qanastek/EMEA-V3 huggingface dataset:
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
46 għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
45 Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk seħħet espożizzjoni għall- AIIRAs mit- tieni trimestru tat- tqala, huwa rrakkomandat kontroll bl - ultrasound tal- funzjoni renali u tal- kranju.
46
fwawar
Not known:
48 Disturbi gastro - intestinali:
47 4.9 Overdose
4. 9 Doża eċċessiva
The effect of the combination of irbesartan and hydrochlorothiazide on morbidity and mortality has not been studied.
50 Ma ġiex studjat l- effett tal- kombinazzjoni ta ’ irbesartan u hydrochlorothiazide fuq il- morbidità u l - imwiet.
49 The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
It- tipi u l- inċidenzi ta ’ episodji avversi rrapportati għal pazjenti ttrattati bil- kombinazzjoni kienu simili għall- profil ta ’ l- episodju avvers għal pazjenti fuq monoterapija.
50 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity.
52 Ma deherx li kien hemm effetti teratoġeniċi f’ firien li ngħataw irbesartan u hydrochlorothiazide flimkien b’ dożi li jipproduċu tossiċità materna.
6.2 Incompatibilities
53 6. 2 Inkompatibilitajiet
Cartons of 30 film-coated tablets; 3 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Pakketti ta ’ 30 pillola miksija b' rita; 3 strixxiet ta ’ 10- il pillola miksija b' rita f’ folji tal - PCV/ PVDC/ Aluminju.
Cartons of 90 film-coated tablets; 9 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Pakketti ta ’ 90 pillola miksija b' rita; 9 strixxiet ta ’ 10- il pillola miksija b' rita f’ folji tal - PCV/ PVDC/ Aluminju.
CoAprovel 300 mg/ 25 mg film-coated tablets.
CoAprovel 300 mg/ 25 mg pilloli miksijin b' rita.
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Kull pillola miksija b' rita fiha 300 mg ta ’ irbesartan u 25 mg ta ’ hydrochlorothiazide.
Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate).
Kull pillola miksija b’ rita fiha 53. 3 mg ta ’ lactose (bħala lactose monohydrate).
Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Roża, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u numru 2788 mnaqqax fuq in- naħa l- oħra.
Hepatic impairment:
56 Indeboliment epatiku:
54 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ CoAprovel f’ pazjenti anzjani.
Metabolic and endocrine effects: thiazide therapy may impair glucose tolerance.
57 Effetti metaboliċi u endokrinali: it- terapija bit- thiazide tista ’ tfixkel it- tolleranza tal- glucose.
55 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Tista ’ sseħħ iperuriċemija jew tiħrax gotta ċara f’ xi pazjenti li jirċievu it- terapija thiazide.
56 Lactose: this medicinal product contains lactose.
Lactose: dan il- prodott mediċinali fih il- lactose.
57 Alcohol: potentiation of orthostatic hypotension may occur;
Alkoħol: jista ’ jkun hemm żieda fil- pressjoni baxxa ortostatika;
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
60 għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
58 Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk seħħet espożizzjoni għall- AIIRAs mit- tieni trimestru tat- tqala, huwa rrakkomandat kontroll bl - ultrasound tal- funzjoni renali u tal- kranju.
59
fwawar
Not known:
62 Disturbi gastro - intestinali:
60 4.9 Overdose
4. 9 Doża eċċessiva
The effect of the combination of irbesartan and hydrochlorothiazide on morbidity and mortality has not been studied.
64 Ma ġiex studjat l- effett tal- kombinazzjoni ta ’ irbesartan u hydrochlorothiazide fuq il- morbidità u l - imwiet.
62 The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
It- tipi u l- inċidenzi ta ’ episodji avversi rrapportati għal pazjenti ttrattati bil- kombinazzjoni kienu simili għall- profil ta ’ l- episodju avvers għal pazjenti fuq monoterapija.
63 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity.
66 Ma deherx li kien hemm effetti teratoġeniċi f’ firien li ngħataw irbesartan u hydrochlorothiazide flimkien b’ dożi li jipproduċu tossiċità materna.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Pregelatinized starch Silicon dioxide Magnesium stearate Red and yellow ferric oxides
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Lamtu preġelatinizzat Silicon dioxide Magnesium stearate Ferric oxides ħomor u sofor
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3350 Red and black ferric oxides Carnauba wax
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3350 Ferric oxides ħomor u suwed Carnauba wax
6.2 Incompatibilities
67 6. 2 Inkompatibilitajiet
65 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
15 October 1998 Date of last renewal:
15 ta ’ Ottubru 1998
66 ANNEX II
69 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- IMPORTAZZJONI U L- ĦRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizzi tal- manifatturi responsabbli għall- importazzjoni u l- ħruġ tal- lott
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc Cedex Franza
Sanofi-Synthelabo Limited Edgefield Avenue Fawdon Newcastle Upon Tyne Tyne & Wear NE3 3TT United Kingdom
Sanofi- Synthelabo Limited Edgefield Avenue Fawdon Newcastle Upon Tyne Tyne & Wear NE3 3TT Ir- Renju Unit
2112 Veresegyhaz Hungary
2112 Veresegyhaz L- Ungerija
Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel 37100 Tours France
Sanofi Winthrop Industrie 30- 36, avenue Gustave Eiffel 37100 Tours Franza
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għall- ħruġ tal- lott konċernat.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
OTHER CONDITIONS
KUNDIZZJONIJIET OĦRA
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3. 0 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qegħda taħdem qabel u waqt li l- prodott ikun fis- suq.
68 ANNEX III
71 ANNESS III
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CoAprovel 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli CoAprovel 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
STATEMENT OF ACTIVE SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZI ATTIVI
Each tablet contains: irbesartan 150 mg and hydrochlorothiazide 12.5 mg
Kull pillola fiha: irbesartan 150 mg u hydrochlorothiazide 12. 5 mg
Excipients: also contains lactose monohydrate.
Sustanzi mhux attivi: fih ukoll lactose monohydrate.
14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
14- il pillola 28 pillola 56 pillola 56 x 1 pillola 98 pillola
EU/ 1/ 98/ 086/ 007 14 tablets EU/ 1/ 98/ 086/ 001 28 tablets EU/ 1/ 98/ 086/ 002 56 tablets EU/ 1/ 98/ 086/ 009 56 x 1 tablets EU/ 1/ 98/ 086/ 003 98 tablets
EU/ 1/ 98/ 086/ 007 14- il pillola EU/ 1/ 98/ 086/ 001 28 pillola EU/ 1/ 98/ 086/ 002 56 pillola EU/ 1/ 98/ 086/ 009 56 x 1 pillola EU/ 1/ 98/ 086/ 003 98 pillola
CoAprovel 150 mg/ 12.5 mg
CoAprovel 150 mg/ 12. 5 mg
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
CoAprovel 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
CoAprovel 150 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
14 - 28 - 56 - 98 tablets:
14 - 28 - 56 – 98- il pillola:
56 x 1 tablets:
56 x 1 pillola:
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
76 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CoAprovel 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli CoAprovel 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
Kull pillola fiha: irbesartan 300 mg u hydrochlorothiazide 12. 5 mg
EU/ 1/ 98/ 086/ 008 14 tablets EU/ 1/ 98/ 086/ 004 28 tablets EU/ 1/ 98/ 086/ 005 56 tablets EU/ 1/ 98/ 086/ 010 56 x 1 tablets EU/ 1/ 98/ 086/ 006 98 tablets
EU/ 1/ 98/ 086/ 008 14- il pillola EU/ 1/ 98/ 086/ 004 28 pillola EU/ 1/ 98/ 086/ 005 56 pillola EU/ 1/ 98/ 086/ 010 56 x 1 pillola EU/ 1/ 98/ 086/ 006 98 pillola
CoAprovel 300 mg/ 12.5 mg
CoAprovel 300 mg/ 12. 5 mg
75 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
78 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
CoAprovel 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
79 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CoAprovel 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
CoAprovel 150 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 30 pillola 56 pillola 56 x 1 pillola 84 pillola 90 pillola 98 pillola
Do not store above 30°C.
80 Taħżinx f’ temperatura ’ l fuq minn 30°C.
77 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
MARKETING AUTHORISATION NUMBERS
NUMRI TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 98/ 086/ 011 14 tablets EU/ 1/ 98/ 086/ 012 28 tablets EU/ 1/ 98/ 086/ 029 30 tablets EU/ 1/ 98/ 086/ 013 56 tablets EU/ 1/ 98/ 086/ 014 56 x 1 tablets EU/ 1/ 98/ 086/ 021 84 tablets EU/ 1/ 98/ 086/ 032 90 tablets EU/ 1/ 98/ 086/ 015 98 tablets
EU/ 1/ 98/ 086/ 011 14- il pillola EU/ 1/ 98/ 086/ 012 28 pillola EU/ 1/ 98/ 086/ 029 30 pillola EU/ 1/ 98/ 086/ 013 56 pillola EU/ 1/ 98/ 086/ 014 56 x 1 pillola EU/ 1/ 98/ 086/ 021 84 pillola EU/ 1/ 98/ 086/ 032 90 pillola EU/ 1/ 98/ 086/ 015 98 pillola
78 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
81 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
14 - 28 - 56 - 84 - 98 tablets:
14 - 28 - 56 - 84 - 98- il pillola:
30 - 56 x 1 - 90 tablets:
30 - 56 x 1 - 90 pillola:
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CoAprovel 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
Do not store above 30°C.
83 Taħżinx f’ temperatura ’ l fuq minn 30°C.
80 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
EU/ 1/ 98/ 086/ 016 14 tablets EU/ 1/ 98/ 086/ 017 28 tablets EU/ 1/ 98/ 086/ 030 30 tablets EU/ 1/ 98/ 086/ 018 56 tablets EU/ 1/ 98/ 086/ 019 56 x 1 tablets EU/ 1/ 98/ 086/ 022 84 tablets EU/ 1/ 98/ 086/ 033 90 tablets EU/ 1/ 98/ 086/ 020 98 tablets
EU/ 1/ 98/ 086/ 016 14- il pillola EU/ 1/ 98/ 086/ 017 28 pillola EU/ 1/ 98/ 086/ 030 30 pillola EU/ 1/ 98/ 086/ 018 56 pillola EU/ 1/ 98/ 086/ 019 56 x 1 pillola EU/ 1/ 98/ 086/ 022 84 pillola EU/ 1/ 98/ 086/ 033 90 pillola EU/ 1/ 98/ 086/ 020 98 pillola
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
84 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
85 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CoAprovel 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 25 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
Kull pillola fiha: irbesartan 300 mg u hydrochlorothiazide 25 mg
Do not store above 30°C.
86 Taħżinx f’ temperatura ’ l fuq minn 30°C.
83 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
EU/ 1/ 98/ 086/ 023 14 tablets EU/ 1/ 98/ 086/ 024 28 tablets EU/ 1/ 98/ 086/ 031 30 tablets EU/ 1/ 98/ 086/ 025 56 tablets EU/ 1/ 98/ 086/ 028 56 x 1 tablets EU/ 1/ 98/ 086/ 026 84 tablets EU/ 1/ 98/ 086/ 034 90 tablets EU/ 1/ 98/ 086/ 027 98 tablets
EU/ 1/ 98/ 086/ 023 14- il pillola EU/ 1/ 98/ 086/ 024 28 pillola EU/ 1/ 98/ 086/ 031 30 pillola EU/ 1/ 98/ 086/ 025 56 pillola EU/ 1/ 98/ 086/ 028 56 x 1 pillola EU/ 1/ 98/ 086/ 026 84 pillola EU/ 1/ 98/ 086/ 034 90 pillola EU/ 1/ 98/ 086/ 027 98 pillola
84 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
87 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
CoAprovel 300 mg/ 25 mg tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 25 mg pilloli irbesartan/ hydrochlorothiazide
86 PACKAGE LEAFLET:
89 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER CoAprovel 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU CoAprovel Pilloli 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
Keep this leaflet.
Żomm dan il- fuljett.
If you have any further questions, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
This medicine has been prescribed for you.
Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What CoAprovel is and what it is used for 2.
X’ inhu CoAprovel u għalxiex jintuża 2.
Before you take CoAprovel 3.
Qabel ma tieħu CoAprovel 3.
How to take CoAprovel 4.
Kif għandek tieħu CoAprovel 4.
How to store CoAprovel 6.
Kif taħżen CoAprovel 6.
WHAT COAPROVEL IS AND WHAT IT IS USED FOR
X’ INHU COAPROVEL U GĦALXIEX JINTUŻA
CoAprovel is a combination of two active substances, irbesartan and hydrochlorothiazide.
CoAprovel hu kombinazzjoni ta ’ żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Irbesartan jappartjeni għall- grupp ta ’ mediċini magħrufin bħala antagonisti tar- riċetturi angiotensin- II.
Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Angiotensin- II hija sustanza li jagħmel il- ġisem li tingħaqad mar- riċetturi fil- vini u ġġegħelhom jissikkaw.
This results in an increase in blood pressure.
B’ hekk tirriżulta żieda fil- pressjoni.
Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan ma jħallix angiotensin- II jingħaqad ma dawn ir- riċetturi, b’ hekk il- vini tad- demm jirrilassaw u l- pressjoni tinżel.
Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
Hydrochlorothiazide hija waħda mill- grupp ta ’ mediċini (jissejħu dijuretiċi thiazide) li jikkaġunaw żieda fil- ħruġ ta ’ l- awrina u b’ hekk tinżel il- pressjoni.
The two active ingredients in CoAprovel work together to lower blood pressure further than if either was given alone.
Iż- żewġ sustanzi attivi f’ CoAprovel jaħdmu flimkien biex inaqqsu l- pressjoni iktar milli kieku jingħataw waħidhom.
CoAprovel 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.
CoAprovel 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 COAPROVEL
QABEL MA TIEĦU COAPROVEL
Do not take CoAprovel if you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide, or any of the other ingredients of CoAprovel or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further clarification) 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 CoAprovel jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal irbesartan u hydrochlorothiazide jew sustanzi oħra ta 'CoAprovel jew għal mediċini kimikament relatati ma ’ sulfonamide (staqsi lit- tabib jew lill- ispiżjar tiegħek għal aktar tagħrif) 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
CoAprovel should not be given to children and adolescents (under 18 years).
CoAprovel m’ għandux jingħata lit- tfal u lill- adoloxxenti (inqas minn 18- il sena).
Take special care with CoAprovel Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems, including kidney transplantation if you suffer from heart problems
Oqgħod attent ħafna b’ CoAprovel Avża lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik: jekk ikollok rimettar jew dijarea eċċessiva jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi jekk inti tbati minn problemi tal- qalb
87 if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
90 jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) jekk issofri minn aldosteroniżmu primarju (kundizzjoni relatata ma ’ produzzjoni għolja ta ’ l - ormon aldosterone, li jikkawża retenzjoni ta ’ sodium u, li min- naħa tiegħu, iżid il- pressjoni fid - demm).
You must tell your doctor if you think that you are (or might become) pregnant.
Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
CoAprovel is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
CoAprovel 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 CoAprovel) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given 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 fi CoAprovel) jekk tesperjenza żieda fis- sensittività tal- ġilda għax- xemx b’ sintomi ta ’ ħruq (bħal ħmura, ħakk, nefħa, bżieżaq) li jseħħu aktar frekwenti min- normal jekk tkun se tagħmel xi operazzjoni (kirurġija) jew tkun se tirċievi anistetiku
Hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Hydrochlorothiazide li jinstab f’ din il- mediċina jista ’ jirriżulta ’ f’ test posittiv ta ’ l- anti- doping.
Diuretic agents such as the hydrochlorothiazide contained in CoAprovel may have an effect on other medicines.
Dijuretiċi bħal hydrochlorothiazide li jinstab f’ CoAprovel jista ’ jkollhom effett fuq mediċini oħra.
Preparations containing lithium should not be taken with CoAprovel without close supervision by your doctor.
Preparazzjonijiet li fihom lithium m’ għandhomx jittieħdu ma ’ CoAprovel jekk ma tkunx taħt is - superviżjoni mill- viċin tat- tabib tiegħek.
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium sparing medicines or other diuretics (water tablets) some laxatives medicines for the treatment of gout therapeutic vitamin D supplements medicines to control heart rhythm medicines for diabetes (oral agents or insulins)
Jista ’ jkollok bżonn tagħmel xi kontroll tad- demm jekk tieħu: supplimenti tal- potassium sostituti tal- melħ li fihom il- potassium mediċini li fihom il- potassium, 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 mediċini għad- dijabete (mediċini li jittieħdu mill- ħalq jew insulina)
It is also important to tell your doctor 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 tgħid lit- tabib tiegħek jekk tkun 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 CoAprovel with food and drink CoAprovel can be taken with or without food.
Meta tieħu CoAprovel ma ’ l- ikel u max- xorb CoAprovel jista ’ jittieħed bi jew mingħajr ikel.
Due to the hydrochlorothiazide contained in CoAprovel, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Minħabba l- hydrochlorothiazide li hemm fi CoAprovel, jekk tixrob l- alkoħol meta tkun qed tieħu l - kura b’ din il- mediċina, jista ’ jkollok sensazzjoni miżjuda ta ’ sturdament meta tqum bil- wieqfa, b’ mod speċjali meta tqum minn pożizzjoni bil- qiegħda.
Pregnancy and breast-feeding You must tell your doctor if you think that you are (or might become) pregnant.
Tqala u Treddigħ Għandek tgħid lit- tabib tiegħek jekk inti tqila (jew taħseb li tista ’ tkun tqila).
Usually, your doctor will advise you to take another medicine instead of CoAprovel, as CoAprovel 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 CoAprovel, minħabba li CoAprovelmhuwiex 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 CoAprovel before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment
The product should not be used during the 2nd and 3rd trimester of pregnancy, or while breast-feeding.
Il- prodott m’ għandux jintuża matul it- 2 u t- 3 trimestru ta ’ tqala.
88 Your doctor will normally advise you to stop taking CoAprovel as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu CoAprovel malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with CoAprovel, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ CoAprovel, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti fuq il- ħila biex issuq u tħaddem magni.
CoAprovel is unlikely to affect your ability to drive or use machines.
CoAprovel 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, talk to your doctor before attempting to drive or use machines.
Jekk tħoss xi ħaġa minn dawn, kellem lit- tabib tiegħek qabel ma tipprova ssuq jew tħaddem magni.
Important information about some of the ingredients of CoAprovel CoAprovel contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ CoAprovel CoAprovel fih il- lactose.
If you have been told by your doctor that you have an intolerance to some sugars (e. g. lactose), contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkor (ngħidu aħna lactose), ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE COAPROVEL
KIF GĦANDEK TIEĦU COAPROVEL
Always take CoAprovel exactly as your doctor has told you.
Dejjem għandek tieħu CoAprovel skond il- parir tat- tabib.
Dosage The usual dose of CoAprovel is one or two tablets a day.
Dożaġġ Id- doża normali ta ’ CoAprovel hija pillola waħda jew tnejn kuljum.
CoAprovel will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
CoAprovel 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 CoAprovel.
It- tabib tiegħek igħidlek kif għandek tagħmel biex taqleb mill- kura li kont qed tieħu qabel għal CoAprovel.
Method of administration CoAprovel is for oral use.
Kif għandek tieħu l- mediċina CoAprovel huwa għal użu orali.
Swallow the tablets with a sufficient amount of fluid (e. g. one glass of water).
Ibla ’ l- pilloli b’ ammont suffiċjenti ta ’ fluwidu (eż. tazza ilma).
You can take CoAprovel with or without food.
Tista ’ tieħu CoAprovel bi jew mingħajr ikel.
Try to take your daily dose at about the same time each day.
Ipprova ħu d- doża ta ’ kuljum tiegħek bejn wieħed u ieħor fl - istess ħin tal- ġurnata kuljum.
It is important that you continue to take CoAprovel until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu CoAprovel sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
L- effett massimu biex tinżel il- pressjoni għandu jintlaħaq f’ 6- 8 ġimgħat wara li tinbeda l- kura.
If you take more CoAprovel than you should If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu CoAprovel aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, għid lit- tabib tiegħek minnufih.
Children should not take CoAprovel CoAprovel should not be given to children under 18 years of age.
It- tfal ma għandhomx jieħdu CoAprovel CoAprovel ma għandux jingħata lil tfal iżgħar minn 18- il sena.
If a child swallows some tablets, contact your doctor immediately.
Jekk tifel/ tifla jibla ’ / tibla ’ xi pilloli, għid lit- tabib tiegħek minnufih.
If you forget to take CoAprovel If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu CoAprovel Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu d- doża li jmiss bħas- soltu.
Like all medicines, CoAprovel can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CoAprovel jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some of these effects may be serious and may require medical attention.
Xi wħud minn dawn l- effetti jistgħu jkunu serji u jistgħu jirrikjedu attenzjoni medika.
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.
Bħal b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi tal- ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata tal- wiċċ, xofftejn u/ jew ilsien ġew irrapportati f’ pazjenti li jieħdu irbesartan.
If you get any of these symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
92 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf CoAprovel u għid lit - tabib tiegħek minnufih.
89 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: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Not known: frequency cannot be estimated from the available data.
Komuni: taffettwa pazjent 1 sa 10 minn kull 100 Mhux komuni: taffettwa pazjent 1 sa 10 minn kull 1, 000 Mhux magħrufa: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli.
Side effects reported in clinical studies for patients treated with CoAprovel were:
L- effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b’ CoAprovel kienu:
Common: nausea/ vomiting, abnormal urination, fatigue and dizziness (including when getting up from a lying or sitting position) and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
Komuni: dardir/ rimettar, tagħmel l- awrina mhux normali, għeja u sturdament (anki meta tqum minn mimdud jew minn bil- qiegħda) u testijiet tad- demm jistgħu juru livelli ogħla ta ’ enzim li jkejjel il- funzjoni tal- muskoli u tal- qalb (creatine kinase) jew livelli għoljin ta ’ sustanzi li jkejlu l- funzjoni tal- kliewi (nitroġenu fl- urea tad- demm, creatinine).
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- attività sesswali).
Blood tests may show lowered levels of potassium and sodium in your blood.
Testijiet tad- demm jistgħu juru livelli aktar baxxi ta ’ potassium u sodium fid- demm tiegħek.
Some undesirable effects have been reported since the marketing of CoAprovel but the frequency for them to occur is not known.
Minn meta CoAprovel tqiegħed fis- suq ġew irrapportati xi effetti mhux mixtieqa iżda l- frekwenza għalihom biex iseħħu m’ hijiex magħrufa.
These undesirable effects are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Dawn l- effetti mhux mixtieqa 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 tal- kliewi, livell ogħla ta ’ potassium f’ demmek u reazzjonijiet allerġiċi bħal raxx, ħorriqija, nefħa fil- wiċċ, fix- xufftejn, fil- ħalq, fl- ilsien jew fil- gerżuma.
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.
In patients taking irbesartan alone, in addition to the side effects listed above, chest pain has also been reported.
F’ pazjenti li qed jieħdu irbesartan waħdu, wieħed għandu jżid ukoll uġigħ fis- sider flimkien ma ’ l- effetti sekondarji irrapportati hawn fuq.
Additional side effects associated with the other component of CoAprovel (hydrochlorothiazide) alone are: loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as yellowing of the skin and/ or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Effetti sekondarji addizzjonali assoċjati mal- komponent l- ieħor ta 'CoAprovel (hydrochlorothiazide) waħdu huma: nuqqas ta ’ aptit; irritazzjoni ta ’ l- istonku; bugħawwiġ fl- istonku; stitikezza, suffejra li tidher bħala sfurija tal- ġilda u/ jew ta ’ l- abjad ta ’ l- għajnejn; infjammazzjoni tal- frixa kkaratterizzata b’ uġigħ sever fil- parti ta ’ fuq ta ’ l- istonku, spiss b’ dardir u rimettar; disturbi fl- irqad; dipressjoni; vista mċajpra; nuqqas ta ’ ċelloli bojod tad- demm, li jistgħu jirriżultaw f’ infezzjonijiet frekwenti, deni; tnaqqis fin- numru ta ’ plejtlits (ċellola tad- demm essenzjali għall- għaqid tad- demm), numru mnaqqas taċ- ċelloli tad- demm ħomor (anemija) ikkaratterizzat minn għejja, uġigħ ta ’ ras, qtugħ ta ’ nifs waqt eżerċizzju, sturdament u dehra pallida; mard fil- kliewi; problemi fil- pulmun inkluż pulmonite jew akkumulazzjoni ta ’ fluwidu fil- pulmun; sensittività miżjuda tal- ġilda fix- xemx; infjammazzjoni tal - vażi tad- demm; marda tal- ġilda kkaratterizzata mit- tqaxxir tal- ġilda fuq il- ġisem kollu; lupus erythematosus tal- ġilda, li hija identifikata minn raxx li jista ’ jidher fuq il- wiċċ, għonq u qorrija; reazzjonijiet allerġiċi; dgħjufija u spażmu tal- muskoli; rata tat- taħbit tal- qalb mibdula; tnaqqis fil - pressjoni tad- demm wara bidla fil- qagħda tal- ġisem; nefħa tal- glandoli tal- bżieq; livelli ta' zokkor għoljin fid- demm; zokkor fl- awrina; żidiet f' xi tipi ta 'xaħam fid- demm; livelli ta' aċidu uriku fid - demm għoljin, li jista ’ jikkawża gotta.
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Huwa magħruf li l- effetti sekondarji assoċjati ma ’ hydrochlorothiazide jistgħu jiżdiedu ma ’ dożi aktar għoljin ta ’ hydrochlorothiazide.
HOW TO STORE COAPROVEL
KIF TAĦŻEN COAPROVEL
Do not use CoAprovel after the expiry date which is stated on the carton and on the blister after EXP.
Tużax CoAprovel wara d- data ta ’ skadenza li tidher fuq il- kaxxa jew fuq il- folja wara JIS.
Do not store above 30°C.
93 Taħżinx f’ temperatura ’ l fuq minn 30°C.
90 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
What CoAprovel contains The active substances are irbesartan and hydrochlorothiazide.
X’ fih CoAprovel Is- sustanzi attivi huma irbesartan u hydrochlorothiazide.
Each tablet of CoAprovel 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ CoAprovel 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 (E172).
Is- sustanzi l- oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, ferric oxide aħmar u isfar (E172).
What CoAprovel looks like and contents of the pack CoAprovel 150 mg/ 12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Id- dehra ta ’ CoAprovel u l- kontenuti tal- pakkett Il- pilloli CoAprovel 150 mg/ 12. 5 mg 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.
CoAprovel 150 mg/ 12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Il- pilloli CoAprovel 150 mg/ 12. 5 mg huma pprovduti f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
Unit dose blister packs of 56 x 1 tablet for delivery in hospitals are also available.
Pakketti ta ’ doża waħda ta ’ 56 x 1 pillola sabiex jitqassmu fl- isptarijiet huma wkoll disponibbli.
Marketing Authorisation Holder SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Franza
Manufacturer SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
Manifattur SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc Cedex - Franza
SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom
SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - Ir- Renju Unit
2112 Veresegyház - Hungary
2112 Veresegyház - L- Ungerija
91 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
94 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
92 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
95 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
93 PACKAGE LEAFLET:
96 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER CoAprovel 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU CoAprovel Pilloli 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
94 if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
97 jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) jekk issofri minn aldosteroniżmu primarju (kundizzjoni relatata ma ’ produzzjoni għolja ta ’ l - ormon aldosterone, li jikkawża retenzjoni ta ’ sodium u, li min- naħa tiegħu, iżid il- pressjoni fid - demm).
95 Your doctor will normally advise you to stop taking CoAprovel as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu CoAprovel malli ssir taf li inti ħriġt tqila.
Dosage The usual dose of CoAprovel is one tablet a day.
Dożaġġ Id- doża normali ta ’ CoAprovel hija pillola waħda kuljum.
CoAprovel will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
CoAprovel ġeneralment jiġi preskritt mit - tabib tiegħek meta l- kura li kont tieħu qabel għal kontra l- pressjoni għolja ma pprovdietx tnaqqis xieraq tal- pressjoni.
If you get any of these symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
99 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf CoAprovel u għid lit - tabib tiegħek minnufih.
96 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:
Do not store above 30°C.
100 Taħżinx f’ temperatura ’ l fuq minn 30°C.
97 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each tablet of CoAprovel 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ CoAprovel 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/ 12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Id- dehra ta ’ CoAprovel u l- kontenuti tal- pakkett Il- pilloli CoAprovel 300 mg/ 12. 5 mg 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.
CoAprovel 300 mg/ 12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Il- pilloli CoAprovel 300 mg/ 12. 5 mg huma pprovduti f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - France
SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel 37100 Tours - Franza
98 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
101 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
99 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
102 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
100 PACKAGE LEAFLET:
103 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER CoAprovel 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU CoAprovel 150 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
101 if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
104 jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) jekk issofri minn aldosteroniżmu primarju (kundizzjoni relatata ma ’ produzzjoni għolja ta ’ l - ormon aldosterone, li jikkawża retenzjoni ta ’ sodium u, li min- naħa tiegħu, iżid il- pressjoni fid - demm).
102 Your doctor will normally advise you to stop taking CoAprovel as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu CoAprovel malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with CoAprovel, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ CoAprovel, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih..
If you get any of these symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
106 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf CoAprovel u għid lit - tabib tiegħek minnufih.
103 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:
Do not use CoAprovel after the expiry date which is stated on the carton and on the blister after EXP.
Tużax CoAprovel wara d- data ta ’ skadenza li tidher fuq il- kaxxa jew fuq it- tikketta wara JIS.
Do not store above 30°C.
107 Taħżinx f’ temperatura ’ l fuq minn 30°C.
104 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Each film-coated tablet of CoAprovel 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ CoAprovel 150 mg/ 12. 5 mg fiha 150 mg irbesartan u 12. 5 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.
Is- sustanzi l- oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, ferric oxides ħomor u sofor, carnauba wax.
What CoAprovel looks like and contents of the pack CoAprovel 150 mg/ 12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Id- dehra ta ’ CoAprovel u l- kontenuti tal- pakkett Il- pilloli miksijin b' rita CoAprovel 150 mg/ 12. 5 mg 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.
CoAprovel 150 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Il- pilloli miksijin b' rita CoAprovel 150 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 30, 56, 84, 90 jew 98 pillola miksija b' rita.
Unit dose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.
Pakketti ta 'folji ta' doża waħda ta ’ 56 x 1 pillola miksija b' rita sabiex jitqassmu fl- isptarijiet huma wkoll disponibbli.
105 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
108 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
106 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
109 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
107 PACKAGE LEAFLET:
110 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER CoAprovel 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU CoAprovel 300 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide