qanastek/EMEA-V3 huggingface dataset:
Foetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs in the F1 generation, was observed when females were treated prior to and throughout gestation.
Tossiċità fetali fil- firien, kif evidenzjat b’ żieda kemmxejn ogħla fil - kustilji supernumerari fil- ġenerazzjoni F1 kienu osservati meta nisa kienu trattati qabel u waqt it- tqala.
As observed in studies with losartan alone, adverse foetal and neonatal effects, including renal toxicity and foetal death, occurred when pregnant rate were treated with the losartan/ hydrochlorothiazide combination during late gestation and/ or lactation.
Kif kien osservat fi studji b’ losartan waħdu, effetti avversi fetali u fi trabi għadhom jitwieldu, li jinkludu tossiċita renali u mewt fetali, seħħew meta meta firien tqal kienu trattati bil- kombinazzjoni ta ’ losartan/ hydrochlorothiazide fl- aħħar tat- tqala u/ jew t- treddigħ.
Cozaar Comp 50 mg/ 12.5 mg, Cozaar Comp 100 mg/ 12.5 mg and Cozaar Comp 100 mg/ 25 mg:
Cozaar Comp 50 mg/ 12. 5 mg, Cozaar Comp 100 mg/ 12. 5 mg and Cozaar Comp 100 mg/ 25 mg:
Each tablet contains the following inactive ingredients: microcrystalline cellulose(E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose(E464).
Kull pillola fiha s- sustanzi li ġejjin: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
Cozaar Comp 50 mg/ 12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Cozaar Comp 50 mg/ 12. 5 mg fihom 4. 24 mg (0. 108 mEq) ta ’ potassju.
Cozaar Comp 100 mg/ 12.5 mg mg contains 8.48 mg (0.216 mEq) of potassium. and Cozaar Comp 100 mg/ 25 mg contains 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 100 mg/ 12. 5 mg mg fihom 8. 48 mg (0. 216 mEq) ta ’ potassju. u Cozaar Comp 100 mg/ 25 mg fihom 8. 48 mg (0. 216 mEq) ta ’ potassju
Cozaar Comp 50 mg/ 12.5 mg and Cozaar Comp 100 mg/ 25 mg also contain, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), and Carnauba wax (E903)
Cozaar Comp 50 mg/ 12. 5 mg u Cozaar Comp 100 mg/ 25 mg fihom ukoll Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), u Carnauba wax (E903)
Cozaar Comp 100 mg/ 12.5 mg also contain: white color concentrate (or the individual ingredients of the concentrate: hydroxypropyl cellulose, hypromellose and titanium dioxide) and carnauba wax.
Cozaar Comp 100 mg/ 12. 5 mg fih ukoll konċentrat ta ’ kulur abjad (għall- ingredjenti individwali tal - konċentrat: hydroxypropyl cellulose, hypromellose u titanium dioxide) u carnauba wax.
Carnauba wax (E903), Titanium dioxide (E171)
33 Carnauba wax (E903), Titanium dioxide (E171)
Cozaar Comp 100 mg/ 25 mg also contain:, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), and Carnauba wax (E903)
Cozaar Comp 100 mg/ 25 mg fih ukoll:, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), u Carnauba wax (E903) 6. 2 Inkompatibilitajiet
Cozaar Comp 50 mg/ 12.5 mg, Cozaar Comp 100 mg/ 25 mg:
Cozaar Comp 50 mg/ 12. 5 mg, Cozaar Comp 100 mg/ 25 mg:
Cozaar Comp 100 mg/ 12.5 mg:
Cozaar Comp 100 mg/ 12. 5 mg:
34 Store in the original package.
Żomm fil- kontenitur oriġinali.
Keep the blister in the outer carton and the keep the bottle tightly closed.
Żomm il- folja fil- kartuna ta ’ barra u l- flixkun magħluq sewwa
Cozaar Comp 50 mg/ 12.5 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
Cozaar Comp 50 mg/ 12. 5 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 4, 7, 10 pilloli, 14- il pillola, 20, 28, 30, 50, 56, 98, jew 280 pillola.
HDPE bottles of 100 tablets.
Fliexken ta ’ l- HDPE b’ 100 pillola.
Cozaar Comp 100 mg/ 12.5 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
Cozaar Comp 100 mg/ 12. 5 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 14, 15- il pillola, 28, 30, 50, 56, 84, 98, jew 280 pillola.
HDPE bottles of 100 tablets.
Fliexken ta ’ l- HDPE b’ 100 pillola
Cozaar Comp 100 mg/ 25 mg > - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Cozaar Comp 100 mg/ 25 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7 pilloli, 14- il pillola, 28, 30, 50, 56, 84, 90, 98, jew 280 pillola.
6.6 Special precautions for disposal< and other handling >
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema < u għal immaniġġar ieħor >
[To be implemented nationally]
[Biex jiġi implimentat fil- pajjiż]
< {DD/MM/YYYY} > < {DD month YYYY} >
< {DD/ MM/ YYYY} > < {DD xahar YYYY} >
35 LABELLING
35 TIKKETTA
Outer carton for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets blister
Kartuna ta ’ barra għal folja ta ’ Cozaar Comp 50 mg/ 12. 5 mg pilloli miksijin b’ rita
Cozaar Comp 50 mg/ 12.5 mg mg film-coated tablets
Cozaar Comp 50 mg / 12. 5 mg mg pilloli miksijin b’ rita
Losartan and hydrochlorothiazide
Losartan u hydrochlorothiazide
Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Kull pillola fiha 50 mg losartan potassium u 12. 5 mg hydrochlorothiazide.
4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 film-coated tablets.
4, 7, 10 pilloli, 14- il pillola, 20, 28, 30, 50, 84, 56, 98, jew 280 pillola miksija b’ rita.
Keep the blister in the outer carton.
Żomm il- flixkun magħluq sew.
[To be completed nationally]
[Sabiex jimtlesta fil- pajjiż stess]
[To be completed nationally]
[Sabiex jitlesta fil- pajjiż stess]
[To be completed nationally]
[Għandu jitlesta fil- pajjiż stess]
[To be completed nationally] [For referral procedures]
[Għandu jitlesta fil- pajjiż stess]
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets
Folji għal Cozaar Comp 50 mg/ 12. 5 mg pilloli miksijin b’ rita
Cozaar Comp 50 mg/ 12.5 mg
Cozaar Comp 50 mg/ 12. 5 mg
[See Annex I - To be completed nationally] [For referral procedures]
[Ara Anness I - Biex jitlesta fil- pajjiż stess]
Outer carton for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets HDPE Bottle
Kartuna ta ’ barra għal Cozaar Comp 50 mg/ 12. 5 mg pilloli miksijin b’ rita Flixkun HDPE
Cozaar Comp 50 mg/ 12.5 mg mg film-coated tablets
Cozaar Comp 50 mg/ 12. 5 mg mg pilloli miksijin b’ rita
STATEMENT OF ACTIVE SUBSTANCE(S)
STATEMENT OF ACTIVE SUBSTANCE( S)
Store in the original bottle.
Aħżen fil- pakkett oriġinali.
11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN 40 11.
[To be completed nationally]
[Għandu jimtela fil- pajjiż stess]
Bottle label for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets HDPE Bottle
Flixkun HDPE
11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN 42 11.
N/ A
Mhux disponibbli
Outer carton for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets blister
Kartuna ta ’ barra għal folja ta ’ Cozaar Comp 100 mg/ 12. 5 mg pilloli miksijin b’ rita
Cozaar Comp 100 mg/ 12.5 mg mg film-coated tablets
Cozaar Comp 100 mg/ 12. 5 mg mg pilloli miksijin b’ rita
Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Kull pillola fiha 100 mg losartan potassium u 12. 5 mg hydrochlorothiazide.
Lactose-monohydrate.
Lactose monohydrate.
14, 15, 28, 30, 50, 56, 84, 90, 98, or 280 film coated-tablets.
14, 15- il pillola, 28, 30, 50, 56, 84, 90, 98, jew 280 pillola miksija b’ rita.
[To be completed nationally][For referral procedures]
[Għandu jitlesta fil- pajjiż stess]
Blister for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets
Folji għal Cozaar Comp 100 mg/ 12. 5 mg pilloli miksijin b’ rita
Cozaar Comp 100 mg/ 12.5 mg
Cozaar Comp 100 mg/ 12. 5 mg
[See Annex I - To be completed nationally] [For referral procedures]
[Ara Anness I - Għandu jitlesta fil- pajjiż stess]
Outer carton for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets HDPE bottle
Kartuna ta ’ barra għal Cozaar Comp 100 mg/ 12. 5 mg pilloli miksija b’ rita Flixkun HDPE
100 film coated-tablets.
100 pillola miksija b’ rita.
Bottle label for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets HDPE bottle
Tikketta tal- flixkun għal Cozaar Comp 100 mg/ 12. 5 mg pilloli miksijin b’ rita Flixkun HDPE
11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN 49 11.
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar Comp 100 mg/ 25 mg film-coated tablets blister
Kartuna ta ’ barra għal folja ta ’ Cozaar Comp 100 mg/ 25 mg pilloli miksijin b’ rita
Cozaar Comp 100 mg/ 25 mg mg film-coated tablets
Cozaar Comp 100 mg/ 25 mg mg pilloli miksijin b’ rita
Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
Kull pillola fiha 100 mg losartan potassium u 25 mg hydrochlorothiazide.
7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 film-coated tablets
7 pilloli, 14- il pillola, 28, 30, 50, 56, 84, 90, 98, jew 280 pillola miksija b’ rita
[To be completed nationally]
< [Għandu jitlesta fil- pajjiż stess] >
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
52 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister for Cozaar Comp 100 mg/ 25 mg film-coated tablets
Folja għal Cozaar Comp 100 mg/ 25 mg pilloli miksijin b’ rita
Outer carton for Cozaar Comp 100 mg/ 25 mg film-coated tablets HDPE bottle
Kartuna ta ’ barra għal Cozaar Comp 100 mg/ 25 mg pilloli miksijin b’ rita Flixkun HDPE
Outer carton for Cozaar Comp 100 mg/ 25 mg film-coated tablets HDPE bottle
Kartuna ta ’ barra għal Flixkun HDPE ta ’ Cozaar Comp 100 mg/ 25 mg pilloli miksijin b’ rita
11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN 56 11.
57 PACKAGE LEAFLET:
57 FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
58 FULJETT TA ’ TAGĦRIF:
COZAAR COMP film-coated Tablets losartan potassium and hydrochlorothiazide
Cozaar Comp pilloli miksijin b’ rita losartan potassium u hydrochlorothiazide
Read all of this leaflet carefully before taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina
What Cozaar Comp is and what it is used for 2.
X’ inhu Cozaar Comp u għalxiex jintuża 2.
Before you take Cozaar Comp 3.
Qabel ma tieħu Cozaar Comp 3.
How to take Cozaar Comp 4.
Kif għandek tieħu Cozaar Comp 4.
How to store Cozaar Comp 6.
Kif taħżen Cozaar Comp 6.
WHAT COZAAR COMP IS AND WHAT IT IS USED FOR
X’ INHU COZAAR COMP U GĦALXIEX JINTUŻA
Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Cozaar Comp hu kombinazzjoni ta ’ antagonist għar- riċettatur ta ’ angiotensin II (losartan) u fijuretiku (hydrochlorothiazide).
Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure).
Cozaar Comp hu indikat għat- trattament ta ’ pressjoni essenzjali għolja (pressjoni tad- demm għolja)
BEFORE YOU TAKE COZAAR COMP
QABEL MA TIEĦU COZAAR COMP
Do not take Cozaar Comp
Tieħux Cozaar Comp
• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients in this medicine. • if you are allergic (hypersensitive) to other sulfonamide-derived substances (e. g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure) • if you are, think you may be or are planning to become pregnant (see also “ Pregnancy and breast-feeding”) • if you are breast-feeding • if you have severely impaired liver function • if you have severely impaired kidney function or your kidneys are not producing any urine. • if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment • if you are suffering from gout
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal losartan, hydrochlorothiazide jew xi sustanza oħra ta ’ Cozaar Comp. • jekk inti allerġiku (għandek sensittività eċċessiva) għal grupp ta ’ mediċini msejħa ‘ mediċini derivati minn sulfonamides ’ (eż. thiazides oħrajn, xi mediċini antibatteriċi bħal co- trimoxazole, staqsi lit- tabib tiegħek jekk m’ intix żgur) • jekk inti, jew jekk taħseb li inti jew qed tippjana li tinqabad tqila (ara wkoll “ Tqala u Treddigħ ”); • jekk qed tredda ’ (ara wkoll sezzjoni 2 Tqala u Treddigħ) • jekk għandek il- funzjoni tal- fwied indebolita severament • jekk għandek il- funzjoni tal- kliewi indebolita severamentjew jekk il- fwied m’ humiex jipproduċu awrina • jekk għandek livelli baxxi ta ’ potassju, livell baxx ta ’ sodju jew livell għoli ta ’ kalċju li ma jistax jiġi kkoreġut bit- trattament. • jekk qed tbati minn gotta.
Take special care with Cozaar Comp
Oqgħod attent ħafna b’ Cozaar Comp
• if you have previously suffered from swelling of the face, lips, throat or tongue
• jekk għandek storja ta ’ nefħa tal- wiċċ, ix- xofftejn, il- griżmejn, u/ jew l- ilsien • jekk qed tieħu d- dijuretiċi (pilloli ta ’ l- ilma)
58 • if you take diuretics (water pills) • if you are on a salt-restricted diet • if you have or have had severe vomiting and/ or diarrhoea • if you have heart failure • if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant • if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function) • if you have ‘ aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘ hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle) • if you are diabetic • if you have had gout • if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus). • if you have high calcium or low potassium levels or you are on a low potassium diet • if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking Losartan potassium and Hydrochlorothiazide tablets. • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland).
59 • jekk qiegħed fuq dieta fejn tirristrinġi l- imluħa • jekk qiegħed jew kont qed tirremetti jew kellek dijarea severa • jekk għandek insuffiċjenza tal- qalb • jekk l- arterji li jwasslu d- demm lil kliewi tiegħek huma dojoq (stenosi ta ’ l- arterji tal- kliewi) jew jekk għandek kilwa waħda biss qed taħdem, jew riċentement kellek trapjant tal- kliewi. • jekk għandek tidjiq ta ’ l- arterji (arteroxlerosi), anġina pectoris (uġigħ fis- sider dovut għal funzjoni batuta tal- qalb) • jekk għandek ‘ stenosi aortika jew mitrali ’ (tidjiq tal- valvi tal- qalb) jew ‘ kardjomajopatija ipertrofika ’ (marda li tikkawża tiħxin fil- muskolu tal- qalb) • jekk int dijabetiku • jekk kellek il- gotta • jekk għandek jew kellek kondizzjoni allerġika, ażma jew kundizzjoni li tikkaġuna uġigħ fil- ġogi, raxxijiet fuq il- ġilda u deni (eritematodus lupus sistemiku). • Jekk għandek livelli għoljin ta ’ kalċju jew livelli baxxi ta ’ potassju jew jekk qiegħed fuq dieta baxx ta ’ potassju. • jekk hemm bżonn li tingħata loppju (anke għand id- dentist) jew qabel intervent kirurġiku, jew jekk għandek tieħu xi testijiet biex tiċċekkja l- funzjoni tal- paratajrojd, għandek tgħid lit- tabib jew l- personel mediku li qed tieħu l- pilloli Losartan u Hydrochlorothiazide. • Jekk tbati minn iperaldosteroniżmu primarju (sindromu assoċjat ma tnixxija ogħla ta ’ l- ormon aldosterone li joħroġ mill- glandola adrenali, ikkawżata minn abnormalità fi ħdan il- glandola).
Diuretic agents such as the hydrochlorothiazide contained in Cozaar Comp may interact with other medicines.
Sustanzi dijuretiċi bħal hydrochlorothiazide li jinsab f’ Cozaar Comp jista jaffettwa jew jiġi affettwat b’ mediċini oħra.
Preparations containing lithium should not be taken with Cozaar Comp without close supervision by your doctor.
Taħlitiet li fihom il- litju m’ għandhomx jittieħdu ma ’ Cozaar Comp mingħajr superviżjoni mill- qrib mit- tabib tiegħek.
Special precautionary measures (e. g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“ water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins).
Miżuri prekawzjonarji speċjali (eż. testijiet tad- demm) jistgħu jkunu xierqa jekk qed tieħu supplimenti tal- potassju, sostituti tal- melħ li fihom il- potassju jew mediċini li ma jħallux t- tnixxija ta ’ potassju, dijuretiċi oħra (“ pilloli ta ’ l- ilma ”) xi purganti, mediċini għat- trattament tal- gotta, mediċini li jikkontrollaw ir- ritmu tal- qalb, jew għad- dijabete (mediċini orali jew insulina).
It is also important for your doctor to know if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, drugs for treatment of fungal infections, or arthritis medicines, resins used for high cholesterol, such as colestyramine, medicines which relax your muscles, sleeping tablets; opioid medicines such as morphine, ‘ pressor amines’ such as adrenaline or other drugs from the same group; (oral agents for diabetes or insulins).
Huwa importanti wkoll li t- tabib tiegħek għandu jkun jaf jekk intiex tieħu mediċini biex tbaxxi l- pressjoni, sterojdi, mediċini biex tittratta l- kanċer, mediċini kontra l- uġigħ, mediċini għat - trattament ta ’ infezzjonijiet tal- moffa, jew mediċini għal artrite, reżini użata għal kolesterol għoli, bħal coleostyramine, mediċini li jirralassaw il- muskoli, pilloli ta ’ l- irqad, mediċini opjojdibħal morfina, ‘ amini pressor ’ bħal adrenalinajew mediċini oħra mill- istess grupp; (aġenti orali għal dijabete jew insulina).
Please also inform your doctor when it is planned to apply iodine contrast media about taking Cozaar Comp.
Jekk jogħġbok informa lit- tabib tiegħek meta hu ppjanat biex ser tapplika midja ta ’ kuntrast bil- jodju għal Cozaar Comp.
Taking Cozaar Comp with food and drink You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may increase each other’ s effects.
Meta tieħu Cozaar Comp ma ’ l- ikel u x- xorb
Dietary salt in excessive quantities may counteract the effect of Cozaar Comp tablets.
Huwa rakkomandat li ma tixrobx alkoħol waqt li qed tieħu dawn il- pilloli: alkoħol u l- pilloli Cozaar Comp jistgħu iħarxu l- effetti ta ’ xulxin.
Cozaar Comp tablets may be taken with or without food.
Melħ djatetiku fi kwantità eċċessiva jista ’ jikkontraponi l- effett tal- pilloli Cozaar Comp Cozaar Comp jista jittieħed ma ’ l- ikel jew fuq stonku vojt.
You should not take Cozaar Comp in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
M’ għandekx tieħu Cozaar Comp fl- ewwel 12- il ġimgħa ta ’ tqala, u m’ għandekx teħodhom għall- ebda raġuni wara t- 13- il ġimgħa peress li l- użu tagħhom jista ’ jkun ta ’ ħsara għat- tarbija.
If you become pregnant while on Cozaar Comp, tell your doctor immediately.
Jekk tinqabad tqila waqt li qed tieħu Cozaar Comp, għid lit- tabib tiegħek minnufih.
A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Bidla għal trattament alternattiv xieraq għandha ssir minn qabel fi tqala ppjanata.
You must not take Cozaar Comp if you are breast-feeding.
60 M’ għandekx tieħu Cozaar Comp jekk qed tredda ’.
Ask your doctor or pharmacist for advice before taking any medicine.
Staqsi lit- tabib jew lill- ispiżjar għal pariri qabel ma tieħu xi mediċina.
59 Use in children and adolescents
L- użu fi tfal u adoloxxenti
There is no experience with the use of Cozaar Comp in children.
M’ hemmx esperjenza dwar l- użu ta ’ Cozaar Comp fi tfal.
Therefore, Cozaar Comp should not be given to children.
Għalhekk, Cozaar Comp m’ għandux jingħata lit- tfal.
Use in elderly patients
L- użu fl- anzjani
Most older patients require the same dose as younger patients.
Cozaar Comp jaħdem ugwalment tajjeb u huwa tollerat sew mill- biċċa l- kbira ta ’ pazjenti adulti akbar u dawk iżgħar minnhom.
When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.
Meta tibda it- trattament b’ din il- mediċina, m’ għandekx tagħmel xogħol li jeħtieġ attenzjoni speċjali (pereżempju, sewqan ta ’ vettura jew tħaddim ta ’ inġenji perikolużi) sakemm tkun taf li tista ’ tittolera l- mediċina tiegħek.
Important information about some of the ingredients of Cozaar Comp
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Cozaar Comp
Cozaar Comp contains lactose.
Cozaar Comp fih il- lattosju.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li inti intolleranti għal- lattosju jew ma tistax tidiġerixxi xi tipi ta ’ zokkor (għandek intolleranza għal xi tipi ta ’ zokkor) kellem lit- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO TAKE COZAAR COMP
KIF GĦANDEK TIEĦU COZAAR COMP
Always take Cozaar Comp exactly as your doctor has instructed you.
Dejjem għandek tieħu Cozaar Comp skond il- parir tat- tabib.
Your doctor will decide on the appropriate dose of Cozaar Comp depending on your condition and whether you are taking other medicines.
It- tabib tiegħek ser jiddeċiedi d- doża xierqa ta ’ Cozaar Comp skond il- kundizzjoni tiegħek u jekk intiex tieħu xi mediċini oħra.
It is important to continue taking Cozaar Comp for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Huwa importanti li tkompli tieħu Cozaar Comp sakemm jibqa ’ jippreskrivih it- tabib tiegħek, peress li din il - mediċina tibqa ’ tikkontrolla l- pressjoni tiegħek.
High Blood Pressure The usual dose of Cozaar Comp for most patients with high blood pressure is 1 tablet of Cozaar Comp 50 mg/ 12.5 mg per day to control blood pressure over the 24-hour period.
Pressjoni tad- demm għolja Id- doża li ġeneralment tingħata ta ’ Cozaar Comp għal biċċa l- kbira tal- pazjenti hi ta ’ hi ta ’ pillola waħda ta ’ 50 mg/ 12. 5 mg kuljum sabiex tikkontrolla l- pressjoni tad- demm tiegħek fuq perijodu ta ’ 24 siegħa.
This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/ 12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/ 25 mg Film-Coated Tablets (a stronger strength) per day.
Din tista ’ tiġi miżjuda għal 2 pilloli darba kuljum għal Losartan/ Hydrochlorothiazide 50 mg/ 12. 5 mg Pilloli Miksijin b’ Rita jew mibdula għal pillola waħda kuljum ta ’ Losartan/ Hydrochlorothiazide 100 mg/ 25mg Pilloli Miksijin b’ Rita (qawwa akbar) kuljum.
The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/ 12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/ 25 mg Film-Coated Tablets
Id- doża massima ta ’ kuljum hi ta ’ 2 pilloli kuljum ta ’ Losartan / hydrochlorothiazide 50 mg/ 12. 5 mg Pilloli Miksijin b’ Rita jew pillola 1 kuljum ta ’ losartan / hydrochlorothiazide 100 mg/ 25 mg Pillola Miksija b’ Rita
If you take more Cozaar Comp than you should
Jekk tieħu Cozaar Comp aktar milli suppost
In case of an overdose, contact your doctor immediately so that medical attention may be given promptly.
F’ każ ta ’ doża eċċessiva, ikkuntattja lit- tabib tiegħek minnufih jew mur l- isptar minnufih sabiex attenzjoni medika tkun tista ’ tingħatalek minnufih.
Overdosage can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.
Doża eċċessiva tista tikkaġuna l- pressjoni tad- demm tiegħek biex taqa ’, palpitazzjonijiet, taħbit tal- qalb kajman, bidla fl- elettroliti tad- demm, u diżidrazzjoni.
If you forget to take Cozaar Comp Try to take Cozaar Comp daily as prescribed.
Jekk tinsa tieħu Cozaar Comp
However, if you miss a dose, do not take an extra dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li nsejt tieħu.
Just resume your usual schedule.
Aqbeż id- doża li tkun insejt tieħu u ħu d- doża li jmisek tieħu fil- jum ta ’ wara.
Like all medicines, Cozaar Comp tablets can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, i- pilloli ta ’ Cozaar Comp jista ’ jkollhom effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you experience the following, stop taking Cozaar Comp tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Jekk tħoss xi wieħed mill- effetti li ġejjin, waqqaf il- pilloli losartan u għid lit- tabib tiegħek minnufih jew mur id- dipartiment ta ’ l- emerġenza ta ’ l- eqreb sptar tiegħek:
60 A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
Reazzjoni allerġika severa (raxx, ħakk, nefħa fil- wiċċ, ix- xofftejn, il- ħalq jew il- griżmejn li jistgħu jikkawżaw diffikultàbiex tibla ’ jew tieħu n- nifs).
This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients.
Dan hu effett kollaterali rari imma serju, li jaffettwa aktar minn persuna 1 f’ kull 10, 000 pazjent imma inqas minn persuna 1 f’ kull 100 pazjent.
You may need urgent medical attention or hospitalisation.
Għandu mnejn ikollok bżonn attenzjoni medika urġenti jew tinżamm l- isptar.
The following side effects have been reported:
L- effetti sekondarji ta ’ mediċini huma kklassifikati kif ġej:
Common (affecting less than one person in 10 but more than one person in 100): • Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder, • Diarrhoea, abdominal pain, nausea, indigestion, • Muscle pain or cramps, leg pain, back pain, • Insomnia, headache, dizziness, • Weakness, tiredness, chest pain, • Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.
Komuni (li jistgħu jaffettwaw anqas minn persuna waħda f’ kull 10 imma aktar minn persuna waħda f’ 100): • Sogħla, infezzjoni fil- passaġġ ta ’ fuq, imnieħer imblukkat, sinusite, disturbi fis- sinus • Dijarea, uġigħ addominali, nawsea, indiġestjoni • Uġigħ fil- muskoli jew bugħawwieġ, uġigħ fir- riġlejn, uġigħ fid- dahar, • Nuqqas ta ’ rqad, uġigħ ta ’ ras, stordament, • Debolezza, għeja, uġigħ fis- sider • Livell ta ’ potassju ogħla (li jista ’ jikkawża ritmu abnormali tal- qalb), livelli ta ’ emoglobina mnaqqsa.
Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients) • Hepatitis (inflammation of the liver), abnormal liver function tests
62 Rari (li jseħħu f’ aktar minn 1 f’ kull 10, 000 pazjent u inqas minn 1 f’ kull 1, 000) • Epatite (infjammazzjoni tal- fwied) testijiet abnormali tal- funzjoni tal- fwied
HOW TO STORE COZAAR COMP
KIF TAĦŻEN COZAAR COMP
Do not use Cozaar Comp after the expiry date which is stated on the container.
Tużax Cozaar Comp wara d- data ta ’ skadenza li tidher fuq kartuna wara JIS.
Store Cozaar Comp in the original package.
Aħżen fil- kontenitur oriġinali.
Keep the blister in the outer carton.
Żomm il- folja fil- kartuna oriġinali.
Do not open the blister pack until you are ready to take the medicine.
Tiftakx il- folja sakemm tkun lest biex tibda tieħu l- mediċina.
What Cozaar Comp contains
X’ fih Cozaar Comp fih
The active substances are losartan potassium and hydrochlorothiazide.
Is- sustanzi attivi huma losartan potassium u hydrochlorothiazide
Cozaar Comp 50 mg/ 12.5 mg > contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 50 mg/ 12. 5 mg fiha 50 mg ta ’ losartan potassium u 12. 5 mg ta ’ hydrochlorothiazide bħala s- sustanzi attivi.
Cozaar Comp100 mg/ 12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 100 mg/ 25 mg fiha 100 mg ta ’ losartan potassium u 25 mg ta ’ hydrochlorothiazide bħala s- sustanzi attivi.
Cozaar Comp 100 mg/ 25 mg > contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 100 mg/ 25 mg fiha 100 mg ta ’ losartan potassium u 25 mg ta ’ hydrochlorothiazide bħala s- sustanzi attivi.
Cozaar Comp 50 mg/ 12.5 mg, Cozaar Comp 100 mg/ 12.5 mgand Cozaar Comp 100 mg/ 25 mg contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose.
Cozaar Comp 50 mg/ 12. 5 mg, Cozaar Comp 100 mg/ 12. 5 mg u Cozaar Comp 100 mg/ 25 mg fihom is - sustanzi l- oħra li ġejjin: microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464)
Cozaar Comp 100 mg/ 12.5 mg mg and Cozaar Comp 100 mg/ 25 mg contain 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 50 mg/ 12. 5 mg fih 4. 24 mg (0. 108mEq) ta ’ potassju, Cozaar Comp 100 mg/ 12. 5 mg u Cozaar Comp 100 mg/ 25 mg fihom 8. 48 mg (0. 216 mEq) potassju.
Cozaar Comp 50 mg/ 12.5 mg and Cozaar Comp 100 mg/ 25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Cozaar Comp 50 mg/ 12. 5 mg u Cozaar Comp 100 mg/ 25 mg fihom ukoll titanium dioxide (E171), quinoline yellow aluminum lake (E104) u carnauba wax (E903).
Cozaar Comp 100 mg/ 12.5 mg also contain: white color concentrate [or the individual ingredients of the concentrate: hydroxypropyl cellulose (E463), hypromellose (E464) and titanium dioxide (E171)] and carnauba wax (E903).
Cozaar Comp 100 mg/ 12. 5 mg fih ukoll: konċentrat tal- kulur abjad [jew l- ingredjenti individwali tal - konċentrat: hydroxypropyl cellulose (E463), hypromellose (E464) u titanium dioxide (E171)] u carnauba wax (E903).
What Cozaar Comp looks like and contents of the pack
Id- dehra ta ’ Cozaar Comp u l- kontenut tal- pakkett
Cozaar Comp 50 mg/ 12.5 mg is supplied as scored or unscored film-coated tablets.
63 Cozaar Comp 50 mg/ 12. 5 mg jiġi bħala pilloli miksijin b’ rita bix- xaqq jew mingħajr xaqq.
Cozaar Comp 100 mg/ 12.5 mg mg is supplied as unscored film-coated tablets.
Cozaar Comp 100 mg/ 12. 5 mg jiġi bħala pilloli miksijin b’ rita mingħajr xaqq
Cozaar Comp 100 mg/ 25 mg is supplied as unscored film-coated tablets.
Cozaar Comp 50 mg/ 12. 5 mg jiġi bħala pilloli miksijin b’ rita mingħajr xaqq
Cozaar Comp is supplied in the following pack sizes:
Cozaar Comp jiġi fid- daqsijiet ta ’ pakketti li ġejjin:
62 Cozaar Comp 50 mg/ 12.5 mg > - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
Cozaar Comp 50 mg/ 12. 5 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 4, 7, 10 pilloli, 14- il pillola, 20, 28, 30, 50, 56, 84, 98, jew 280 pillola.
HDPE bottles of 100 tablets.
Fliexken tal- HDPE ta ’ 100 pillola.
Cozaar Comp 100 mg/ 12.5 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
Cozaar Comp 100 mg/ 12. 5 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 14, 15- il pillola, 28, 30, 50, 56, 84, 90, 98, jew 280 pillola.
Cozaar Comp 100 mg/ 25 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Cozaar Comp 100 mg/ 25 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7 pilloli, 14- il pillola, 28, 30, 50, 56, 98, jew 280 pillola.
HDPE bottles of 100 tablets.
Fliexken tal- HDPE ta ’ 100 pillola
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u Manifattur
< To be completed nationally >
< Għandu jitlesta fil- pajjiż stess >
This medicinal product is authorized in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- Istati Memebri u fiż- ŻEE taħt l- ismijiet li ġejjin:
Austria Austria Belgium Belgium Belgium Belgium Bulgaria Cyprus Cyprus Denmark Denmark Denmark Denmark Estonia
L- Awstrija L- Awstrija Il- Belġju Il- Belġju Il- Belġju Il- Belġju Il- Bulgarija Ċipru Ċipru Id- Danimarka Id- Danimarka Id- Danimarka Id- Danimarka L- Estonja
Estonia Finland Finland France
L- Estonja Il- Finlandja Il- Finlandja Franza
Germany Germany Germany Germany Germany Germany Greece
LORZAAR PLUS 50/ 12, 5 mg Filmtabletten 64
LORZAAR PLUS 50/ 12,5 mg Filmtabletten CARDOPAL PLUS 50/ 12,5 mg Filmtabletten LORZAAR VARIPHARM PLUS 50/ 12,5 mg Filmtabletten FORTZAAR 100/ 25 mg Filmtabletten FORTZAAR VARIPHARM 100/ 25 mg Filmtabletten LORZAAR PLUS forte 100/ 12,5 mg Filmtabletten HYZAAR
CARDOPAL PLUS 50/ 12, 5 mg Filmtabletten LORZAAR VARIPHARM PLUS 50/ 12, 5 mg Filmtabletten FORTZAAR 100/ 25 mg Filmtabletten FORTZAAR VARIPHARM 100/ 25 mg Filmtabletten LORZAAR PLUS forte 100/ 12, 5 mg Filmtabletten HYZAAR HYZAAR 100/ 25 Hyzaar 50/ 12. 5 mg
Hungary Ireland Ireland
L- Ungerija L- Irlanda L- Irlanda
Italy HIZAAR 50 mg + 12,5 mg compresse rivestite con film Italy HIZAAR 100 mg + 25 mg compresse rivestite con film
L- Italja L- Italja
Italy FORZAAR 100 mg + 25 mg compresse rivestite con film Italy NEO-LOTAN PLUS 50 mg + 12,5 mg compresse rivestite con film Italy NEO-LOTAN PLUS 100 mg + 25 mg compresse rivestite con film Italy LOSAZID 50 mg + 12,5 mg compresse rivestite con film Italy LOSAZID 100 mg + 25 mg compresse rivestite con film Latvia Latvia Lithuania
L- Italja L- Italja L- Italja L- Italja L- Italja Il- Latvija Il- Latvija Il- Litwanja
Lithuania Luxembourg Luxembourg Luxembourg Luxembourg Malta
Il- Litwanja Il- Lussemburgu Il- Lussemburgu Il- Lussemburgu Il- Lussemburgu Malta
Netherlands Netherlands Netherlands Poland Poland Portugal Portugal Portugal Portugal Portugal Romania Romania Slovenia Slovenia Spain Spain Sweden Sweden
L- Olanda L- Olanda L- Olanda Il- Polonja Il- Polonja Il- Portugall Il- Portugall Il- Portugall Il- Portugall Il- Portugall Ir- Rumanija Ir- Rumanija
London, 3 September 2008 Doc.
Londra, 3 ta ’ Settembru 2008 Dok.
EMEA/ CHMP/ 494914/ 2008
EMEA/ CHMP/ 494928/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar Comp and associated names
OPINJONI WARA RIFERIMENT SKOND L- ARTIKOLU 30 GĦAL Cozaar Comp u ismijiet assoċjati
International Non-Proprietary Name (INN): losartan + hydrochlorothiazide
Denominazzjoni Komuni Internazzjonali (DKI): losartan + hydrochlorothiazide
Cozaar Comp and associated names, 50/ 12.5 mg; 100/ 12.5 mg; 100/ 25 mg, film coated tablets is a fixed dose combination of losartan and hydrochlorothiazide.
Cozaar Comp u ismijiet assoċjati, 50/ 12. 5 mg; 100/ 12. 5 mg; 100/ 25 mg, pilloli miksijin b’ rita hija kombinazzjoni ta ’ doża fissa ta ’ losartan u hydrochlorothiazide.
Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Losartan huwa antagonista riċettur tat- tip angiotensin II (Ang - II) attiv oralment, li jaġixxi fuq is- subtip tar- riċettur AT1, b’ hekk jimblokka l- effett ta ’ Ang- II fil- kaskada tas- sistema ta ’ anġjotensin tar- renin (RAS).
Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Hydrochlorothiazide (HCTZ) huwa dijuretiku b’ thiazide li ntuża wkoll bħala sustanza kontra l- pressjoni għolja.
The losartan/ hydrochlorothiazide combination is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Il- kombinazzjoni losartan/ hydrochlorothiazide hija indikata għall- kura tal- pressjoni għolja f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata b’ mod adegwat b’ losartan jew b’ hydrochlorothiazide.
On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar Comp. and associated names.
Fit- 23 ta ’ Frar 2007, id- Danimarka ippreżentat lill- EMEA riferment skont l- Artikolu 30 tad- Direttiva 2001/ 83/ KE, kif emendata, sabiex jiġu armonizzati s- sommarji tal- karatteristiċi tal- prodott, il- fuljett ta ’ tagħrif u t- tikketta awtorizzati fuq livell nazzjonali tal- prodott mediċinali Cozaar Comp. u l- ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Cozaar Comp. and associated names approved across EU Member States, with respect to the following indications:
Il- bażi tar- riferiment kien li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) ta ’ Cozaar Comp. u l- ismijiet assoċjati approvati madwar l- Istati Membri tal- UE fir- rigward tal- indikazzjonijiet li ġejjin:
Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide; As first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk; Reduction of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.
Il- kura tal- pressjoni għolja f’ pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata b’ mod adegwat b’ losartan jew b’ hydrochlorothiazide; Bħala kura tal- ewwel pass f’ pazjenti bi pressjoni għolja moderata għal severa u f’ pazjenti b’ riskju kardjovaskulari għoli jew għoli ħafna; Tnaqqis tal - morbidità u mortalità kardjovaskulari f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikolari tax- xellug.
The procedure started on 22 March 2007.
Il- proċedura bdiet fit- 22 ta ’ Marzu 2007.
The Marketing Authorisation Holder provided supplementary information on 23 July 2007.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ta informazzjoni supplimentari fit- 23 ta ’ Lulju 2007.
During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
Matul il- laqgħa tiegħu tal- 21 - 24 ta ’ April 2008, is- CHMP, fid- dawl tad- dejta ġenerali ippreżentata u tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, Tikketta u Fuljett ta ’ Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar Comp. and associated names.
Is- CHMP ta opinjoni pożittiva fl- 24 ta ’ April 2008 u rrakkomanda l- armonizzazzjoni tal- SPC, tikketta u fuljett ta ’ tagħrif għal Cozaar Comp. u l- ismijiet assoċjati.
The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Il- konklużjonijiet xjentifiċi huma mogħtija fl- Anness II flimkien mal- SPC, tikketta u fuljett ta ’ tagħrif emendati fl- Anness III
A Decision was issued by the European Commission on 3 September 2008.
Inħarġet Deċiżjoni mill- Kummissjoni Ewropea fit- 3 ta ’ Settembru 2008.
Invented name
Isem Ivvintat losartan potassium
Merck Sharp & Dohme GmbH Donau-City-Straße 6 1220 Wien Austria
Merck Sharp & Dohme GmbH Donau- City- Straße 6, 1220 Wien, L- Awstrija
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B- 1180 Brussels, Il- Belġju
Film-coated tablet
21 X 12, 5 MG Pillola miksija b’ rita + 14 X 50 MG
Invented name
Il- Belġju
Rue Egide Van Ophem 108 B-1180 Brussels Belgium
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brussels, Il - Belġju
100 mg
100 mg Pillola miksija b’ rita
50 mg
50 mg Pillola miksija b’ rita
Belgium
2 Il- Belġju
Film-coated tablet
12, 5 MG Pillola miksija b’ rita X 50 MG
1407 Sofia Bulgaria
1407 Sofia, Il- Bulgarja
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, L- Olanda
Film-coated tablet
50MG Pillola miksija b’ rita
Film-coated tablet
100MG Pillola miksija b’ rita
Invented name
Id- Danimarka
12.5 mg
12, 5 mg Pillola miksija b’ rita
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem L- Olanda
12.5 mg + 50 mg
12, 5 mg + 50 Pillola miksija b’ rita mg
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estonia
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn, L- Estonja
Film-coated tablet
100mg Pillola miksija b’ rita
Film-coated tablet
50mg Pillola miksija b’ rita
Film-coated tablet
12, 5mg Pillola miksija b’ rita
Finland
3 Il- Finlandja
Waarderweg 39 P. O. Box 581 2003 PC HAARLEM the Netherlands
Waarderweg 39 P. O. Box 581 2003 PC HAARLEM L- Olanda
Invented name
Il- Finlandja
Hoche 75114 Paris Cedex 08 France
Hoche 75114 Paris Cedex 08, Franza
Cozaar 100 mg film-coated tablets
Cozaar 100 mg Pillola 100 mg miksija b’ ritas
Scored coated tablet
Scored coated tablet
MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Germany
MSD Chibropharm GmbH Postfach 1202 D- 85530 Haar, Il- Ġermanja
Invented name
Il- Ġermanja
Germany
4 Il- Ġermanja
VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 85540, Haar, Germany
VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 85540, Haar, Il- Ġermanja
Tatoiou Street, Nea Erythraia 14671 Greece
Tatoiou Street, Nea Erythraia 14671, Il- Greċja
Invented name
L- Ungerija
Film-coated tablet
Pilloli, miksija b’ rita
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme Limited COZAAR 50 mg 50 mg Hertford Road, Hoddesdon, Herts Pillola miksija b’ ritas EN11 9BU, Ir- Renju Unit
Cozaar
Jittieħed mill- ħalq
12.5 mg
5 L- Irelanda
Ireland
Hertford Road, Hoddesdon, Herts Pillola miksija b’ ritas EN11 9BU, Ir- Renju Unit L- Irlanda
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU United Kingdom
Hertford Road, Hoddesdon, Herts Pillola miksija b’ ritas EN11 9BU, Ir- Renju Unit L- Italja
Fabbroni 6, 00191 Rome, Italy
Fabbroni 6, 00191 Rome, L - Italja
Fabbroni 6, 00191 Rome, Italy
Fabbroni 6, 00191 Rome, L- Italja
NEO-LOTAN 100 mg 100 mg compresse rivestite con film
100 mg 100 mg rivestite
Pharmaceutical Form
00144 Rome, L- Italja
Italy
6 Italy
Sigma-Tau Industrie Farmaceutiche Riunite S. p. A. - Viale Shakespeare 47, 00144 Rome Italy
Sigma- Tau Industrie Farmaceutiche Riunite S. p. A. - Viale Shakespeare 47, 00144 Rome, L- Italja
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV-1013, Riga Latvia
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV- 1013, Riga, Il- Latvija
Cozaar 50 mg film-coated 50 mg tablets
Cozaar 50 mg Pillola 50 mg miksija b’ ritas
Film-coated tablet
Pillola miksija b’ ritas
Cozaar 100 mg film-coated 100 mg tablets
Cozaar 100 mg Pillola 100 mg miksija b’ ritas
Cozaar 12.5 mg (Losartan)
Cozaar 12, 5 mg (Losartan)
COZAAR
COZAAR 100 mg 100 mg
COZAAR
COZAAR 12, 5 mg 12, 5 mg
Therabel Pharma S. A. - Rue Egide Van Ophem 108 B-1180 Brussels Belgium
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brussels, Il - Belġju
Therabel Pharma S. A. - Rue Egide Van Ophem 108 B-1180 Brussels Belgium
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brussels, Il- Belġju
10 Member State
Il- Lussemburgu
Luxembourg Therabel Pharma S. A. - Rue Egide Van Ophem 108 B-1180 Brussels Belgium
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brussels, Il- Belġju
21 x 12.5 mg + 14 x 50 mg
MG Pillola miksija b’ rita MG
Film-coated tablet
Jittieħed mill- ħalq
Malta Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Ir- Renju Unit
100mg
100mg Pillola miksija b’ rita
The Merck Sharp & Dohme Netherlands PO Box 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem L- Olanda
Oral use
L- Olanda
Invented name
Il- Polonja
12.5 mg
12. 5 mg Pillola miksija b’ rita
Poland
8 Il- Polonja
Invented name
Il- Portugall
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova 2700-547 Amadora Portugal
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1- 1° Venda Nova 2700- 547 Amadora, Il- Portugall
Romania
Ir- Romanija
1A, Clă direa C1, Etaj 3 Sector 1, Bucureş ti Romania
1A, Clădirea C1, Etaj 3 Sector 1, Bucureşti, Ir- Romanija
Film-coated tablet
50 mg Pillola miksija b’ rita
Merck Sharp & Dohme, inovativna zdravila d. o. o., Š martinska cesta 140, 1000 Ljubljana Slovenia
Merck Sharp & Dohme, inovativna zdravila d. o. o., Šmartinska cesta 140, 1000 Ljubljana, Is- Slovenja
C/ Josefa Valcárcel, 38 28027 Madrid Spain
C / Josefa Valcárcel, 38 28027 MADRID, Spanja
Strength
10 Spanja
Cozaar 12,5 mg + 50 mg filmdragerade tabletter
Cozaar 12, 5 mg + 50 12, 5 + 50 mg Pillola miksija b’ rita mg filmdragerade tabletter
12.5 mg + 50 mg
L- Iżvezja
Film-coated tablet
Cozaar 50 mg 50 mg Pillola miksija b’ rita filmdragerade tabletter
Cozaar 50 mg filmdragerade tabletter
Cozaar 100 mg 100 mg Pillola miksija b’ rita filmdragerade tabletter
50 mg
COZAAR 50 MG 50MG Pillola miksija b’ rita PILLOLA MIKSIJA B’ RITAS
Film-coated tablet
COZAAR 25 MG 25MG Pillola miksija b’ rita PILLOLA MIKSIJA B’ RITAS
Sweden
11 L- Iżlanda
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU United Kingdom
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem L- Olanda
15 Member State
L- Iżlanda
Marketing Authorisation Holder
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem L- Olanda
United Kingdom
In- Norveġja
COZAAR 25 mg film-coated tablets
Pillola miksija b’ rita
16 ANNEX II
12 ANNESS II
17 SCIENTIFIC CONCLUSIONS
13 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ COZAAR U ISMIJIET ASSOĊJATI (ARA ANNESS I)
Cozaar (losartan) was included in the list of products for Product Information harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of the Directive 2001/ 83/ EC in order to resolve divergences amongst the nationally authorised SPCs and therefore to harmonise these divergent SPCs across the European Union.
Cozaar (losartan) kien inkluż fil- lista tal- prodotti għall- armonizzazzjoni tat- Tagħrif tal- Prodott, imfassla mis- CMD( h), b’ mod konformi ma ’ l- Artikolu 30( 2) tad- Direttiva 2001/ 83/ KE sabiex issolvi diverġenzi fost SPCs awtorizzati fuq livell nazzjonali u għaldaqstant biex ikunu armonizzati dawn l - SPCs diverġenti fl- Unjoni Ewropea kollha.
Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Losartan huwa antagonist tar- riċettur angiotensin II (Ang - II) attiv oralment li jaħdem fuq is- sottotip ta ’ riċettur AT1, b’ hekk jimblokka l- effett ta ’ Ang- II fil - kaskata tas- sistema ta ’ renin angiotensin (RAS).
Losartan is indicated for the treatment of hypertension.
Losartan huwa indikat għall- kura tal- pressjoni għolja.
Losartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, hypertension and microalbuminuria (> 30 mg/ 24 hours) or proteinuria (> 900 mg/ 24 hours).
Losartan jista ’ jittardja wkoll il- progressjoni ta ’ nefropatija dijabetika u huwa indikat ukoll għat - tnaqqis fil- progressjoni ta ’ mard renali f’ pazjenti b’ dijabete tip 2, pressjoni għolja u mikroalbuminurja (> 30 mg/ 24 siegħa) jew proteinurja (> 900 mg/ 24 siegħa).
Therapeutic Indications (SPC section 4.1)
Indikazzjonijiet terapewtiċi (SPC sezzjoni 4. 1)
- Treatment of essential hypertension.
- Kura ta ’ pressjoni għolja essenzjali
The efficacy and safety are well established for the indication “ treatment of essential hypertension”.
L- effikaċja u s- sigurtà huma stabbiliti sewwa għall- indikazzjoni “ kura ta ’ pressjoni għolja essenzjali ”.