qanastek/EMEA-V3 huggingface dataset:
The marketing authorisation holder is Bayer Healthcare AG.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Bayer Healthcare AG.
The full EPAR for Kinzalmono is available here.
L- EPAR sħiħ għal Kinzalmono jista ’ jiġi kkonsultat hawn.
Kinzalmono 20 mg tablets
Kinzalmono 20 mg pilloli
Each tablet contains 20 mg telmisartan.
Kull pillola fiha 20 mg telmisartan.
Each tablet contains 84 mg sorbitol (E420).
Kull pillola fiha 84 mg ta ’ sorbitol (E420).
White round tablets engraved with the code number '50H 'on one side and the company logo on the other side.
Pilloli bojod tondi li fuqhom hemm imnaqqax in- numru tal- kodiċi ‘ 50H ’ fuq naħa waħda u l- logo tal - kumpanija fuq in- naħa l- oħra.
Treatment of essential hypertension in adults.
Il- kura ta ’ pressjoni tad- demm għolja essenzjali fl- adulti.
The usually effective dose is 40 mg once daily.
Id- doża effettiva normalment hi ta ’ 40 mg darba kuljum.
Some patients may already benefit at a daily dose of 20 mg.
Xi pazjenti jistgħu jibbenefikaw anke b’ doża ta ’ 20 mg kuljum.
In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily.
F’ każijiet fejn il- pressjoni ta ’ demm fil- mira ma tintlaħaqx, id- doża ta ’ telmisartan tista ’ tiżdied għal massimu ta ’ 80 mg darba kuljum.
Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan.
Inkella, telmisartan jista ’ jintuża flimkien ma ’ tipi ta ’ dijuretiċi tat- tip thiazide, bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il- pressjoni tad- demm b’ telmisartan.
When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1).
Meta wieħed jikkunsidra li jżid id- doża, irid iżomm f’ moħħu li l - effett anti- ipertensiv ġeneralament jintlaħaq wara minn erba ’ sa tmien ġimgħat mill- bidu tal- kura (ara sezzjoni 5. 1).
Telmisartan may be taken with or without food.
Telmisartan jista ’ jittieħed mal- ikel jew mingħajr l- ikel.
No posology adjustment is required for patients with mild to moderate renal impairment.
M’ hemmx bżonn ta ’ aġġustament fil- pożoloġija għal pazjenti li għandhom indeboliment renali minn ħafif sa moderat.
Limited experience is available in patients with severe renal impairment or haemodialysis.
Hemm esperjenza limitata disponibbli f’ pazjenti b’ indeboliment sever renali li qegħdin fuq l- emodijalisi.
A lower starting dose of 20 mg is recommended in these patients (see section 4.4).
Doża tal- bidu aktar baxxa ta ’ 20 mg hi rakkomandata f’ dawn il- pazjenti (ara sezzjoni 4. 4).
In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).
F’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat, il- pożoloġija m’ għandhiex taqbeż 40 mg darba kuljum (ara sezzjoni 4. 4).
Elderly No dose adjustment is necessary for elderly patients.
Anzjani L- ebda aġġustament fid- doża mhu meħtieġ għal pazjenti anzjani.
Paediatric patients Kinzalmono is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pazjenti pedjatriċi Kinzalmono mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is- sigurtà u l- effikaċja.
2 • Second and third trimester of pregnancy (see sections 4.4 and 4.6) • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1) • It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Disturbi ostruttivi biljari • Indeboliment sever epatiku
Angiotensin II receptor antagonists should not be initiated during pregnancy.
Antagonisti tar- riċetturi ta ’ angiotensin II m’ għandhomx jinbdew waqt it- tqala.
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.
Ħlief jekk it- tkomplija tal- kura bl- antagonisti tar- riċetturi ta ’ angiotensin II tkun ikkunsidrata li hi essenzjali, il- pazjenti li jkunu qed jippjanaw li joħorġu tqal għandha tinbidlilhom il- kura għal waħda b’ kura alternattiva b’ mediċini kontra l- pressjoni għolja li għandhom profil tas- sigurtà stabbilit għall- użu fit- tqala.
Kinzalmono is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Kinzalmono m’ għandux jingħata lil pazjenti b’ kolestasi, b’ disturbi ostruttivi tal- marrara jew li għandhom indeboliment sever epatiku (ara sezzjoni 4. 3), għax telmisartan huwa eliminat fil- biċċa l - kbira tiegħu mal- bili.
These patients can be expected to have reduced hepatic clearance for telmisartan.
Jista ’ jkun mistenni li dawn il- pazjenti jkollhom rata ta ’ tneħħija epatika mnaqqsa għal telmisartan.
Kinzalmono should be used only with caution in patients with mild to moderate hepatic impairment.
Kinzalmono għandu jintuża biss bl- attenzjoni f’ pazjenti li għandhom indeboliment epatiku minn ħafif sa moderat.
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Hemm riskju miżjud ta ’ pressjoni baxxa ħafna severa u insuffiċjenza renali meta pazjenti bi stenosi bilaterali fl- arterja renali jew bi stenosi ta ’ l- arterja għal kilwa waħda li tkun taħdem, ikunu kkurati bi prodotti mediċinali li jaffettwaw is- sistema renin- angiotensin- aldosterone.
Renal impairment and kidney transplantation:
Indeboliment renali u trapjant renali:
When Kinzalmono is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Meta Kinzalmono jintuża f’ pazjenti li għandhom indeboliment fil- funzjoni renali, monitoraġġ perjodiku tal- livelli tal- potassium u tal- krejatinina tas- serum hu rakkomandat.
There is no experience regarding the administration of Kinzalmono in patients with recent kidney transplantation.
M’ hemmx esperjenza dwar l- għoti ta ’ Kinzalmono f’ pazjenti bi trapjant renali riċenti.
Symptomatic hypotension, especially after the first dose of Kinzalmono, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pressjoni baxxa ħafna sintomatika, speċjalment wara l- ewwel doża ta ’ Kinzalmono, tista ’ sseħħ f’ pazjenti li għandhom volum u/ jew sodium li jkun tnaqqas minn terapija dijuretika vigoruża, restrizzjoni tal- melħ fid- dieta, dijarea jew rimettar.
Such conditions should be corrected before the administration of Kinzalmono.
Dawn il- kundizzjonijiet għandhom jiġu kkoreġuti qabel l- għoti ta ’ Kinzalmono.
Volume and/ or sodium depletion should be corrected prior to administration of Kinzalmono.
It- tnaqqis tal- volum u/ jew tas- sodium għandu jiġi kkoreġut qabel l- għoti ta ’ Kinzalmono.
Dual blockade of the renin-angiotensin-aldosterone system:
Imblokk doppju tas- sistema renin- angiotensin- aldosterone:
As a consequence of inhibiting the renin- angiotensin-aldosterone system, hypotension and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.
Bħala konsegwenza tal- inibizzjoni tas - sistema renin- angiotensin- aldosterone, pressjoni baxxa u tibdil fil- funzjoni renali (li jinkludi insuffiċjenza renali akuta) kienu rrappurtati f’ individwi suxxettibbli, speċjalment jekk jingħataw flimkien prodotti mediċinali li jaffettwaw din is- sistema.
Dual blockade of the renin-angiotensin-aldosterone system (e. g. by adding an ACE- inhibitor to an angiotensin II receptor antagonist) is therefore not recommended in patients with already controlled blood pressure and should be limited to individually defined cases with close monitoring of renal function.
L- imblokk doppju tas- sistema renin - angiotensin- aldosterone (eż. billi żżid inibitur ACE ma ’ antagonist tar- riċettur ta ’ angiotensin II) għalhekk mhuwiex rakkomandat f’ pazjenti li diġà għandhom pressjoni tad- demm ikkontrollata u għandu jkun limitat għal każijiet li huma individwalment definiti, b’ monitoraġġ mill- qrib tal- funzjoni renali.
In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
F’ pazjenti fejn it- ton vaskulari u l- funzjoni renali jiddependu b’ mod predominanti mill- attività tas - sistema renin- angiotensin- aldosterone (eż. pazjenti b’ insuffiċjenza konġestiva severa tal- qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta ’ l- arterja renali), il- kura bi prodotti mediċinali
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Pazjenti b’ aldosteroniżmu primarju ġeneralment mhux ser jirrispondu għal prodotti mediċinali kontra l- pressjoni għolja li jaġixxu permezz ta ’ l- inibizzjoni tas- sistema renin- angiotensin.
Therefore, the use of telmisartan is not recommended.
Għalhekk, l- użu ta ’ telmisartan mhuwiex rakkomandat.
3 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Stenosi tal- valv mitrali u aortiku, kardjomijopatija ipertropika ostruttiva:
Hyperkalaemia:
Iperkalemija:
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
L- użu ta ’ prodotti mediċinali li jaffettwaw is- sistema renin- angiotensin- aldosterone, jista ’ jikkawża l - iperkalemija.
In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/ or in patients with intercurrent events, hyperkalaemia may be fatal.
Fl- anzjani, f’ pazjenti b’ insuffiċjenza renali, f’ pazjenti dijabetiċi, f’ pazjenti li jkunu kkurati fl- istess ħin bi prodotti mediċinali oħrajn li jistgħu jżidu l- livelli tal- potassium, u/ jew f’ pazjenti b’ avvenimenti interkurrenti, l- iperkalemija tista ’ tkun fatali.
Before considering the concomitant use of medicinal products that affect the renin-angiotensin- aldosterone system, the benefit risk ratio should be evaluated.
Qabel tikkunsidra l- użu fl- istess ħin ta ’ prodotti mediċinali li jaffettwaw is- sistema renin- angiotensin - aldosterone, il- proporzjon tal- benefiċċju/ riskju għandu jkun evalwat.
The main risk factors for hyperkalaemia to be considered are:
Il- fatturi ewlenin tar- riskju għall- iperkalemija li għandhom ikunu kkunsidrati huma:
- Diabetes mellitus, renal impairment, age (> 70 years)
- Dijabete mellitus, indeboliment renali, età (> 70 sena)
- Combination with one or more other medicinal products that affect the renin-angiotensin-
- Kumbinazzjoni ma ’ prodott mediċinali wieħed jew aktar li jaffettwaw is- sistema renin -
aldosterone system and/ or potassium supplements.
angiotensin- aldosterone u/ jew is- supplimenti tal- potassium.
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Prodotti mediċinali jew klassijiet terapewtiċi ta ’ prodotti mediċinali li jistgħu jikkawżaw l- iperkalemija huma sostituti tal- melħ li fihom il- potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar - riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim.
- Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic
- Avvenimenti interkurrenti, b’ mod partikulari d- deidrazzjoni, dikumpensazzjoni akuta
acidosis, worsening of renal function, sudden worsening of the renal condition (e. g. infectious diseases), cellular lysis (e. g. acute limb ischemia, rhabdomyolysis, extend trauma).
kardijaka, aċidożi metabolika, funzjoni renali li tmur għall- agħar, kundizzjoni renali li tmur għall- agħar għal għarrieda (eż. mard infettiv), lisi ċellulari (eż. iskemija akuta fir- riġlejn jew fid- dirgħajn, rabdomijolosi, estensjoni tat- trawma).
Close monitoring of serum potassium in at risk patients is recommended (see section 4.5).
Monitoraġġ mill- qrib tal- potassium fis- serum f’ pazjenti li qegħdin f’ riskju hu rakkomandat (ara sezzjoni 4. 5).
This medicinal product contains sorbitol (E420).
Dan il- prodott mediċinali fih is- sorbitol (E420).
Patients with rare hereditary problems of fructose intolerance should not take Kinzalmono.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall- fructose m’ għandhomx jieħdu Kinzalmono.
As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Bħal fil- każ ta ’ inibituri ta ’ l- enzimi li jibdlu angiotensin, telmisartan u l- antagonisti l- oħrajn tar - riċettur ta ’ angiotensin II, jidher li huma anqas effettivi li jbaxxu 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.
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Bħal kull mediċina kontra l- pressjoni għolja, it- tnaqqis eċċessiv fil- pressjoni tad- demm f’ pazjenti b’ kardjopatija iskemika jew b’ mard karjovaskulari iskemiku, jista ’ jirriżulta f’ infart mijokardijaku jew puplesija.
Interaction studies have only been performed in adults.
L- istudji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott, saru biss fuq l- adulti.
As with others drugs acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
Bħal mediċini oħrajn li jaġixxu fuq is- sistema renin- angiotensin- aldosterone, telmisartan jista ’ jikkawża l- iperkalemija (ara sezzjoni 4. 4).
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti- inflammatory drugs (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Ir- riskju jista ’ jiżdied f’ każ li l- kura tingħata flimkien ma ’ prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l- iperkalemija (sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar- riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
The occurrence of hyperkalaemia depends on associated risk factors.
L- okkorrenza ta ’ l- iperkalemija tiddependi fuq fatturi marbuta mar- riskju.
The risk is increased in case of the above-mentioned treatment combinations.
Ir- riskju jiżdied f’ każ tal - kumbinazzjonijiet tal- kura msemmija hawn fuq.
A
Ir- riskju hu partikularment għoli flimkien ma ’ dijuretiċi li ma jneħħux potassium, u meta jkunu kombinati ma ’ sostituti tal- melħ li fihom il - potassium.
4 combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.
Kumbinazzjoni ma ’ inibituri ta ’ ACE jew NSAIDs, pereżempju, tirriżulta f’ anqas riskju, bil- patt li l- prekawzjonijiet għall- użu jkunu segwiti b’ mod strett.
Concomitant use not recommended
L- użu fl- istess ħin mhuwiex rakkomandat
Potassium sparing diuretics or potassium supplements:
Dijuretiċi li ma jneħħux potassium jew supplimenti tal- potassium:
Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Telf ta ’ potassium ikkaġunat minn dijuretiċi huwa attenwat mill- antagonisti tar- riċettur ta ’ angiotensin II bħal telmisartan.
Potassium sparing diuretics e. g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
Dijuretiċi li ma jneħħux potassium, eż. spirinolactone, eplerenone, triamterene, jew amiloride, supplimenti tal- potassium, jew sostituti tal- melħ li fihom il- potassium jistgħu jwasslu għal żieda sinifikanti fil- potassium fis- serum.
If concomitant use is indicated because of documented hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
Jekk l- użu fl- istess ħin ikun indikat minħabba li jkun hemm ipokalemija dokumentata, dawn għandhom jintużaw bl- attenzjoni u b’ monitoraġġ frekwenti tal - potassium fis- serum.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Żidiet riversibbli fil- konċentrazzjonijiet tal- lithium fis- serum u t- tossiċità kienu rrappurtati waqt l - għoti fl- istess ħin ta ’ lithium ma ’ inibituri ta ’ l- enzimi li jibdlu l- angiotensin, u, mal- antagonisti tar - riċettur ta ’ angiotensin II, li jinkludu telmisartan.
If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Jekk l- użu ta ’ din il- kumbinazzjoni jkun meħtieġ, monitoraġġ bl- attenzjoni tal- livelli tal- lithium fis- serum hu rakkomandat.
Concomitant use requiring caution
L- użu fl- istess ħin li jeħtieġ l- attenzjoni
NSAIDs (i. e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non- selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
NSAIDs (i. e. acetylsalicylic acid f’ korsijiet tad- dożaġġ kontra l- infjammazzjoni, inibituri COX- 2 u NSAIDs mhux selettivi) jistgħu jnaqqsu l- effett kontra l- pressjoni għolja ta ’ l- antagonisti tar- riċettur ta ’ angiotensin II.
In some patients with compromised renal function (e. g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
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.
Therefore, the combination should be administered with caution, especially in the elderly.
Għalhekk, din il - kumbinazzjoni ta ’ mediċini għandha tingħata bl- attenzjoni, speċjalment lil persuni anzjani.
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Il- pazjenti għandhom jingħataw l- ilma b’ mod adegwat u għandha tingħata konsiderazzjoni lill- monitoraġġ tal - funzjoni renali wara l- bidu ta ’ terapija fl- istess ħin u perjodikament wara dan.
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Fi studju wieħed, l- għoti flimkien ta ’ telmisartan u ramipril wassal għal żieda ta ’ sa 2. 5 darbiet fl - AUC0- 24 u s- Cmax ta ’ ramipril u ramiprilat.
The clinical relevance of this observation is not known.
Ir- rilevanza klinika ta ’ din l- osservazzjoni mhijiex magħrufa.
Diuretics (thiazide or loop diuretics):
Dijuretiċi (thiazide jew dijuretiċi loop):
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Il- kura fil- passat b’ dożi qawwija ta ’ dijuretiċi bħal furosemide (dijuretiku loop) u hydrochlorothiazide (dijuretiku thiazide) tista ’ tirriżulta fi tnaqqis tal- volum u f’ riskju ta ’ pressjoni tad- demm baxxa ħafna meta tibda t- terapija b’ telmisartan.
To be taken into account with concomitant use
5 Biex jiġi kkunsidrat mal- użu fl- istess ħin
The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
L- effett ta ’ telmisartan li jbaxxi l- pressjoni tad- demm jista ’ jiżdied bl- użu fl- istess ħin ta ’ prodotti mediċinali oħrajn kontra l- pressjoni għolja.
Corticosteroïds (systemic route):
Kortikosterojdi (rotta sistemika):
Reduction of the antihypertensive effect.
Tnaqqis ta ’ l- effett kontra l- pressjoni għolja.
5 The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
L- użu ta ’ antagonisti tar- riċetturi ta ’ angiotensin II mhuwiex rakkomandat matul l- ewwel trimestru tat - tqala (ara sezzjoni 4. 4).
Pregnancy (see section 4.3 and 4.4):
Tqala (ara sezzjoni 4. 3 u 4. 4):
There are no adequate data from the use of Kinzalmono in pregnant women.
M’ hemmx tagħrif dwar l- użu ta ’ Kinzalmono f’ nisa tqal.
Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Filwaqt li m’ hemm l- ebda dejta epidemjoloġika kkontrollata fuq ir- riskju b’ antagonisti tar - riċetturi ta ’ angiotensin II, riskji simili jistgħu jkunu jeżistu għal din il- klassi ta ’ mediċini.
Angiotensin II receptor antagonist therapy exposure 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).
Espożizzjoni għall- kura b’ antagonisti tar- riċetturi ta ’ angiotensin II matul it- tieni u t- tielet trimestri hu magħruf li jinduċi fetotossiċità (tnaqqis fil- funzjoni renali, oligoidramnios, ittardjar fl- ossifikazzjoni tal- kranju) u tossiċità fit- trabi tat- twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija).
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see also sections 4.3 and 4.4).
Trabi li ommijiethom ikunu ħadu antagonisti tar- riċetturi ta ’ angiotensin II, għandhom ikunu taħt osservazzjoni mill- qrib għal pressjoni baxxa (ara wkoll sezzjonijiet 4. 3 u 4. 4).
Telmisartan is contraindicated during lactation since it is not known whether it is excreted in human milk.
Telmisartan hu kontra- indikat matul it- treddigħ għax mhux magħruf jekk jitneħħiex fil- ħalib tal - bniedem.
However, when driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy.
Madankollu, meta ssuq il - vetturi jew tħaddem il- makkinarju, għandek tikkunsidra l- fatt li l- isturdament jew in- ngħas jistgħu xi kultant iseħħu meta wieħed ikun qed jieħu terapija kontra l- pressjoni għolja.
4.8 Undesirable effects
6 4. 8 Effetti mhux mixtieqa
The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials.
L- inċidenza ta ’ l- avvenimenti avversi rrappurtati b’ telmisartan (41. 4%) kienet ġeneralment komparabbli mal- plaċebo (43. 9%) fil- provi li saru li kienu kkontrollati bil- plaċebo.
The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients.
L- inċidenza ta ’ l - avvenimenti avversi ma ’ kinitx marbuta mad- doża u ma wriet l- ebda korrelazzjoni mas- sess, ma ’ l- età, jew mar- razza tal- pazjenti.
The adverse drug reactions listed below have been accumulated from all clinical trials including 5788 hypertensive patients treated with telmisartan.
Ir- reazzjonijiet avversi għall- mediċina elenkati hawn taħt inġabru mill- provi kliniċi kollha, li jinkludu 5788 pazjent bil- pressjoni għolja kkurati b’ telmisartan.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data.
Ir- reazzjonijiet avversi ġew ikklassifikati skond kategoriji ta ’ frekwenza bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
L - effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji:
Upper respiratory tract infection including pharyngitis and sinusitis
Infezzjoni fl- apparat respiratorju ta ’ fuq li tinkludi farinġite u sinusite
Urinary tract infection including cystitis
Infezzjoni fl- apparat ta ’ l- awrina li tinkludi ċistite
Eosinophilia
Anemija, tromboċitopenja Eosinofilja
Hypersensitivity, anaphylactic reaction
Sensittività eċċessiva, reazzjoni anafilattika
Anxiety, depression
Ansjetà, dipressjoni
Syncope, insomnia
Sinkope, nuqqas ta ’ rqad
Vertigo
Sturdament
Tachycardia Bradycardia
Takikardija Bradikardija
Hypotension Orthostatic hypotension
Pressjoni baxxa Pressjoni baxxa meta wieħed ikun bilwieqfa
Gastrointestinal disorders
7 Disturbi gastro- intestinali
Abdominal pain, diarrhoea, dry mouth, dyspepsia, flatulence Stomach upset, vomiting
Stonku mqalleb, rimettar
Hepatic function abnormal/ liver disorder
Funzjoni epatika anormali/ disturb fil- fwied
Hyperhidrosis, pruritus Erythema, angioedema, urticaria Drug eruption, toxic skin eruption, rash, eczema
Iperidrosi, ħakk Eritema, anġjoedema, urtikarja Eruzzjoni minħabba l- mediċina, eruzzjoni tossika tal- ġilda, raxx, ekżema
Muscoloskeletal and connective tissue disorders
Disturbi muskolu- skeletrali u tal- connective tissue
Myalgia Arthralgia, back pain (e. g. sciatica), muscle cramps, pain in limb, weakness
Mijalġja Artralġja, uġigħ fid- dahar (eż. xjatika), spażmi tal- muskoli, uġigħ fid- dirgħajn/ riġlejn, dgħjufija
Renal impairment including acute renal failure
Indeboliment renali li jinkludi insuffiċjenza renali akuta
Influenza-like illness Drug ineffective
Uġigħ fis- sider Mard li jixbah l- influwenza Mediċina ma tkunux effettiva
Blood uric acid increased, blood creatinine increased, hepatic enzyme increased, blood creatine phosphokinase increased
Żieda fil- uric acid fid- demm, żieda fil- krejatinina fid- demm, żieda fl- enzimi epatiċi, żieda fil - creatine phosphokinase fid- demm
There is limited information available with regard to overdose in humans.
Hemm informazzjoni limitata disponibbli fir- rigward ta ’ doża eċċessiva fil- bnedmin.
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
L- iktar manifestazzjonijiet prominenti ta ’ doża eċċessiva ta ’ telmisartan kienu pressjoni tad - demm baxxa ħafna u takikardja; il- bradikardija, sturdament, żieda fil- livell tal- krejatinina fis- serum u insuffiċjenza renali akuta kienu osservati wkoll..
Suggested measures include induction of emesis and / or gastric lavage.
Miżuri ssuġġeriti jinkludu li l- pazjent jiġi mġiegħel jirremetti u/ jew il- ħasil ġastriku.
Activated charcoal may be useful in the treatment of overdosage.
Faħam attivat (activated charcoal) jista ’ jkun utli fil- kura ta ’ doża eċċessiva.
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacement given quickly.
Jekk il- pressjoni titbaxxa, il- pazjent għandu jinżamm mimdud fuq dahru, u jingħata malajr sostitut tal - melħ u tal- volum.
Angiotensin II Antagonists, plain, ATC Code:
Antagonisti ta ’ angiotensin II, sempliċi, Kodiċi ATC:
Mechanism of action:
Mekkaniżmu tal- azzjoni:
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Telmisartan hu antagonist tar- riċettur ta ’ angiotensin II (tip AT1) li hu effettiv u speċifiku, u hu oralment attiv.
Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Telmisartan jieħu post angiotensin II b’ affinità għolja ħafna mis- sit fejn jeħel fis - sottotip tar- riċettur AT1, li hu responsabbli għall- azzjonijiet magħrufa ta ’ angiotensin II.
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Telmisartan ma jesibixxi l- ebda attività agonista parzjali għar- riċettur AT1.
Telmisartan selectively binds the AT1 receptor.
Telmisartan jeħel b’ mod selettiv mar - riċettur AT1.
Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors.
Telmisartan ma jurix affinità għal riċetturi oħrajn, li jinkludu AT2 u riċetturi AT oħrajn anqas karatterizzati.
The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Il- rwol funzjonali ta ’ dawn ir- riċetturi mhuwiex magħruf, kif lanqas hu magħruf l- effett ta ’ l- istimulazzjoni żejda possibbli tagħhom minn angiotensin II, li l- livelli tiegħu jiżdiedu permezz ta ’ telmisartan.
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Telmisartan ma jinibixxix l- enzima li tibdel angiotensin (kininase II), l- enzima li tiddegrada wkoll bradykinin.
Therefore it is not expected to potentiate bradykinin- mediated adverse effects.
Għalhekk mhux mistenni li ssaħħaħ l- effetti avversi medjati minn bradykinin.
In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Fil- bniedem, doża ta ’ 80 mg ta ’ telmisartan kważi tinibixxi kompletament iż- żieda fil- pressjoni tad - demm ikkawżata minn angiotensin II.
The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of treatment and is sustained during long-term therapy.
It- tnaqqis massimu fil- pressjoni tad- demm ġeneralment jinkiseb wara 4 sa 8 ġimgħat mill- bidu tal- kura, u jinżamm matul terapija fit- tul.
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
L- effett kontra l- pressjoni tad- demm jippersisti l- ħin kollu għal 24 siegħa wara d- dożaġġ, u jinkludi l - aħħar 4 sigħat qabel id- doża li jkun imiss, kif muri mill- kejl tal- pressjoni tad- demm ambulatorja.
This is confirmed by trough to peak ratios consistently above 80% seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Dan hu kkonfermat mill- proporzjonijiet bejn il- livelli l- aktar baxxi imqabbla ma ’ l- ogħla livelli, li kienu aktar minn 80% b’ mod konsistenti, osservati wara li ngħataw dożi ta ’ 40 u 80 mg ta ’ telmisartan fi provi kliniċi b’ telmisartan ikkontrollati bi plaċebo.
There is an apparent trend to a dose relationship to a time to 8 recovery of baseline systolic blood pressure (SBP).
Hemm tendenza apparenti għal relazzjoni bejn doża u l- ħin ta ’ l- irkupru tal- linja bażi tal- pressjoni sistolika tad- demm (SBP).
In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
F’ dan ir- rigward, id - dejta dwar il- pressjoni dijastolika tad- demm (DBP) hi inkonsistenti.
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 u dik dijastolika, mingħajr ma jaffettwa r- rata tal- polz.
The contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined.
Il- kontribuzzjoni ta ’ l- effett dijuretiku u natrijuretiku tal- prodott mediċinali għall- attività ipotensiva tagħha, għad trid tkun definita.
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 anti- ipertensivi (dan intwera fi provi kliniċi li qabblu telmisartan ma ’ amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
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 ta ’ sogħla xotta kienet anqas 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.
Beneficial effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
L- effetti ta ’ benefiċċju ta ’ telmisartan fuq il- mortalità u l- morbożità kardjovaskulari għadhom mhumiex magħrufa.
Absorption of telmisartan is rapid although the amount absorbed varies.
L- assorbiment ta ’ telmisartan hu mgħaġġel, għalkemm l- ammont assorbit ivarja.
The mean absolute bioavailability for telmisartan is about 50%.
Il- medja tal - biodisponibilità assoluta għal telmisartan hi ta ’ madwar 50%.
When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6% (40 mg dose) to approximately 19% (160 mg dose).
Meta telmisartan jittieħed ma ’ l- ikel, it - tnaqqis taż- żona taħt il- kurva tal- konċentrazzjoni tal- plażma- żmien (AUC0- ∞) ta ’ telmisartan tvarja minn madwar 6% (doża ta ’ 40 mg) sa madwar 19% (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 ta ’ telmisartan, il- konċentrazzjonijiet fil- plażma huma simili, kemm jekk telmisartan jittieħed ma ’ ikel kif ukoll mingħajru.
There is no linear relationship between doses and plasma levels.
M’ hemm l- ebda relazzjoni lineari bejn id- dożi u l- livelli tal- plażma.
Cmax and to a lesser extent AUC increase disproportionately at doses above 40 mg.
Is- Cmax u, fi grad anqas l- AUC, jiżdiedu b’ mod sproporzjonat f’ dożi ta ’ aktar minn 40 mg.
Telmisartan is largely bound to plasma protein (> 99.5%), mainly albumin and alpha-1 acid glycoprotein.
Telmisartan fil- biċċa l- kbira tiegħu jeħel mal- proteina fil- plażma (> 99. 5%), primarjament ma ’ l - albumina u alpha- 1 acid glycoprotein.
The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Il- medja ta ’ l- istat fiss apparenti tal- volum tad- distribuzzjoni (Vdss) hija ta ’ madwar 500 l.
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Telmisartan hu metabolat permezz ta ’ konjugazzjoni għal glucuronide tal- kompost prinċipali.
No pharmacological activity has been shown for the conjugate.
L- ebda attività farmakoloġika ma ntweriet għall- konjugat.
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of > 20 hours.
Telmisartan hu kkaratterizzat minn farmakokinetiċi b’ decay bi- esponenzjali, b’ half- life ta ’ l - eliminazzjoni terminali ta ’ > 20 siegħa.
The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
L- ogħla konċentrazzjoni fil- plażma (Cmax) u, fi grad anqas, iż - żona taħt il- kurva ta ’ konċentrazzjoni fil- plażma- ħin (AUC), jiżdiedu b’ mod sproporzjonat mad- doża.
There is no evidence of clinically relevant accumulation of telmisartan taken at the recommended dose.
M’ hemmx evidenza ta ’ akkumulazzjoni ta ’ telmisartan li hi klinikament rilevanti meta dan jittieħed fid- doża rakkomandata.
Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
Il- konċentrazzjonijiet fil- plażma kienu ogħla fin- nisa milli fl- irġiel, mingħajr ma kien hemm influwenza rilevanti fuq l- effikaċja.
After oral (and intravenous) administration telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Wara teħid mill- ħalq (u minn ġol- vina), telmisartan jiġi kważi eliminat kollu ma ’ l- ippurgar, primarjament bħala kompost mhux mibdul.
Cumulative urinary excretion is < 1% of dose.
L- eliminazzjoni kumulattiva fl- awrina hi ta ’ < 1% tad - doża.
Total plasma clearance (Cltot) is high (approximately 1,000 ml/ min) compared with hepatic blood flow (about 1,500 ml/ min).
It- tneħħija totali mill- plażma (Cltot) hi għolja (madwar 1, 000 ml/ min) meta mqabbla mal- fluss tad- demm epatiku (madwar 1, 500 ml/ min).
Gender effects:
Effetti tas- sess:
9 Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Differenzi fil- konċentrazzjonijiet fil- plażma kienu osservati, bis- Cmax u l- AUC li kienu madwar 3 darbiet u darbtejn ogħla, rispettivament, fin- nisa meta mqabbla mal- irġiel.
The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Il- farmakokinetiċi ta ’ telmisartan ma jvarjawx bejn l- anzjani u dawk li għandhom inqas minn 65 sena.
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations was observed.
F’ pazjenti b’ indeboliment renali minn moderat sa sever, l- irduppjar tal- konċentrazzjonijiet fil- plażma kien osservat.
However, lower plasma concentrations were observed in patients with renal insufficiency undergoing dialysis.
Madankollu, konċentrazzjonijiet fil- plażma aktar baxxi kienu ossevati f’ pazjenti b’ insuffiċjenza renali li kienu qegħdin fuq id- dijalisi.
Telmisartan is highly bound to plasma protein in renal-insufficient patients and cannot be removed by dialysis.
Telmisartan jeħel ħafna mal- proteina fil- plażma f’ pazjenti b’ insuffiċjenza renali, u ma jkunx jista ’ jitneħħa permezz tad- dijalisi.
The elimination half-life is not changed in patients with renal impairment.
Il- half- life ta ’ l - eliminazzjoni ma tinbidilx f’ pazjenti b’ indeboliment renali.
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- biodisponibilità assoluta sa kważi 100%.
5.3 Preclinical safety data
10 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Fi studji dwar is- sigurtà ta ’ qabel l- użu kliniku, id- dożi li pproduċew esponiment li kien komparabbli għal dak fil- medda terapewtika klinika, ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit), bidliet fl- emodinamiċi renali (żieda fin- nitrogen ta ’ l- urea u l - krejatinina fid- demm), kif ukoll żieda fil- potassium fis- serum f’ annimali normotensivi.
In dogs, renal tubular dilation and atrophy were observed.
Fil- klieb it - twessiegħ tubulari renali u l- atrofija kienu osservati.
Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs.
Ħsara fil- mukuża gastrika (tgħawwir, ulċeri jew infjammazzjoni) kienu wkoll osservati fil- firien u fil- klieb.
These pharmacologically- mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Dawn l- effetti mhux mixtieqa, medjati b’ mod farmakoloġiku, magħrufa minn studji dwar is- sigurtà ta ’ qabel l- użu kliniku, kemm b’ inibituri ta ’ l- enzimi li jibdlu l- angiotensin kif ukoll b’ antagonisti tar- riċettur ta ’ angiotensin II, kienu evitati b’ teħid ta ’ suppliment mielaħ mill- ħalq.
In both species, increased plasma renin activity and hypertrophy/ hyperplasia of the renal juxtaglomerular cells were observed.
Fiż- żewġ speċi, żieda fl- attività tar- renin fil- plażma u ipertrofija/ iperplasija taċ- ċelluli juxtaglomerular kienet osservata.
These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Dawn il- bidliet, u anke l- effett tal- kategorija ta ’ l- inibituri ta ’ l- enzimi li jibdlu l - angiotensin u antagonisti oħrajn tar- riċettur ta ’ angiotensin II, ma jidhirx li għandhom sinifikat kliniku.
There is no evidence of a teratogenic effect, but animal studies indicated some hazardous potential of telmisartan to the postnatal development of the offspring such as lower body weight, delayed eye opening, and higher mortality.
M’ hemm l- ebda evidenza ta ’ effett teratoġeniku, iżda studji fuq l- annimali indikaw li xi potenzjal ta ’ periklu ta ’ telmisartan għall- iżvilupp ta ’ wara t- twelid tal- frieħ bħal piż tal- ġisem iktar baxx, dewmien fil- ftuħ ta ’ l- għajnejn u mortalità ogħla.
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Ma kien hemm 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.
Povidone (K25) Meglumine Sodium hydroxide Sorbitol (E420) Magnesium stearate.
Povidone (K25) Meglumine Sodium hydroxide Sorbitol (E420) Magnesium stearate
10 3 years
3 snin
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill - umdità.
Aluminium/ aluminium blisters (PA/ PA/ Al/ PVC/ Al).
Folji tal- aluminju/ aluminju (PA/ PA/ Al/ PVC/ Al).
One blister contains 7 tablets.
Folja waħda fiha 7 pilloli.
Blister with 14, 28, 56, or 98 tablets.
Folja b’ 14, 28, 56, jew 98 pillola.
6.6 Special precautions for disposal
11 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
EU/ 1/ 98/ 091/ 009 (14 tablets) EU/ 1/ 98/ 091/ 010 (28 tablets) EU/ 1/ 98/ 091/ 011 (56 tablets) EU/ 1/ 98/ 091/ 012 (98 tablets)
EU/ 1/ 98/ 091/ 009 (14- il pillola) EU/ 1/ 98/ 091/ 010 (28 pillola) EU/ 1/ 98/ 091/ 011 (56 pillola) EU/ 1/ 98/ 091/ 012 (98 pillola)
16 December 1998 Date of last renewal:
16 ta ’ Diċembru, 1998 Data ta ’ l- aħħar tiġdid:
16 December 2008
16 ta ’ Diċembru, 2008
Kinzalmono 40 mg tablets
Kinzalmono 40 mg pilloli
Each tablet contains 40 mg telmisartan.
Kull pillola fiha 40 mg telmisartan.
Each tablet contains 169 mg sorbitol (E420).
Kull pillola fiha 169 mg ta ’ sorbitol (E420).
White oblong tablets engraved with the code number '51H 'on one side.
Pilloli bojod b’ forma oblunga li fuqhom hemm imnaqqax in- numru tal- kodiċi ‘ 51H ’ fuq naħa waħda.
4.3 Contraindications
13 4. 3 Kontra- indikazzjonijiet
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1) • Second and third trimester of pregnancy (see sections 4.4 and 4.6)
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1) • It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Disturbi ostruttivi biljari • Indeboliment sever epatiku
13 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Stenosi tal- valv mitrali u aortiku, kardjomijopatija ipertropika ostruttiva:
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti- inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Ir- riskju jista ’ jiżdied f’ każ li l- kura tingħata flimkien ma ’ prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l- iperkalemija (sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium, inibituri ta ’ ACE, antagonisti tar- riċettur ta ’ angiotensin II, prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni (NSAIDs, li jinkludu inibituri COX- 2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
The risk is particularly high in combination with potassium sparing-diuretics, and when combined with salt substitutes containing potassium.
Ir- riskju hu partikularment għoli flimkien ma ’ dijuretiċi li ma jneħħux potassium, u meta jkunu kombinati ma ’ sostituti tal- melħ li fihom il - potassium.
A combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.
Kumbinazzjoni ma ’ inibituri ta ’ ACE jew NSAIDs, pereżempju, tirriżulta f’ anqas riskju, bil- patt li l- prekawzjonijiet għall- użu jkunu segwiti b’ mod strett.
14 Concomitant use not recommended
L- użu fl- istess ħin mhuwiex rakkomandat
Concomitant use to be taken into account
16 Biex jiġi kkunsidrat mal- użu fl- istess ħin
15 Pregnancy (see section 4.3 and 4.4):
Tqala (ara sezzjoni 4. 3 u 4. 4):
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Ir- reazzjonijiet avversi ġew ikklassifikati skond kategoriji ta ’ frekwenza bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli).
Anaemia, thrombocytopenia Eosinophilia
Anemija, tromboċitopenja Eosinofilja
Gastrointestinal disorders
18 Disturbi gastro- intestinali
Chest pain Influenza-like illness Drug ineffective
Uġigħ fis- sider Mard li jixbah l- influwenza Mediċina ma tkunux effettiva
17 Investigations
Investigazzjonijiet
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
L- iktar manifestazzjonijiet prominenti ta ’ doża eċċessiva ta ’ telmisartan kienu pressjoni tad - demm baxxa ħafna u takikardja; il- bradikardija, sturdament, żieda fil- livell tal- krejatinina fis- serum u insuffiċjenza renali akuta kienu osservati wkoll.