qanastek/EMEA-V3 huggingface dataset:
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).
L- effikaċja anti- ipertensiva ta ’ telmisartan hi komparabbli ma ’ dik ta ’ mediċini li jirrappreżentaw kategoriji oħrajn ta ’ prodotti mediċinali kontra l- pressjoni għolja (dan intwera fi provi kliniċi li qabblu telmisartan ma ’ amlodipine, atenolol, enalapril, hydrochlorothiazide, u 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.
Meta l- kura b’ telmisartan titwaqqaf ħesrem, il- pressjoni tad- demm terġa ’ lura għal kif kienet qabel ma bdiet il- kura, fuq perjodu ta ’ diversi ġranet, mingħajr ma ’ jkun hemm ħjiel ta ’ pressjoni għolja rebound.
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.
L- inċidenza totali ta ’ sogħla xotta kienet inqas b’ mod sinifikanti f’ pazjenti kkurati b’ telmisartan milli f’ dawk li ngħataw inibituri ta ’ l- enzimi li jibdlu l- angiotensin, fi provi kliniċi li qabblu direttament iż - żewġ kuri kontra l- pressjoni għolja.
11 The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
L- effetti ta ’ telmisartan fuq il- mortalità u l- morbożità kardjovaskulari għadhom mhumiex magħrufa.
The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Hydrochlorothiazide huwa dijuretiku thiazide Il- mekkaniżmu ta ’ l- effett kontra l- pressjoni għolja ta ’ dijuretiċi thiazides mhuwiex magħruf b’ mod sħiħ.
Thiazides have an effect on the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
It- thiazides għandhom effett fuq il- mekkaniżmi tubulari renali ta ’ l- assorbiment mill- ġdid ta ’ l- elettroliti, u jżidu b’ mod dirett it- tneħħija ta ’ sodium u chloride bejn wieħed u ieħor f’ ammonti ekwivalenti.
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.
L- azzjoni dijuretika ta ’ hydrochlorothiazide tnaqqas il- volum tal- plażma, tgħolli l- attività tar- renin fil- plażma, iżżid it- tnixxija ta ’ aldosterone, b’ żidiet konsegwenti fit- tneħħija tal- potassium u bicarbonate fl- awrina, u tnaqqis fil- potassium fis - serum.
Presumably through blockade of the renin- angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Hu maħsub li permezz ta ’ l- imblukkar tas- sistema renin- angiotensin- aldosterone, l- għoti flimkien ta ’ telmisartan għandu tendenza li jreġġa ’ lura t- telf tal- potassium assoċjat ma ’ dawn id - dijuretiċi.
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.
B’ hydrochlorothiazide, il- bidu tad- dijuresi jibda fi żmien sagħtejn, u l- effett massimu jseħħ wara madwar 4 sigħat, filwaqt li l- azzjoni tippersisti għal madwar 6- 12- il siegħa.
Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Studji epidemjoloġiċi wrew li kura fit- tul b’ hydrochlorothiazide tnaqqas ir- riskju ta ’ mortalità u l - morbożità kardjovaskulari.
The effects of Fixed Dose Combination of telmisartan/ HCTZ on mortality and cardiovascular morbidity are currently unknown.
12 L- effetti tat- taħlita fissa tad- doża ta ’ telmisartan/ HCTZ fuq il- mortalità u l- morbożità kardjovaskulari għadhom mhumiex magħrufa.
Concomitant administration of hydrochlorothiazide and telmisartan does not appear to affect the pharmacokinetics of either substance in healthy subjects.
L- għoti flimkien ta ’ hydrochlorothiazide u telmisartan ma jidhirx li jaffettwa l- farmakokinetika ta ’ l - ebda waħda miż- żewġ mediċini f’ persuni f’ saħħithom.
Following oral administration peak concentrations of telmisartan are reached in 0.5 – 1.5 h after dosing.
Wara l- għoti mill- ħalq, konċentrazzjonijiet massimi ta ’ telmisartan jintlaħqu wara 0. 5 – 1. 5 siegħa wara d- dożaġġ.
The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42% and 58%, respectively.
Il- bijodisponibilità assoluta ta ’ telmisartan f’ doża ta ’ 40 mg u 160 mg kienet ta ’ 42% u 58%, rispettivament.
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.
L- ikel inaqqas ftit il- bijodisponibilità ta ’ telmisartan bi tnaqqis fl- erja taħt il- kurva tal- konċentrazzjoni tal- plażma - ħin (AUC) ta ’ madwar 6% bil- pillola ta ’ 40 mg, u madwar 19% wara doża ta ’ 160 mg.
By 3 hours after administration plasma concentrations are similar whether telmisartan is taken fasting or with food.
Sa 3 sigħat wara l- għoti, il - konċentrazzjonijiet fil- plażma huma simili, kemm jekk telmisartan jittieħed fl- istat sajjem jew ma ’ ikel.
The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
It- tnaqqis żgħir fl- AUC mhux mistenni li jikkawża tnaqqis fl- effikaċja terapewtika.
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.
Il - farmakokinetika ta ’ meta telmisartan jingħata mill- ħalq hi non- lineari f’ dożi minn 20 – 160, b’ żidiet iktar minn proporzjonali tal- konċentrazzjonijiet fil- plażma (Cmax u AUC) b’ dożi li jiżdiedu.
Telmisartan does not accumulate significantly in plasma on repeated administration.
Telmisartan ma jakkumulaz b’ mod sinifikanti fil- plażma meta jingħata ripetutament.
Following oral administration of Kinzalkomb peak concentrations of hydrochlorothiazide are reached in approximately 1.0 – 3.0 hours after dosing.
Wara l- għoti ta ’ Kinzalkomb mill- ħalq, il- konċentrazzjonijiet massimi ta ’ hydrochlorothiazide jintlaħqu wara madwar 1. 0 – 3. 0 sigħat wara d- dożaġġ.
Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60%.
Ibbażat fuq it- tneħħija kumulattiva renali ta ’ hydrochlorothiazide, il- bijodisponibilità assoluta kienet ta ’ madwar 60%.
Telmisartan is highly bound to plasma proteins (> 99.5%) mainly albumin and alpha l- acid glycoprotein.
Telmisartan jeħel ħafna mal- proteini fil- plażma (> 99. 5%), l- aktar ma ’ l- albumina u alpha- 1 acid glycoprotein.
The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Il- volum apparenti tad- distribuzzjoni għal telmisartan hu ta ’ madwar 500 litru, li jindika twaħħil addizzjonali mat- tessut.
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83 – 1.14 l/ kg.
Hydrochlorothiazide jeħel mal- proteini fil- plażma f’ ammont ta ’ 68%, u l- volum apparenti tad - distribuzzjoni hu ta ’ 0. 83- 1. 14 l/ kg.
Biotransformation and elimination:
Bijotrasformazzjoni u eliminazzjoni:
Following either intravenous or oral administration of 14 C-labelled telmisartan most of the administered dose (> 97%) was eliminated in faeces via biliary excretion.
Wara l- għoti ġol- vini jew mill- ħalq ta ’ telmisartan ittikkettat 14C, il- biċċa l- kbira tad- doża li tingħata (> 97%) kienet eliminata fl- ippurgar permezz ta ’ tneħħija biljari.
Only minute amounts were found in urine.
Fl- awrina nstabu biss ammonti żgħar ħafna.
Telmisartan is metabolised by conjugation to form a pharmacologically inactive acylglucuronide.
Telmisartan hu metabolizzat permezz ta ’ konjugazzjoni li tifforma acylglucuronide, li hu farmakoloġikament inattiv.
The glucuronide of the parent compound is the only metabolite that has been identified in humans.
Il- glucuronide tal- kompost ewlieni hu l- uniku metabolit li kien identifikat fil- bniedem.
After a single dose of 14C-labelled telmisartan the glucuronide represents approximately 11% of the measured radioactivity in plasma.
Wara doża waħda ta ’ telmisartan ittikkettat 14 C, il- glucuronide jirrappreżenta madwar 11% tar- radjuattività mkejla fil- plażma.
The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
L- isoenzimi ta ’ ċitokrom P450 mhumiex involuti fil- metaboliżmu ta ’ telmisartan.
Total plasma clearance of telmisartan after oral administration is > 1500 ml/ min.
It- tneħħija totali ta ’ telmisartan mill - plażma wara l- għoti mill- ħalq hi ta ’ 1500 ml/ min.
Terminal elimination half-life was > 20 hours.
Il- half- life tat- tneħħija terminali kienet ta ’ > 20 siegħa.
Hydrochlorothiazide is not metabolised in man and is excreted almost entirely as unchanged substance in urine.
Hydrochlorothiazide ma jkunx metabolizzat fil- bniedem u jitneħħa kważi kollu bħala sustanza mhux mibdula fl- awrina.
About 60% of the oral dose is eliminated as unchanged substance within 48 hours.
Madwar 60% tad- doza orali titneħħa bħala sustanza mhux mibdula fi żmien 48 siegħa.
Renal clearance is about 250 – 300 ml/ min.
Ir- rata ta ’ tneħħija renali hi ta ’ madwar 250- 300 ml/ min.
The terminal elimination half-life of hydrochlorothiazide is 10 – 15 hours.
Il- half- life ta ’ l - eliminazzjoni terminali ta ’ hydrochlorothiazide hi ta ’ 10 – 15- il siegħa.
12 Special populations
Popolazzjonijiet speċjali
Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Il- farmakokinetika ta ’ telmisartan mhumiex differenti bejn pazjenti anzjani u dawk li għandhom inqas minn 65 sena.
Plasma concentrations of telmisartan are generally 2 – 3 times higher in females than in males.
Il- konċentrazzjonijiet ta ’ telmisartan fil- plażma huma ġeneralment 2- 3 darbiet ogħla fin- nisa milli fl- irġiel.
In clinical trials however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women.
Madankollu, fil- provi kliniċi, ma nstabu l- ebda żidiet sinifikanti fin- nisa fir- rispons tal - pressjoni tad- demm, jew fl- inċidenza ta ’ pressjoni baxxa meta wieħed ikun bilwieqfa.
There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
Kien hemm tendenza għal konċentrazzjonijiet ogħla ta ’ hydrochlorothiazide fil- plażma f’ pazjenti nisa milli fl- irġiel.
