Edarbi

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Edarbi 20 mg tablets 
Edarbi 40 mg tablets 
Edarbi 80 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Edarbi 20 mg tablets 
Each tablet contains 20 mg of azilsartan medoxomil (as potassium). 
 
Edarbi 40 mg tablets 
Each tablet contains 40 mg of azilsartan medoxomil (as potassium). 
 
Edarbi 80 mg tablets 
Each tablet contains 80 mg of azilsartan medoxomil (as potassium). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet. 
 
Edarbi 20 mg tablets 
White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the 
other. 
 
Edarbi 40 mg tablets 
White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the 
other. 
 
Edarbi 80 mg tablets 
White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the 
other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Edarbi is indicated for the treatment of essential hypertension in adults. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended starting dose is 40 mg once daily. The dose may be increased to a maximum of 
80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose. 
 
Near-maximal antihypertensive effect is evident at 2 weeks, with maximal effects attained by 
4 weeks. 
 
If blood pressure is not adequately controlled with Edarbi alone, additional blood pressure reduction 
can be achieved when this treatment is coadministered with other antihypertensive medicinal 



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products, including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel 
blockers (see sections 4.3, 4.4, 4.5 and 5.1). 
 
Special populations 
 
Elderly (65 years and over) 
No initial dose adjustment with Edarbi is necessary in elderly patients (see section 5.2), although 
consideration can be given to 20 mg as a starting dose in the very elderly (≥ 75 years), who may be at 
risk of hypotension. 
 
Renal impairment 
Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal 
disease as there is no experience of use of Edarbi in these patients (see sections 4.4 and 5.2). 
Hemodialysis does not remove azilsartan from the systemic circulation. 
No dose adjustment is required in patients with mild or moderate renal impairment. 
 
Hepatic impairment 
Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not 
recommended in this patient group (see sections 4.4 and 5.2). 
As there is limited experience of use of Edarbi in patients with mild to moderate hepatic impairment 
close monitoring is recommended and consideration should be given to 20 mg as a starting dose (see 
section 5.2).  
 
Intravascular volume depletion 
For patients with possible depletion of intravascular volume or salt depletion (e.g. patients with 
vomiting, diarrhoea or taking high doses of diuretics), Edarbi should be initiated under close medical 
supervision and consideration can be given to 20 mg as a starting dose (see section 4.4). 
 
Black population 
No dose adjustment is required in the black population, although smaller reductions in blood pressure 
are observed compared with a non-black population (see section 5.1). This generally has been true for 
other angiotensin II receptor (AT1) antagonists and angiotensin-converting enzyme inhibitors. 
Consequently, uptitration of Edarbi and concomitant therapy may be needed more frequently for 
blood pressure control in black patients. 
 
Paediatric population 
The safety and efficacy of Edarbi in children and adolescents aged 0 to < 18 years have not yet been 
established. 
No data are available. 
 
Method of administration 
 
Edarbi is for oral use and may be taken with or without food (see section 5.2). 
 
4.3 Contraindications 
 
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
- Second and third trimester of pregnancy (see sections 4.4 and 4.6). 
- The concomitant use of Edarbi with aliskiren-containing products is contraindicated in patients with 

diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.5 and 5.1). 
 
4.4 Special warnings and precautions for use 
 
Activated renin-angiotensin-aldosterone system (RAAS) 
In patients whose vascular tone and renal function depend predominantly on the activity of the RAAS 
(e.g. patients with congestive heart failure, severe renal impairment or renal artery stenosis), treatment 



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with medicinal products that affect this system, such as angiotensin-converting enzyme (ACE) 
inhibitors and angiotensin II receptor antagonists, has been associated with acute hypotension, 
azotaemia, oliguria or, rarely, acute renal failure. The possibility of similar effects cannot be excluded 
with Edarbi.  
 
Caution should be exercised in hypertensive patients with severe renal impairment, congestive heart 
failure or renal artery stenosis, as there is no experience of use of Edarbi in these patients (see 
sections 4.2 and 5.2).  
 
Excessive blood pressure decreases in patients with ischaemic cardiomyopathy or ischaemic 
cerebrovascular disease could result in a myocardial infarction or stroke. 
 
Dual blockade of the 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. 
 
Kidney transplantation  
There is currently no experience on the use of Edarbi in patients who have recently undergone kidney 
transplantation. 
 
Hepatic impairment 
Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not 
recommended in this patient group (see sections 4.2 and 5.2). 
 
Hypotension in volume- and /or salt-depleted patients 
In patients with marked volume- and/or salt-depletion (e.g. patients with vomiting, diarrhoea or taking 
high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with 
Edarbi. Hypovolemia should be corrected prior to administration of Edarbi, or the treatment should 
start under close medical supervision, and consideration can be given to a starting dose of 20 mg. 
 
Primary hyperaldosteronism 
Patients with primary hyperaldosteronism generally will not respond to antihypertensive medicinal 
products acting through inhibition of the RAAS. Therefore, the use of Edarbi is not recommended in 
these patients. 
 
Hyperkalaemia 
Based on experience with the use of other medicinal products that affect the RAAS, concomitant use 
of Edarbi with potassium-sparing diuretics, potassium supplements, salt substitutes containing 
potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to 
increases in serum potassium in hypertensive patients (see section 4.5). In the elderly, in patients with 
renal insufficiency, in diabetic patients and/or in patients with other co-morbidities, the risk of 
hyperkalaemia, which may be fatal, is increased. Monitoring of potassium should be undertaken as 
appropriate. 
 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy  
Special caution is indicated in patients suffering from aortic or mitral valve stenosis, or hypertrophic 
obstructive cardiomyopathy (HOCM). 
 



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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). 
 
Lithium 
As with other angiotensin II receptor antagonists the combination of lithium and Edarbi is not 
recommended (see section 4.5). 
 
Edarbi contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Concomitant use not recommended  
 
Lithium 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concurrent use of lithium and angiotensin-converting enzyme inhibitors. A similar effect may occur 
with angiotensin II receptor antagonists. Due to the lack of experience with concomitant use of 
azilsartan medoxomil and lithium, this combination is not recommended. If the combination proves 
necessary, careful monitoring of serum lithium levels is recommended. 
 
Caution required with concomitant use  
 
Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, 
acetylsalicylic acid (> 3 g/day), and non-selective NSAIDs  
When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective 
COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the 
antihypertensive effect may occur. Furthermore, concomitant use of angiotensin II receptor 
antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase 
in serum potassium. Therefore, adequate hydration and monitoring of renal function at the beginning 
of the treatment are recommended. 
 
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other 
substances that may increase potassium levels  
Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing 
potassium, or other medicinal products (e.g. heparin) may increase potassium levels. Monitoring of 
serum potassium should be undertaken as appropriate (see section 4.4). 
 
Additional information  
 
Clinical trial data has shown that dual blockade of the 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). 
 
No clinically significant interactions have been reported in studies of azilsartan medoxomil or 
azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, 
ketoconazole, metformin, and warfarin. 
 



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Azilsartan medoxomil is rapidly hydrolysed to the active moiety azilsartan by esterases in the 
gastrointestinal tract and/or during drug absorption (see section 5.2). In vitro studies indicated that 
interactions based on esterase inhibition are unlikely. 
 
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 trimester 
of pregnancy (see sections 4.3 and 4.4). 
 
There are no data from the use of azilsartan medoxomil in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). 
 
Epidemiological evidence regarding the risk of teratogenicity following exposure to angiotensin 
converting enzyme inhibitors during the first trimester of pregnancy has not been conclusive; 
however, a small increase in risk cannot be excluded. Whilst there are 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 anti-hypertensive 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). 
 
Breast-feeding  
Because no information is available regarding the use of azilsartan medoxomil during breastfeeding, 
Edarbi is not recommended and alternative treatments with better established safety profiles during 
breastfeeding are preferable, especially while breast-feeding a newborn or preterm infant. 
 
Fertility 
No data are available on the effect of azilsartan medoxomil on human fertility. Nonclinical studies 
demonstrated that azilsartan did not appear to affect male or female fertility in the rat (see 
section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Azilsartan medoxomil has no or negligible influence on the ability to drive and use machines. 
However it should be taken into account that occasionally dizziness or tiredness may occur. 
 



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4.8 Undesirable effects 
 
Summary of the safety profile 
Edarbi at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated 
for up to 56 weeks. In these clinical studies, adverse reactions associated with treatment with Edarbi 
were mostly mild or moderate, with an overall incidence similar to placebo. The most common 
adverse reaction was dizziness. The incidence of adverse reactions with this treatment was not 
affected by gender, age, or race. Adverse reactions were reported at a similar frequency for the Edarbi 
20 mg dose as with the 40 and 80 mg doses in one placebo controlled study. 
 
Tabulated list of adverse reactions 
Adverse reactions based on pooled data (40 and 80 mg doses) are listed below according to system 
organ class and preferred terms. These are ranked by 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), including isolated reports. Within each 
frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

System organ class Frequency  Adverse reaction 
Nervous system disorders Common Dizziness  
Vascular disorders Uncommon Hypotension 
Gastrointestinal disorders Common 

Uncommon 
Diarrhoea 
Nausea 

Skin and subcutaneous tissue 
disorders 

Uncommon 
Rare 

Rash, pruritus 
Angioedema  

Musculoskeletal and 
connective tissue disorders 

Uncommon Muscle spasms 

General disorders and 
administration site conditions 

Uncommon Fatigue 
Peripheral oedema 

Investigations Common 
 
Uncommon 

Blood creatine phosphokinase increased 
 
Blood creatinine increased 
Blood uric acid increased / Hyperuricemia  

 
Description of selected adverse reactions 
When Edarbi was coadministered with chlortalidone, the frequencies of blood creatinine increased 
and hypotension were increased from uncommon to common. 
 
When Edarbi was coadministered with amlodipine, the frequency of peripheral oedema was increased 
from uncommon to common, but was lower than amlodipine alone. 
 
Investigations 
 
Serum creatinine 
The incidence of elevations in serum creatinine following treatment with Edarbi was similar to 
placebo in the randomised placebo-controlled monotherapy studies. Coadministration of Edarbi with 
diuretics, such as chlortalidone, resulted in a greater incidence of creatinine elevations, an observation 
consistent with that of other angiotensin II receptor antagonists and angiotensin converting enzyme 
inhibitors. The elevations in serum creatinine during coadminstiration of Edarbi with diuretics were 
associated with larger blood pressure reductions compared with a single medicinal product. Many of 
these elevations were transient or nonprogressive while subjects continued to receive treatment. 
Following discontinuation of treatment, the majority of the elevations that had not resolved during 
treatment were reversible, with the creatinine levels of most subjects returning to baseline or near-
baseline values. 
 



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Uric acid  
Small mean increases of serum uric acid were observed with Edarbi (10.8 µmol/l) compared with 
placebo (4.3 µmol/l). 
 
Hemoglobin and hematocrit  
Small decreases in hemoglobin and hematocrit (mean decreases of approximately 3 g/l and 1 volume 
percent, respectively) were observed in placebo-controlled monotherapy studies. This effect is also 
seen with other inhibitors of the RAAS. 
 
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 
 
Symptoms 
Based on pharmacological considerations, the main manifestation of an overdose is likely to be 
symptomatic hypotension and dizziness. During controlled clinical studies in healthy subjects, once 
daily doses up to 320 mg of azilsartan medoxomil were administered for 7 days and were well 
tolerated. 
 
Management 
If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs 
monitored. 
 
Azilsartan is not removed by dialysis. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, 
plain, ATC Code: C09CA09. 
 
Mechanism of action 
Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, 
azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the 
AT1 receptor in multiple tissues (see section 5.2). Angiotensin II is the principal pressor agent of the 
RAAS, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, 
cardiac stimulation, and renal reabsorption of sodium. 
 
Blockade of the AT1 receptor inhibits the negative regulatory feedback of angiotensin II on renin 
secretion, but the resulting increases in plasma renin activity and angiotensin II circulating levels do 
not overcome the antihypertensive effect of azilsartan. 
 
Essential hypertension 
In seven double blind controlled studies, a total of 5,941 patients (3,672 given Edarbi, 801 given 
placebo, and 1,468 given active comparator) were evaluated. Overall, 51% of patients were male and 
26% were 65 years or older (5% ≥ 75 years); 67% were white and 19% were black.  
 
Edarbi was compared with placebo and active comparators in two 6 week randomised, double blind 
studies. Blood pressure reductions compared with placebo based on 24 hour mean blood pressure by 
ambulatory blood pressure monitoring (ABPM) and clinic blood pressure measurements at trough are 



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shown in the table below for both studies. Additionally, Edarbi 80 mg resulted in significantly greater 
reductions in SBP than the highest approved doses of olmesartan medoxomil and valsartan. 
 

 Placebo Edarbi 
20 mg 

Edarbi 
40 mg# 

Edarbi 
80 mg# 

OLM-M 
40 mg# 

Valsartan 
320 mg# 

Primary end point: 
24 Hour Mean SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) 
Study 1  
Change from BL -1.4 -12.2 * -13.5 * -14.6 *† -12.6  - 
Study 2  
Change from BL  -0.3  - -13.4 * -14.5 *† -12.0  -10.2  
Key Secondary End Point: 
Clinic SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) (LOCF) 
Study 1  
Change from BL  -2.1  -14.3 * -14.5 * -17.6 * -14.9  - 
Study 2 
Change from BL -1.8  - -16.4 *† -16.7 *† -13.2 -11.3  
OLM-M = olmesartan medoxomil, LS = least squares, LOCF = last observation carried forward 
* Significant difference vs. Placebo at 0.05 level within the framework of the step-wise analysis 
† Significant difference vs. Comparator(s) at 0.05 level within the framework of the step-wise 

analysis 
# Maximum dose achieved in study 2. Doses were force-titrated at Week 2 from 20 to 40 mg 

and 40 to 80 mg for Edarbi, and 20 to 40 mg and 160 to 320 mg, respectively, for olmesartan 
medoxomil and valsartan  

 
In these two studies, clinically important and most common adverse events included dizziness, 
headache and dyslipidemia. For Edarbi, olmesartan medoxomil and valsartan, respectively dizziness 
was observed at an incidence of 3.0%, 3.3% and 1.8%; headache at 4.8%, 5.5% and 7.6% and 
dyslipidemia at 3.5%, 2.4% and 1.1%. 
 
