qanastek/EMEA-V3 huggingface dataset:
14 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.
If concomitant use is indicated because of documented hypokalemia 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.
To be taken into account with concomitant use
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.
16 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.
15 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).
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk tkun seħħet espożizzjoni għal antagonisti tar- riċetturi ta ’ angiotensin II mit- tieni trimestru tat - tqala, hu rakkomandat li jsir kontroll bl- ultrasond tal- funzjoni renali u tal- kranju.
The adverse drug reactions listed below have been accumulated from all clinical trials including 5788 hypertensive patients treated with telmisartan.
17 Ir- reazzjonijiet avversi għall- mediċina elenkati hawn taħt inġabru mill- provi kliniċi kollha, li jinkludu 5788 pazjent bil- pressjoni għolja kkurati b’ telmisartan.
Upper respiratory tract infection including pharyngitis and sinusitis),
Infezzjoni fl- apparat respiratorju ta ’ fuq li tinkludi farinġite u sinusite
Eye disorders:
Disturbi fl- għajnejn
Hepato-biliary disorders
18 Disturbi fil- fwied u fil- marrara
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 -
Haemoglobin decreased
creatine phosphokinase fid- demm Tnaqqis fl- emoglobina
Angiotensin II Antagonists, plain ATC Code:
Antagonisti ta ’ angiotensin II, sempliċi, Kodiċi ATC:
Mechanism of action:
19 Mekkaniżmu tal- azzjoni:
There is an apparent trend to a dose relationship to a time to
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.
18 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).
Linearity/ non-linearity:
20 Linearità/ non- linearità:
19 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.
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.
21 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.
6.3 Shelf life 20 4 years
4 snin
Aluminium/ aluminium blisters (PA/ Al/ PVC/ Al or PA/ PA/ Al/ PVC/ Al). One blister contains 7 or 10 tablets.
Folja waħda fiha 7 jew 10 pilloli.
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 b’ doża waħda bi 28 x 1 pilloli.
173 D-55216 Ingelheim am Rhein Germany
173 22 D- 55216 Ingelheim am Rhein Il- Ġermanja
EU/ 1/ 98/ 090/ 001 (14 tablets) EU/ 1/ 98/ 090/ 002 (28 tablets) EU/ 1/ 98/ 090/ 003 (56 tablets) EU/ 1/ 98/ 090/ 004 (98 tablets) EU/ 1/ 98/ 090/ 013 (28 x 1 tablets) EU/ 1/ 98/ 090/ 015 (84 tablets) EU/ 1/ 98/ 090/ 017 (30 tablets) EU/ 1/ 98/ 090/ 019 (90 tablets)
EU/ 1/ 98/ 090/ 001 (14- il pillola) EU/ 1/ 98/ 090/ 002 (28 pillola) EU/ 1/ 98/ 090/ 003 (56 pillola) EU/ 1/ 98/ 090/ 004 (98 pillola) EU/ 1/ 98/ 090/ 013 (28 x 1 pillola) EU/ 1/ 98/ 090/ 015 (84 pillola) EU/ 1/ 98/ 090/ 017 (30 pillola) EU/ 1/ 98/ 090/ 019 (90 pillola)
Micardis 80 mg tablets
Micardis 80 mg pilloli
White oblong tablets engraved with the code number '52H 'on one side and the company logo on the other side.
Pilloli bojod b’ forma oblunga li fuqhom hemm imnaqqax in- numru tal- kodiċi ‘ 52H ’ fuq naħa waħda u l- logo tal- kumpanija fuq in- naħa l- oħra.
Micardis is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pazjenti pedjatriċi Micardis mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is - sigurtà u l- effikaċja.
22 • 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
Primary aldosteronism:
25 Aldosteroniżmu primarju:
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), trimethoprim.
As with others drugs acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
26 Bħal mediċini oħrajn li jaġixxu fuq is- sistema renin- angiotensin- aldosterone, telmisartan jista ’ jikkawża l- iperkalemija (ara sezzjoni 4. 4).
24 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.
25 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).
The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients.
28 avvenimenti avversi ma ’ kinitx marbuta mad- doża u ma wriet l- ebda korrelazzjoni mas- sess, ma ’ l- età, jew mar- razza tal- pazjenti.