This is not considered to be of clinical relevance.
Din ma kinitx ikkunsidrata li għandha rilevanza klinika.
Renal excretion does not contribute to the clearance of telmisartan.
L- eliminazzjoni renali ma tikkontribwixxix għat- tneħħija ta ’ 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 dosage adjustment is necessary in patients with decreased renal function.
Ibbażat fuq esperjeza modesta f’ pazjenti b’ indeboliment renali minn ħafif sa moderat (tneħħija tal- krejatinina ta ’ 30- 60 ml/ min, medja ta ’ madwar 50 ml/ min), l- ebda aġġustament fid -
Telmisartan is not removed from blood by haemodialysis.
Telmisartan ma jitneħħiex mid- demm bl - emodijalisi.
In patients with impaired renal function the rate of hydrochlorothiazide elimination is reduced.
F’ pazjenti b’ indeboliment fil- funzjoni renali, ir- rata tat- tneħħija ta ’ hydrochlorothiazide titnaqqas.
In a typical study in patients with a mean creatinine clearance of 90 ml/ min the elimination half-life of hydrochlorothiazide was increased.
Fi studju tipiku f’ pazjenti b’ medja ta ’ tneħħija tal- krejatinina ta ’ 90 ml/ min, il- half- life ta ’ l - eliminazzjoni ta ’ hydrochlorothiazide żdiedet.
In functionally anephric patients the elimination half-life is about 34 hours.
F’ pazjenti li huma funzjonalment aneferiċi, il- half- life ta ’ l- eliminazzjoni hi ta ’ madwar 34 siegħa.
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100%.
Studji farmakokinetiċi f’ pazjenti b’ indeboliment epatiku juru żieda fil- bijodisponibilità assoluta sa kważi 100%.
The elimination half-life is not changed in patients with hepatic impairment.
Il- half- life ta ’ l- eliminazzjoni ma tinbidilx f’ pazjenti b’ indeboliment epatiku.
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.
Fi studji dwar is- sigurtà qabel l- użu kliniku li saru bl- għoti flimkien ta ’ telmisartan u hydrochlorothiazide f’ firien u klieb bi pressjoni tad- demm normali, dożi li pproduċew espożizzjoni komparabbli ma ’ dik fil- medda terapewtika klinika, ma żvelaw l- ebda sejbiet addizzjonali li ma kinux diġà osservati bl- għoti ta ’ kull mediċina waħidha.
The toxicological findings observed appear to have no relevance to human therapeutic use.
Is- sejbiet tossikoloġiċi osservati jidhru li m’ għandhom l- ebda rilevanza għall- użu terapewtiku fil- bniedem.
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.
Is- sejbiet tossikoloġiċi magħrufa sew minn studji li kienu saru qabel l- użu kliniku b’ inibituri ta ’ l - enzimi li jibdlu l- angiotensin u b ’ antagonisti tar- riċetturi ta ’ angiotensin II kienu: tnaqqis fil- parametri taċ- ċelluli l- ħomor (eritroċiti, emoglobina, ematokrit), bidliet ta ’ l- emodinamika renali (żieda fin - nitroġenu ta ’ l- urea fid- demm u krejatinina), żieda fl- attività tar- renin fil- plażma, ipertrofija/ iperplasija taċ- ċelluli juxtaglomerulari, u ħsara mukożali gastrika.
Gastric lesions could be prevented/ ameliorated by oral saline supplementation and group housing of animals.
Il- leżjonijiet gastriċi setgħu jkunu evitati/ jittaffew permezz ta ’ supplimentazzjoni orali ta ’ melħ, kif ukoll billi l- annimali nżammem fi gruppi.
In dogs renal tubular dilation and atrophy were observed.
Fil- klieb, it- twessigħ tubulari renali u l- atrofija kienu osservati.
These findings are considered to be due to the pharmacological activity of telmisartan.
Dawn is- sejbiet huma kkunsidrati li huma minħabba l- attività farmakoloġika ta ’ telmisartan.
Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Telmisartan ma wera l- ebda evidenza ta ’ mutaġeniċità u ta ’ attività klastoġenika rilevanti fi studji in vitro, u l- ebda evidenza ta ’ karċinoġeneċità fil- firien u fil- ġrieden.
Studies with hydrochlorothiazide have shown equivocal evidence for a genotoxic or carcinogenic effect in some experimental models.
Studji b’ hydrochlorothiazide urew evidenza ekwivoka għal effett ġenotossiku jew karċinoġeniku f’ xi mudelli sperimentali.
However, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Madankollu, l- esperjenza estensiva fil- bniedem b’ hydrochlorothiazide ma wrietx rabta bejn l- użu tiegħu u ż- żieda fin- neoplażmi.
For the foetotoxic potential of the telmisartan/ hydrochlorothiazide combination see section 4.6.
Għall- potenzjal fetotossiku tat- taħlita ta ’ telmisartan/ hydrochlorothiazide, ara sezzjoni 4. 6.
6.1 List of excipients
Lista ta ’ sustanzi mhux attivi
Lactose monohydrate Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25)
Lactose monohydrate Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) sorbitol (E420),
13 Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
6. 2.
6.2 Incompatibilities
Inkompatibilitajiet
Aluminium/ aluminium blisters (PA/ Al/ PVC/ Al or PA/ PA/ Al/ PVC/ Al).
Aluminju/ folji ta ’ l- aluminju (PA/ Al/ PVC/ Al jew PA/ PA/ Al/ PVC/ Al).
One blister contains 7 or 10 tablets.
Folja waħda fiha 7 jew 10 pilloli.
Blister with 14, 28, 56, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Folja b’ 14, 28, 56, 90, jew 98 pillola jew folji perforati bid- doża ta ’ l- unità bi 28 x 1 pillola.
Occasionally, the outer layer of the blister pack has been observed to separate from the inner layer between the blister pockets.
Xi kultant, kien osservat li s- saff ta ’ barra tal- pakkett tal- folji jinqala ’ mis- saff ta ’ ġewwa bejn il - pakketti tal- folji.
No action needs to be taken if this is observed.
M’ hemmx bżonn li tittieħed azzjoni jekk jiġri dan.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ:
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
Date of first authorisation:19 April 2002 Date of last renewal:
19 ta ’ April 2002 Data ta ’ l- aħħar tiġdid:
19 April 2007
19 ta ’ April, 2007
Kinzalkomb 80 mg/ 12.5 mg tablets
Kinzalkomb 80 mg/ 12. 5 mg pilloli
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Kull pillola fiha 80 mg ta ’ telmisartan u 12. 5 mg ta ’ hydrochlorothiazide.
Each tablet contains 112 mg of lactose monohydrate and 338 mg sorbitol (E420).
Kull pillola fiha 112 mg ta ’ lactose monohydrate u 338 mg ta ’ sorbitol (E420).
Red and white oval shaped two layer tablet engraved with the code number'H8 '.
Pillola ħamra u bajda b’ żewġ saffi, b’ forma ovali, b’ żewġ saffi, imnaqqxa bin- numru tal- kodiċi 'H8'.
Kinzalkomb fixed dose combination (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
It- taħlita fissa tad- doża ta ’ Kinzalkomb (80 mg telmisartan/ 12. 5 mg ta ’ hydrochlorothiazide) hi indikata għal pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered
Meta jkun klinikament xieraq, bidla diretta minn monoterapija għat- taħlita tista ’ tkun ikkunsidrata.
4.3 Contraindications
16 4. 3 Kontra indikazzjonijiet
15 • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). • Second and third trimester of pregnancy and lactation (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.
• Sensittività eċċessiva għas- sustanzi attivi jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1). • Sensittività eċċessiva għal sustanzi oħrajn derivati minn sulphonamides (għax hydrochlorothiazide hu prodott mediċinali derivat minn sulphonamide). • It- tieni u t- tielet trimestru tat- tqala u t- treddigħ (ara sezzjonijiet 4. 4 u 4. 6).  • Kolestasi u mard ostruttiv tal- marrara. • Indeboliment epatiku sever. • Indeboliment renali sever (rata ta ’ tneħħija ta ’ krejatinina ta ’ < 30 ml/ min). • Ipokalemija refrattarja, iperkalċemija.
Primary aldosteronism:
17 Aldosteroniżmu primarju:
16 Metabolic and endocrine effects:
Effetti metaboliċi u endokrinali:
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia, and hypochloraemic alkalosis).
It- thiazides, inkluż hydrochlorothiazide, jistgħu jikkawżaw żbilanċ fil- fluwidu jew żbilanċ fl- elettroliti (li jinkludi ipokalemija, iponatremija u alkalosi ipokloremika).
Patients with rare hereditary problems of fructose intolerance and/ or with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
18 intolleranza għal galactose, bid- defiċjenza ta ’ Lapp lactase jew b’ assorbiment ħażin ta ’ glucose - galactose, m’ għandhomx jieħdu din il- mediċina.
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.
Bħal fil- każ ta ’ l- antagonisti l- oħrajn kollha tar- riċettur ta ’ angiotensin II, telmisartan jidher li hu inqas effettiv f’ li jbaxxi l- pressjoni tad- demm f’ nies suwed milli f’ nies li mhumiex suwed, possibbilment minħabba l- prevalenza ogħla ta ’ livelli baxxi ta ’ renin fil- popolazzjoni sewda bi pressjoni għolja.
17 Other:
Oħrajn:
Periodic monitoring of serum potassium and ECG is recommended when Kinzalkomb 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.
Monitoraġġ perjodiku tal- livell tal- potassium fis- serum u ECG huma rakkomandati meta Kinzalkomb jingħata ma ’ dawn il - prodotti mediċinali affettwati minn disturbi fil- livell tal- potassium fis- serum (eż. digitalis glycosides, u anti- arritimiċi) u mal- prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti - arritimici), bl- ipokalemija, li hi fattur li jippredisponi t- torsades de pointes.
Antidiabetic medicinal products (oral agents and insulin):
Prodotti mediċinali kontra d- dijabete (mediċini li jittieħdu mill- ħalq u insulina):
In some patients with compromised renal function (eg 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.
F’ xi pazjenti li għandhom il- funzjoni renali kompromessa (eż. pazjenti deidratati jew pazjenti anzjani b’ funzjoni renali kompromessa), l- għoti flimkien ta ’ antagonisti tar- riċettur ta ’ angiotensin II u mediċini li jinibixxu cyclo- oxygenase, jista ’ jirriżulta f’ deterjorament addizzjonali tal- funzjoni renali, li jinkludi l- possibbiltà ta ’ insuffiċjenza akuta renali, li normalment tkun riversibbli.
Cytotoxic agents (e. g. cyclophosphamide, methotrexate):
20 Mediċini ċitotossiċi (eż. cyclophosphamide, methotrexate):
19 Pregnancy (see section 4.3):
Tqala (ara sezzjoni 4. 3):
20 Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni
Hepatobiliary disorders
22 Disturbi fil- fwied u fil- marrara
Rare::
Rari:
Back pain, muscle spasms, myalgia Arthralgia, muscle cramps, pain in limb
Uġigħ fid- dahar, spażmi fil- muskoli, majalġja Artralġja, bugħawwieġ fil- muskoli, uġigħ fir- riġlejn jew fid - dirgħajn
21 Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with Kinzalkomb, even if not observed in clinical trials with this product.
Informazzjoni addizzjonali dwar komponenti individwali L- effetti mhux mixtieqa li kienu rrappurtati qabel b’ wieħed mill- komponenti individwali jistgħu jsaħħu l- effetti mhux mixtieqa b’ Kinzalkomb, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
22 Infections and infestations
Infezzjonijiet u infestazzjonijiet
Gastrointestinal disorders
24 Disturbi gastro- intestinali
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.
L- iktar sintomi prominenti ta ’ doża eċċessiva ta ’ telmisartan kienu pressjoni tad- demm baxxa ħafna u takikardja; bradikardja, sturdament, rimettar, żieda fil- livell tal- krejatinina fis- serum, u insuffiċjenza renali akuta kienu wkoll irrappurtati..
Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis.
Doża eċċessiva b’ hydrochlorothiazide hi marbuta ma ’ tnaqqis fl- elettroliti (ipokalemija, ipokloremija) u ipovolemija li tirriżulta minn dijuresi eċċessiva.
24 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.
Meta l- kura b’ telmisartan titwaqqaf ħesrem, il- pressjoni tad- demm terġa ’ lura għal kif kienet qabel ma bdiet il- kura, fuq perjodu ta ’ diversi ġranet, mingħajr ma ’ jkun hemm ħjiel ta ’ pressjoni għolja rebound.
The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
L- effetti ta ’ telmisartan fuq il- mortalità u l- morbożità kardjovaskulari għadhom mhumiex magħrufa.
The effects of Fixed Dose Combination of telmisartan/ HCTZ on mortality and cardiovascular morbidity are currently unknown.
26 L- effetti tat- taħlita fissa tad- doża ta ’ telmisartan/ HCTZ fuq il- mortalità u l- morbożità kardjovaskulari għadhom mhumiex magħrufa.
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83 – 1.14 1/ kg.
Hydrochlorothiazide jeħel mal- proteini fil- plażma f’ ammont ta ’ 68%, u l- volum apparenti tad - distribuzzjoni hu ta ’ 0. 83- 1. 14 l/ kg.
Lactose monohydrate
Lista ta ’ sustanzi mhux attivi
26 Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Lactose monohydrate Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) sorbitol (E420),
6.4 Special precautions for storage
28 6. 4 Prekawzjonijiet speċjali għall- ħażna
Kinzalkomb 80 mg/ 25 mg tablets
Kinzalkomb 80 mg/ 25 mg pilloli
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Kull pillola fiha 80 mg ta ’ telmisartan u 25 mg ta ’ hydrochlorothiazide.
Each tablet contains 99 mg of lactose monohydrate and 338 mg sorbitol (E420).
Kull pillola fiha 99 mg ta ’ lactose monohydrate u 338 mg ta ’ sorbitol (E420).
Yellow and white oval shaped tablet engraved with the code'H9 '.
Pillola safra u bajda, b’ forma ovali, imnaqqxa bil- kodiċi 'H9'.
Kinzalkomb fixed dose combination (80 mg telmisartan/ 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb 80 mg/ 12.5 mg (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Kinzalkomb taħlita fissa tad- doża (80 mg telmisartan/ 25 mg hydrochlorothiazide) hi indikata f’ pazjenti li pressjoni tad- demm tagħhom ma tkunx ikkontrollata b’ mod adegwat b’ Kinzalkomb 80 mg/ 12. 5 mg (80 mg telmisartan/ 12. 5 mg hydrochlorothiazide) jew f’ pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
Kinzalkomb 80 mg/ 25 mg may be administered in patients whose blood pressure is not adequately controlled by Kinzalkomb 80 mg/ 12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Kinzalkomb 80 mg/ 25 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ Kinzalkomb 80 mg/ 12. 5 mg jew lil pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
Kinzalkomb is also available at the dose strengths 40 mg/ 12.5 mg and 80 mg/ 12.5 mg
Kinzalkomb hu disponibbli wkoll f’ dożi b’ qawwa ta ’ 40 mg/ 12. 5 mg u 80 mg / 12. 5 mg
29 4.3 Contraindications
30 4. 3 Kontra indikazzjonijiet
• Hypersensitivity to any of the active substances or to any of the excipients (see section 6.1). • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). • Second and third trimester of pregnancy and lactation (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.
• Sensittività eċċessiva għas- sustanzi attivi jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1). • Sensittività eċċessiva għal sustanzi oħrajn derivati minn sulphonamides (għax hydrochlorothiazide hu prodott mediċinali derivat minn sulphonamide). • It- tieni u t- tielet trimestru tat- tqala u t- treddigħ (ara sezzjonijiet 4. 4 u 4. 6).  • Kolestasi u mard ostruttiv tal- marrara. • Indeboliment epatiku sever. • Indeboliment renali sever (rata ta ’ tneħħija ta ’ krejatinina ta ’ < 30 ml/ min). • Ipokalemija refrattarja, iperkalċemija.
Primary aldosteronism:
31 Aldosteroniżmu primarju:
30 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Stenosi tal- valv mitrali u aortiku, kardjomijopatija ipertropika ostruttiva:
Metabolic and endocrine effects:
Effetti metaboliċi u endokrinali:
Patients with rare hereditary problems of fructose intolerance and/ or with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
32 intolleranza għal galactose, bid- defiċjenza ta ’ Lapp lactase jew b’ assorbiment ħażin ta ’ glucose - galactose, m’ għandhomx jieħdu din il- mediċina.
31 Ethnic differences:
Differenzi etniċi:
Other:
Oħrajn:
- others (e. g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
- oħrajn (eż. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
32 Other antihypertensive agents:
Mediċini oħrajn kontra l- pressjoni għolja:
Cytotoxic agents (e. g. cyclophosphamide, methotrexate):
34 Mediċini ċitotossiċi (eż. cyclophosphamide, methotrexate):
Based on their pharmacological properties it can be expected that the following medicinal product may potentiate the hypotensive effects of all antihypertensives including telmisartan:
Ibbażat fuq il- proprjetajiet farmakoloġiċi tagħhom, jista ’ jkun mistenni li l- prodotti mediċinali li ġejjin jistgħu jżidu l- effetti ipotensivi tal- mediċini kollha kontra l- pressjoni għolja, li jinkludu telmisartan:
33 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
L- użu ta ’ atagonisti tar- riċetturi ta ’ angiotensin II mhuwiex rakkomandat matul l- ewwel trimestru tat - tqala (ara sezzjoni 4. 4).
Pregnancy (see section 4.3):
Tqala (ara sezzjoni 4. 3):
Fixed Dose Combination The overall incidence and pattern of adverse events reported with Kinzalkomb 80 mg/ 25 mg was comparable with Kinzalkomb 80 mg/ 12.5 mg.
Taħlita Fissa tad- Doża L- inċidenza totali u l- andament ta ’ l- avvenimenti avversi rrappurtati b’ Kinzalkomb 80 mg/ 25 mg kienu komparabbli ma ’ dawk b’ Kinzalkomb 80 mg/ 12. 5 mg.
A dose-relationship of undesirable effects was not established and they showed no correlation with gender, age or race of the patients.
35 assoċjati mad- doża ma ’ kinitx stabbilita, u l- effetti ma wrew l- ebda korrelazzjoni mas- sess, ma ’ l- età, jew mar- razza tal- pazjenti.
34 Infections and infestations
Infezzjonijiet u infestazzjonijiet
Dizziness Syncope, paraesthesia Insomnia, sleep disorders
Sturdament Sinkope, parestesija Nuqqas ta ’ rqad, disturb fl- irqad
Diarrhoea, dry mouth, flatulence Abdominal pain, constipation, dyspepsia, vomiting Gastritis
Dijarea, ħalq xott, gass, Uġigħ addominali, stitikezza, dispepsja, rimettar Gastrite
Hepatobiliary disorders
36 Disturbi fil- fwied u fil- marrara
35 Investigations
Investigazzjonijiet
Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with Kinzalkomb, even if not observed in clinical trials with this product.
Informazzjoni addizzjonali dwar komponenti individwali L- effetti mhux mixtieqa li kienu rrappurtati qabel b’ wieħed mill- komponenti individwali jistgħu jsaħħu l- effetti mhux mixtieqa b’ Kinzalkomb, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
Upper respiratory tract infection, urinary tract infection including cystitis)
Infezzjoni fil- parti ta ’ fuq tal- apparat respiratorju, infezzjoni fl - apparat tal- awrina li tinkludi ċistite
Anaemia aplastic, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis, thrombocytopenia
Anemija aplastika, anemija emolitika, insuffiċjenza fil - funzjoni tal- mudullun, lewkopenja, newtropenija, agranuloċitosi, tromboċitopenija
Not known:
Mhux magħrufa
Kinzalkomb is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
39 Kinzalkomb hu taħlita ta ’ antagonist tar- riċetturi ta ’ angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Din it- taħlita ta ’ dawn l- ingredjenti għandha effett miżjud kontra l- pressjoni għolja, u tbaxxi l- pressjoni tad- demm iktar milli kieku jingħata xi komponent wieħed biss.
38 In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
F’ pazjenti bi pressjoni għolja, telmisartan inaqqas kemm il- pressjoni sistolika kif ukoll dik dijastolika, mingħajr ma jaffettwa r- rata tal- polz.
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 (SBP/ DBP) was demonstrated (difference in adjusted mean changes from baseline).
Fi prova klinika kkontrollata double blind (n=687 pazjenti evalwati għall- effikaċja) f’ dawk li ma rrispondewx għat- taħlita ta ’ 80 mg/ 12. 5 mg, intwera effett inkrementali li jnaqqas il- pressjoni tad - demm tat- taħlita ta ’ 80 mg/ 25 mg meta mqabbel mal- kura li tkompliet bit- taħlita ta ’ 80 mg/ 12. 5 mg, ta ’ 2. 7/ 1. 6 mm Hg (SBP/ DBP) (differenza fil- medja tat- tibdiliet aġġustati mil- linja bażi).
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).
Fi prova follow- up bit- taħlita 80 mg/ 25 mg, il- pressjoni tad- demm tnaqqset b’ mod ulterjuri (u rriżultat fi tnaqqis totali ta ’ 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=2121 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.
F’ analiżi pooled ta ’ provi kliniċi, ikkontrollati bil- plaċebo u double- blind vs. valsartan/ hydrochlorothiazide 160 mg/ 25 mg (n=2121 pazjenti evalwati għall- effikaċja), intwera effett li jbaxxi l- pressjoni tad- demma li kien akbar b’ mod sinifikanti, ta ’ 2. 2/ 1. 2 mm Hg (SBP/ DBP) (differenza fil- medja tat- tibdiliet aġġustati mil- linja bażi) favur it- taħlita ta ’ telmisartan/ hydrochlorothiazide 80 mg/ 25 mg.
The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
40 Hydrochlorothiazide huwa dijuretiku thiazide Il- mekkaniżmu ta ’ l- effett kontra l- pressjoni għolja ta ’ dijuretiċi thiazides mhuwiex magħruf b’ mod sħiħ.
The effects of Fixed Dose Combination of telmisartan/ HCTZ on mortality and cardiovascular morbidity are currently unknown.
L- effetti tat- taħlita fissa tad- doża ta ’ telmisartan/ HCTZ fuq il- mortalità u l- morbożità kardjovaskulari għadhom mhumiex magħrufa.
Special populations
41 Popolazzjonijiet speċjali
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 dosage adjustment is necessary in patients with decreased renal function.
Ibbażat fuq esperjeza modesta f’ pazjenti b’ indeboliment renali minn ħafif sa moderat (tneħħija tal- krejatinina ta ’ 30- 60 ml/ min, medja ta ’ madwar 50 ml/ min), l- ebda aġġustament fid - dożaġġ mhu meħtieġ f’ pazjenti b’ funzjoni renali mnaqqsa.
No additional preclinical studies have been performed with the Fixed Dose Combination product 80 mg/ 25 mg.
Ma saru l- ebda studji kliniċi addizzjonali bil- prodott tat- Taħlita Fissa tad- Doża ta ’ 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.
Fi studji dwar is- sigurtà qabel l- użu kliniku li saru bl- għoti flimkien ta ’ telmisartan u hydrochlorothiazide f’ firien u klieb bi pressjoni tad- demm normali, dożi li pproduċew espożizzjoni komparabbli ma ’ dik fil- medda terapewtika klinika, ma żvelaw l- ebda sejbiet addizzjonali li ma kinux diġà osservati bl - għoti ta ’ kull mediċina waħidha.
40 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.
Is- sejbiet tossikoloġiċi magħrufa sew minn studji li kienu saru qabel l- użu kliniku b’ inibituri ta ’ l - enzimi li jibdlu l- angiotensin u b ’ antagonisti tar- riċetturi ta ’ angiotensin II kienu: tnaqqis fil- parametri taċ- ċelluli l- ħomor (eritroċiti, emoglobina, ematokrit), bidliet ta ’ l- emodinamika renali (żieda fin - nitroġenu ta ’ l- urea fid- demm u krejatinina), żieda fl- attività tar- renin fil- plażma, ipertrofija/ iperplasija taċ- ċelluli juxtaglomerulari, u ħsara mukożali gastrika.
Lactose monohydrate Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Yellow ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
42 Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Yellow ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) sorbitol (E420),
Pack sizes: blister with 14, 28, 56, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets
Folja b’ 14, 28, 56, jew 98 pillola jew folji perforati bid- doża ta ’ l- unità bi 28 x 1 pillola.
42 ANNEX II
44 ANNESS II
43 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
45 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 6.1, 02 July 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni tal- Manifattura jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 6. 1, tat- 2 ta ’ Lulju, 2007, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jibda jinbiegħ.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0, 30 March 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni tal- Manifattura jrid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 1. 0 tat - 30 ta ’ Marzu, 2007, tal- Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju. • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
44 ANNEX III
46 ANNESS III
Carton
Kartuna
Kinzalkomb 40 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
Kinzalkomb 40 mg/ 12. 5 mg pilloli telmisartan/ hydrochlorothiazide
Contains lactose monohydrate and sorbitol (E420).
Fih lactose monohydrate u sorbitol (E420).
Read the package leaflet for further information.
Aqra l- fuljett ta ’ tagħrif għal aktar informazzjoni.
14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
14- il pillola 28 pillola 56 pillola 98 pillola 28 x 1 pillola
14 tablets 28 tablets 28 x 1 unit dose tablets 56 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola tad- doża ta ’ l- unità 56 pillola 98 pillola
< Batch > {number}
< Lott > {numru}
Kinzalkomb 40 mg/ 12.5 mg
Kinzalkomb 40 mg/ 12. 5 mg
48 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister of 7 tablets
Folja b’ 7 pilloli
< Lot > {number}
< Lott > {numru}
MON TUE WED THU FRI SAT SUN
TNEJN TLIETA ERBGĦA ĦAMIS ĠIMGĦA SIBT ĦADD
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Unit dose blister (28x1 tablets pack) or any non 7 count blister
Folja tad- doża ta ’ l- unità (pakkett ta ’ 28x1 pillola) jew kwalunkwe folja li biha ma tistax tgħodd 7 darbiet
Kinzalkomb 80 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
Kinzalkomb 80 mg/ 12. 5 mg pilloli telmisartan/ hydrochlorothiazide
51 This medicinal product does not require any special storage conditions.
53 Dan il- prodott mediċinali m’ għandux bżonn ħażna speċjali.
14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola 56 pillola 98 pillola
Kinzalkomb 80 mg/ 12.5 mg
Kinzalkomb 80 mg/ 12. 5 mg pilloli
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
54 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
56 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Kinzalkomb 80 mg/ 25 mg tablets telmisartan/ hydrochlorothiazide
Kinzalkomb 80 mg/ 25 mg pilloli telmisartan/ hydrochlorothiazide
55 This medicinal product does not require any special storage conditions.
57 Dan il- prodott mediċinali m’ għandux bżonn ħażna speċjali.
Kinzalkomb 80 mg/ 25 mg
Kinzalkomb 80 mg/ 25 mg pilloli
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
59 PACKAGE LEAFLET:
61 FULJETT TA ’ TAGĦRIF:
What Kinzalkomb is and what it is used for 2.
X’ inhu Kinzalkomb u għalxiex jintuża 2.
Before you take Kinzalkomb 3.
Qabel ma tieħu Kinzalkomb 3.
How to take Kinzalkomb 4.
Kif għandek tieħu Kinzalkomb 4.
How to store Kinzalkomb 6.
Kif taħżen Kinzalkomb 6.
WHAT KINZALKOMB IS AND WHAT IT IS USED FOR
X’ INHU KINZALKOMB U GĦALXIEX JINTUŻA
Kinzalkomb is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Kinzalkomb hu taħlita ta ’ żewġ sustanzi attivi, telmisartan u hydrochlorothiazide f’ pillola waħda.
Both of these substances help to control high blood pressure.
Dawn iż- żewġ sustanzi jgħinu biex jikkontrollaw il- pressjoni tad- demm għolja.
- Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
- Telmisartan jagħmel parti minn grupp ta ’ mediċini li jissejħu antagonisti tar- riċetturi ta ’
Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure.
Angiotensin- II hu sustanza magħmula fil- ġisem tiegħek li tikkawża li l - vini/ arterji tad- demm jidjiequ, u b’ hekk tiżdied il- pressjoni tad- demm.
Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Telmisartan jimblokka l- effett ta ’ angiotensin II biex b’ hekk il- vini u l- arterji jitwessgħu, u l- pressjoni tad- demm tonqos.
- Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause
- Hydrochlorothiazide jagħmel parti minn grupp ta ’ mediċini msejħa dijuretiċi thiazide, li
your urine output to increase, leading to a lowering of your blood pressure.
jikkawżaw żieda fl- ammont ta ’ l- awrina, u dan iwassal għal tnaqqis fil- pressjoni tad- demm tiegħek.
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.
Jekk il- pressjoni tad- demm għolja ma tkunx ikkurata, tista ’ tagħmel ħsara lill- vini jew arterji f’ diversi organi, u dan xi kultant jista ’ jwassal għal attakk qalb, insuffiċjenza tal- kliewi jew tal- qalb, puplesija, jew li wieħed jagħma.
There are usually no symptoms of high blood pressure before damage occurs.
Ġeneralment ma jkunx hemm sintomi ta ’ pressjoni tad- demm għolja qabel ma ssir il- ħsara.
Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Għaldaqstant hu importanti li tkejjel il- pressjoni tad- demm regolarment biex tivverifika li qiegħda fil- medda normali.
Kinzalkomb is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not controlled enough when either telmisartan or hydrochlorothiazide is used alone.
Kinzalkomb jintuża għall- kura ta ’ pressjoni tad- demm għolja (pressjoni għolja essenzjali) f’ pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata biżżejjed meta jew telmisartan jew hydrochlorothiazide jintużaw waħidhom.
BEFORE YOU TAKE KINZALKOMB
QABEL MA ’ TIEĦU KINZALKOMB
Do not take Kinzalkomb
Tiħux Kinzalkomb
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Kinzalkomb tablets (see "Further information" for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder) or any other severe liver disease.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew għal xi sustanzi oħra fil- pilloli Kinzalkomb (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra).