red and white blood cell count, serious 
allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, 
restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible 
signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute myopia or 
acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed 
pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition 
mimicking a disease called systemic lupus erythematosus where the body’s immune system attacks the 
body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, 
redness of the skin, blistering of the lips, eyes or mouth, skin peeling , fever (possible signs of 
erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the 
urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood 
volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in 
patients with a diagnosis of diabetes mellitus, or fat in the blood. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Actelsar HCT 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, blister or bottle label after 
“EXP”. The expiry date refers to the last day of that month. “Lot”, which is printed on the carton, 
refers to the batch number. 
 
For Al/Al blisters and HDPE tablet container 
This medicine does not require any special storage conditions. 
 
For Al/PVC/PVDC blister 
Do not store above 30ºC. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Actelsar HCT contains  
- The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg 

telmisartan and 12.5 mg hydrochlorothiazide. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


88 

- The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, 
povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421). 

 
What Actelsar HCT looks like and contents of the pack 
Actelsar HCT 80 mg/12.5 mg tablets are white or almost white, 9.0 x 17.0 mm capsule-shaped tablets 
marked with “TH 12.5” on both sides. 
 
Pack sizes 
Al/Al blister packs: 14, 30, 28, 56, 84, 90 and 98 tablets  
Al/PVC/PVDC blister packs: 14, 28, 56, 84, 90 and 98 tablets 
Tablet containers: 30, 90 and 250 tablets 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland 
 
Manufacturer 
Actavis hf. 
Reykjavíkurvegur 78, 220 Hafnarfjörður, Iceland 
 
Actavis Ltd. 
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland / Islande / Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande / Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 (0)35 542 99 33 
 

Eesti 
UAB Teva Baltics Eesti Filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 



89 

Ελλάδα 
Specifar A.B.E.E. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0 
 

España 
Aurovitas Spain, S.A.U. 
Tfno.: +34 91 630 86 45 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 22 345 93 00 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 (0) 20 180 5900 
 

Κύπρος 
Specifar A.B.E.E.  
Τηλ: +30 2118805000 
Ελλάδα 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1977628500 
 

 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/


90 

Package leaflet: Information for the user 
 

Actelsar HCT 80 mg/25 mg tablets 
telmisartan/hydrochlorothiazide 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Actelsar HCT is and what it is used for 
2. What you need to know before you take Actelsar HCT 
3. How to take Actelsar HCT 
4. Possible side effects 
5. How to store Actelsar HCT 
6. Contents of the pack and other information 
 
 
1. What Actelsar HCT is and what it is used for 
 
Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide in one 
tablet. Both of these substances help to control high blood pressure. 
 
- Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. 

Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow 
thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the 
blood vessels relax, and your blood pressure is lowered. 

- Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your 
urine output to increase, leading to a lowering of your blood pressure. 

 
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead 
sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms 
of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure 
to verify if it is within the normal range. 
 
Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood 
pressure is not controlled enough when telmisartan is used alone. 
 
 
2. What you need to know before you take Actelsar HCT 
 
Do not take Actelsar HCT 
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in 

section 6). 
- if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines. 
- if you are more than 3 months pregnant. (It is also better to avoid Actelsar HCT in early 

pregnancy – see pregnancy section). 
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with 

drainage of the bile from the liver and gall bladder) or any other severe liver disease. 
- if you have severe kidney disease. 



91 

- if your doctor determines that you have low potassium levels or high calcium levels in your 
blood that do not get better with treatment. 

- if you have diabetes or impaired kidney function and you are treated with a blood pressure 
lowering medicine containing aliskiren. 

 
If any of the above applies to you, tell your doctor or pharmacist before taking Actelsar HCT. 
 
Warnings and precautions  
Talk to your doctor before taking Actelsar HCT if you are suffering or have ever suffered from any of 
the following conditions or illnesses: 
 
- Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body 

water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, 
vomiting, or haemodialysis. 

- Kidney disease or kidney transplant. 
- Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). 
- Liver disease. 
- Heart trouble. 
- Diabetes. 
- Gout. 
- Raised aldosterone levels (water and salt retention in the body along with imbalance of various 

blood minerals). 
- Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body’s 

immune system attacks the body. 
- The active substance hydrochlorothiazide can cause an unusual reaction, resulting in a decrease 

in vision and eye pain. These could be symptoms of fluid accumulation in the vascular layer of 
the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours 
to weeks of taking Actelsar HCT. This can lead to permanent vision impairment, if not treated. 

- if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. 
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase 
the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin 
from sun exposure and UV rays while taking Actelsar HCT  

 
Talk to your doctor before taking Actelsar HCT if you are taking: 
- any of the following medicines used to treat high blood pressure: 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have 
diabetes-related kidney problems. 

- aliskiren. 
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes 
(e.g. potassium) in your blood at regular intervals. See also information under the heading “Do 
not take Actelsar HCT”. 

- digoxin. 
 
You must tell your doctor if you think you are (or might become) pregnant. Actelsar HCT is not 
recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it 
may cause serious harm to your baby if used at that stage (see pregnancy section). 
 
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms 
of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, 
muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart 
rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor. 
 
You should also tell your doctor if you experience an increased sensitivity of the skin to the sun with 
symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than 
normal. 
 
In case of surgery or anaesthetics, you should tell your doctor that you are taking Actelsar HCT. 



92 

 
Actelsar HCT may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Actelsar HCT in children and adolescents up to the age of 18 years is not recommended. 
 
Other medicines and Actelsar HCT 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Your doctor may need to change the dose of these other medicines or take other 
precautions. In some cases you may have to stop taking one of the medicines. This applies especially 
to the medicines listed below taken at the same time with Actelsar HCT: 
 
- Lithium containing medicines to treat some types of depression. 
- Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, (“water 

tablets”), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), 
amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G 
sodium (an antibiotic), and salicylic acid and derivatives. 

- Medicines that may increase blood potassium levels such as potassium-sparing diuretics, 
potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an 
immunosuppressant drug) and other medicinal products such as heparin sodium (an 
anticoagulant). 

- Medicines that are affected by changes of the blood potassium level such as heart medicines 
(e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, 
amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, 
levomepromazine) and other medicines such as certain antibiotics (e.g. sparfloxacine, 
pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine). 

- Medicines for the treatment of diabetes (insulins or oral agents such as metformin). 
- Cholestyramine and colestipol, medicines for lowering blood fat levels. 
- Medicines to increase blood pressure, such as noradrenaline. 
- Muscle relaxing medicines, such as tubocurarine. 
- Calcium supplements and/or vitamin D supplements. 
- Anti-cholinergic medicines (medicines used to treat a variety of disorders such as 

gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, 
Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden. 

- Amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain 
illnesses caused by viruses). 

- Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-
steroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis. 

- If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not 
take Actelsar HCT” and “Warnings and precautions”). 

- Digoxin. 
 
Actelsar HCT may increase the blood pressure lowering effect of other medicines used to treat high 
blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). 
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. You may notice this as dizziness when standing up. You should consult with your 
doctor if you need to adjust the dose of your other medicine while taking Actelsar HCT. 
 
The effect of Actelsar HCT may be reduced when you take NSAIDs (non steroidal anti-inflammatory 
medicines, e.g. acetylsalicyl acid or ibuprofen). 
 
Actelsar HCT with food and alcohol 
 
You can take Actelsar HCT with or without food. 
Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall 
more and/or increase the risk of you becoming dizzy or feeling faint. 



93 

 
Pregnancy and breast-feeding 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Actelsar HCT before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Actelsar HCT. Actelsar HCT is not 
recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may 
cause serious harm to your baby if used after the third month of pregnancy. 
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding. Actelsar HCT is not 
recommended for mothers who are breast-feeding and your doctor may choose another treatment for 
you if you wish to breast-feed. 
 
Driving and using machines 
Some people feel dizzy or tired when taking Actelsar HCT. If you feel dizzy or tired, do not drive or 
operate machinery. 
 
 
3. How to take Actelsar HCT 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. You can 
take Actelsar HCT with or without food. The tablets should be swallowed with some water or other 
non-alcoholic drink. It is important that you take Actelsar HCT every day until your doctor tells you 
otherwise. 
 
If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day. 
 
If you take more Actelsar HCT than you should 
If you accidentally take too many tablets you may experience symptoms such as low blood pressure 
and rapid heartbeat. Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney 
failure, have also been reported. Due to the hydrochlorothiazide component, markedly low blood 
pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness 
and muscle cramps and/or irregular heartbeat associated with the concomitant use of medicinal 
products such as digitalis or certain anti-arrhythmic treatments. Contact your doctor, pharmacist, or 
your nearest hospital emergency department immediately. 
 
If you forget to take Actelsar HCT 
If you forget to take a dose, do not worry. Take it as soon as you remember, then carry on as before. If 
you do not take your tablet on one day, take your normal dose on the next day. Do not take a double 
dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious and need immediate medical attention: 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis* (often called “blood poisoning”), is a severe infection with whole-body inflammatory 
response, rapid swelling of the skin and mucosa (angioedema); blistering and peeling of the top layer 



94 

of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or 
of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop 
taking the medicine and see their doctor immediately. If these effects are not treated they could be 
fatal. Increased incidence of sepsis has been observed with telmisartan only, however it can not be 
ruled out for Actelsar HCT. 
 
Possible side effects of Actelsar HCT: 
 
Common (may affect up to 1 in 10 people): 
Dizziness 
 
Uncommon (may affect up to 1 in 100 people): 
Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles 
(paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low 
blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), 
diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability 
to get or keep an erection), chest pain, increased blood uric acid levels. 
 
Rare (may affect up to 1 in 1000 people): 
Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a 
disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and 
fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), 
impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick 
(vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are 
more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as 
itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, 
muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic 
enzymes or creatine phosphokinase in the blood. 
 
Adverse reactions reported with one of the individual components may be potential adverse reactions 
with Actelsar HCT, even if not observed in clinical trials with this product. 
 
Telmisartan 
In patients taking telmisartan alone the following additional side effects have been reported: 
 
Uncommon (may affect up to 1 in 100 people): 
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract 
infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate 
(bradycardia), kidney impairment including acute kidney failure, weakness, cough. 
 
Rare (may affect up to 1 in 1000 people): 
 Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious 
allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in 
diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, 
decreased haemoglobin (a blood protein), somnolence. 
 
Very rare (may affect up to 1 in 10,000 people): 
Progressive scarring of lung tissue (interstitial lung disease)** 
 
*The event may have happened by chance or could be related to a mechanism currently not known. 
 
**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. 
However, it is not known whether telmisartan was the cause.  
 
Hydrochlorothiazide 
In patients taking hydrochlorothiazide alone the following additional side effects have been reported: 
 



95 

Common (may affect up to 1 in 10 people): 
Feeling sick (nausea), low blood magnesium level. 
 
Rare (may affect up to 1 in 1,000 people): 
Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in 
skin or other tissue caused by bleeding), high blood calcium level, headache. 
 
Very rare (may affect up to 1 in 10,000 people): 
Increased pH (disturbed acid-base balance) due to low blood chloride level. 
 
Side effects of unknown frequency (frequency cannot be estimated from the available data) 
Inflammation of the salivary gland, skin and lip cancer (Non-melanoma skin cancer), decreases in the 
number (or even lack) of cells in the blood, including low red and white blood cell count, serious 
allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, 
restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible 
signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute myopia or 
acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed 
pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition 
mimicking a disease called systemic lupus erythematosus where the body’s immune system attacks the 
body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, 
redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of 
erythema multiforme),weakness, kidney inflammation or impaired kidney function, glucose in the 
urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood 
volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in 
patients with a diagnosis of diabetes mellitus, or fat in the blood. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Actelsar HCT 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, blister or bottle label after 
“EXP”. The expiry date refers to the last day of that month. “Lot”, which is printed on the carton, 
refers to the batch number. 
 
For Al/Al blisters and HDPE tablet container 
This medicine does not require any special storage conditions. 
 
For Al/PVC/PVDC blister 
Do not store above 30ºC. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Actelsar HCT contains  
- The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg 

telmisartan and 25 mg hydrochlorothiazide. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


96 

- The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, 
povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421). 

 
What Actelsar HCT looks like and contents of the pack 
Actelsar HCT 80 mg/25 mg tablets are white or almost white, 9.0 x 17.0 mm oval-shaped and 
biconvex tablets marked with “TH” on one side and “25” on the other side. 
 
Pack sizes 
Al/Al blister packs: 14, 28, 30, 56, 84, 90 and 98 tablets 
Al/PVC/PVDC blister packs: 28, 56, 84, 90 and 98 tablets 
Tablet containers: 30, 90 and 250 tablets 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland 
 
Manufacturer 
Actavis hf. 
Reykjavíkurvegur 78, 220 Hafnarfjörður, Iceland 
 
Actavis Ltd. 
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland / Islande / Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande / Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 (0)35 542 99 33 
 

Eesti 
UAB Teva Baltics Eesti Filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 



97 

Ελλάδα 
Specifar A.B.E.E. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0 
 

España 
Aurovitas Spain, S.A.U. 
Tfno.: +34 91 630 86 45 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 22 345 93 00 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 (0) 20 180 5900 
 

Κύπρος 
Specifar A.B.E.E.  
Τηλ: +30 2118805000 
Ελλάδα 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1977628500 
 

 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET