qanastek/EMEA-V3 huggingface dataset:
MicardisPlus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
MicardisPlus m’ għandux jintuża f’ pazjenti b’ indeboliment renali sever (rata ta ’ tneħħija tal- krejatinina ta ’ < 30 ml/ min) (ara sezzjoni 4. 3).
There is no experience regarding the administration of MicardisPlus in patients with recent kidney transplantation.
M’ hemmx esperjenza dwar l- għoti ta ’ MicardisPlus f’ pazjenti bi trapjant riċenti tal- kliewi.
Experience with MicardisPlus is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
L- esperjenza b’ MicardisPlus hi modesta f’ dawk il- pazjenti b’ indeboliment renali minn ħafif sa moderat, u għalhekk, monitoraġġ pejodiku tal- livelli tal- potassium, tal- krejatinina u ta ’ l- uric acid serum hu rakkomandat.
Such conditions should be corrected before the administration of MicardisPlus.
Dawn il- kundizzjonijiet għandhom ikunu kkoreġuti qabel l- għoti ta ’ MicardisPlus.
Therefore, the use of MicardisPlus is not recommended.
Għalhekk, l- użu ta ’ MicardisPlus mhuwiex rakkomandat.
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in MicardisPlus, minimal or no effects were reported.
Żieda fil- livelli tal- kolesterol u tat- trigliċeridi kienet assoċjata ma ’ terapija dijuretika b’ thiazide; madankollu, bid- doża ta ’ 12. 5 mg li hemm f’ MicardisPlus, effetti minimi kienu rrappurtati, jew l- ebda effett.
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of MicardisPlus, hyperkalaemia might occur.
Għal kuntrarju, minħabba l- antaġoniżmu tar- riċetturi ta ’ angiotensin II (AT1) mill- komponent ta ’ telmisartan ta ’ MicardisPlus, tista ’ sseħħ l- iperkalemija.
Although clinically significant hyperkalaemia has not been documented with MicardisPlus, risk factors for the development of hyperkalaemia include renal insufficiency and/ or heart failure, and diabetes mellitus.
Għalkemm iperkalemija klinikament sinifikanti ma kinitx dokumentata b’ MicardisPlus, fatturi ta ’ riskju għall- iżvilupp ta ’ iperkalemija jinkludu insuffiċenzja renali u/ jew insuffiċjenza tal- qalb, u dijabete mellitus.
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with MicardisPlus (see section 4.5).
Dijuretiċi potassium - sparing, supplimenti tal- potassium jew sostituti tal- potassium li fihom il- melħ, għandhom jingħataw bl- attenzjoni flimkien ma ’ MicardisPlus (ara sezzjoni 4. 5).
There is no evidence that MicardisPlus would reduce or prevent diuretic-induced hyponatraemia.
M’ hemm l- ebda evidenza li MicardisPlus jista ’ inaqqas jew jimpedixxi iponatremija kkawżata mid - dijuretiċi.
Interaction studies have only been performed in adults.
Studji dwar l- interazzjoni saru biss fuq l- adulti.
Rare cases have also been reported with angiotensin II receptor antagonists (including MicardisPlus).
Każijiet rari kienu irrappurtati wkoll b’ antagonisti ta ’ riċetturi ta ’ angiotensin II (li jinkludu MicardisPlus).
Co- administration of lithium and MicardisPlus is not recommended (see section 4.4).
L- għoti flimkien ta ’ lithium u MicardisPlus mhuwiex rakkomandat (ara sezzjoni 4. 4).
Periodic monitoring of serum potassium and ECG is recommended when MicardisPlus is administered with these 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 MicardisPlus 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.
There are no adequate data from the use of MicardisPlus in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ MicardisPlus f’ nisa tqal.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq l- annimali wrew tossiċità riproduttiva (ara sezzjoni 5. 3).
MicardisPlus is contraindicated during lactation since it is not known whether telmisartan is excreted in human milk.
MicardisPlus hu kontra- indikat matul it- treddigħ għax mhux magħruf jekk telmisartan jitneħħiex fil- ħalib tal- bniedem.
Fixed Dose Combination The overall incidence of adverse events reported with MicardisPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Taħlita Fissa tad- Doża L- inċidenza totali ta ’ avvenimenti avversi rrappurtati b’ MicardisPlus kienet komparabbli ma ’ dawk irrappurtati b’ telmisartan waħdu fi provi kkontrollati u randomised li saru fuq 1471 pazjent li kienu randomised biex jirċievu telmisartan flimkien ma ’ hydrochlorothiazide (835) jew telmisartan biss
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with MicardisPlus.
Reazzjonijiet avversi li huma magħrufa li jseħħu meta kull komponent jingħata waħdu, iżda li ma kinux osservati fil- provi kliniċi, jistgħu jseħħu matul il- kura b’ MicardisPlus.
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 jistgħux ikunu stmati mid- dejta disponibbli).
7 Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni
8 Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with MicardisPlus, 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’ MicardisPlus, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
Adverse reactions of unknown frequency reported with the use of telmisartan alone include:.
Reazzjonijiet avversi ta ’ frekwenza mhux magħrufa rrappurtati bl- użu ta ’ telmisartan waħdu jinkludu:
Gastrointestinal disorders Stomach discomfort Not known:
9 Disturbi gastro- intestinali
9 Infections and infestations
Infezzjonijiet u infestazzjonijiet
Psychiatric disorders Not known:
Disturbi psikjatriċi
, Restlessness
Mhux magħrufa:
Eye disorders
Sturdament
Light-headedness
Disturbi fl- għajnejn
Renal and
Disturbi fil- kliewi u fis- sistema urinarja
urinary disorders Not known:
Mhux magħrufa:
MicardisPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
11 MicardisPlus hu taħlita ta ’ antagonist tar- riċettur ta ’ angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
MicardisPlus once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
MicardisPlus mogħti darba kuljum jipproduċi tnaqqis effettiv u stabbli fil- pressjoni tad- demm fil - medda kollha tad- doża terapewtika.
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 gradwalment terġa ’ lura għal- livelli ta ’ qabel il- kura, fuq perjodu ta ’ diversi ġranet, mingħajr l- ebda evidenza ta ’ pressjoni għolja rebound.
11 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.
Following oral administration of MicardisPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 – 3.0 hours after dosing.
Wara l- għoti ta ’ MicardisPlus mill- ħalq, il- konċentrazzjonijiet massimi ta ’ hydrochlorothiazide jintlaħqu wara madwar 1. 0 – 3. 0 sigħat wara d- dożaġġ.
About 60% of the oral dose is eliminated as unchanged substance
Madwar 60% tad- doza orali titneħħa bħala sustanza mhux mibdula fi żmien 48 siegħa.
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.
Lactose monohydrate Magnesium stearate Maize starch
Lista ta ’ sustanzi mhux attivi
13 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),
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandhux bżonn ħażna speċjali.
Blister with 14, 28, 30, 56, 84, 90, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Folja b’ 14, 28, 30, 56, 84, 90, jew 98 pillola jew folji perforati bid- doża ta ’ l - unità bi 28 x 1 pillola.
MicardisPlus 80 mg/ 12.5 mg tablets
MicardisPlus 80 mg/ 12. 5 mg pilloli
Red and white oval shaped two layer tablet engraved with the company logo and the code'H8 '.
Pillola ħamra u bajda b’ żewġ saffi, b’ forma ovali, imnaqqxa bil- logo tal- kumpanija u l- kodiċi 'H8'.
MicardisPlus 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 ’ MicardisPlus (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.
16 • 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.
17 Metabolic and endocrine effects:
Effetti metaboliċi u endokrinali:
18 Other:
Oħrajn:
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
It- tħarrix jew l- attivazzjoni ta ’ lupus erythematosus sistemiku kien irrappurtat bl- użu ta ’ djuretiċi ta ’ thiazide.
Periodic monitoring of serum potassium and ECG is recommended when MicardisPlus 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 MicardisPlus 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.
20 Pregnancy (see section 4.3):
Tqala (ara sezzjoni 4. 3):
21 Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni
22 Investigations
Investigazzjonijiet
Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with MicardisPlus, 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’ MicardisPlus, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
Infections and infestations Not known:
Infezzjonijiet u infestazzjonijiet
Gastrointestinal disorders Stomach discomfort Not known:
Disturbi gastro- intestinali
23 Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include:
Reazzjonijiet avversi ta ’ frekwenza mhux magħrufa rrappurtati bl- użu ta ’ hydrochlorothiazide waħdu jinkludu:
Endocrine disorders
Disturbi fis- sistema endokrinarija
24 There is limited information available for telmisartan with regard to overdose in humans.
Hemm informazzjoni limitata disponibbli għal telmisartan fir- rigward ta ’ doża eċċessiva fil- bnedmin.
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.
MicardisPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
25 MicardisPlus hu taħlita ta ’ antagonist tar- riċettur ta ’ angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
The antihypertensive efficacy of telmisartan is comparable to that of agents
F’ pazjenti bi pressjoni għolja, telmisartan inaqqas kemm il- pressjoni sistolika kif ukoll dik dijastolika, mingħajr ma jaffettwa r- rata tal- polz.
25 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 kontra l- pressjoni għolja (dan intwera fi provi kliniċi li qabblu telmisartan ma ’ amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
The cytochrome
Wara doża waħda ta ’ telmisartan ittikkettat 14 C, il- glucuronide jirrappreżenta madwar 11% tar- radjuattività mkejla fil- plażma.
26 P450 isoenzymes are not involved in the metabolism of telmisartan.
L- isoenzimi ta ’ ċitokrom P450 mhumiex involuti fil- metaboliżmu 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.
27 (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.
27 Lactose monohydrate 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),
Blister with 14, 28, 30, 56, 84, 90 or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Folja b’ 14, 28, 30, 56, 84, 90, jew 98 pillola jew folji perforati bid- doża ta ’ l - unità bi 28 x 1 pillola.
28 Date of first authorisation:19 April 2002 Date of last renewal:
19 ta ’ April 2002 Data ta ’ l- aħħar tiġdid:
MicardisPlus 80 mg/ 25 mg tablets
MicardisPlus 80 mg/ 25 mg pilloli
Yellow and white oval shaped tablet engraved with the company logo and the code'H9 '.
Pillola safra u bajda, b’ forma ovali, imnaqqxa bil- logo tal- kumpanija u l- kodiċi 'H9'.
MicardisPlus fixed dose combination (80 mg telmisartan/ 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus 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.
MicardisPlus 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’ MicardisPlus 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.
MicardisPlus 80 mg/ 25 mg may be administered in patients whose blood pressure is not adequately controlled by MicardisPlus 80 mg/ 12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
MicardisPlus 80 mg/ 25 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ MicardisPlus 80 mg/ 12. 5 mg jew lil pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
MicardisPlus is also available at the dose strengths 40 mg/ 12.5 mg and 80 mg/ 12.5 mg
MicardisPlus hu disponibbli wkoll f’ dożi b’ qawwa ta ’ 40 mg/ 12. 5 mg u 80 mg / 12. 5 mg
30 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 section s 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.
31 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
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.
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.
Pazjenti bi problemi rari ereditarji ta ’ intolleranza għal fructose u/ jew bi problemi rari ereditarji ta ’
32 Ethnic differences:
32 intolleranza għal galactose, bid- defiċjenza ta ’ Lapp lactase jew b’ assorbiment ħażin ta ’ glucose - galactose, m’ għandhomx jieħdu din il- mediċina.
33 Other antihypertensive agents:
Mediċini oħrajn kontra l- pressjoni għolja:
The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
L- effett tar- rilassanti tal - muskoli skeletriċi li mhumiex depolarizzanti jista ’ jissaħħaħ b’ hydrochlorothiazide
34 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
Fixed Dose Combination The overall incidence and pattern of adverse events reported with MicardisPlus 80 mg/ 25 mg was comparable with MicardisPlus 80 mg/ 12.5 mg.
Taħlita Fissa tad- Doża L- inċidenza totali u l- andament ta ’ l- avvenimenti avversi rrappurtati b’ MicardisPlus 80 mg/ 25 mg kienu komparabbli ma ’ dawk b’ MicardisPlus 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.
Ir- relazzjoni ta ’ l- effetti mhux mixtieqa assoċjati mad- doża ma ’ kinitx stabbilita, u l- effetti ma wrew l- ebda korrelazzjoni mas- sess, ma ’ l- età, jew mar- razza tal- pazjenti.
Adverse reactions reported in all clinical trials and occurring more frequently (p ≤ 0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
35 Reazzjonijiet avversi rrappurtati fil- provi kliniċi kollha u li seħħew b’ mod iktar frekwenti (p ≤0. 05) meta ngħata telmisartan flimkien ma ’ hydrochlorothiazide milli meta ngħata l- plaċebo, qed jintwerew hawn taħt skond il- klassi tas- sistema ta ’ l- organi.
35 Infections and infestations
Infezzjonijiet u infestazzjonijiet
Dizziness Syncope, paraesthesia Insomnia, sleep disorders
Sturdament Sinkope, parestesija Nuqqas ta ’ rqad, disrurbi fl- irqad
Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased
Żieda tal- uric acid fid- demm Żieda fil- krejatinina fid- demm, żieda fil- creatine phosphokinase fid- demm, żieda fl- enzimi epatiċi fid- demm
37 Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include:
Reazzjonijiet avversi ta ’ frekwenza mhux magħrufa rrappurtati bl- użu ta ’ hydrochlorothiazide waħdu jinkludu:
38 There is limited information available for telmisartan with regard to overdose in humans.
Hemm informazzjoni limitata disponibbli għal telmisartan fir- rigward ta ’ doża eċċessiva fil- bnedmin.
The most prominent manifestations of telmisartan overdose werehypotension 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.
MicardisPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
39 MicardisPlus hu taħlita ta ’ antagonist tar- riċettur ta ’ angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
39 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).
40 Distribution:
Distribuzzjoni:
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.
Gastric lesions could be prevented/ ameliorated by
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.
41 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.
Pack sizes: blister with 14, 28, 30, 56, 90, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets
Folja b’ 14, 28, 30, 56, 84, 90, jew 98 pillola jew folji perforati bid- doża ta ’ l - unità bi 28 x 1 pillola.
43 ANNEX II
44 ANNESS II
44 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
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 3.0, 05 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 3. 0, tal- 5 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.
46 A.
46 ANNESS III
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
MicardisPlus 40 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
MicardisPlus 40 mg/ 12. 5 mg pilloli telmisartan/ hydrochlorothiazide
14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets 28 x 1 tablets
14- il pillola 28 pillola 30 pillola 56 pillola 84 pillola 90 pillola 98 pillola 28 x 1 pillola
48 EXP:
JIS:
14 tablets 28 tablets 28 x 1 unit dose tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola tad- doża ta ’ l- unità 30 pillola 56 pillola 84 pillola 90 pillola 98 pillola
MicardisPlus 40 mg/ 12.5 mg
MicardisPlus 40 mg/ 12. 5 mg
Blister of 7tablets
Folja b’ 7 pilloli
50 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
MicardisPlus 80 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
MicardisPlus 80 mg/ 12. 5 mg pilloli telmisartan/ hydrochlorothiazide
14 tablets 28 tablets 28 x 1 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola 30 pillola 56 pillola 84 pillola 90 pillola 98 pillola
MicardisPlus 80 mg/ 12.5 mg
MicardisPlus 80 mg/ 12. 5 mg
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
54 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
56 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
MicardisPlus 80 mg/ 25 mg tablets telmisartan/ hydrochlorothiazide
MicardisPlus 80 mg/ 25 mg pilloli telmisartan/ hydrochlorothiazide
14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 28 x 1 tablets
14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 28 x 1 pillola
14 tablets 28 tablets 28 x 1 tablets 30 tablets 56 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola 30 pillola 56 pillola 90 pillola 98 pillola
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
58 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
What MicardisPlus is and what it is used for 2.
X’ inhu MicardisPlus u għalxiex jintuża 2.
Before you take MicardisPlus 3.
Qabel ma tieħu MicardisPlus 3.
How to take MicardisPlus 4.
Kif għandek tieħu MicardisPlus 4.
How to store MicardisPlus 6.
Kif taħżen MicardisPlus 6.
WHAT MICARDISPLUS IS AND WHAT IT IS USED FOR
X’ INHU MICARDISPLUS U GĦALXIEX JINTUŻA
MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
MicardisPlus hu taħlita ta ’ żewġ sustanzi attivi, telmisartan u hydrochlorothiazide f’ pillola waħda.
MicardisPlus 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.
MicardisPlus 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 MICARDISPLUS
QABEL MA ’ TIEĦU MICARDISPLUS
Do not take MicardisPlus
Tiħux MicardisPlus
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in MicardisPlus 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 MicardisPlus (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra). • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide.
61 • if you have severe kidney disease. • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
62 • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ). • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
If any of the above applies to you, tell your doctor or pharmacist before taking MicardisPlus.
Jekk xi wieħed minn dawn is- sintomi t’ hawn fuq japplika għalik, għid lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu MicardisPlus.
Take special care with MicardisPlus
Oqgħod attent ħafna b’ MicardisPlus
- Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
- Stenosi ta ’ l- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi).
MicardisPlus is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section Pregnancy and breast-feeding).
MicardisPlus mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek wara 3 xhur ta ’ tqala (ara s- sezzjoni Tqala u treddigħ).
In case of surgery or anaesthetics, you should tell your doctor that you are taking MicardisPlus.
F’ każ ta ’ operazzjoni jew anestetiċi, għandek tgħid lit- tabib tiegħek li qed tieħu MicardisPlus.
The use of MicardisPlus in children and adolescents up to the age of 18 years is not recommended.
L- użu ta ’ MicardisPlus fit- tfal u fl- adolexxenti sa l- età ta ’ 18- il sena mhuwiex rakkomandat.
This applies especially to the medicines listed below taken at the same time with MicardisPlus:
Dan japplika b’ mod speċjali għal mediċini elenkati hawn taħt li jittieħdu fl- istess ħin ma ’ MicardisPlus:
- Lithium containing medicines to treat some types of depression.
- Mediċini li fihom il- lithium għall- kura ta ’ xi tipi ta ’ dipressjoni
62 amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
MicardisPlus may increase the blood pressure lowering effect of other medicines and you should consult with your doctor if you need to adjust the dose of your other medicine while taking MicardisPlus.
MicardisPlus jista ’ jżid l- effett li jbaxxi l- pressjoni tad- demm ta ’ mediċini oħrajn, u għandek tkellem lit- tabib tiegħek jekk ikollok bżonn taġġusta d- doża tal- mediċina l- oħra tiegħek meta tkun qed tieħu MicardisPlus.
As with other blood pressure lowering medicines, the effect of MicardisPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen).
Bħal ma jiġri b’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm, l- effetti ta ’ MicardisPlus jistgħu jitnaqqsu meta tieħu NSAIDs (non steroidal anti- inflammatory drugs, eż. aspirina jew ibuprofen).
Taking MicardisPlus with food and drink
Meta tieħu MicardisPlus ma ’ l- ikel u max- xorb
You can take MicardisPlus with or without food.
Tista ’ tieħu MicardisPlus ma ’ l- ikel jew mingħajr l- ikel.
Usually, your doctor will advise you to take another medicine instead of MicardisPlus, as MicardisPlus is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek ser jagħtik parir biex tieħu mediċina oħra minflok MicardisPlus, għax MicardisPlus mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jintuża wara 3 xhur ta ’ tqala.
Appropriate antihypertensive drug must usually replace MicardisPlus before starting a pregnancy.
Mediċina adattata kontra l- pressjoni għolja trid normalment tissostitwixxi MicardisPlus qabel il- bidu ta ’ tqala.
MicardisPlus should not be used during the second and third trimester of pregnancy.
MicardisPlus m’ għandux jintuża matul it- tieni u t- tielet trimestru tat- tqala.
Your doctor will normally advise you to stop taking MicardisPlus as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu MicardisPlus hekk kif issir taf li inti tqila.
If you become pregnant during therapy with MicardisPlus, please inform and see your doctor without delay.
Jekk inti toħroġ tqila matul kura b’ MicardisPlus, jekk jogħġbok informa u ara lit- tabib tiegħek mingħajr dewmien.
You must not take MicardisPlus if you are breast-feeding.
M’ għandekx tieħu MicardisPlus jekk qed tredda ’.
No information is available on the effect of MicardisPlus on the ability to drive or operate machinery.
M’ hemm l- ebda informazzjoni disponibbli dwar l- effett ta ’ MicardisPlus fuq il- ħila li ssuq jew tħaddem makkinarju.
Important information about some of the ingredients of MicardisPlus
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ MicardisPlus
MicardisPlus contains milk sugar (lactose) and sorbitol.
MicardisPlus fih zokkor tal- ħalib (lactose) u sorbitol.
If you are intolerant to some sugars, consult your doctor before taking MicardisPlus.
Jekk għandek intolleranza għal xi tipi ta ’ zokkor, għandek tikkuntattja lit- tabib tiegħek qabel ma tieħu MicardisPlus.
HOW TO TAKE MICARDISPLUS
KIF GĦANDEK TIEĦU MICARDISPLUS
Always take MicardisPlus exactly as your doctor has told you.
Dejjem għandek tieħu MicardisPlus skond il- parir eżatt tat- tabib.
The usual dose of MicardisPlus is one tablet a day.
64 Id- doża normali hi ta ’ pillola waħda darba kuljum.
It is important that you take MicardisPlus every day until your doctor tells you otherwise.
Hu importanti li tieħu MicardisPlus kuljum sakemm it- tabib tiegħek jagħtik parir ieħor.
63 If your liver is not working properly, the usual dose should not exceed 40 mg/ 12.5 mg once a day.
Jekk il- fwied tiegħek mhux qed jaħdem kif suppost, id- doża tas- soltu m’ għandhiex taqbeż 40 mg/ 12. 5 mg darba kuljum.
If you take more MicardisPlus than you should If you accidentally take too many tablets contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu MicardisPlus aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
If you forget to take MicardisPlus If you forget to take a dose, do not worry.
Jekk tinsa tieħu MicardisPlus Jekk tinsa tieħu doża, tinkwetax.
Like all medicines, MicardisPlus can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, MicardisPlus jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Uncommon side effects may include:
Effetti sekondarji mhux komuni jistgħu jinkudu:
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth, flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain, increased blood uric acid levels.
Tnaqqis fil- livelli tal- potassium fid- demm; ansjetà; ħass ħażin (sinkope); sensazzjoni ta ’ tnemnim, sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar (parestesija); tħoss kollox idur bik (vertigo); taħbit tal- qalb mgħaġġel (takikardija), disturbi fir- ritmu tat- taħbit tal- qalb, pressjoni tad- demm baxxa, il - pressjoni tad- demm taqa ’ f’ daqqa meta tkun bilwieqfa; qtugħ ta ’ nifs (dispneja); sintomi ta ’ stonku mqalleb bħal dijarea; ħalq xott, gass; uġigħ fid- dahar, spażmi fil- muskoli, uġigħ fil- muskoli; disfunzjoni erettili (ma tkunx kapaċi jkollok jew iżżomm erezzjoni); uġigħ fis- sider, żieda fil- livelli tal- uric acid fid- demm.
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin; increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, or fat in the blood.
Infjammazzjoni tal- glandola tal- bżieq; tnaqqis fin- numru ta ’ ċelluli fid- demm, li jinkludu għadd baxx taċ- ċelluli tad- demm ħomor u taċ- ċelluli tad- demm bojod, għadd baxx tal- plejtlets (tromboċitopenija); reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), infjammazzjoni tal- vini jew arterji (vaskulite nekrotizzanti), tnaqqis jew telf tal- aptit; nuqqas ta ’ kwiet f’ ġismek, dgħjufija, sturdament; vista mċajpra jew tara kollox isfar; frixa infjammata, stonku mqalleb; sfurija tal- ġilda jew ta ’ l- għajnejn (suffejra); disturbi tal- ġilda bħal vini jew arterji infjammati; żieda fis- sensittività għad - dawl tax- xemx, jew infafet u tqaxxir fis- saff ta ’ fuq tal- ġilda (nekrolisi epidermali tossika); infjammazzjoni tal- kliewi jew indeboliment fil- funzjoni tal- kliewi; deni; indeboliment fil- bilanċ tal - elettroliti, livelli għolja ta ’ kolesterol fid- demm, tnaqqis fil- volum tad- demm, glucose fl- awrina (glikosurja), żieda fil- livelli tal- glucose, uric acid, jew xaħam fid- demm.
HOW TO STORE MICARDISPLUS
KIF TAĦŻEN MICARDISPLUS
Do not use MicardisPlus after the expiry date which is stated on the carton after “ EXP”.
Tużax MicardisPlus wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
What MicardisPlus contains
X’ fih MicardisPlus
The active substances are telmisartan and hydrochlorothiazide.
Is- sustanzi attivi huma telmisartan u hydrochlorothiazide.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
66 Is- sustanzi l- oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
What MicardisPlus looks like and contents of the pack
Id- dehra ta ’ MicardisPlus u l- kontenuti tal- pakkett
MicardisPlus 40 mg/ 12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the company logo and the code'H4 '.
Il- pilloli MicardisPlus 40 mg/ 12. 5 mg huma ħomor u bojod, b’ forma ovali, imnaqqxa bil- logo tal - kumpanija u l- kodiċi 'H4'.
MicardisPlus is available in blisters packs containing 14, 28, 30, 56, 84, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
MicardisPlus hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 30, 56, 90 jew 98 pillola, jew pakketti tal- folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
66 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
España Boehringer Ingelheim España S. A.
67 Boehringer Ingelheim España S. A.
Portugal Boehringer Ingelheim, Lda.
Boehringer Ingelheim, Lda.
68 PACKAGE LEAFLET:
68 FULJETT TA ’ TAGĦRIF:
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in MicardisPlus 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 MicardisPlus (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra). • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide.
69 • if you have severe kidney disease. • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
69 • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ). • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
70 amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
You can take MicardisPlus tablets with or without food.
Tista ’ tieħu MicardisPlus ma ’ l- ikel jew mingħajr l- ikel.
The usual dose of MicardisPlus is one tablet a day.
71 Id- doża normali hi ta ’ pillola waħda darba kuljum.
71 If your liver is not working properly, the usual dose should not exceed 40 mg/ 12.5 mg once a day.
Jekk il- fwied tiegħek mhux qed jaħdem kif suppost, id- doża tas- soltu m’ għandhiex taqbeż 40 mg/ 12. 5 mg darba kuljum.
If you take more MicardisPlus than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu MicardisPlus aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
Common side effects may include:
Effetti sekondarji komuni jistgħu jinkudu:
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth; flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain; increased blood uric acid levels.
Tnaqqis fil- livelli tal- potassium fid- demm; ansjetà; ħass ħażin (sinkope); sensazzjoni ta ’ tnemnim, sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar (parestesija); tħoss kollox idur bik (vertigo); taħbit tal- qalb mgħaġġel (takikardija), disturbi fir- ritmu tat- taħbit tal- qalb, pressjoni tad- demm baxxa, il - pressjoni tad- demm taqa ’ f’ daqqa meta tkun bilwieqfa; qtugħ ta ’ nifs (dispneja); sintomi ta ’ stonku mqalleb bħal dijarea; ħalq xott, gass; uġigħ fid- dahar, spażmi fil- muskoli, uġigħ fil- muskoli; disfunzjoni erettili (ma tkunx kapaċi jkollok jew iżżomm erezzjoni); uġigħ fis- sider, żieda fil- livelli tal- uric acid fid- demm.
Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
72 Telmisartan F’ pazjenti li kienu qed jieħdu telmisartan waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
72 Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Hydrochlorothiazide F’ pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati: