qanastek/EMEA-V3 huggingface dataset:
EU/ 1/ 08/ 465/ 001 - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 003 - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 005 - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 007 - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 009 - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 011 - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 013 - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 465/ 018 - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 465/ 019 - Cartons of 7 film-coated tablets in all aluminium blisters
EU/ 1/ 08/ 465/ 001 - Kaxex ta ’ 14- il pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 002 - Kaxex ta ’ 14- il pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 08/ 465/ 003 - Kaxex ta ’ 28 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 004 - Kaxex ta ’ 28 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 08/ 465/ 005 - Kaxex ta ’ 30 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 006 - Kaxex ta ’ 30 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 08/ 465/ 007 - Kaxex ta ’ 50x1 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 008 - Kaxex ta ’ 50x1 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 08/ 465/ 009 - Kaxex ta ’ 84 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 010 - Kaxex ta ’ 84 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 08/ 465/ 011 - Kaxex ta ’ 90 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 012 - Kaxex ta ’ 90 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 08/ 465/ 013 - Kaxex ta ’ 100 pillola miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 014 - Kaxex ta ’ 100 pillola miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum EU/ 1/ 08/ 465/ 018 - Kaxex ta ’ 7 pilloli miksija b’ rita fil- folji tal- PVC/ PVDC/ Alu EU/ 1/ 08/ 465/ 018 - Kaxex ta ’ 7 pilloli miksija b’ rita fil- folji kollha kemm huma ta ’ l- aluminjum 12 9.
Clopidogrel Winthrop 300 mg film-coated tablets
Clopidogrel Winthrop 300 mg pilloli miksija b’ rita
14
14 titkompla għal mhux anqas minn erba ’ ġimgħat.
maintenance dose, clopidogrel should be given as a single daily dose of 75 mg with or
Bħala doża ta ’ manteniment, clopidogrel għandu jingħata bħala doża waħda ta ’ 75 mg kuljum ma ’ l- ikel jew fuq stonku vojt.
4.4 Special warnings and precautions for use
Avviżi speċjali u prekawzjonijiet speċjali għall- użu 4. 4
15 In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Minħabba n- nuqqas ta ’ tagħrif, clopidogrel ma jistgħax jiġi rakkomandat waqt l- ewwel 7 ijiem wara puplesija iskemika akuta.
Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
L- esperjenza f’ pazjenti b’ mard moderat fil- fwied li jista ’ jkollhom dijatesi qed inixxu d- demm hija limitata.
No clinically significant pharmacodynamic interactions were observed when clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine.
Ma ġewx osservati interazzjonijiet farmakodinamiċi li kienu klinikament sinifikanti meta colpidogrel ingħata flimkien ma ’ atenolol, nifedipine, jew kemm atenolol u nifedipine. Barra minn hekk, l- attivita` farmakodinamika ta ’ clopidogrel ma ġietx influwenzata b’ mod sinifikanti mit- teħid flimkien ma ’ phenobarbital, cimetidine, jew oestrogen.
16 Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co- administration of phenobarbital, cimetidine, or oestrogen.
16 Il- karatteristiċi farmakokinetiċi ta ’ digoxin jew theophylline ma ġewx modifikati bl- amministrazjoni flimkien ma ’ clopidogrel.
The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Antaċidi ma mmodifikawx kemm gie assorbit clopidogrel.
This could potentially lead to increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, which are metabolised by Cytochrome P450 2C9.
Potenzjalment dan jista ’ jwassal għal livelli ogħla fil- plażma ta ’ prodotti mediċinali bħal phenytoin u tolbutamide u NSAIDs, li huma metabolizzati minn Cytochrome P450 2C9.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Winthrop.
Bħala miżura ta ’ prekawzjoni, id- treddigħ m’ għandux jitkompla waqt il- kura b ’ Clopidogrel Winthrop.
17 In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (< 100mg:
17 F' CURE, ir- rata ta ’ avvenimenti ta 'fsada maġġuri għal clopidogrel+ASA kienet tiddependi fuq id - doża ta ’ ASA (< 100 mg:
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
L- inċidenza ta ’ fsada maġġuri kienet simili bejn il- gruppi (1. 3% kontra 1. 1% għal gruppi clopidogrel + ASA u l- plaċebo + ASA, rispettivament).
Hallucinations, confusion
Alluċinazzjonijiet, konfużjoni Tibdiliet fit- togħma
Intracranial bleeding (some cases were
intrakranjali (ġew irrapportati xi każijiet b’ eżitu fatali), uġigħ ta ’ ras, parestiżja, sturdament
Taste disturbances
Disturbi fl- għajnejn
reported with fatal outcome), headache, paraesthesia, dizziness
Fsada fl- għajn (tal- konġuntiva, okulari, tar - retina)
18
18 Sistema tal- klassifika ta ’ l- organi
Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Fsada fil- passaġġ respiratorju (emoptisi, emorraġija fil- pulmun), bronkospażmu, pulmonite interstizjali Emorraġija gastro -
Gastrointestinal disorders
Emorraġija Ulċera gastrika u Emorraġija Disturbi gastro - intestinali u tar - ulċera dwodenali, tar - intestinali
Gastrointestinal haemorrhage, diarrhoea, abdominal
gastro - intestinali, dijarea, uġigħ
Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea,
gastrite, rimettar, retroperitonew tqalligħ, stitikezza, gas fl -
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis,
retroperitonew b’ eżitu fatali, pankreatite, kolite (inklużi kolite ulċerattiva jew limfoċitika),
pain, dyspepsia constipation, flatulence
addominali, istonku stomatite dispepsja Disturbi fil- fwied u fil - marrara
colitis (including ulcerative or lymphocytic colitis), stomatitis
Insuffiċjenza akuta tal - fwied, epatite, test tal - funzjoni tal- fwied anormali Dermatite bulloża
Hepato-biliary disorders
Disturbi fil- ġilda u fit -
Acute liver failure, hepatitis, abnormal liver function test
(nekroliżi tossika ta ’ l -
Skin and subcutaneous tissue disorders
tessuti ta ’ taħt il- ġilda Disturbi muskolu - skeltrali, tat- tessut konnettiv u fl- għadam
Bruising Rash, pruritus, skin bleeding (purpura)
fsada fil- ġilda (purpura)
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
epidermide, Sindromu ta ’ Stevens Johnson, eritema multiforme), anġjoedima, raxx eritematika, urtikarja, ekżema, lichen planus Fsada muskolu- skeltrali (emartrożi), artrite, artralġja, majalġja
19 4.9 Overdose
4. 9 Doża eċċessiva
Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the amplification of platelet activation by released ADP.
Clopidogrel jinibixxi wkoll l- aggregazzjoni tal- plejtlets li tkun indotta minn agonisti oħra billi jibblukka l - amplifikazzjoni ta ’ l- attivazzjoni tal- plejtlets li sseħħ permezz ta’ l- ADP meħlus.
8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to
F’ pazjenti li ddaħħlu fil- prova minħabba infart mijokardijaku reċenti biss, clopidogrel kien numerikament inqas, imma mhux statistikament differenti minn ASA (RRR = - 4. 0%; CI: minn - 22. 5 sa 11. 7 [p=0. 639]). Barra minn hekk, l- analiżi tas - sottogrupp skond l- eta` ssuġġeriet li l- benefiċċju ta ’ clopidogrel għal pazjenti li kellhom iktar minn 75 sena kien inqas minn dak osservat f’ pazjenti ≤75 sena.
20 18.7 [p=0.258]).
20 Sindromu koronarju akut
21 The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Il- benefiċċji osservati bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari oħra akuti u fit - tul (bħall - heparin/ LMWH, antagonisti ta ’ GPIIb/ IIIa, prodotti mediċinali li jbaxxu l- lipidi, imblokkaturi tar- riċetturi beta u inibituri ta ’ ACE).
22 The kinetics of the main circulating metabolite were linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150 mg of clopidogrel.
Il- karatteristiċi kinetiċi tal- metabolit ċirkolanti prinċipali kienu lineari (il- konċentrazzjonijiet fil - plażma żdiedu b’ mod proporzjonali mad- doża) fil- medda tad- doża ta ’ bejn 50 u 150 mg ta ’ clopidogrel.
6. 3 Shelf-life
Ma jgħoddx f’ dan il- każ.
3 years
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
6.4 Special precautions for storage
3 snin 6. 4 Prekawzjonijiet speċjali għall- ħażna
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 7.
MARKETING AUTHORISATION NUMBERS
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
25 ANNEX II
25 ANNESS II
- Clopidogrel Winthrop 75 mg film-coated tablets
- Clopidogrel Winthrop 75 mg pilloli miksija b' rita
Sanofi Winthrop Industrie 1, route 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 Winthrop Industrie 6, boulevard de l'Europe F -21800 Quétigny France
Sanofi Winthrop Industrie 6, Boulevard de l’ Europe F- 21800 Quétigny Franza
- Clopidogrel Winthrop 300 mg film-coated tablets
- Clopidogrel Winthrop 300 mg pilloli miksija b' rita
27 ANNEX III
27 ANNESS III
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14, 28, 30, 50x1, 84, 90 or 100 tablets
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Clopidogrel Winthrop 75 mg film-coated tablets clopidogrel
Clopidogrel Winthrop 75 mg pillola miksija b’ rita clopidogrel
It also contains: hydrogenated castor oil and lactose.
Fiha ukoll: castor oil idroġenat u lactose.
Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France – F-75013 Paris - France
Sanofi Pharma Bristol- Myers Squibb SNC 174 Avenue de France – F- 75013 Paris – Franza
EU/1/08/465/001 14 tablets EU/1/08/465/002 14 tablets EU/1/08/465/003 28 tablets EU/1/08/465/004 28 tablets EU/1/08/465/005 30 tablets EU/1/08/465/006 30 tablets EU/1/08/465/007 50x1 tablets EU/1/08/465/008 50x1 tablets EU/1/08/465/009 84 tablets EU/1/08/465/010 84 tablets EU/1/08/465/011 90 tablets EU/1/08/465/012 90 tablets EU/1/08/465/013 100 tablets EU/1/08/465/014 100 tablets EU/1/08/465/018 7 tablets EU/1/08/465/019 7 tablets
EU/ 1/ 08/ 465/ 001 14– il pillola EU/ 1/ 08/ 465/ 002 14– il pillola EU/ 1/ 08/ 465/ 003 28 pillola EU/ 1/ 08/ 465/ 004 28 pillola EU/ 1/ 08/ 465/ 005 30 pillola EU/ 1/ 08/ 465/ 006 30 pillola EU/ 1/ 08/ 465/ 007 50x1 pilloli EU/ 1/ 08/ 465/ 008 50x1 pilloli EU/ 1/ 08/ 465/ 009 84 pillola EU/ 1/ 08/ 465/ 010 84 pillola EU/ 1/ 08/ 465/ 011 90 pillola EU/ 1/ 08/ 465/ 012 90 pillola EU/ 1/ 08/ 465/ 013 100 pillola EU/ 1/ 08/ 465/ 014 100 pillola EU/ 1/ 08/ 465/ 018 7 pilloli EU/ 1/ 08/ 465/ 019 7 pilloli
31 PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta ’ 7, 14, 28 jew 84 pillola)
Clopidogrel Winthrop 75 mg film-coated tablets clopidogrel
Clopidogrel Winthrop 75 mg pilloli miksija b’ rita clopidogrel
32 PARTICULARS TO APPEAR ON BLISTERS (boxes of 30, 50x1, 90 or 100 tablets)
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- FOLJI (kaxxi ta’ 30, 50x1, 90 jew 100 pillola)
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Clopidogrel Winthrop 300 mg film-coated tablets clopidogrel
Clopidogrel Winthrop 300 mg pilloli miksija b’ rita clopidogrel
Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France – F-75013 Paris - France
Sanofi Pharma Bristol- Myers Squibb SNC 174 Avenue de France F - 75013 Paris – Franza
EU/1/08/465/015 4x1 film-coated tablets EU/1/08/465/016 30x1 film-coated tablets EU/1/08/465/017 100x1 film-coated tablets
EU/ 1/ 08/ 465/ 015 4x1 pilloli miksija b’ rita EU/ 1/ 08/ 465/ 016 30x1 pilloli miksija b’ rita EU/ 1/ 08/ 465/ 017 100x1 pilloli miksija b’ rita
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJA/ kaxxa ta ’ 4x1, 30x1 jew 100x1 pilloli
37 PACKAGE LEAFLET:
37 FULJETT TA ’ TAGĦRIF:
What Clopidogrel Winthrop is and what it is used for 2.
X’ inhu Clopidogrel Winthrop u għalxiex jintuża 2.
Before you take Clopidogrel Winthrop 3.
Qabel ma tieħu Clopidogrel Winthrop 3.
How to take Clopidogrel Winthrop 4.
Kif għandek tieħu Clopidogrel Winthrop 4.
Possible side effects 5 How to store Clopidogrel Winthrop 6.
Kif taħżen Clopidogrel Winthrop 6.
WHAT CLOPIDOGREL WINTHROP IS AND WHAT IT IS USED FOR
X’ INHU CLOPIDOGREL WINTHROP U GĦALXIEX JINTUŻA
Clopidogrel Winthrop belongs to a group of medicines called antiplatelet medicinal products.
Clopidogrel Winthrop jifforma parti minn grupp ta ’ mediċini msejħa prodotti mediċinali ta ’ kontra l - plejtlets.
Clopidogrel Winthrop is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel Winthrop jittieħed biex inaqqas ir- riskju li ċapep tad- demm (trombi) jifformaw fl- arterji mwebbsin (arterji), proċess imsejjaħ aterotrombożi, li jista ’ jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal- qalb, jew mewt).
You have been prescribed Clopidogrel Winthrop to help prevent blood clots and reduce the risk of these severe events because:
Ingħatajt Clopidogrel Winthrop biex inaqqas ir- riskju ta ’ ċapep tad- demm u l- konsegwenzi severi tagħhom għaliex:
- You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial
- Kellek uġigħ sever f’ sidrek magħruf bħala ‘ anġina mhux stabbli ’ jew ‘ infart mijokardijaku ’
BEFORE YOU TAKE CLOPIDOGREL WINTHROP
QABEL MA TIEĦU CLOPIDOGREL WINTHROP
Do not take Clopidogrel Winthrop:
Tieħux Clopidogrel Winthrop:
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Winthrop; • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; • If you suffer from severe liver disease.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- clopidogrel jew sustanzi oħra ta ’ Clopidogrel Winthrop; • Jekk tbati minn kundizzjoni medika li fil- preżent qiegħda tikkawża fsada, bħal ulċera fl- istonku jew fsada ġewwa l- moħħ; • Jekk tbati minn mard sever tal- fwied.
38 If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking clopidogrel.
38 Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu clopidogrel.
Take special care with Clopidogrel Winthrop:
Oqgħod attent ħafna b ’ Clopidogrel Winthrop:
a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
kundizzjoni medika li tpoġġik f’ riskju ta ’ fsada interna (bħal ulċera fl- istonku) mard fid- demm li jwassal għal fsada interna (dmija f’ xi tessuti, organi jew ġogi ta ’ ġismek);
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days • if you are taking another type of medicine (see ‘Taking other medicines’). • if you have kidney or liver disease
• jekk fl- aħħar sebat ijiem kellek ċappa ta 'demm f' arterja f' moħħok (puplesija iskemika) • jekk qiegħed/ qiegħda tieħu xi tip ta ’ mediċina oħra (ara ‘ Meta tieħu mediċini oħra ’). • jekk tbati minn mard tal- kliewi jew tal- fwied.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Winthrop in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Jekk ħassejt uġigħ qawwi f’ sidrek (anġina mhux stabbli jew attakk tal- qalb), jista ’ jingħatalek Clopidogrel Winthrop flimkien ma ’ acetylsalicylic acid, sustanza inkorporata f’ ħafna mediċini użati biex itaffu l- uġigħ u jnaqqsu d- deni.
39 Taking Clopidogrel Winthrop with food and drink:
39 Tqala u treddigħ
It is preferable not to use this product during pregnancy and breast-feeding.
Huwa preferibbli li ma tużax dan il- prodott waqt it- tqala u t- treddigħ.
If you become pregnant while taking Clopidogrel Winthrop, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Jekk toħroġ tqila waqt li qiegħda tieħu Clopidogrel Winthrop, għarraf minnufih lit- tabib tiegħek billi huwa rrakkomandat li ma tieħux clopidrogrel waqt it- tqala.
While taking Clopidogrel Winthrop, consult your doctor about the breast-feeding of a baby.
Waqt li qiegħed tieħu Clopidogrel Winthrop, għandek tikkonsulta mat- tabib tiegħek dwar it- treddigħ tat- tarbija.
Clopidogrel Winthrop contains lactose and hydrogenated castor oil.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Clopodogrel Winthrop Clopidogrel Winthrop fih lactose u castor oil idroġenat.
HOW TO TAKE CLOPIDOGREL WINTHROP
KIF GĦANDEK TIEĦU CLOPIDOGREL WINTHROP 3.
Always take Clopidogrel Winthrop exactly as your doctor has told you.
Dejjem għandek tieħu Clopidogrel Winthrop skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispżjar tiegħek jekk ikollok xi dubju.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Winthrop (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Jekk kellek uġigħ sever f’ sidrek (anġina instabbli jew attakk tal- qalb), it- tabib jista ’ jagħtik 300 mg ta ’ Clopidogrel Winthrop (pillola 1 ta '300 mg jew 4 pilloli ta ’ 75 mg) darba fil- bidu tal- kura.
Then, the usual dose is one 75-mg tablet of Clopidogrel Winthrop per day to be taken orally with or without food, and at the same time each day.
Wara, id - doża normali hija ta ’ pillola waħda ta ’ 75 mg Clopidogrel Winthrop kuljum li għandha tittieħed mill - ħalq ma ’ l- ikel jew fuq stonku vojt u fl- istess ħin kull ġurnata.
If you take more Clopidogrel Winthrop than you should:
Jekk tieħu Clopidogrel Winthrop aktar milli suppost:
If you forget to take Clopidogrel Winthrop:
Jek tinsa tieħu Clopidogrel Winthrop:
If you forget for more than 12 hours, simply take the next single dose at the usual time.
Jekk tinsa tieħu Clopidogrel Winthrop għal aktar minn 12- il siegħa, sempliċiment ħu d- doża waħda li jkun imiss fil- ħin tas- soltu.
If you stop taking Clopidogrel Winthrop:
Meta tieqaf tieħu Clopidogrel Winthrop:
Like all medicines, Clopidogrel Winthrop can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Clopidogrel Winthrop jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see ‘Take special care with Clopidogrel Winthrop’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Clopidogrel Winthrop ').
If you experience prolonged bleeding when taking Clopidogrel Winthrop If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Jekk tbati minn fsada għal perijodu twil waqt li qed tieħu Clopidogrel Winthrop Jekk taqta 'x' imkien jew tweġġa', id- demm jista 'jdum aktar mis- soltu biex jieqaf.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘Take special care with Clopidogrel Winthrop’).
Madanakollu, jekk id- demm li ħiereġ jinkwetak, għandek tkellem lit- tabib tiegħek minnufih (ara 'Oqgħod attent ħafna b' Clopidogrel Winthrop ').
HOW TO STORE CLOPIDOGREL WINTHROP
KIF TAĦŻEN CLOPIDOGREL WINTHROP
41 If Clopidogrel Winthrop is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
41 Jekk Plavix huwa fornut ġo folji kollha kemm huma ta ’ l- aluminju, din il- mediċina m’ għandhiex bżonn ħażna speċjali.
If Clopidogrel Winthrop is supplied in all aluminium blisters, it does not require any special storage conditions.
Tużax clopidogrel jekk tinnota xi sinjali visibli ta ’ deterjorament.
What Clopidogrel Winthrop contains The active substance is clopidogrel.
X’ fih Clopidogrel Winthrop Is- sustanza attiva hi clopidogrel.
What Clopidogrel Winthrop looks like and contents of the pack
Id- dehra ta ’ Clopidogrel Winthrop u l- kontenuti tal- pakkett
Clopidogrel Winthrop 75-mg tablets are round, biconvex, pink, film-coated tablets engraved on one side with the number ‘75’ and on the other side with the number ‘1171’.
Il- pilloli ta ’ Clopidogrel Winthrop 75- mg huma tondi, konvessi miż- żewġ naħat, ta ’ kulur roża, pilloli miksija b’ rita bin- numru ‘ 75 ’ imnaqqax fuq naħa waħda u n- numru ‘ 1171 ’ imnaqqax fuq in- naħa l - oħra.
Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France - F-75013 Paris - France
Sanofi Pharma Bristol Myers Squibb SNC 174 Avenue de France - F- 75013 Paris – Franza
België/Belgique/ Belgien sanofi-aventis Belgium Tél/Tel: +32 (0)2 710 54 00
42 Luxembourg/ Luxemburg België/ Belgique/ Belgien sanofi- aventis Belgium sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00 (Belgique/ Belgien) Tél/ Tel: +32 (0) 2 710 54 00
43 This leaflet was last approved in MM/YYYY
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
44 PACKAGE LEAFLET:
44 FULJETT TA ’ TAGĦRIF:
Clopidogrel Winthrop 300-mg film-coated tablets clopidogrel
Clopidogrel Winthrop 300 mg pilloli miksija b’ rita clopidogrel
Clopidogrel Winthrop is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel Winthrop jittieħed biex inaqqas ir- riskju li ċapep tad- demm (trombi) jifformaw fl- arterji mwebbsin, proċess imsejjaħ aterotrombosi, li jista ’ jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal- qalb, jew mewt).
Do not take Clopidogrel Winthrop:
Tiħux Clopidogrel Winthrop:
45 If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking clopidogrel.
45 Jekk taħseb li xi waħda minn dawn tgħodd għalik, jew jekk għandek xi dubju, ħu parir tat- tabib tiegħek qabel tibda tieħu clopidogrel.
• if you have had a clot in an artery of your brain (ischemic stroke) which occurred within the last seven days • if you are taking another type of medicine (see ‘Taking other medicines’). • if you have kidney or liver disease
• jekk fl- aħħar sebat ijiem kellek ċappa ta 'demm f' arterja f' moħħok (puplesija iskemika) • jekk qiegħed/ qiegħda tieħu xi tip ta ’ mediċina oħra (ara ‘ Meta tieħu mediċini oħra ’). • jekk tbati minn mard tal- kliewi jew tal- fwied.
While you are taking Clopidogrel Winthrop: • You should tell your doctor if a surgery (including dental) is planned. • You should also tell your doctor immediately if you develop a medical condition that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see ‘POSSIBLE SIDE EFFECTS’). • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Waqt li qiegħed/ qiegħda tieħu clopidogrel: • Għandek tgħid lit- tabib tiegħek jekk għandek xi operazzjoni ppjanata (anki tas- snien). • Għandek ukoll tgħid lit- tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika li tinkludi deni u tbenġil taħt il- ġilda li jidher bħal tikek ħomor irqaq, flimkien ma 'jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal- ġilda jew ta' l- għajnejn (suffejra) (ara 'EFFETTI SEKONDARJI LI JISTA' JKOLLU '). • Jekk taqta' x' imkien jew tweġġa ', id- demm jista' jdum aktar mis- soltu biex jieqaf.
Food/meals have no influence.
Meta tiehu Clopidogrel Winthrop ma ’ l- ikel jew ix- xorb Ikel/ ikliet m’ għandhomx effett.
It is preferable not to use this product during pregnancy and breast-feeding.
46 Tqala u treddigħ Huwa preferibbli li ma tużax dan il- prodott waqt it- tqala u t- treddigħ.
If you become pregnant while taking clopidogrel, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Jekk toħroġ tqila waqt li qiegħda tieħu Clopidogrel Winthrop, għarraf minnufih lit- tabib tiegħek billi huwa rrakkomandat li ma tiħux clopidogrel fit- tqala.
Clopidogrel Winthrop contains lactose and hydrogenated castor oil.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Clopidogrel Winthrop Clopidogrel Winthrop fih lactose u castor oil idroġenat.
HOW TO TAKE CLOPIDOGREL WINTHROP
KIF GĦANDEK TIEĦU CLOPIDOGREL WINTHROP
Then, the usual dose is one 75 mg tablet of Clopidogrel Winthrop per day to be taken orally with or without food, and at the same time each day.
Wara, id - doża normali hija ta ’ pillola waħda ta ’ 75 mg Clopidogrel Winthrop kuljum li għandha tittieħed mill - ħalq ma ’ l- ikel jew fuq stonku vojt u fl- istess ħin kull ġurnata.
not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see ‘Take special care with Clopidogrel Winthrop’).
huwa assoċjat jew le ma ’ emoraġija li tidher taħt il- ġilda bħala tikek ħomor irqaq u/ jew konfużjoni (ara 'Oqgħod attent ħafna b' Clopidogrel Winthrop ').
The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding.
L- iżjed effett komuni (jaffettwa minn 1 sa 10 pazjenti minn kull 100) irrappurtat b ’ Clopidogrel Winthrop hija l- fsada.
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine.
Din tista 'sseħħ bħala fsada fl- istonku jew fl- imsaren, tbenġil, ematoma (fsada
If you experience prolonged bleeding when taking Clopidogrel Winthrop If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Jekk tbati minn fsada għal perjodu twil waqt li qed tieħu clopidogrel Jekk taqta 'x' imkien jew tweġġa', id- demm jista 'jdum aktar mis- soltu biex jieqaf.
48 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.
What Clopidogrel Winthrop looks like and contents of the pack
48 Id- dehra ta ’ Clopidogrel Winthrop u l- kontenuti tal- pakkett
Clopidogrel Winthrop 300-mg tablets are oblong, pink, film-coated tablets engraved on one side with the number ‘300’ and on the other side with the number ‘1332’.
Il- pilloli ta ’ Clopidogrel Winthrop 300 mg huma oblungi, ta ’ kulur roża, pilloli miksija b’ rita bin - numru ‘ 300 ’ imnaqqax fuq naħa waħda u n- numru ‘ 1332 ’ imnaqqax fuq in- naħa l- oħra.
They are supplied in cardboard cartons containing 4x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Issibhom f’ kaxex tal- kartun li fihom 4x1, 30x1 u 100x1 pilloli ġo folji mtaqqbin ta ’ doża waħda magħmulin kollha kemm huma mill- aluminju.
49 Deutschland Winthrop Arzneimittel GmbH Tel.: +49 (0)81 41 35 72 - 0
Norge Deutschland sanofi- aventis Norge AS Winthrop Arzneimittel GmbH Tel.: +49 (0) 81 41 35 72 - 0
Ireland sanofi-aventis Ireland Ltd.
49 Slovenija Ireland sanofi- aventis d. o. o. sanofi- aventis Ireland Ltd.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jaslu għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Coaprovel?
X’ inhu Coaprovel?
Coaprovel is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Coaprovel huwa mediċina li fiha żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
It is available as oval tablets (peach:
Jiġi bħala pilloli ovali (lewn il- ħawħ:
150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink:
150 mg jew 300 mg irbesartan u 12. 5 mg hydrochlorothiazide; roża:
300 mg irbesartan and 25 mg hydrochlorothiazide).
300 mg irbesartan u 25 mg hydrochlorothiazide).
What is Coaprovel used for?
Għalxiex jintuża Coaprovel?
Coaprovel is used in adults 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.
Coaprovel jintuża f’ adulti li jkollhom ipertensjoni essenzjali (pressjoni għolja tad- demm) li ma tkunx ikkontrollata adegwatament b’ irbesartan jew b’ hydrochlorothiazide waħedhom. ‘ Essenzjali ’ tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Coaprovel used?
Kif jintuża Coaprovel?
Coaprovel is taken by mouth, with or without food.
Coaprovel jittieħed mill- ħalq, ma ’ l- ikel jew fuq stonku vojt.
The dose of Coaprovel to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Id- doża ta ’ Coaprovel li għandha tintuża tiddependi mid- doża ta ’ irbesartan jew ta ’ hydrochlorothiazide li l- pazjent ikun qed jieħu qabel.
Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Dożi ogħla minn 300 mg irbesartan u 25 mg hydrochlorothiazide darba kuljum m’ humiex rakkomandati.
Coaprovel may be added to other treatments for hypertension.
Coaprovel jista ’ jiżdied ma ’ trattamenti oħra għall- pressjoni għolja.
How does Coaprovel work?
Kif jaħdem Coaprovel?
Coaprovel contains two active substances, irbesartan and hydrochlorothiazide.
Coaprovel fih żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
Irbesartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Irbesartan hu ‘ antagonist tar- riċetturi ta ’ Anġjotensina II ’, li jfisser li jimblokka l- azzjoni ta ’ ormon fil - ġisem magħruf bħala Anġjotensina II.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Anġjotensina II huwa vażokostrittur (sustanza li ddejjaq il- vini u l- arterji) qawwi.
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Billi jimblokka r- riċetturi li normalment jeħel magħhom Anġjotensina II, irbesartan iwaqqaf l- ormon milli jkollu effett, u jħalli l- arterji u l- vini jitwessgħu.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Hydrochlorothiazide huwa dijuretiku, li huwa tip ieħor ta ’ trattament għall- pressjoni għolja.
It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Jaħdem billi jżid il- produzzjoni ta ’ l- awrina, inaqqas l- ammont ta ’ fluwidu fid- demm u jbaxxi l- pressjoni.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Il- kombinazzjoni taż- żewġ sustanzi attivi għandha effett addittiv, u tnaqqas il- pressjoni b’ mod iktar qawwi minn mediċina waħda meta tintuża waħidha.
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 mill- pressjoni għolja, bħar- riskju li wieħed isofri puplesija.
How has Coaprovel been studied?
Kif ġie studjat Coaprovel?
Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel.
Irbesartan waħdu ilu approvat fl- Unjoni Ewropea (UE) sa mill- 1997 taħt l- ismijiet Karvea u Aprovel.
It can be used with hydrochlorothiazide to treat hypertension.
Jista ’ jintuża ma ’ hydrochlorothiazide biex jittratta l- pressjoni għolja.
The studies of 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- istudji ta ’ Karvea/ Aprovel 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Karvea/ Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Coaprovel.
Reproduction is authorised provided the source is acknowledged. użat ma ’ hydrochlorothiazide bħala pilloli separati ntużaw b’ appoġġ għall- użu ta ’ Coaprovel.
Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Saru wkoll iktar studji b’ dożi ta ’ 300 mg irbesartan f’ kombinazzjoni ma ’ 25 mg hydrochlorothiazide.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il - mezz ewlieni tal- kejl ta ’ l- effikaċja kien it- tnaqqis fil- pressjoni dijastolika (il- pressjoni mkejla bejn żewġ taħbitiet tal- qalb).
What benefit has Coaprovel shown during the studies?
Liema benefiċċju wera Coaprovel waqt l- istudji mwettqa?
Coaprovel was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Coaprovel kien iktar effikaċi mill- plaċebo (trattament finta) u minn hydrochlorothiazide waħdu fit - tnaqqis tal- pressjoni dijastolika.
Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.
Iż- żieda tad- doża għal 300 mg irbesartan u 25 mg hydrochlorothiazide tista ’ twassal għal iktar tnaqqis fil- pressjoni.
What is the risk associated with Coaprovel?
X’ inhu r- riskju assoċjat ma ’ Coaprovel?
The most common side effects with Coaprovel (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 muscle).
L- iktar effett sekondarju komuni ma ’ Coaprovel (li deher f’ bejn pazjent wieħed u 10 minn kull 100) huma l- isturdament, dardir jew remettar, awrinar mhux normali, għeja, u żidiet fil- livelli ta ’ nitroġenu fl- urea tad- demm (BUN, prodott tat- tkissir tal- proteini), kreatinina (prodott tat- tkissir tal- muskoli) u kreatina kinażi (creatine kinase, enzim fil- muskoli).
For the full list of all side effects reported with Coaprovel, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurati ma ’ Coaprovel, ara l- Fuljett ta ’ Tagħrif.
Coaprovel should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Coaprovel m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal irbesartan, hydrochlorothiazide, sulfonamides, jew għal xi sustanza oħra tiegħu.
It must not be used in women who are more than three months pregnant or who are breast-feeding.
M’ għandux jintuża f’ nisa li għandhom iktar minn tliet xhur tqala jew li jkunu qegħdin ireddgħu.
Its use during the first three months of pregnancy is not recommended.
L- użu tiegħu fl- ewwel tliet xhur tat- tqala mhuwiex rakkomandat.
Coaprovel 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.
Coaprovel lanqas ma għandu jintuża f’ pazjenti li jkollhom problemi severi fil- fwied, fil- kliewi jew fis- sistema biljari, livelli baxxi wisq ta ’ potassju, u livelli għoljin wisq ta ’ kalċju.
Care must be taken when using Coaprovel with other medicines that have an effect on blood potassium levels.
Wieħed għandu joqgħod attent meta juża Coaprovel ma ’ mediċini oħrajn li jista ’ jkollhom effett fuq il - livell tal- potassju fid- demm.
The full list of these medicines is given in the Package Leaflet.
Il- lista sħiħa ta ’ dawn il- mediċini tinstab fil- Fuljett ta ’ Tagħrif.
Why has Coaprovel been approved?
Għaliex ġie approvat Coaprovel?
The Committee for Medicinal Products for Human Use (CHMP) decided that Coaprovel’ s benefits are greater than its risks for the treatment of essential hypertension in adult 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 ’ Coaprovel huma ikbar mir- riskji tiegħu għat- trattament ta ’ pressjoni għolja essenzjali f’ pazjenti adulti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata adegwatament fuq irbesartan jew hydrochlorothiazide waħedhom.
The Committee recommended that Coaprovel be given marketing authorisation.
Il- Kumitat irrakkomanda li Coaprovel jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Coaprovel:
Iktar tagħrif dwar Coaprovel:
The European Commission granted a marketing authorisation valid throughout the EU for Coaprovel to Sanofi Pharma Bristol-Myers Squibb SNC on 15 October 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Coaprovel lil Sanofi Pharma Bristol- Myers Squibb SNC fil- 15 ta ’ Ottubru 1998.
The marketing authorisation was renewed on 15 October 2003 and on 15 October 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 15 ta ’ Ottubru 2003 u fil- 15 ta ’ Ottubru 2008.
The full EPAR for Coaprovel is available here.
L- EPAR sħiħ għal Coaprovel jista ’ jiġi konsultat hawn.
This summary was last updated in 10-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
CoAprovel 150 mg/ 12.5 mg tablets.
CoAprovel 150 mg/ 12. 5 mg pilloli.
Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Kull pillola fiha 150 mg ta ’ irbesartan u 12. 5 mg ta ’ hydrochlorothiazide.
Each tablet contains 26.65 mg of lactose (as lactose monohydrate).
Kull pillola miksija b’ rita fiha 26. 65 mg ta ’ lactose (bħala lactose monohydrate).
Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Lewn il- ħawħa, ibbuzzata fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u numru 2775 mnaqqax fuq in- naħa l- oħra.
Treatment of essential hypertension.
Kura għall- pressjoni għolja essenzjali.
This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Din id- doża fissa kombinata hija indikata f’ pazjenti adulti li għandhom pressjoni għolja li mhiex kontrollata sew b ’ irbesartan jew b ’ hydrochlorothiazide waħidhom (ara sezzjoni 5. 1).
CoAprovel can be taken once daily, with or without food.
CoAprovel jista ’ jittieħed darba kuljum, ma ’ l- ikel jew waħdu.
Dose titration with the individual components (i. e. irbesartan and hydrochlorothiazide) may be recommended.
It- titrazzjoni tad- doża bis- sustanzi individwali (i. e. irbesartan u hydochlorothiazide) tista ’ tiġi rrikmandata.
When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:
Għandha tiġi kkonsidrata l- bidla diretta minn monoterapija għall- kombinazzjonijiet fissi meta tkun klinikament adattata:
CoAprovel 150 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; CoAprovel 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/ 12.5 mg.
CoAprovel 150 mg/ 12. 5 mg jista ’ jingħata f ’ pazjenti, fejn il- pressjoni mhix qed tiġi kkontrollata sew b’ hydrochlorothiazide jew irbesartan 150 mg waħidhom; CoAprovel 300 mg/ 12. 5 mg jista ’ jingħata lill- pazjenti li mhux qed ikunu kkontrollati b’ mod suffiċjenti b’ irbesartan 300 mg jew b’ CoAprovel 150 mg/ 12. 5 mg.
CoAprovel 300 mg/ 25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/ 12.5 mg.
CoAprovel 300 mg/ 25 mg jista ’ jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b’ mod suffiċjenti b’ CoAprovel 300 mg/ 12. 5 mg.
Doses higher than 300 mg irbesartan/ 25 mg hydrochlorothiazide once daily are not recommended.
Mhux irrikmandati dożi ogħla minn 300 mg irbesartan/ 25 mg hydrochlorothiazide darba kuljum.
When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see section 4.5).
Meta neċessarju, CoAprovel jista jingħata ma ’ prodott mediċinali ieħor kontra l- pressjoni għolja (ara sezzjoni 4. 5).
Renal impairment: due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/ min).
Indeboliment renali: minħabba li fih il- komponent ta ’ hydrochlorothiazide, CoAprovel mhux irrikmandat għall- pazjenti b’ disfunzjoni renali severa (tneħħija tal- krejatinina < 30 ml/ min).
Loop diuretics are preferred to thiazides in this population.
F’ din il - popolazzjoni, id- dijuretiċi loop huma ppreferuti mit- thiazides.
No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/ min (see sections 4.3 and 4.4).
M’ hemmx bżonn aġġustar tad- doża f’ pazjenti b’ indeboliment renali fejn il- tneħħija tal- krejatinina renali hija ≥ 30 ml/ min (ara sezzjonijiet 4. 3 u 4. 4).
CoAprovel is not indicated in patients with severe hepatic impairment.
CoAprovel mhux indikat f’ pazjenti b’ indeboliment epatiku sever.
Thiazides should be used with caution in patients with impaired hepatic function.
Thiazides għandhom jiġu użati b’ attenzjoni f’ pazjenti b’ indeboliment epatiku.
No dosage adjustment of CoAprovel is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
M’ hemmx bżonn aġġustar fid - doża ta ’ CoAprovel f’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 4. 3).
2 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
2 Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ CoAprovel f’ pazjenti anzjani.
Paediatric patients:
Pazjenti tfal:
CoAprovel is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
CoAprovel m’ huwiex rakkomandat għall- użu fit- tfal u l- adoloxxenti minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja.
Hypersensitivity to the active substances, to any of the excipients (see section 6.1), or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimester of pregnancy (see sections 4.4 and 4.6) Lactation (see section 4.6) Severe renal impairment (creatinine clearance < 30 ml/ min) Refractory hypokalaemia, hypercalcaemia Severe hepatic impairment, biliary cirrhosis and cholestasis
Sensittività eċċessiva għas- sustanzi attivi, għal xi sustanzi mhux attivi (ara sezzjoni 6. 1) jew għal xi sustanzi oħra derivati minn sulfonamide (hydrochlorothiazide hija sustanza derivata minn sulfonamide) It- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) Treddigħ (ara sezzjoni 4. 6) Indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min) Ipokalimja rifrattorja, iperkalċimja Indeboliment epatiku sever, ċirrożi biljari u kolestażi
Hypotension - Volume-depleted patients:
Pressjoni baxxa - Pazjenti bi tnaqqis ta ’ volum:
CoAprovel has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
CoAprovel 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 CoAprovel.
Dawn il- kondizzjonijiet għandhom jiġu korretti qabel tinbeda il- kura b’ CoAprovel.
Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.
Stenożi ta ’ l- arterja renali- Pressjoni għolja renovaskulari: hemm riskju ikbar ta ’ pressjoni baxxa severa u ta ’ insuffiċjenza renali meta pazjenti li għandhom stenożi bilaterali ta ’ l- arterja renali, jew stenożi ta ’ l- arterja li tagħti għall- kilwa waħda taħdem, jiġu kkurati b’ impedituri ta ’ l- enzima li tikkonverti l - angiotensin jew b ’ antagonisti tar- riċetturi angiotensin- II.
While this is not documented with CoAprovel, a similar effect should be anticipated.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ CoAprovel, effetti simili għandhom ikunu mistennija.
Renal impairment and kidney transplantation: when CoAprovel 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 CoAprovel 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 CoAprovel in patients with a recent kidney transplantation.
M’ hemmx esperjenza meta CoAprovel jingħata lill- pazjenti li riċentament kellhom trapjant tal- kliewi.
CoAprovel should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
CoAprovel m’ għandux jintuża f’ pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3).
Thiazide diuretic-associated azotemia may occur in patients with impaired renal function.
Pazjenti b’ indeboliment tal- funzjoni renali jista ’ jkollhom ażotemija assoċjata mad- dijuretiku thiazide.
No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/ min.
M’ hemmx bżonn aġġustar fid- doża f’ pazjenti b’ indeboliment renali jekk il- tneħħija tal- krejatinina tkun ≥ 30 ml/ min.
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/ min but < 60 ml/ min) this fixed dose combination should be administered with caution.
Madankollu, f’ pazjenti b’ indeboliment renali minn ħafif sa moderat (tneħħija tal- krejatinina ≥ 30 ml/ min iżda < 60 ml/ min) din id- doża fissa kombinata għandha tiġi mogħtija b’ attenzjoni.
Hepatic impairment: thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Indeboliment epatiku: thiazides għandhom jintużaw b’ attenzjoni f’ pazjenti b’ indeboliment tal- funzjoni epatika jew b’ mard progressiv fil- fwied, minħabba li tibdil żgħir ta ’ fluwidu u ta ’ bilanċ fl- elettroliti jista ’ jwassal għall- koma epatika.