In active-comparator studies with either valsartan or ramipril, the blood-pressure-lowering effect with 
Edarbi was sustained during long-term treatment. Edarbi had a lower incidence of cough (1.2%) 
compared with ramipril (8.2%). 
 
The antihypertensive effect of azilsartan medoxomil occurred within the first 2 weeks of dosing with 
the full effect achieved by 4 weeks. The blood pressure lowering effect of azilsartan medoxomil was 
also maintained throughout the 24 hour dosing interval. The placebo-corrected trough-to-peak ratios 
for SBP and DBP were approximately 80% or higher. 
 
Rebound hypertension was not observed following abrupt cessation of Edarbi therapy after 6 months 
of treatment. 
 
No overall differences in safety and effectiveness were observed between elderly patients and younger 
patients, but greater sensitivity to blood pressure lowering effects in some elderly individuals cannot 
be ruled out (see section 4.2). As with other angiotensin II receptor antagonists and angiotensin 
converting enzyme inhibitors the antihypertensive effect was lower in black patients (usually a low-
renin population). 
 
Coadministration of Edarbi 40 and 80 mg with a calcium channel blocker (amlodipine) or a thiazide-
type diuretic (chlortalidone) resulted in additional blood pressure reductions compared with the other 
antihypertensive alone. Dose dependent adverse events including dizziness, hypotension and serum 
creatinine elevations were more frequent with diuretic coadministration compared with Edarbi alone, 
while hypokalemia was less frequent compared with diuretic alone. 
 



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Beneficial effects of Edarbi on mortality and cardiovascular morbidity and target organ damage are 
currently unknown. 
 
Effect on cardiac repolarisation 
A thorough QT/QTc study was conducted to assess the potential of azilsartan medoxomil to prolong 
the QT/QTc interval in healthy subjects. There was no evidence of QT/QTc prolongation at a dose of 
320 mg of azilsartan medoxomil. 
 
Additional information 
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. 
 
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. 
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. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Edarbi in one or more subsets of the paediatric population in hypertension (see section 4.2 for 
information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Following oral administration, azilsartan medoxomil is rapidly hydrolyzed to the active moiety 
azilsartan in the gastrointestinal tract and/or during absorption. Based on in vitro studies, 
carboxymethylenebutenolidase is involved in the hydrolysis in the intestine and liver. In addition, 
plasma esterases are involved in the hydrolysis of azilsartan medoxomil to azilsartan. 
 
Absorption 
The estimated absolute oral bioavailability of azilsartan medoxomil based on plasma levels of 
azilsartan is approximately 60%. After oral administration of azilsartan medoxomil, peak plasma 
concentrations (Cmax) of azilsartan are reached within 1.5 to 3 hours. Food does not affect the 
bioavailability of azilsartan (see section 4.2). 
 



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Distribution 
The volume of distribution of azilsartan is approximately 16 litres. Azilsartan is highly bound to 
plasma proteins (> 99%), mainly serum albumin. Protein binding is constant at azilsartan plasma 
concentrations well above the range achieved with recommended doses. 
 
Biotransformation 
Azilsartan is metabolised to two primary metabolites. The major metabolite in plasma is formed by O-
dealkylation, referred to as metabolite M-II, and the minor metabolite is formed by decarboxylation, 
referred to as metabolite M-I. Systemic exposures to the major and minor metabolites in humans were 
approximately 50% and less than 1% that of azilsartan, respectively. M-I and M-II do not contribute 
to the pharmacologic activity of azilsartan medoxomil. The major enzyme responsible for azilsartan 
metabolism is CYP2C9. 
 
Elimination 
Following an oral dose of 14C-labelled azilsartan medoxomil, approximately 55% of radioactivity was 
recovered in faeces and approximately 42% in urine, with 15% of the dose excreted in urine as 
azilsartan. The elimination half-life of azilsartan is approximately 11 hours and renal clearance is 
approximately 2.3 ml/min. Steady-state levels of azilsartan are achieved within 5 days and no 
accumulation in plasma occurs with repeated once-daily dosing. 
 
Linearity/non-linearity 
Dose proportionality in exposure was established for azilsartan in the azilsartan medoxomil dose 
range of 20 mg to 320 mg after single or multiple dosing. 
 
Characteristics in specific groups of patients 
 
Paediatric population 
The pharmacokinetics of azilsartan have not been studied in children under 18 years of age. 
 
Older people 
Pharmacokinetics of azilsartan do not differ significantly between young (age range 18-45 years) and 
elderly (age range 65-85 years) patients. 
 
Renal impairment 
In patients with mild, moderate, and severe renal impairment azilsartan total exposure (AUC) was 
+30%, +25% and +95% increased. No increase (+5%) was observed in end-stage renal disease 
patients who were dialysed. However, there is no clinical experience in patients with severe renal 
impairment or end stage renal disease (see section 4.2). Hemodialysis does not remove azilsartan from 
the systemic circulation. 
 
Hepatic impairment 
Administration of Edarbi for up to 5 days in subjects with mild (Child-Pugh A) or moderate 
(Child-Pugh B) hepatic impairment resulted in slight increase in azilsartan exposure (AUC increased 
by 1.3 to 1.6 fold, see section 4.2). Edarbi has not been studied in patients with severe hepatic 
impairment. 
 
Gender 
Pharmacokinetics of azilsartan do not differ significantly between males and females. No dose 
adjustment is necessary based on gender. 
 
Race 
Pharmacokinetics of azilsartan do not differ significantly between black and white populations. No 
dose adjustment is necessary based on race. 
 



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5.3 Preclinical safety data 
 
In preclinical safety studies, azilsartan medoxomil and M-II, the major human metabolite, were 
examined for repeated-dose toxicity, reproduction toxicity, mutagenicity and carcinogenicity. 
 
In the repeated-dose toxicity studies, doses producing exposure comparable to that in the clinical 
therapeutic range caused reduced red cell parameters, changes in the kidney and renal 
haemodynamics, as well as increased serum potassium in normotensive animals. These effects, which 
were prevented by oral saline supplementation, do not have clinical significance in treatment of 
hypertension. 
 
In rats and dogs, increased plasma renin activity and hypertrophy/hyperplasia of the renal 
juxtaglomerular cells were observed. These changes, also a class effect of angiotensin converting 
enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical 
significance. 
 
Azilsartan and M-II crossed the placenta and were found in the fetuses of pregnant rats and were 
excreted into the milk of lactating rats. In the reproduction toxicity studies, there were no effects on 
male or female fertility. There is no evidence of a teratogenic effect, but animal studies indicated 
some hazardous potential to the postnatal development of the offspring such as lower body weight, a 
slight delay in physical development (delayed incisor eruption, pinna detachment, eye opening), and 
higher mortality. 
 
Azilsartan and M-II showed no evidence of mutagenicity and relevant clastogenic activity in in vitro 
studies and no evidence of carcinogenicity in rats and mice. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Mannitol (E 421) 
Fumaric acid (E 297) 
Sodium hydroxide 
Hydroxypropylcellulose (E 463) 
Croscarmellose sodium 
Microcrystalline cellulose (E 460) 
Magnesium stearate (E 572) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Store in the original package in order to protect from light and moisture. 
This medicinal product does not require any special temperature storage conditions. 
 



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6.5 Nature and contents of container 
 
Aluminum blisters 
 
Pack sizes: 
 
14, 28, 56 or 98 tablets; or 
 
Aluminum blisters integrated with desiccant. 
 
Pack sizes: 
 
14, 28, 30, 56, 90 or 98 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Takeda Pharma A/S 
Delta Park 45 
2665 Vallensbaek Strand 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/734/001 14 tablets 
EU/1/11/734/002 28 tablets 
EU/1/11/734/012 30 tablets 
EU/1/11/734/003 56 tablets 
EU/1/11/734/013 90 tablets 
EU/1/11/734/004 98 tablets 
EU/1/11/734/005 14 tablets 
EU/1/11/734/006 28 tablets 
EU/1/11/734/014 30 tablets 
EU/1/11/734/007 56 tablets 
EU/1/11/734/015 90 tablets 
EU/1/11/734/008 98 tablets 
EU/1/11/734/016 14 tablets 
EU/1/11/734/009 28 tablets 
EU/1/11/734/017 30 tablets 
EU/1/11/734/010 56 tablets 
EU/1/11/734/018 90 tablets 
EU/1/11/734/011 98 tablets 
EU/1/11/734/019 14 tablets 
EU/1/11/734/020 28 tablets 
EU/1/11/734/021 56 tablets 
EU/1/11/734/022 98 tablets 
EU/1/11/734/023 14 tablets 
EU/1/11/734/024 28 tablets 
EU/1/11/734/025 56 tablets 



14 

EU/1/11/734/026 98 tablets 
EU/1/11/734/027 14 tablets 
EU/1/11/734/028 28 tablets 
EU/1/11/734/029 56 tablets 
EU/1/11/734/030 98 tablets 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 7 December 2011 
Date of latest renewal:14 November 2016 
 
 
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. 
 
 



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

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 
 



16 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Takeda Ireland Ltd. 
Bray Business Park  
Kilruddery 
Co Wicklow 
Ireland 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs 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 any 
subsequent updates 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) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



19 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Edarbi 20 mg tablets 
azilsartan medoxomil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg azilsartan medoxomil (as potassium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets 
56 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 
 
 



20 

9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 
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 
 
Takeda Pharma A/S 
Delta Park 45 
2665 Vallensbaek Strand 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/734/001 14 tablets 
EU/1/11/734/002 28 tablets 
EU/1/11/734/012 30 tablets 
EU/1/11/734/003 56 tablets 
EU/1/11/734/013 90 tablets 
EU/1/11/734/004 98 tablets 
EU/1/11/734/019 14 tablets 
EU/1/11/734/020 28 tablets 
EU/1/11/734/021 56 tablets 
EU/1/11/734/022 98 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Edarbi 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



21 

 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC {number} 
SN {number} 
NN {number} 
 
 



22 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Edarbi 20 mg tablets 
azilsartan medoxomil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda Logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



23 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Edarbi 40 mg tablets 
azilsartan medoxomil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg azilsartan medoxomil (as potassium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets 
56 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 
 
Store in the original package in order to protect from light and moisture. 



24 

 
 
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 
 
Takeda Pharma A/S 
Delta Park 45 
2665 Vallensbaek Strand 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/734/005 14 tablets 
EU/1/11/734/006 28 tablets 
EU/1/11/734/014 30 tablets 
EU/1/11/734/007 56 tablets 
EU/1/11/734/015 90 tablets 
EU/1/11/734/008 98 tablets 
EU/1/11/734/023 14 tablets 
EU/1/11/734/024 28 tablets 
EU/1/11/734/025 56 tablets 
EU/1/11/734/026 98 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Edarbi 40 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



25 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC {number} 
SN {number} 
NN {number} 
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Edarbi 40 mg tablets 
azilsartan medoxomil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda Logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



26 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Edarbi 80 mg tablets 
azilsartan medoxomil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg azilsartan medoxomil (as potassium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets 
56 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 
 
Store in the original package in order to protect from light and moisture. 



27 

 
 
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 
 
Takeda Pharma A/S 
Delta Park 45 
2665 Vallensbaek Strand 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/734/016 14 tablets 
EU/1/11/734/009 28 tablets 
EU/1/11/734/017 30 tablets 
EU/1/11/734/010 56 tablets 
EU/1/11/734/018 90 tablets 
EU/1/11/734/011 98 tablets 
EU/1/11/734/027 14 tablets 
EU/1/11/734/028 28 tablets 
EU/1/11/734/029 56 tablets 
EU/1/11/734/030 98 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Edarbi 80 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



28 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC {number} 
SN {number} 
NN {number} 
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Edarbi 80 mg tablets 
azilsartan medoxomil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda Logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



30 

Package leaflet: Information for the user 
 

Edarbi 20 mg tablets 
Edarbi 40 mg tablets 
Edarbi 80 mg tablets 
azilsartan medoxomil 

 
 
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 Edarbi is and what it is used for 
2. What you need to know before you take Edarbi 
3. How to take Edarbi 
4. Possible side effects 
5. How to store Edarbi 
6. Contents of the pack and other information 
 
 
1. What Edarbi is and what it is used for 
 
Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of medicines 
called angiotensin II receptor antagonists (AIIRAs). Angiotensin II is a substance which occurs 
naturally in the body and which causes the blood vessels to tighten, therefore increasing your blood 
pressure. Edarbi blocks this effect so that the blood vessels relax, which helps lower your blood 
pressure. 
 
This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 
18 years of age). 
 
A reduction in your blood pressure will be measureable within 2 weeks of initiation of treatment and 
the full effect of your dose will be observed by 4 weeks. 
 
 
2. What you need to know before you take Edarbi 
 
Do NOT take Edarbi if you  
- are allergic to azilsartan medoxomil or any of the other ingredients of this medicine (listed in 

section 6). 
- are more than 3 months pregnant. (It is also better to avoid this medicine in early 

pregnancy - see pregnancy section). 
- have diabetes or impaired kidney function and you are treated with a blood pressure lowering 

medicine containing aliskiren. 
 
Warnings and precautions 
Talk to your doctor before taking Edarbi, especially if you 
- have kidney problems. 
- are on dialysis or had a recent kidney transplant. 
- have severe liver disease. 



31 

- have heart problems (including heart failure, recent heart attack). 
- have ever had a stroke. 
- have low blood pressure or feel dizzy or lightheaded. 
- are vomiting, have recently had severe vomiting, or have diarrhoea. 
- have raised levels of potassium in your blood (as shown in blood tests). 
- have a disease of the adrenal gland called primary hyperaldosteronism. 
- have been told that you have a narrowing of the valves in your heart (called “aortic or mitral 

valve stenosis”) or that the thickness of your heart muscle is abnormally increased (called 
“obstructive hypertrophic cardiomyopathy”). 

- are taking any of the following medicines used to treat high blood pressure: 
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have 

diabetes-related kidney problems. 
o 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 Edarbi”. 
You must tell your doctor if you think you are (or might become) pregnant. Edarbi 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 section "Pregnancy section and 
breast-feeding"). Edarbi may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
There is limited data on the use of Edarbi in children or adolescents under 18 years of age. Therefore, 
this medicine should not be given to children or adolescents. 
 
Other medicines and Edarbi 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Edarbi can affect the way some other medicines work and some medicines can have an effect on 
Edarbi. 
 
In particular, tell your doctor if you are taking any of the following medicines: 
- Lithium (a medicine for mental health problems) 
- Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib 

(medicines to relieve pain and inflammation) 
- Acetylsalicyclic acid if taking more than 3 g per day (medicine to relieve pain and 

inflammation) 
- Medicines that increase the amount of potassium in your blood; these include potassium 

supplements, potassium-sparing medicines (certain ‘water tablets’) or salt substitutes 
containing potassium 

- Heparin (a medicine for thinning the blood) 
- Diuretics (water tablets) 
- Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme 

inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan, 
telmisartan, irbesartan). 

 
Your doctor may need to change your dose and/or to take other precautions if you are taking an 
ACE-inhibitor or aliskiren (see also information under the headings “Do not take Edarbi” and 
“Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 



32 

advise you to stop taking this medicine before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Edarbi. 
Edarbi is not recommended in early 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. Edarbi is not recommended for mothers who are breast-
feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially 
if your baby is newborn, or was born prematurely. 
 
Driving and using machines  
Edarbi is unlikely to have an effect on driving or using machines. However some people may feel 
tired or dizzy when taking this medicine and if this happens to you, do not drive or use any tools or 
machines. 
 
Edarbi contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’. 
 
 
3. How to take Edarbi 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. It is important to keep taking Edarbi every day at the same time. 
Edarbi is for oral use. Take the tablet with plenty of water. 
You can take this medicine with or without food. 
 
- The usual starting dose is 40 mg once a day. Your doctor may increase this dose to a maximum 

of 80 mg once a day depending on blood pressure response. 
- For patients such as the very elderly (75 years and above) your doctor may recommend a lower 

starting dose of 20 mg once a day. 
- If you suffer from mild or moderate liver disease your doctor may recommend a lower starting 

dose of 20 mg once a day. 
- For patients who recently have lost body fluids e.g. through vomiting or diarrhoea, or by taking 

water tablets, your doctor may recommend a lower starting dose of 20 mg once a day. 
- If you suffer from other coexisting illnesses such as severe kidney disease or heart failure your 

doctor will decide on the most appropriate starting dose. 
 
If you take more Edarbi than you should 
If you take too many tablets, or if someone else takes your medicine, contact your doctor immediately. 
You may feel faint or dizzy if you have taken more than you should. 
 
If you forget to take Edarbi 
Do not take a double dose to make up for a forgotten dose. Just take the next dose at the usual time. 
 
If you stop taking Edarbi 
If you stop taking Edarbi, your blood pressure may increase again. Therefore do not stop taking 
Edarbi without first talking to your doctor about alternative treatment options. 
 
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. 
 



33 

Stop taking Edarbi and seek medical help immediately if you have any of the following allergic 
reactions, which occur rarely (may affect up to 1 in 1,000 people): 
- Difficulties in breathing, or swallowing, or swelling of the face, lips, tongue and/or throat 

(angioedema) 
- Itching of the skin with raised lumps. 
 
Other possible side effects include:  
Common side effects (may affect up to 1 in 10 people): 
- Dizziness 
- Diarrhoea 
- Increased blood creatine phosphokinase (an indicator of muscle damage). 

 
Uncommon side effects (may affect up to 1 in 100 people): 
- Low blood pressure, which may make you feel faint or dizzy  
- Feeling tired 
- Swelling of the hands, ankles or feet (peripheral oedema) 
- Skin rash and itching 
- Nausea 
- Muscle spasms 
- Increased serum creatinine in the blood (an indicator of kidney function) 
- Increased uric acid in the blood. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
- Changes in blood test results including decreased levels of a protein in the red blood cells 

(haemoglobin).  
 
When Edarbi is taken with chlortalidone (a water tablet), higher levels of certain chemicals in 
the blood (such as creatinine), which are indicators of kidney function, have been seen 
commonly (in less than 1 in 10 users), and low blood pressure is also common. 
 
Swelling of the hands, ankles or feet is more common (in less than 1 in 10 users) when Edarbi is 
taken with amlodipine (a calcium channel blocker for treating hypertension) than when Edarbi is 
taken alone (less than 1 in 100 users). The frequency of this effect is highest when amlodipine is 
taken alone. 
 
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 Edarbi 
 
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 after EXP. The expiry date 
refers to the last day of the month. 
 
Store Edarbi in the original package in order to protect it from light and moisture. 
This medicine does not require any special temperature storage conditions. 
 
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. 
 
 



34 

6. Contents of the pack and other information 
 
What Edarbi contains  
- The active substance is azilsartan medoxomil (as potassium). 
Edarbi 20 mg: Each tablet contains 20 mg azilsartan medoxomil (as potassium) 
Edarbi 40 mg: Each tablet contains 40 mg azilsartan medoxomil (as potassium) 
Edarbi 80 mg: Each tablet contains 80 mg azilsartan medoxomil (as potassium) 
 
- The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, 

croscarmellose sodium, microcrystalline cellulose, and magnesium stearate. 
 
What Edarbi looks like and contents of the pack 
The tablets are white round debossed with “ASL” on one side and either “20”, “40” or “80” on the 
other. 
Edarbi is provided in blisters with either 14 tablets or 15 tablets in cartons containing 14, 28, 56 or 
98 tablets and blisters integrated with desiccant with either 14 tablets or 15 tablets in cartons 
containing 14, 28, 30, 56, 90 or 98 tablets. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder: 
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark 
 
Manufacturer:  
Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Takeda Belgium 
Tél/Tel: +32 2 464 06 11 
takeda-belgium@takeda.com 
 

Lietuva 
Takeda UAB 
Tel: +370 521 09 070 
 

България 
Такеда България 
Тел.: +359 2 958 27 36; +359 2 958 15 29 
 

Luxembourg/Luxemburg 
Takeda Belgium 
Tél/Tel: +32 2 464 06 11 
takeda-belgium@takeda.com 
 

Česká republika 
Takeda Pharmaceuticals Czech Republic s.r.o 
Tel: +420 234 722 722 
 

Magyarország 
Takeda Pharma Kft. 
Tel.: +361 2707030 
 

Danmark 
Takeda Pharma A/S 
Tlf: +45 46 77 11 11 
 

Malta 
Takeda Italia S.p.A. 
Tel: +39 06 5026 01 
 

Deutschland 
Takeda GmbH 
Tel: +49 (0) 800 825 3325 
medinfoEMEA@takeda.com 
 

Nederland 
Takeda Nederland bv 
Tel: +31 20 203 5492 
medinfoEMEA@takeda.com 



35 

Eesti 
Takeda Pharma AS 
Tel: +372 6177 669 
 

Norge 
Takeda AS 
Tlf: + 47 6676 3030 
infonorge@takeda.com 

 
Ελλάδα 
ΒΙΑΝΕΞ Α.Ε. 
Τηλ: +30 210 80 09 111 120 
 

 
Österreich 
Takeda Pharma Ges.m.b.H. 
Tel: +43 (0) 800-20 80 50 

España 
Takeda Farmacéutica España S.A 
Tel: +34 917 90 42 22 
spain@takeda.com 

Polska 
Takeda Pharma sp. z o.o. 
Tel.: +48 22 608 13 00 
 

 
France 
Takeda France SAS 
Tél: +33 1 40 67 33 00 
medinfoEMEA@takeda.com 
 

 
Portugal 
Tecnimede - Sociedade Técnico-Medicinal, S.A 
Tel: +351 21 041 41 00 
dmed.fv@tecnimede.pt 
 

Hrvatska 
Takeda Pharmaceuticals Croatia d.o.o. 
Tel: +385 1 377 88 96 
 

România 
Takeda Pharmaceuticals SRL 
Tel: +40 21 335 03 91 

Ireland 
Takeda Products Ireland Limited  
Tel: +44 (0) 1628 537 900 
 

Slovenija 
Takeda GmbH, Podružnica Slovenija 
Tel: +386 (0) 59 082 480 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
vistor@vistor.is 
 

Slovenská republika 
Takeda Pharmaceuticals Slovakia s.r.o 
Tel: +421 (2) 20 602 600 
 

Italia 
Takeda Italia S.p.A. 
Tel: +39 06 5026 01 

Suomi/Finland 
Takeda Oy 
Puh/Tel: +358 20 746 5000 
 

Κύπρος 
Takeda Pharma A/S 
Τηλ: +45 46 77 11 11 
 

Sverige 
Takeda Pharma AB 
Tel: + 46 8 731 28 00 
infosweden@takeda.com 
 

Latvija 
Takeda Latvia SIA 
Tel: +371 67840082 
 
 

United Kingdom 
Takeda UK Ltd 
Tel: +44 (0) 1628 537 900 
 

This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
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