qanastek/EMEA-V3 huggingface dataset:
How to store Irbesartan Hydrochlorothiazide BMS 6.
Kif taħżen Irbesartan Hydrochlorothiazide BMS 6.
WHAT IRBESARTAN HYDROCHLOROTHIAZIDE BMS IS AND WHAT IT IS USED FOR
X’ INHU IRBESARTAN HYDROCHLOROTHIAZIDE BMS U GĦALXIEX JINTUŻA
Irbesartan Hydrochlorothiazide BMS is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS hu kombinazzjoni ta ’ żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
The two active ingredients in Irbesartan Hydrochlorothiazide BMS work together to lower blood pressure further than if either was given alone.
Iż- żewġ sustanzi attivi f’ Irbesartan Hydrochlorothiazide BMS jaħdmu flimkien biex inaqqsu l - pressjoni iktar milli kieku jingħataw waħidhom.
Irbesartan Hydrochlorothiazide BMS is used in the treatment of high blood pressure (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Irbesartan Hydrochlorothiazide BMS jintuża fil- kura għall- pressjoni għolja (pressjoni għolja essenzjali), meta l- kura b’ irbesartan jew hydrochlorothiazide waħedhom ma tipprovdix kontroll adattat għall- pressjoni tiegħek.
BEFORE YOU TAKE IRBESARTAN HYDROCHLOROTHIAZIDE BMS
QABEL MA TIEĦU IRBESARTAN HYDROCHLOROTHIAZIDE BMS
Do not take Irbesartan Hydrochlorothiazide BMS if you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide, or any of the other ingredients of Irbesartan Hydrochlorothiazide BMS or to sulfonamide-derived medicines during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding if you have severe liver or kidney problems if you have difficulty in producing urine if you have a condition which is associated with persistently high calcium or low potassium levels in your blood
Tiħux Irbesartan Hydrochlorothiazide BMS jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal irbesartan u hydrochlorothiazide jew sustanzi oħra ta 'Irbesartan Hydrochlorothiazide BMS jew għall- mediċini derivati mis - sulfonamide matul l- aħħar sitt xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ jekk qegħda tredda ’ jekk inti għandek problemi severi tal- fwied jew tal- kliewi jekk inti għandek diffikultà biex tagħmel l- awrina jekk inti għandek kondizzjoni assoċjata ma ’ livelli persistenti ta ’ calcium għoli jew potassium baxx fid- demm tiegħek
Irbesartan Hydrochlorothiazide BMS should not be given to children and adolescents (< 18 years).
Irbesartan Hydrochlorothiazide BMS m’ għandux jingħata lit- tfal u lill- adoloxxenti (< 18- il sena).
Take special care with Irbesartan Hydrochlorothiazide BMS if you suffer from excessive vomiting or diarrhoea if you suffer from kidney problems, including kidney transplantation
Oqgħod attent ħafna b’ Irbesartan Hydrochlorothiazide BMS jekk inti tbati minn rimettar jew dijarea eċċessiva jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi
92 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
92 jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Irbesartan Hydrochlorothiazide BMS is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Irbesartan Hydrochlorothiazide BMS mhuwiex rakkomandat kmieni matul it- tqala u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek wara l- ewwel 3 xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ.
You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide BMS) if you are to undergo any surgery or receive anaesthetics
Int għandek tgħid ukoll lit- tabib tiegħek: jekk int qiegħed/ qiegħda fuq dieta nieqsa mill- melħ jekk int qed turi sinjali bħal għatx mhux tas- soltu, ħalq xott, għejja ġenerali, ngħas, uġigħ fil - muskoli jew bugħawwieġ, dardir, rimettar jew taħbit tal- qalb mgħaġġel mhux normali li jistgħu jseħħu minħabba effett eċċessiv ta ’ hydrochlorothiazide (li hemm f’ Irbesartan Hydrochlorothiazide BMS) jekk inti għandek bżonn tagħmel xi operazzjoni jew tirċievi anistetiku
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide BMS may interact with other medicines.
Dijuretiċi bħal hydrochlorothiazide li jinstab f’ Irbesartan Hydrochlorothiazide BMS jista ’ jkun ikollhom interazzjoni ma ’ mediċini oħra.
Preparations containing lithium should not be taken with Irbesartan Hydrochlorothiazide BMS without close supervision by your doctor.
Preparazzjonijiet li fihom lithium m’ għandhomx jittieħdu ma ’ Irbesartan Hydrochlorothiazide BMS jekk ma tkunx taħt is- superviżjoni mill- viċin tat- tabib tiegħek.
Special precautionary measures (e. g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium sparing medicines, other diuretics (water tablets), some laxatives, medicines for the treatment of gout, therapeutic vitamin D supplements, medicines to control heart rhythm or for diabetes (oral agents or insulins).
Jista ’ jkun tajjeb li jittieħdu miżuri speċjali ta ’ prekawzjoni (p. e. testijiet tad- demm) jekk int tieħu supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium, jew mediċini potassium sparing, dijuretiċi oħra (pilloli ta ’ l- ilma), xi lassattivi, mediċini għall- kura tal- gotta, supplimenti terapewtiċi tal- vitamina D, mediċini biex jikkontrolaw ir- ritmu tal- qalb jew għad- dijabete (mediċini li jittieħdu mill- ħalq jew insulina).
It is also important for your doctor to know if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers or arthritis medicines.
Huwa importanti wkoll li t- tabib tiegħek ikun jaf jekk intix qed tieħu mediċini oħra biex tniżżel il- pressjoni tad- demm, sterojdi, mediċini biex tikkura il- kanċer, mediċini li jtaffu l- uġigħ u mediċini għall- artrite.
Taking Irbesartan Hydrochlorothiazide BMS with food and drink Irbesartan Hydrochlorothiazide BMS can be taken with or without food.
Meta tieħu Irbesartan Hydrochlorothiazide BMS ma ’ l- ikel u max- xorb Irbesartan Hydrochlorothiazide BMS jista ’ jittieħed bi jew mingħajr ikel.
Usually, your doctor will advise you to take another medicine instead of Irbesartan Hydrochlorothiazide BMS, as Irbesartan Hydrochlorothiazide BMS 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 jagħtik parir li tieħu mediċina oħra minflok Irbesartan Hydrochlorothiazide BMS, minħabba li Irbesartan Hydrochlorothiazide BMSmhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Irbesartan Hydrochlorothiazide BMS before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Irbesartan Hydrochlorothiazide BMSqabel il- bidu ta ’ tqala.
Your doctor will normally advise you to stop taking Irbesartan Hydrochlorothiazide BMS as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Irbesartan Hydrochlorothiazide BMS malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Irbesartan Hydrochlorothiazide BMS, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Irbesartan Hydrochlorothiazide BMS, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Irbesartan Hydrochlorothiazide BMS is unlikely to affect your ability to drive or use machines.
Irbesartan Hydrochlorothiazide BMS mhux suppost li jtellfek milli ssuq jew tħaddem magni.
However, occasionally dizziness or weariness may occur during treatment of high blood pressure.
Madankollu, xi kultant sturdament jew għeja jinħassu waqt il- kura ta ’ kontra l- pressjoni għolja.
If you experience these, you should consult your doctor before attempting such activities.
Jekk tħoss xi ħaġa minn dawn, għandek tirreferi lit- tabib tiegħek qabel ma tagħmel dawn l- attivitajiet.
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS contains lactose monohydrate (see “ Further information”).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS fih il- lactose monohydrate (ara “ Aktar tagħrif ”).
HOW TO TAKE IRBESARTAN HYDROCHLOROTHIAZIDE BMS
KIF GĦANDEK TIEĦU IRBESARTAN HYDROCHLOROTHIAZIDE BMS
Always take Irbesartan Hydrochlorothiazide BMS exactly as your doctor has told you.
Dejjem għandek tieħu Irbesartan Hydrochlorothiazide BMS skond il- parir tat- tabib.
Irbesartan Hydrochlorothiazide BMS will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
Irbesartan Hydrochlorothiazide BMS ġeneralment jiġi preskritt mit- tabib tiegħek meta l- kura li kont tieħu qabel għal kontra l- pressjoni għolja ma pprovdietx tnaqqis xieraq tal- pressjoni.
Your doctor will instruct you how to switch from the previous treatment to Irbesartan Hydrochlorothiazide BMS.
It- tabib tiegħek igħidlek kif għandek tagħmel biex taqleb mill- kura li kont qed tieħu qabel għal Irbesartan Hydrochlorothiazide BMS.
The usual dose of Irbesartan Hydrochlorothiazide BMS is one or two tablets a day.
Id- doża normali ta ’ Irbesartan Hydrochlorothiazide BMS hija ta ’ pillola waħda jew tnejn kuljum.
Kind of administration For oral use The tablets should be swallowed with a sufficient amount of fluid (e. g. one glass of water).
Kif għandek tieħu l- mediċina Użu orali Il- pilloli għandhom jinbelgħu ma ’ ammont suffiċjenti ta ’ fluwidu (p. e. tazza ilma).
You can take Irbesartan Hydrochlorothiazide BMS with or without food.
Irbesartan Hydrochlorothiazide BMS jista ’ jittieħed ma ’ l- ikel jew waħdu.
You should try to take your daily dose at about the same time each day.
Inti għandek tipprova tieħu d- doża tiegħek tal- ġurnata kważi fl- istess ħin kuljum.
It is important that you continue to take Irbesartan Hydrochlorothiazide BMS until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Irbesartan Hydrochlorothiazide BMS sakemm it- tabib ma jgħidlekx mod ieħor.
If you take more Irbesartan Hydrochlorothiazide BMS than you should If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Jekk tieħu Irbesartan Hydrochlorothiazide BMS aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, jew jekk tifel/ tifla tibla ’ xi ftit, għid lit- tabib tiegħek immedjatament.
If you forget to take Irbesartan Hydrochlorothiazide BMS If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Irbesartan Hydrochlorothiazide BMS Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu d- doża li jmiss bħas- soltu.
Like all medicines, Irbesartan Hydrochlorothiazide BMS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Irbesartan Hydrochlorothiazide BMS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of the side effects listed below is defined using the following convention:
Il- frekwenza ta ’ l- effetti sekondarji elenkati hawn taħt hija definita bl- użu tal- konvenzjoni segwenti:
Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than1 in 100 patients
Komuni: mill- anqas 1 f’ 100 u anqas minn 1 f’ 10 pazjenti Mhux komuni: mill- anqas 1 f’ 1000 u anqas minn 1 f’ 100 pazjent
Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide BMS were:
L- effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b’ Irbesartan Hydrochlorothiazide BMS kienu:
Common: nausea/ vomiting, abnormal urination, fatigue and dizziness (including when getting up from a lying or sitting position).
Komuni: dardir/ rimettar, tagħmel l- awrina mhux normali, għeja u sturdament (anki meta tqum minn mimdud jew minn bil- qiegħda).
Uncommon: diarrhoea, low blood pressure, fainting, heart rate increased, flushing, swelling and sexual dysfunction (problems with sexual performance).
Mhux komuni: dijarea, pressjoni baxxa, ħass ħażin, taħbit mgħaġġel tal- qalb, fwawar, nefħa, u disturb sesswali (problemi fl- attivita` sesswali).
In addition your doctor may identify abnormal changes in your blood components:
Ukoll it- tabib tiegħek jista ’ jidentifika tibdil mhux normali fil- komponenti tad- demm:
Common: blood urea nitrogen increased, creatinine increased and creatine kinase increased.
Komuni: żieda fl- urea nitrogen tad- demm, żieda fil- krejatinina u kreatina kinasi.
Uncommon: serum potassium decreased and sodium decreased.
Mhux komuni: tnaqqis tal- potassium fis- serum u tnaqqis tas- sodium.
Occasional side effects reported since the marketing of Irbesartan Hydrochlorothiazide BMS are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired renal function.
Effetti sekondarji li ġew irrapportati kultant minn meta Irbesartan Hydrochlorothiazide BMS tqiegħed fuq is- suq huma: uġigħ ta ’ ras, żarżir fil- widnejn, sogħla, disturbi fit- togħma, indiġestjoni, uġigħ fil - ġogi u fil- muskoli, funzjoni tal- fwied anormali u indeboliment fil- funzjoni renali.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/ or tongue have been reported in patients taking irbesartan.
94 Bħal ma jiġri b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi fil- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata fill- wiċċ, fix- xufftejn u/ jew fl- ilsien ġew irrapportati f’ pazjenti li ħadu irbesartan.
If you think you are developing such a reaction or get short of breath stop taking Irbesartan Hydrochlorothiazide BMS and seek immediate medical attention.
Jekk taħseb li qed tiżviluppa din ir- reazzjoni jew qed jonqoslok in- nifs tiħux Irbesartan Hydrochlorothiazide BMS u fittex immedjatament attenzjoni medika.
94 As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Bħal ma jiġri f’ kombinazzjoni ta ’ żewġ sustanzi attivi, effetti sekondarji assoċjati ma ’ komponenti waħidhom ma jistgħux jiġu esklużi.
The other component of Irbesartan Hydrochlorothiazide BMS (hydrochlorothiazide) has been associated rarely with other more serious side effects mainly affecting the blood, the skin or the kidneys.
Il- komponent l- ieħor ta ’ Irbesartan Hydrochlorothiazide BMS (hydrochlorothiazide) ġie assoċjat rarament ma ’ effetti oħrajn iktar serji li jaffettwaw prinċipalment id- demm, il- ġilda jew il- kliewi.
While this was not observed with Irbesartan Hydrochlorothiazide BMS, occurrence of such side effects cannot be excluded.
Għalkemm dawn ma ġewx osservati b’ Irbesartan Hydrochlorothiazide BMS, effetti sekondarji bħal dawn ma jistgħux jiġu esklużi.
HOW TO STORE IRBESARTAN HYDROCHLOROTHIAZIDE BMS
KIF TAĦŻEN IRBESARTAN HYDROCHLOROTHIAZIDE BMS
Do not use Irbesartan Hydrochlorothiazide BMS after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Irbesartan Hydrochlorothiazide BMS wara d- data ta ’ skadenza li tidher fuq il- kaxxa jew fuq il - folja wara JIS.
What Irbesartan Hydrochlorothiazide BMS contains
X’ fih Irbesartan Hydrochlorothiazide BMS
The active substances are irbesartan and hydrochlorothiazide.
Is- sustanzi attivi huma irbesartan u hydrochlorothiazide.
Each tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg fiha 150 mg irbesartan u 12. 5 mg hydrochlorothiazide.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, red and yellow ferric oxides.
Is- sustanzi l- oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, ferric oxide aħmar u isfar.
What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack
Id- dehra ta ’ Irbesartan Hydrochlorothiazide BMS u l- kontenuti tal- pakkett
Irbesartan Hydrochlorothiazide BMS tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Il- pilloli Irbesartan Hydrochlorothiazide BMS huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2775 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide BMS tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Il- pilloli huma pprovduti f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
Unit dose blister packs of 56 x 1 tablets for delivery in hospitals are also available.
Pakketti ta ’ doża waħda ta ’ 56 x 1 pilloli sabiex jitqassmu fl- isptarijiet huma wkoll disponibbli.
95 Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
95 Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
96 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
96 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide BMS Pilloli 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
99 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
99 jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
The usual dose of Irbesartan Hydrochlorothiazide BMS is one tablet a day.
Id- doża normali ta ’ Irbesartan Hydrochlorothiazide BMS hija ta ’ pillola waħda kuljum.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/ or tongue have been reported in patients taking irbesartan.
101 Bħal ma jiġri b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi fil- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata fill- wiċċ, fix- xufftejn u/ jew fl- ilsien ġew irrapportati f’ pazjenti li ħadu irbesartan.
101 As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Bħal ma jiġri f’ kombinazzjoni ta ’ żewġ sustanzi attivi, effetti sekondarji assoċjati ma ’ komponenti waħidhom ma jistgħux jiġu esklużi.
Each tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Il- pilloli Irbesartan Hydrochlorothiazide BMS huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2776 fuq in- naħa l- oħra.
102 Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
102 Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
103 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
103 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
105 PACKAGE LEAFLET:
105 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
106 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
106 jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Usually, your doctor will advise you to take another medicine instead of Irbesartan Hydrochlorothiazide BMS, as Irbesartan Hydrochlorothiazide BMS 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 jagħtik parir li tieħu mediċina oħra minflok Irbesartan Hydrochlorothiazide BMS, minħabba li Irbesartan Hydrochlorothiazide BMS mhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Irbesartan Hydrochlorothiazide BMS before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Irbesartan Hydrochlorothiazide BMS qabel il- bidu ta ’ tqala.
If you become pregnant during therapy with Irbesartan Hydrochlorothiazide BMS, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b’ Irbesartan Hydrochlorothiazide BMS, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/ or tongue have been reported in patients taking irbesartan.
108 Bħal ma jiġri b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi fil- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata fill- wiċċ, fix- xufftejn u/ jew fl- ilsien ġew irrapportati f’ pazjenti li ħadu irbesartan.
108 As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Bħal ma jiġri f’ kombinazzjoni ta ’ żewġ sustanzi attivi, effetti sekondarji assoċjati ma ’ komponenti waħidhom ma jistgħux jiġu esklużi.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg fiha 150 mg irbesartan u 12. 5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide BMS huma lewn il- ħawħa, ibbuzzati fuq iż - żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2875 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 56, 84 jew 98 pillola miksija b' rita.
Unit dose blister packs of 56 x 1 film-coated tablets for delivery in hospitals are also available.
Pakketti ta 'folji ta' doża waħda ta ’ 56 x 1 pilloli miksijin b' rita sabiex jitqassmu fl- isptarijiet huma wkoll disponibbli.
109 Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
109 Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
110 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
110 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
112 PACKAGE LEAFLET:
112 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
113 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
113 jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/ or tongue have been reported in patients taking irbesartan.
115 Bħal ma jiġri b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi fil- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata fill- wiċċ, fix- xufftejn u/ jew fl- ilsien ġew irrapportati f’ pazjenti li ħadu irbesartan.
115 As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Bħal ma jiġri f’ kombinazzjoni ta ’ żewġ sustanzi attivi, effetti sekondarji assoċjati ma ’ komponenti waħidhom ma jistgħux jiġu esklużi.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide BMS huma lewn il- ħawħa, ibbuzzati fuq iż - żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2876 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 56, 84 jew 98 pillola miksija b' rita.
116 Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
116 Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
117 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
117 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
119 PACKAGE LEAFLET:
119 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
120 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
120 jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/ or tongue have been reported in patients taking irbesartan.
122 Bħal ma jiġri b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi fil- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata fill- wiċċ, fix- xufftejn u/ jew fl- ilsien ġew irrapportati f’ pazjenti li ħadu irbesartan.
122 As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Bħal ma jiġri f’ kombinazzjoni ta ’ żewġ sustanzi attivi, effetti sekondarji assoċjati ma ’ komponenti waħidhom ma jistgħux jiġu esklużi.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide BMS huma roża, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2788 fuq in- naħa l- oħra.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Il- pilloli miksijin b' rita Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg huma fornuti fi strixxi ta '14, 28, 56, 84 jew 98 pillola miksija b' rita.
123 Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
123 Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
124 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
124 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
What is Irbesartan Hydrochlorothiazide Winthrop?
X' inhu Irbesartan Hydrochlorothiazide Winthrop?
Irbesartan Hydrochlorothiazide Winthrop is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop huwa mediċina li fiha żewġ sustanzi attivi, irbesartan u l - idroklorotijażide (hydrochlorothiazide).
This medicine is the same as Coaprovel, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Coaprovel, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Coaprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Winthrop.
Il - kumpanija li tipproduċi Coaprovel qablet li t- tagħrif xjentifiku tagħha jista 'jintuża għal Irbesartan Hydrochlorothiazide Winthrop.
What is Irbesartan Hydrochlorothiazide Winthrop used for?
Għal xiex jintuża Irbesartan Hydrochlorothiazide Winthrop?
Irbesartan Hydrochlorothiazide Winthrop is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Irbesartan Hydrochlorothiazide Winthrop jintuża f' pazjenti li għandhom ipertensjoni essenzjali (pressjoni tad- demm għolja) li mhijiex ikkontrollata adegwatament b' irbesartan jew bl - idroklorotijażide meħudin waħedhom.
Irbesartan Hydrochlorothiazide Winthrop has not been tested in patients below 18 years of age.
'Essenzjali' tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Irbesartan Hydrochlorothiazide Winthrop used?
Kif jintuża Irbesartan Hydrochlorothiazide Winthrop?
Irbesartan Hydrochlorothiazide Winthrop is taken by mouth, with or without food.
Irbesartan Hydrochlorothiazide Winthrop jittieħed b' mod orali, anki fuq stonku vojt.
The dose of Irbesartan Hydrochlorothiazide Winthrop to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Id- doża ta 'Irbesartan Hydrochlorothiazide Winthrop li għandha tintuża tiddependi mid- doża ta' irbesartan jew ta 'idroklorotijażide li l- pazjent kien qiegħed jieħu qabel.
Irbesartan Hydrochlorothiazide Winthrop may be added to other treatments for hypertension.
Irbesartan Hydrochlorothiazide Winthrop jista 'jintuża flimkien ma' trattamenti għall- ipertensjoni.
How does Irbesartan Hydrochlorothiazide Winthrop work?
Kif jaħdem Irbesartan Hydrochlorothiazide Winthrop?
Irbesartan Hydrochlorothiazide Winthrop contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop fih żewġ sustanzi attivi, irbesartan u l- idroklorotijażide.
By lowering the blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Bit- tnaqqis tal- pressjoni tad- demm, jitnaqqas ir - riskju kkawżat minn pressjoni tad- demm għolja, bħal puplesija.
How has Irbesartan Hydrochlorothiazide Winthrop been studied?
Kif ġie studjat Irbesartan Hydrochlorothiazide Winthrop?
The studies of Karvea/ Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Winthrop.
Bħala appoġġ għall- użu ta 'Irbesartan Hydrochlorothiazide Winthrop, intużaw l- istudji mwettqa fuq Karvea/ Aprovel flimkien ma' l - idroklorotijażide f' pilloli separati.
What benefit has Irbesartan Hydrochlorothiazide Winthrop shown during the studies?
X' benefiċċji wera Irbesartan Hydrochlorothiazide Winthrop waqt l- istudji mwettqa?
Irbesartan Hydrochlorothiazide Winthrop was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Irbesartan Hydrochlorothiazide Winthrop irriżulta aktar effikaċi mill- plaċebo (trattament finta) u mill - idroklorotijażide meħudin waħedhom fit- tnaqqis tal- pressjoni tad- demm dijastolika.
What is the risk associated with Irbesartan Hydrochlorothiazide Winthrop?
X' inhuma r- riskji assoċjati ma 'Irbesartan Hydrochlorothiazide Winthrop?
The most common side effects with Irbesartan Hydrochlorothiazide Winthrop (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen( BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
L- effetti sekondarji l- aktar komuni b' Irbesartan Hydrochlorothiazide Winthrop (li dehru f' bejn pazjent 1 u 10 minn 100) huma sturdament, nawżea (dardir) jew remettar, disturbi urinarji, għeja kbira u żieda fil- livelli tan- nitroġenu urejku tad- demm (blood urea nitrogen, BUN, prodott ta 'skart mill- proteini), tal- kreatinina (prodott ta' skart mill- muskoli) u kreatina kinażi (creatine kinase, enzima li tinsab fil - muskoli).
For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Winthrop, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Irbesartan Hydrochlorothiazide Winthrop, ara l- Fuljett ta' Tagħrif.
Irbesartan Hydrochlorothiazide Winthrop should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Irbesartan Hydrochlorothiazide Winthrop ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan, għall- idroklorotijażide, għas- sulfonamidi, jew għal kwalunkwe ingredjent ieħor.
Irbesartan Hydrochlorothiazide Winthrop should also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Irbesartan Hydrochlorothiazide Winthrop ma għandux jintuża wkoll minn pazjenti 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 Irbesartan Hydrochlorothiazide Winthrop with other medicines that have an effect on blood potassium levels.
Irbesartan Hydrochlorothiazide Winthrop għandu jintuża b' kawtela meta użat ma 'mediċini oħra li jkollhom effett fuq il- livelli ta' potassju fid- demm.
Why has Irbesartan Hydrochlorothiazide Winthrop been approved?
Għaliex ġie approvat Irbesartan Hydrochlorothiazide Winthrop?
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide Winthrop’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Irbesartan Hydrochlorothiazide Winthrop huma ogħla mir- riskji tiegħu fit- trattament ta' l- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata adegwatament b' irbesartan jew bl- idroklorotijażide meħudin waħedhom.
The Committee recommended that Irbesartan Hydrochlorothiazide Winthrop be given marketing authorisation.
Il- Kumitat irrakkomanda li Irbesartan Hydrochlorothiazide Winthrop jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Irbesartan Hydrochlorothiazide Winthrop:
Aktar tagħrif dwar Irbesartan Hydrochlorothiazide Winthrop:
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC on 19 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Irbesartan Hydrochlorothiazide Winthrop lil Sanofi Pharma Squibb Pharma SNC fid- 19 ta 'Jannar 2007.
The full EPAR for Irbesartan Hydrochlorothiazide Winthrop is available here.
L- EPAR sħiħ għal Irbesartan Hydrochlorothiazide Winthrop jista 'jiġi kkonsultat hawn.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg tablets.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg pilloli.
Irbesartan Hydrochlorothiazide Winthrop can be taken once daily, with or without food.
Irbesartan Hydrochlorothiazide Winthrop jista ’ jittieħed darba kuljum, ma ’ l- ikel jew waħdu.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg jista ’ jingħata f ’ pazjenti, fejn il - pressjoni mhix qed tiġi kkontrollata sew b’ hydrochlorothiazide jew irbesartan 150 mg waħidhom; Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg jista ’ jingħata lill- pazjenti li mhux qed ikunu kkontrollati b’ mod suffiċjenti b’ irbesartan 300 mg jew b’ Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg jista ’ jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b’ mod suffiċjenti b’ Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg.
When necessary, Irbesartan Hydrochlorothiazide Winthrop may be administered with another antihypertensive medicinal product (see section 4.5).
Meta neċessarju, Irbesartan Hydrochlorothiazide Winthrop jista jingħata ma ’ prodott mediċinali ieħor kontra l- pressjoni għolja (ara sezzjoni 4. 5).
Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide Winthrop is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/ min).
Indeboliment renali: minħabba li fih il- komponent ta ’ hydrochlorothiazide, Irbesartan Hydrochlorothiazide Winthrop mhux irrikmandat għall- pazjenti b’ disfunzjoni renali severa (tneħħija tal- krejatinina < 30 ml/ min).
2 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
2 Tnaqqis fil- volum intravaskulari: tnaqqis ta ’ volum u/ jew ta ’ sodium, għandhom jiġu ikkoreġuti qabel ma ’ jingħata Irbesartan Hydrochlorothiazide Winthrop.
Irbesartan Hydrochlorothiazide Winthrop is not indicated in patients with severe hepatic impairment.
Irbesartan Hydrochlorothiazide Winthrop mhux indikat f’ pazjenti b’ indeboliment epatiku sever.
No dosage adjustment of Irbesartan Hydrochlorothiazide Winthrop is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
M’ hemmx bżonn aġġustar fid- doża ta ’ Irbesartan Hydrochlorothiazide Winthrop f’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 4. 3).
Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide Winthrop is necessary in elderly patients.
Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ Irbesartan Hydrochlorothiazide Winthrop f’ pazjenti anzjani.
Irbesartan Hydrochlorothiazide Winthrop has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Irbesartan Hydrochlorothiazide Winthrop kien rarament assoċjat ma ’ pressjoni baxxa sintomatika f’ pazjenti bi pressjoni għolja mingħajr fatturi ta ’ riskju oħra għall- pressjoni baxxa.
Symptomatic hypotension may be expected to occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Pressjoni baxxa sintomatika tista ’ tkun iżjed mistennija f’ pazjenti li jbatu minn tnaqqis ta ’ volum u/ jew sodium minħabba terapija dijuretika qawwija, dieta restritta mill - melħ, dijarea jew rimettar.
Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Winthrop.
Dawn il- kondizzjonijiet għandhom jiġu korretti qabel tinbeda il- kura b’ Irbesartan Hydrochlorothiazide Winthrop.
While this is not documented with Irbesartan Hydrochlorothiazide Winthrop, a similar effect should be anticipated.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Irbesartan Hydrochlorothiazide Winthrop, effetti simili għandhom ikunu mistennija.
Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide Winthrop is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Indeboliment renali u trapjant tal- kliewi: meta Irbesartan Hydrochlorothiazide Winthrop jintuża f’ pazjenti b’ indeboliment tal- funzjoni renali, hija rrikmandata osservazzjoni perjodika tal- livelli tal - potassium fis- serum, tal- krejatinina u tal- uric acid.
There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Winthrop in patients with a recent kidney transplantation.
M’ hemmx esperjenza meta Irbesartan Hydrochlorothiazide Winthrop jingħata lill- pazjenti li riċentament kellhom trapjant tal- kliewi.
Irbesartan Hydrochlorothiazide Winthrop should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Irbesartan Hydrochlorothiazide Winthrop m’ għandux jintuża f’ pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3).
There is no clinical experience with Irbesartan Hydrochlorothiazide Winthrop in patients with hepatic impairment.
Għad m’ hemmx esperjenza klinika b’ Irbesartan Hydrochlorothiazide Winthrop f’ pazjenti b’ indeboliment epatiku.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
3 Stenożi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva: bħal fil- każ ta ’ vażodilatorji oħra, għandha tingħata attenzjoni speċjali f’ pazjenti li jsofru minn stenożi aortika jew mitrali jew kardjomijopatija ipertrofika ostruttiva.
3 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
Therefore, the use of Irbesartan Hydrochlorothiazide Winthrop is not recommended.
Għalhekk, mhux irrikmandat l- użu ta ’ Irbesartan Hydrochlorothiazide Winthrop.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide Winthrop, minimal or no effects were reported.
Żidiet fil- livelli tal- kolesterol u tat- trigliċeridi ġew assoċjati mat- terapija dijuretika thiazide; madankollu b’ doża ta ’ 12. 5 mg ta ’ Irbesartan Hydrochlorothiazide Winthrop, l- effetti li ġew irrapportati kienu minimi jew xejn.
Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide Winthrop hyperkalaemia might occur, especially in the presence of renal impairment and/ or heart failure, and diabetes mellitus.
Għal kuntrarju, minħabba li Irbesartan Hydrochlorothiazide Winthrop fih irbesartan, jista jkun hemm iperkalimja speċjalment fil - preżenza ta ’ indeboliment renali u/ jew insuffiċenza tal- qalb u dijabete.
Potassium-sparing diuretics, potassium supplements or potassium- containing salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide Winthrop (see section 4.5).
Id- dijuretiċi li ma jnaqqsux il- potassium, supplimenti tal- potassium jew sostituti li fihom il- potassium għandhom jingħataw b’ attenzjoni flimkien ma ’ Irbesartan Hydrochlorothiazide Winthrop (ara sezzjoni 4. 5).
Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide Winthrop is not recommended (see section 4.5).
Lithium: mhux irrikmandat l- użu flimkien ta ’ lithium u Irbesartan Hydrochlorothiazide Winthrop (ara sezzjoni 4. 5).
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Bħal ma jiġri b’ kull mediċina kontra pressjoni għolja, it- tnaqqis eċċessiv ta ’ pressjoni f’ pazjenti li jbatu minn kardjopatija iskemika jew minn mard kardjovaskulari iskemiku jista ’ jwassal għal infart mijokardijaku jew għal attakk ta ’ puplesija.
4 Pregnancy:
4 Reazzjonijiet ta ’ sensittività eċċessiva għal hydrochlorothiazide jistgħu jinħassu f’ pazjenti li għandhom jew m’ għandhomx rekord ta ’ allerġija jew ażżma tal- bronki, imma hemm aktar ċans li jiġru f’ pazjenti li kellhom dawn l- attakki.