Haemoglobin decreased
4. 9 Doża eċċessiva
28 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).
29 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.
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.
32 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.
6.3 Shelf life 30 4 years
4 snin
Aluminium/ aluminium blisters (PA/ Al/ PVC/ Al or PA/ PA/ Al/ PVC/ Al).
Folji tal- aluminju/ aluminju (PA/ Al/ PVC/ Al jew PA/ PA/ Al/ PVC/ Al).
EU/ 1/ 98/ 090/ 005 (14 tablets) EU/ 1/ 98/ 090/ 006 (28 tablets) EU/ 1/ 98/ 090/ 007 (56 tablets) EU/ 1/ 98/ 090/ 008 (98 tablets) EU/ 1/ 98/ 090/ 014 (28 x 1 tablets) EU/ 1/ 98/ 090/ 016 (84 tablets) EU/ 1/ 98/ 090/ 018 (30 tablets) EU/ 1/ 98/ 090/ 020 (90 tablets)
EU/ 1/ 98/ 090/ 005 (14- il pillola) EU/ 1/ 98/ 090/ 006 (28 pillola) EU/ 1/ 98/ 090/ 007 (56 pillola) EU/ 1/ 98/ 090/ 008 (98 pillola) EU/ 1/ 98/ 090/ 014 (28 x 1 pillola) EU/ 1/ 98/ 090/ 016 (84 pillola) EU/ 1/ 98/ 090/ 018 (30 pillola) EU/ 1/ 98/ 090/ 020 (90 pillola)
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
32 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
35 A DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott
KG D-55216 Ingelheim am Rhein Germany
KG D- 55216 Ingelheim am Rhein Il- Ġermanja
Boehringer Ingelheim France 12, rue André Huet 51100 Reims France
Boehringer Ingelheim France 12, rue André Huet 51100 Reims Franza
Micardis 20 mg tablets telmisartan
Micardis 20 mg pilloli telmisartan
This medicinal product does not require any special storage conditions.
39 Dan il- prodott mediċinali ma jeħtieġ l- ebda kundizzjonijiet speċjali tal- ħażna.
Micardis 40 mg tablets telmisartan
Micardis 40 mg pilloli telmisartan
14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets 84 tablets 30 tablets 90 tablets
14- il pillola 28 pillola 56 pillola 98 pillola 28 x 1 pilloli 84 pillola 30 pillola 90 pillola
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Unit dose blister (28 x 1 tablets pack) or any non 7 count blister
Folja b’ doża waħda (pakkett ta ’ 28 x 1 pilloli) jew kwalunkwe folja li biha ma tistax tgħodd 7 darbiet
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Micardis 80 mg tablets telmisartan
Micardis 80 mg pilloli telmisartan
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
47 PACKAGE LEAFLET:
51 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Micardis 20 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Micardis 20 mg pilloli Telmisartan
please tell your doctor or pharmacist.
imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Micardis is and what it is used for 2.
X’ inhu Micardis u għalxiex jintuża 2.
Before you take Micardis 3.
Qabel ma tuża Micardis 3.
How to take Micardis 4.
Kif għandek tuża Micardis 4.
How to store Micardis 6.
Kif taħżen Micardis 6.
WHAT MICARDIS IS AND WHAT IT IS USED FOR
X’ INHU MICARDIS U GĦALXIEX JINTUŻA
Micardis belongs to a class of medicines known as angiotensin II receptor antagonists.
Micardis jagħmel parti minn klassi ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi ta ’ angiotensin II.
Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Micardis jimblokka l- effett ta ’ angiotensin II biex b’ hekk il - vini u l- arterji jitwessgħu, u l- pressjoni tad- demm tiegħek tonqos.
Micardis is used to treat essential hypertension (high blood pressure). ‘ Essential’ means that the high blood pressure is not caused by any other condition.
Micardis jintuża biex jikkura pressjoni għolja essenzjali (pressjoni tad- demm għolja). ‘ Essenzjali ’ tfisser li pressjoni tad- demm għolja mhijiex ikkawżata minn xi kundizzjoni oħra.
BEFORE YOU TAKE MICARDIS
QABEL MA ’ TUŻA MICARDIS
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Micardis tablets (see section Further information for a list of other ingredients). • 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 the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Tiħux Micardis • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew sustanzi oħra inklużi fil- pilloli Micardis (ara s- sezzjoni Aktar tagħrif għal- lista ta ’ ingredjenti oħrajn) • 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- fwied u mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal - fwied.
If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.
Jekk xi wieħed minn dawn is- sintomi t’ hawn fuq japplika għalik, għid lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu Micardis.
Take special care with Micardis
Oqgħod attent ħafna b’ Micardis
48 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
52 • Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek • Dijabete
Micardis 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).
Micardis 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 anaesthesia, you should tell your doctor that you are taking Micardis.
F’ każ li jkollok bżonn ta ’ operazzjoni jew loppju, għandek tgħid lit- tabib tiegħek li qed tieħu Micardis.
The use of Micardis in children and adolescents up to the age of 18 years is not recommended.
L- użu ta ’ Micardis fit- tfal u fl- adolexxenti sal- età ta ’ 18- il sena mhuwiex rakkomandat.
As with all other angiotensin II receptor antagonists, Micardis may be less effective in lowering the blood pressure in black patients.
Bħal fil- każ tal- antagonisti l- oħrajn kollha tar- riċettur ta ’ angiotensin II, Micardis jista ’ jkun inqas effettiv biex inaqqas il- pressjoni tad- demm f’ pazjenti suwed.
Your doctor may need to change the dose of these other medicines or take other precautions.
It- tabib tiegħek jista ’ jkollu bżonn li jibdel id- doża ta ’ dawn il- mediċini l- oħrajn, jew jieħu prekawzjonijiet oħrajn.
This applies especially to the medicines listed below taken at the same time with Micardis:
Dan japplika b’ mod speċjali għal mediċini elenkati hawn taħt li jittieħdu fl- istess ħin ma ’ Micardis:
• Lithium containing medicines to treat some types of depression. • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen), heparin, immunosuppressives (e. g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. • Diuretics ('water tablets'), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
• Mediċini li fihom il- lithium għall- kura ta ’ xi tipi ta ’ dipressjoni. • Mediċini li jistgħu jżidu il- livelli tal- potassium fid- demm bħal sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium (ċerti ‘ pilloli tal- awrina ’), inibituri ACE, antagonisti tar- riċettur ta ’ angiotensin II, NSAIDs (mediċini mhux sterojdi kontra l - infjammazzjoni, eż. aspirina jew ibuprofen), eparina, immunosoppressivi (eż. cyclosporin jew tacrolimus), u l- antibijotiku trimethoprim. • Id- dijuretiċi (‘ pilloli tal- awrina ’), speċjalment jekk jittieħdu f’ dożi għoljin flimkien ma ’ Micardis, jistgħu jwasslu għal telf eċċessiv ta ’ ilma mill- ġisem u pressjoni tad- demm baxxa (ipotensjoni).
As with other blood pressure lowering medicines, the effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen) or corticosteroids.
Bħala ma jiġri b’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm, l- effetti ta ’ Micardis jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini mhux sterojdi kontra l- infjammazzjoni, eż. aspirina jew ibuprofen) jew kortikosterojdi.
Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.
Micardis jista ’ jżid l- effett ta ’ tnaqqis tal- pressjoni tad- demm ta ’ mediċini oħra li jintużaw għall- kura ta ’ pressjoni tad- demm għolja.
Taking Micardis with food and drink
Meta tieħu Micardis ma ’ l- ikel u max- xorb
You can take Micardis with or without food.
Tista ’ tieħu Micardis mal- ikel jew mingħajr l- ikel.
You must tell your doctor if you think that you are (or might become) pregnant.
53 Għandek tgħid lit- tabib tiegħek jekk taħseb li inti (jew jekk tista ’ toħroġ) tqila.
Usually, your doctor will advise you to take another medicine instead of Micardis, as Micardis 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 Micardis, għax Micardis 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 Micardis before starting a pregnancy.
Mediċina adattata kontra l- pressjoni għolja trid normalment tissostitwixxi Micardis qabel il- bidu ta ’ tqala.
Micardis should not be used during the second and third trimester of pregnancy.
Micardis m’ għandux jintuża matul it- tieni u t- tielet trimestru tat- tqala.
49 Your doctor will normally advise you to stop taking Micardis as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Micardis hekk kif issir taf li inti tqila.
If you become pregnant during therapy with Micardis, please inform and see your doctor without delay.
Jekk inti toħroġ tqila matul kura b’ Micardis, jekk jogħġbok informa u ara lit- tabib tiegħek mingħajr dewmien.
You must not take Micardis if you are breast-feeding.
M’ għandekx tieħu Micardis jekk qed tredda ’.
No information is available on the effect of Micardis on the ability to drive or operate machinery.
M’ hemm l- ebda informazzjoni disponibbli dwar l- effett ta ’ Micardis fuq il- ħila li ssuq jew tħaddem makkinarju.
Some people feel dizzy or tired when they are treated for high blood pressure.
Xi nies iħossuhom storduti jew għajjenin meta jkunu kkurati għal pressjoni tad- demm għolja.
Important information about some of the ingredients of Micardis
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Micardis
Micardis contains sorbitol.
Micardis fih is- sorbitol.
If you are intolerant to some sugars, consult your doctor before taking Micardis.
Jekk għandek intolleranza għal xi tipi ta ’ zokkor, għandek tikkuntattja lit- tabib tiegħek qabel ma tieħu Micardis.
HOW TO TAKE MICARDIS
KIF GĦANDEK TUŻA MICARDIS
Always take Micardis exactly as your doctor has told you.
Dejjem għandek tuża Micardis skond il- parir eżatt tat- tabib tiegħek.
The usual dose of Micardis is one tablet a day.
Id- doża normali ta ’ Micardis hi ta ’ pillola waħda darba kuljum.
It is important that you take Micardis every day until your doctor tells you otherwise.
Hu importanti li tieħu Micardis kuljum sakemm it- tabib tiegħek jgħidlek biex tieqaf.
If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ Micardis hu qawwi jew dgħajjef wisq, kellem lit - tabib jew lill- ispiżjar tiegħek.
The usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period.
Id- doża normali ta ’ Micardis għall- biċċa l- kbira tal- pazjenti hi ta ’ pillola waħda ta ’ 40 mg pillola darba kuljum biex tikkontrolla l- pressjoni tad- demm għal perjodu ta ’ 24 siegħa.
Micardis may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
Micardis jista ’ jintuża flimkien ma ’ dijuretiċi (‘ pilloli tal- awrina ’) bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il- pressjoni tad- demm b’ Micardis.
If you take more Micardis than you should
Jekk tieħu Micardis aktar milli suppost
If you forget to take Micardis
54 Jekk tinsa tieħu Micardis
Like all medicines, Micardis can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Micardis jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
50 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
Urinary tract infections, increase in certain white blood cells (eosinophilia), allergic reaction (e. g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), slow heart rate (bradycardia), drug rash, eczema (a skin disorder), inflammation of the tendons, ineffectiveness of Micardis and decreased haemoglobin (a blood protein).
Effetti sekondarji ta ’ frekwenza mhux magħrufa jistgħu jinkludu: infezzjonijiet fl- apparat urinarju, żieda f’ ċerti ċelluli tad- demm bojod (eosinofilja), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n- nifs, tħarħir, nefħa tal- wiċċ jew pressjoni tad- demm baxxa), rata ta ’ taħbit tal- qalb bil- mod (bradikardija), raxx minħabba l- mediċina, ekżema (disturb tal- ġilda), infjammazzjoni tal- tendini, ineffettività ta ’ Micardis u tnaqqis fl- emoglobina (proteina tad- demm).
HOW TO STORE MICARDIS
KIF TAĦŻEN MICARDIS
Do not use Micardis after the expiry date which is stated on the carton after “ EXP”.
Tużax Micardis wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
Medicines should not be disposed of via wastewater or household waste.
55 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Micardis contains
X’ fih Micardis
What Micardis looks like and contents of the pack
Id- dehra ta ’ Micardis u l- kontenuti tal- pakkett
Micardis 20 mg tablets are white, round and engraved with the code number '50H 'on one side and the company logo on the other side.
Il- pilloli Micardis 20 mg huma bojod, b’ forma tonda u mnaqqxa bin- numru tal- kodiċi ‘ 50H ’ fuq naħa waħda u l- logo tal- kumpanija fuq in- naħa l- oħra.
51 Micardis is available in blister packs containing 14, 28, 56, or 98 tablets.
Micardis hu disponibbli f’ pakketti b’ folji ta ’ 14, 28, 56 u 98 pillola.
and
u
52 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
56 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
54 PACKAGE LEAFLET:
58 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Micardis 40 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Micardis 40 mg pilloli Telmisartan
How to take Micardis 4.
Kif għandek tuża Micardisi 4.
BEFORE YOU TAKE MICARDIS
QABEL MA TUŻA MICARDIS
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Micardis tablets (see section Further information for a list of other ingredients). • 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 liver and gall bladder) or any other severe liver disease.
Tiħux Micardis • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew sustanzi oħra inklużi fil- pilloli Micardis (ara s- sezzjoni Aktar tagħrif għal- lista ta ’ ingredjenti oħrajn) • 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- fwied u mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal - fwied.
55 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
59 • Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek • Dijabete
As with all other angiotensin antagonists, Micardis may be less effective in lowering the blood pressure in black patients.
Bħal fil- każ tal- antagonisti l- oħrajn kollha ta ’ angiotensin, Micardis jista ’ jkun inqas effettiv biex inaqqas il- pressjoni tad- demm f’ pazjenti suwed.
56 Your doctor will normally advise you to stop taking Micardis as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Micardis hekk kif issir taf li inti tqila.
The usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Id- doża normali ta ’ Micardis għall- biċċa l- kbira tal- pazjenti hi ta ’ pillola waħda ta ’ 40 mg pillola darba kuljum biex tikkontrolla l- pressjoni tad- demm għal perjodu ta ’ 24 siegħa.
Alternatively, Micardis may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
Inkella, Micardis jista ’ jintuża flimkien ma ’ dijuretiċi (‘ pilloli tal- awrina ’) bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il- pressjoni tad- demm b’ Micardis.
If you forget to take Micardis
Jekk tinsa tieħu Micardis
If you have any further questions on the use of this product, ask your doctor or pharmacist.
61 Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib jew lill - ispiżjar tiegħek.
57 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
58 Micardis 40 mg tablets are white, oblong-shaped, and engraved with the code number '51H 'on one side and the company logo on the other side.
Il- pilloli Micardis 40 mg huma bojod, b’ forma oblunga u mnaqqxa bin- numru tal- kodiċi ‘ 51H ’ fuq naħa waħda u bil- logo tal- kumpanija fuq in- naħa l- oħra.
Micardis is available in blister packs containing 14, 28, 30, 56, 84, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Micardis hu disponibbli f’ pakketti b’ folji ta ’ 14, 28, 30, 56, 84, 90 u 98 pillola, jew pakketti bil- folji bid- doża tal- unità li fihom 28 x 1 pilloli.
59 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
63 64 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
61 PACKAGE LEAFLET:
66 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Micardis 80 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Micardis 80 mg pilloli Telmisartan
Before you take Micardis 3.
Qabel ma tuża Micardis pilloli 3.
How to take Micardis 4.
Kif għandek tuża Micardis pilloli 4.
How to store Micardis 6.
Kif taħżen Micardis pilloli 6.
Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
67 Jekk jogħġbok għid lit- tabib tiegħek jekk qed tbati jew jekk fil- passat batejt minn kwalunkwe mill - kundizzjonijiet jew mard li ġejjin:
62 • Kidney disease or kidney transplant. • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
• Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek • Dijabete
You can take Micardis with or without food.
68 Tista ’ tieħu Micardis mal- ikel jew mingħajr l- ikel.
63 Your doctor will normally advise you to stop taking Micardis as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Micardis hekk kif issir taf li inti tqila.
If you forget to take Micardis
69 Jekk tinsa tieħu Micardis Jekk tinsa tieħu doża, tinkwetax.
These side effects may occur with certain frequencies, which are defined as follows:
Bħal kull mediċina oħra, Micardis jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
64 very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
Medicines should not be disposed of via wastewater or household waste.
70 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
65 Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number '52H 'on one side and the company logo on the other side.
Il- pilloli Micardis 80 mg huma bojod, b’ forma oblunga u mnaqqxa bin- numru tal- kodiċi ‘ 52H ’ fuq naħa waħda u bil- logo tal- kumpanija fuq in- naħa l- oħra.
66 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
71 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
67 Κύπρος Boehringer Ingelheim Ellas A. E.
72 Κύπρος Boehringer Ingelheim Ellas A. E.
What is MicardisPlus?
X' inhu MicardisPlus?
MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
MicardisPlus huwa mediċina li fiha żewġ sustanzi attivi, telmisartan u hydrochlorothiazide.
What is MicardisPlus used for?
Għal xiex jintuża MicardisPlus?
MicardisPlus is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
'Essenzjali' tfisser li l- pressjoni tad- demm għolja mhijiex ikkawżata minn xi kundizzjoni oħra.
The safety and effectiveness of MicardisPlus have not been established in patients below 18 years of age.
Is- sigurtà u l- effikaċja ta 'MicardisPlus ma ntwerewx f' pazjenti taħt l- età ta' 18- il sena.
How is MicardisPlus used?
Kif jintuża MicardisPlus?
MicardisPlus is taken by mouth once a day with liquid, with or without food.
MicardisPlus jittieħed oralment darba kuljum ma 'xarba likwida, mal- ikel jew mingħajru.
The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/ 12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/ 12.5 mg tablets.
Id- doża ta 'MicardisPlus li għandha tintuża tiddependi mid- doża ta' telmisartan li l- pazjent kien qiegħed jieħu qabel: il- pazjenti li qegħdin jieħdu 40 mg telmisartan għandhom jieħdu pilloli tal- 40/ 12. 5 mg filwaqt li l- pazjenti li kienu qegħdin jieħdu 80 mg telmisartan għandhom jieħdu pilloli tat- 80/ 12. 5 mg.
The 80/ 25 mg tablets are used in patients whose blood pressure is not controlled using the 80/ 12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.
Il- pilloli tat- 80/ 25 mg jintużaw minn pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata permezz ta 'pilloli tat- 80/ 12. 5 mg jew li l- qagħda tagħhom ġiet stabbli permezz ta' żewġ sustanzi attivi meħuda separatament qabel ma qalbu għal MicardisPlus.
How does MicardisPlus work?
Kif jaħdem MicardisPlus?
MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.
MicardisPlus fih żewġ sustanzi attivi, telmisartan u hydrochlorothiazide.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Billi jimblokka r- riċetturi li magħhom l- anġjotensina II teħel normalment, telmisartan iwaqqaf l- ormon milli jkollu effett, b' hekk iħalli l- arterji u l- vini jitwessgħu.
How has MicardisPlus been studied?
Kif ġie studjat MicardisPlus?
MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
MicardisPlus ġiet studjat f' ħames studji ewlenin li involvew total ta '2, 985 pazjent li jbatu minn ipertensjoni minn ħafifa għal moderata.
In four of these studies (2,272 patients), MicardisPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone.
F' erbgħa fost dawn l- istudji (jiġifieri 2, 272 pazjent), MicardisPlus tqabbel mal- plaċebo (trattament finta) u ma 'telmisartan meħud waħdu.
What benefit has MicardisPlus shown during the studies?
X' inhuma l- benefiċċji ta 'MicardisPlus li ntwerew f' dawn l- istudji?
MicardisPlus was more effective than placebo and than telmisartan taken alone in reducing diastolic blood pressure.
MicardisPlus kellu aktar effett mill- plaċebo u minn telmisartan waħdu fit- tnaqqis tal- pressjoni tad - demm dijastolika.
What is the risk associated with MicardisPlus?
X' inhu r- riskju assoċjat ma 'MicardisPlus?
The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness.
L- aktar effett sekondarju komuni b' MicardisPlus (li dehru f' bejn pazjent wieħed u 10 fost 100) huwa l - isturdament.
For the full list of all side effects reported with MicardisPlus, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtata b' MicardisPlus, ara l- Fuljett ta 'Tagħrif.
MicardisPlus should not be used in people who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulfonamides or any of the other ingredients (including sorbitol).
MicardisPlus ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal telmisartan, hydrochlorothiazide, sulfonamide jew kwalunkwe fost l- ingredjenti l- oħra (inkluż sorbitol).
MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
MicardisPlus ma għandux jintuża wkoll minn persuni li jbatu minn problemi gravi fil- fwied, kliewi jew problemi biljari, persuni li jkollhom livelli wisq baxxi ta 'potassju fid- demm, jew livelli wisq għoljin ta' kalċju fid - demm.
Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels.
MicardisPlus għandu jintuża b' kawtela meta użat ma 'mediċini oħra li jkollhom effett fuq il- livelli ta' potassju fid- demm.
Why has MicardisPlus been approved?
Għaliex ġie approvat MicardisPlus?
The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li MicardisPlus għandu iktar benefiċċji milli riskji fit- trattament tal- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad - demm tagħhom mhijiex adegwatament ikkontrollata b' telmisartan waħdu.
The Committee recommended that MicardisPlus be given marketing authorisation.
Il- Kumitat irrakkomanda li MicardisPlus jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about MicardisPlus:
Tagħrif ieħor dwar MicardisPlus:
The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus to Boehringer Ingelheim International GmbH on 19 April 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal MicardisPlus lil Boehringer Ingelheim International GmbH fid- 19 ta 'April 2002.
The marketing authorisation was renewed on 19 April 2007.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 19 ta 'April 2007.
The full EPAR for MicardisPlus is available here.
L- EPAR sħiħ dwar MicardisPlus jista 'jiġi kkonsultat hawn.
40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg
40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 40 mg/ 12. 5 mg 80 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg 80 mg/ 25 mg
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blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC)
folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC)
14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 84 tablets 84 tablets 30 tablets 90 tablets 30 tablets 90 tablets 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 56 pillola 98 pillola 14- il pillola 28 pillola 28 x 1 pillola 56 pillola 98 pillola 84 pillola 84 pillola 30 pillola 90 pillola 30 pillola 90 pillola 14- il pillola 28 pillola 28 x 1 pillola 30 pillola 56 pillola 90 pillola 98 pillola
MicardisPlus 40 mg/ 12.5 mg tablets
MicardisPlus 40 mg/ 12. 5 mg pilloli
Red and white oval shaped two layer tablet engraved with the company logo and the code'H4 '.
Pillola ħamra u bajda b’ żewġ saffi, b’ forma ovali, imnaqqxa bil- logo tal- kumpanija u l- kodiċi 'H4'.
MicardisPlus fixed dose combination (40 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 (40 mg telmisartan/ 12. 5 mg ta ’ hydrochlorothiazide) hi indikata għal pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
Adults MicardisPlus should be taken once daily with liquid, with or without food in patients whose blood pressure is not adequately controlled by telmisartan alone.
Adulti MicardisPlus għandu jittieħed darba kuljum mal- likwidu, ma ’ l- ikel jew mingħajr ikel f’ pazjenti li l - pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
• MicardisPlus 40 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Micardis 40 mg • MicardisPlus 80 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Micardis 80 mg
• MicardisPlus 40 mg/ 12. 5 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ Micardis 40 mg • MicardisPlus 80 mg/ 12. 5 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ Micardis 80 mg
In patients with mild to moderate hepatic impairment the posology should not exceed MicardisPlus 40 mg/ 12.5 mg once daily.
F’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat, il- pożoloġija m’ għandhiex taqbeż MicardisPlus 40 mg/ 12. 5 mg darba kuljum.
MicardisPlus is not indicated in patients with severe hepatic impairment.
MicardisPlus mhuwiex indikat f’ pazjenti b’ indeboliment epatiku sever.
MicardisPlus is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
MicardisPlus mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is- sigurtà u l- effikaċja.
MicardisPlus should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
MicardisPlus m’ għandux jingħata lil pazjenti b’ kolestasi, b’ disturbi ostruttivi tal- marrara jew li għandhom insuffiċjenza epatika severa (ara sezzjoni 4. 3), għax telmisartan hu eliminat fil- biċċa l- kbira tiegħu mal- bili.
In addition, MicardisPlus should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Flimkien ma ’ dan, MicardisPlus għandu jintuża bl- attenzjoni f’ pazjenti b’ indeboliment tal- funzjoni epatika jew mard progressiv tal- fwied, għax tibdil żgħir fil- fluwidu u fil- bilanċ ta ’ l- elettroliti jista ’ jikkawża koma epatika.
There is no clinical experience with MicardisPlus in patients with hepatic impairment.
M’ hemm l- ebda esperjenza klinika b’ MicardisPlus f’ pazjenti b’ indeboliment epatiku.