qanastek/EMEA-V3 huggingface dataset:
Following an oral dose/ intravenous administration of 14C-labeled losartan in man, about 35% / 43% of radioactivity is recovered in the urine and 58%/ 50% in the faeces.
Wara doża meħuda mill- ħalq/ ġol- vina ta ’ losartan ittikkettat b’ 14C fil- bniedem, madwar 35% / 43% ta ’ radjoattività ġiet irkuprata fl- urina u 58% / 50% fl- ippurgar.
In elderly hypertensive patients the plasma concentrations of losartan and its active metabolite do not differ essentially from those found in young hypertensive patients.
F’ pazjenti anzjani bil- pressjoni għolja l- konċentrazzjoni ta ’ losartan u tal- metabolit attiv tiegħu fil- plażma m’ humiex daqshekk differenti minn dawk li jidhru f’ pazjenti żgħażagħ bil- pressjoni għolja
In female hypertensive patients the plasma levels of losartan were up to twice as high as in male hypertensive patients, while the plasma levels of the active metabolite did not differ between men and women.
F’ pazjenti nisa bi pressjoni għolja l- livelli ta ’ losartan fil- plażma kienu darbtejn ogħla minn dawk ta ’ pazjenti rġiel bil- pressjoni għolja, filwaqt li l- livelli tal- metabolit attiv fil- plażma ma kienx differenti bejn l- irġiel u n- nisa.
In patients with mild to moderate alcohol-induced hepatic cirrhosis, the plasma levels of losartan and its active metabolite after oral administration were respectively 5 and 1.7 times higher than in young male volunteers (see section 4.2 and 4.4).
F’ pazjenti li għandhom ċirrosi tal- fwied minn ħafif sa moderat, ikkaġunat mill- alkoħol, il- livelli ta ’ losartan u l- metabolit attiv fil- plażma wara l- għoti mill- ħalq kienu ta ’ 5 darbiet u 1. 7 darbiet ogħla rispettivament minn dawk ta ’ voluntieri rġiel żgħażagħ (ara sezzjonijiet 4. 2 u 4. 4).
Plasma concentrations of Losartan are not altered in patients with a creatinine clearance above 10 ml/ minute.
Il- konċentrazzjonijiet ta ’ Losartan fil- plażma m’ humiex mibdula f’ pazjenti li għandhom it- tneħħija ta ’ kreatinina ’ l fuq minn 10 ml/ minuta.
Compared to patients with normal renal function, the AUC for Losartan is about 2-times higher in haemodialysis dialysis patients.
Meta mqabbla ma ’ pazjenti f’ funzjoni renali normali, l- AUC għal Losartan huwa madwar darbtejn ogħla f’ pazjenti b’ emodijaliżi.
The plasma concentrations of the active metabolite are not altered in patients with renal impairment or in heamodialysis patients.
Il- konċentrazzjonijiet tal- metabolit attiv fil- plażma m’ humiex mibdula f’ pazjenti b’ indeboliment fil- kliewi jew pazjenti fuq emodijaliżi.
Neither Losartan nor the active metabolite can be removed by haemodialysis.
La Losartan u lanqas il- metabolit attiv ma jistgħu jiġu eliminati b’ emodijaliżi.
Pharmacokinetics in paediatric patients The pharmacokinetics of losartan have been investigated in 50 hypertensive paediatric patients > 1 month to < 16 years of age following once daily oral administration of approximately 0.54 to 0.77 mg/ kg of losartan (mean doses).
Il- farmakokinetiċi f’ pazjenti tfal Il- farmakokinetiċi ta ’ losartan ġew mistħarrġa f’ 50 pazjent tifel u tifla bil- pressjoni għolja fl- etajiet ta ’ > minn xahar sa < 16- il sena wara l- għoti mill- ħalq kuljum ta ’ madwar 0. 54 sa 0. 77 mg/ kg ta ’ losartan (dożi medji).
The results showed that the active metabolite is formed from losartan in all age groups.
Ir- riżultati wrew li l- metabolit attiv jiġi fformat minn losartan fl- etajiet kollha.
The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school age children and adolescents.
Ir- riżultati wrew kważi l- istess parametri farmakokinetiċi ta ’ losartan wara t- teħid mill- ħalq fi trabi u tfal żgħar, tfal qabel ma jibdew l- iskola, tfal li jinsabu fl- etajiet ta ’ l- iskola u adoloxxenti.
The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Il- parametri farmakokinetiċi tal- metabolit inbiddlu ferm aktar bejn l- istess gruppi ta ’ eta.
When comparing preschool children with adolescents these differences became statistically significant.
Meta ġew mqabbla l- etajiet ta ’ tfal ta ’ qabel l- iskola u l- adoloxxenti dawn id- differenzi kienu statistikament sinifikanti.
Exposure in infants/ toddlers was comparatively high.
L- espożizzjoni fi trabi u tfal żgħar kienet komparativament għolja.
5.3 Preclinical safety data
33 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential.
Tagħrif miġbur qabel l- użu kliniku ma juri ebda periklu għal bniedem skond studji konvenzjonali ta ’ farmakoloġija ġenerali, ġenotossiċità u possibilità karċinoġenika.
In repeated dose toxicity studies, the administration of losartan induced a decrease in the red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum and occasional rises in serum creatinine, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Fi studji dwar l- effett tossiku minn dożi ripetuti, l- għoti ta ’ losartan issensitizza tnaqqis fil- parametri taċ- ċelluli l- ħomor tad- demm (eritroċiti, emoglobina u ematokrit), żieda fil- urea- N fis- serum u kull tant żmien żidied fil- livell ta ’ kreatinina fis- serum, piż imnaqqas tal- qalb (mingħajr spjegazzjoni ħistoloġika), u bidliet gastro - intestinali (feriti mukużi tar- rita, ulċeri, tgħawwir, emorraġiji).
Like other substances that directly affect the renin-angiotensin system, losartan has been shown to induce adverse effects on the late foetal development, resulting in foetal death and malformations.
Bħal fil- każ ta ’ sustanzi oħra li jaffettwaw is- sistema renin- angiotensin, losartan intwera li jissensitizza effetti avversi fl- aħħar żminijiet ta ’ żvilupp tal- fetu, li jirriżulta fil- mewt tat- fetu u mankamenti.
37 6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
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 mhux attivi li ġejjin: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
Cozaar 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts:
Cozaar 12. 5 mg, 25 mg, 50 mg u 100 mg fihom ukoll il- potassju fl- ammonti li ġejjin:
1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
1. 06 mg (0. 027 mEq), 2. 12 mg (0. 054 mEq), 4. 24 mg (0. 108 mEq) u 8. 48 mg (0. 216 mEq) rispettivament.
Cozaar 12.5 mg tablets also may contain carnauba wax E 903, titanium dioxideE171, indigo carmine E132 aluminum lake.
Il- pilloli ta ’ 12. 5 mg Cozaar jista ’ jkun fihom ukoll carnauba wax (E903), titanium dioxide (E171), indigo carmine aluminum lake (E132).
Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Il- pilloli ta ’ 25 mg Cozaar jista ’ jkun fihom ukoll Carnauba wax (E903), Titanium dioxide (E171).
Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Il- pilloli ta ’ 50 mg Cozaar jista ’ jkun fihom ukoll Carnauba wax (E903), Titanium dioxide (E171).
Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Il- pilloli ta ’ 100 mg Cozaar jista ’ jkun fihom ukoll Carnauba wax (E903), Titanium dioxide (E171).
Store in the original package.
Żomm fil- kontenitur oriġinali.
Cozaar 12.5 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets.
Cozaar 12. 5 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7 pilloli, 14- il pillola, 21, 28, 50, 98 pillola, 210 pilloli jew 500 pillola.
A package containing 35 tablets (21 pcs of 12.5 mg tablet and 14 pcs of the 50 mg tablet) or 28 tablets (21 pcs of 12.5 mg tablet and 7 pcs of the 50 mg tablet) is available in a PVC/ PE/ PVDC titration blister package.
Pakkett li fih 35 pillola (21 biċċa b’ pillola ta ’ 12. 5 mg u 14- il biċċa b’ pillola ta ’ 50 mg) jew 28 pillola (21 biċċa b’ pilloli ta ’ 12. 5 mg u 7 biċċiet b’ polloli ta ’ 50 mg) huwa disponibbli f’ pakkett ta ’ folji dożati tal - PVC/ PE/ PVDC.
Cozaar 25 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.
Cozaar 25 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7 jew 28 pillola.
Cozaar 50 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
34 Cozaar 50 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7, 10 pilloli, 14, 15- il pillola, 20, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
HDPE bottles of 100 or 300 tablets.
Fliexken ta ’ l- HDPE b’ 100 jew 300 pillola.
PVC/ aluminum foil/ nylon blisters with aluminum foil lidding in packs of 10, 14 and 28.
Folji tal- PVC/ fojl ta ’ l- aluminju/ najlon b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 10, 14 u 28 pillola.
A package containing 35 tablets (21 pcs of 12.5 mg tablet and 14 pcs of the 50 mg tablet) or 28 tablets (21 pcs of 12.5 mg tablet and 7 pcs of the 50 mg tablet) is available in a PVC/ PE/ PVDC titration blister package.
Pakkett li fih 35 pillola (21 biċċa b’ pillola ta ’ 12. 5 mg u 14- il biċċa b’ pillola ta ’ 50 mg) jew 28 pillola (21 biċċa b’ pillola ta ’ 12. 5 mg u 7 biċċiet b’ polloli ta ’ 50 mg) huwa disponibbli f’ pakkett ta ’ folji dożati tal- PVC/ PE/ PVDC.
Cozaar 100 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Cozaar 100 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7, 10 pilloli, 14, 15- il pillola, 20, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
HDPE bottles of 100 tablets.
Fliexken ta ’ HDPE ta ’ 100 pillola.
38 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema < u għal immaniġġar ieħor >
[To be implemented nationally]
[Għandu jiġi implimentat fil- pajjiż stess]
[To be implemented nationally]
[Għandha tiġi implimentata fil- pajjiż stess]
39 LABELLING
35 TIKKETTA
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 12.5 mg blister
Kartuna ta ’ barra għal folja ta ’ Cozaar 12. 5 mg
Cozaar 12.5 mg film-coated tablets
Cozaar 12. 5 mg pilloli miksija b’ rita
Each tablet contains 12.5 mg losartan potassium.
Kull pillola fiha 12. 5 mg losartan potassium.
Lactose monohydrate.
Lactose monhydrate.
7, 14, 21, 28, 50, 98, 210 or 500 film-coated tablets.
7, 14, 21, 28, 50, 98, 210 jew 500 pillola miksija b’ rita.
Keep the blister in the outer carton.
Żomm il- folja fil- kartuna ta ’ barra
[To be completed nationally] [For referral procedures]
[Għandu jitlesta fil- pajjiż stess] [Għal proċeduri ta ’ riferiment]
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister for Cozaar 12.5 mg film-coated tablets
Folji għal Cozaar 12. 5 mg, pilloli miksija b’ rita
Cozaar 12.5 mg film-coated tablets
Cozaar 12. 5 mg pilolli miksija b’ rita
[See Annex I - To be completed nationally] [For referral procedures]
[Ara Anness I - Biex jitlesta fil- pajjiż stess] [Għal proċeduri ta ’ riferiment]
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
39 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 12.5 mg HDPE bottle
Kartuna ta ’ barra ta ’ Cozaar 12. 5 mg Flixkun HDPE
Store in the original bottle.
Żomm fil- filixkun oriġinali
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle label for Cozaar 12.5 mg HDPE bottle
Tikketta tal- flixkun għal Cozaar 12. 5 mg Flixkun HDPE
Lactose monohydrate.
Lattosju monohydrate.
Store in the original bottle.
Żomm fil- flixkun oriġinali
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 25 mg
Kartuna ta ’ barra għal Cozaar 25 mg
Cozaar 25 mg film-coated tablets
Cozaar 25 mg pilloli miksija b’ rita
Each tablet contains 25 mg losartan potassium.
Kull pillola fiha 25 mg losartan potassium.
7 film-coated tablets 28 film-coated tablets
7 pilloli miksija b’ rita 28 pillola miksija b’ rita
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMMFEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN 44 11.
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister for Cozaar 25 mg film-coated tablets
Folja għal Cozaar 25 mg pilloli miksija b’ rita
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 50 mg blister
Kartuna ta ’ barra għal folja ta ’ Cozaar 50 mg
Cozaar 50 mg film-coated tablets
Cozaar 50 mg pilloli miksija b’ rita
Each tablet contains 50 mg losartan potassium.
Kull pillola fiha 50 mg losartan potassium.
7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 jew 500 pillola.
11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN 47 11.
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister for Cozaar 50 mg film-coated tablets
Folja għal Cozaar 50 mg pilloli miksija b’ rita
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 50 mg HDPE bottle
Kartuna ta ’ barra għal Cozaar 50 mg Flixkun HDPE
100 or 300 tablets.
100 jew 300 pillola.
Store in the original bottle.
Aħżen fil- kontenitur oriġinali
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle label for Cozaar 50 mg HDPE bottle
Tikketta tal- flixkun għal Cozaar 50 mg, Flixkun HDPE
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 100 mg blister
Kartuna ta ’ barra għal folji għal Cozaar 100 mg
Cozaar 100 mg film-coated tablets
Cozaar 100 mg pilloli miksija b’ rita
Each tablet contains 100 mg losartan potassium.
Kull pillola fiha 100 mg losartan potassium.
7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 pillola.
Keep the blister in the outer carton.
Aħżen fil- kontenitur oriġinali
59 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister for Cozaar 100 mg film-coated tablets
Folji għal Cozaar 100 mg pilloli miksija b’ rita
BATCH NUMBER
NUMRU TAL_ LOTT
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
56 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 100 mg HDPE Bottle
Kartuna ta ’ barra għal għal Cozaar 100 mg Flixkun HDPE
100 tablets.
100 pillola.
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle label for Cozaar 100 mg HDPE Bottle
Tikketta tal- flixkun għal Cozaar 100 mg Flixkun HDPE
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Cozaar 12.5 mg and 50 mg (titration package blister)
Kartuna ta ’ barra għal Cozaar 12. 5 mg u 50 mg (pakkett ta ’ folji għad- dożaġġ)
Cozaar 12.5 mg film-coated tablets Cozaar 50 mg film-coated tablets
Cozaar 12. 5 mg pilloli miksija b’ rita Cozaar 12. 5 mg pilloli miksija b’ rita
Each Cozaar 12.5 mg film-coated mg tablet contains 12.5 mg losartan potassium.
Kull pillola Cozaar miksija b’ rita ta ’ 12. 5 mg fiha 12. 5 mg losartan potassium.
Each Cozaar 50 mg film-coated mg tablet contains 50 mg losartan potassium.
Kull pillola Cozaar miksija b’ rita ta ’ 50 mg fiha 50 mg losartan potassium.
28 day initiation pack Each pack contains a total of 35 tablets:
Pakkett tal- bidu ta ’ 28 jum Kull pakkett fih total ta ’ 35 pillola:
21 film-coated tablets of 12.5 mg and 14 film-coated tablets of 50 mg losartan potassium.
21 pillola miksija b’ rita ta ’ 12. 5 mg u 14- il pilloli miksija b’ rita ta ’ 50 mg losartan potassium.
Each pack contains a total of 28 tablets:
Kull pakkett fih total ta ’ 28 pillola:
21 film-coated tablets of 12.5 mg and 7 film-coated tablets of 50 mg losartan potassium.
21 pillola miksija b’ rita ta ’ 12. 5 mg u 7 pilloli miksija b’ rita ta ’ 50 mg losartan potassium.
10.
Żomm il- folja fil- kartuna ta ’ barra 61 10.
66 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Trifold Blister for Cozaar 12.5 mg film-coated tablets Blister for Cozaar 50 mg film-coated tablets
62 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT Titlija Folja għal pilloli miksijin b’ rita ta ’ Cozaar 12. 5 mg Folja għal pilloli miksijin b’ rita ta ’ Cozaar 50 mg
Cozaar 12.5 mg film-coated tablets Cozaar 50 mg film-coated tablets
Cozaar 12. 5 mg pilloli miksijin b’ rita Cozaar 50 mg pilloli miksijin b’ rita
[See Annex I - To be completed nationally]
[Ara Anness I - Biex jitlesta fil- pajjiż stess]
WEEK 1 (day 1-7) 1 tablet = 12,5 mg daily Use this card first
ĠIMGĦA 1 (Jum 1- 7) Pillola 1 = 12. 5 mg kuljum Uża din il- kard l- ewwel
WEEK 2 (Day 8-14) 2 tablets = 25 mg once daily
ĠIMGĦA 2 (Jum 8- 14) 2 pilloli = 25 mg darba kuljum
WEEK 3 (day 15-21) 1 tablet = 50 mg daily
ĠIMGĦA 3 (Jum 15- 21) Pillola 1 = 50 mg kuljum
WEEK 4 (day 22-28) 1 tablet = 50 mg daily
ĠIMGĦA 4 (Jum 22- 28) Pillola 1 = 50 mg
67 PACKAGE LEAFLET:
64 FULJETT TA ’ TAGĦRIF:
Cozaar film-coated tablets losartan potassium
Cozaar pilloli miksijin b’ rita losartan potassium
What Cozaar is and what it is used for 2.
X’ inhu Cozaar u għalxiex jintuża 2.
Before you take Cozaar 3.
Qabel ma tieħu Cozaar 3.
How to take Cozaar 4.
Kif għandek tieħu Cozaar 4.
How to store Cozaar 6.
Kif taħżen Cozaar 6.
WHAT Cozaar IS AND WHAT IT IS USED FOR
X’ INHU Cozaar U GĦALXIEX JINTUŻA
Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Losartan jappartjeni għal grupp ta ’ mediċini msejħa antagonisti tar- riċettatur ta ’ angiotensin- II.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten.
Angiotensin- II hija sustanza li tiġi magħmula fil- ġisem li tintrabat ma ’ riċettaturi li jinsabu fil- vażi tad- demm u ġġagħlhom jidjiequ.
This results in an increase in blood pressure.
Dan jirriżulta f’ żieda fil- pressjoni tad- demm.
Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure.
Losartan jevita r- rabta ta ’ angiotensin- II ma ’ dawn ir- riċettaturi, u b’ hekk il- vażi tad- demm jistgħu jistrieħ li b’ riżultat t’ hekk tonqos il- pressjoni.
Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes
Losartan inaqqas il- funzjoni tal- kliewi f’ pazjenti li għandhom pressjoni għolja u dijabete ta ’ tip 2.
Cozaar is used • to treat patients with high blood pressure (hypertension) • to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein). • to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor.
• biex jittratta l- pressjoni għolja tad- demm (pressjoni għolja); • sabiex jipproteġi il- kliewi f’ pazjenti li għandhom pressjoni għolja u dijabete ta ’ tip 2 b’ evidenza ta ’ funzjoni renali indebolita u protejnurja ≥ 0. 5 g kuljum (kundizzjoni fejn l- urina fiha ammont abnormali ta ’ proteini); • biex jittratta pazjenti b’ insuffiċjenza kardijaka kronika meta terapija b’ mediċini speċifiċi msejħa impedituri ta ’ enżimi li jikkonvertu anġjotensin (impedituri ACE, mediċina użata biex tnaqqas il- pressjoni għolja) mhix konsidrata adattata mit- tabib tiegħek.
If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan. • in patients with high blood pressure and a thickening of the left ventricle, COZAAR has been shown to decrease the risk of stroke (“ LIFE indication”).
Cozaar intwera li jista ’ jnaqqas r- riskju ta ’ puplesija (“ indikazzjoni LIFE ”).
BEFORE YOU TAKE Cozaar
QABEL MA TIEĦU Cozaar
Do not take Cozaar
Tieħux Cozaar
• if you are allergic (hypersensitive) to losartan or to any of its other ingredients, • if your liver function is severely impaired, • if you are, think you may be or are planning to become pregnant (see also “ Pregnancy and breast-feeding”), 68 • if you are breast-feeding.
• jekk inti allerġiku/ a (tbati minn pressjoni għolja) għal losartan jew għal xi waħda mis- sustanzi l- oħra, • jekk il- funzjoni tal- fwied huwa indebolit b’ mod sever, • jekk inti, taħseb li inti jew qed tippjana li tinqabad tqila (ara wkoll “ Tqala u Treddigħ ”),
Take special care with Cozaar
65 • jekk qed tredda ’.
It is important to tell your doctor before taking Cozaar:
Huwa importanti li tgħid lit- tabib tiegħek qabel ma ’ tieħu Cozaar:
• if you have had a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) (see also section 4 ‘ Possible side effects’), • if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/ or salt in your body, • if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 ‘ Dosage in special patient groups’), • if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently, • if your liver function is impaired (see sections 2 "Do not take Losartan" and 3 ‘ Dosage in special patient groups’), • if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias.
• jekk għandek storja ta ’ anġjodema (nefħa tal- wiċċ, ix- xofftejn, il- griżmejn, u/ jew l- ilsien) (ara wkoll sezzjoni 4 ‘ Effetti sekondarji li jista ’ jkollu ’), • jekk tbat minn remettar jew dijarea eċessiva, li jwassal għal telf kbir ta ’ fluwidi u/ jew mluħa minn ġismek, • jekk qed tieħu xi dijuretiċi (mediċini li jżidu l- ammont ta ’ ilma li tgħaddi mill- kliewi) jew qed fuq dieta ristretta ta ’ mluħa li twassal għal telf kbir ta ’ fluwidu u mluħa minn ġismek (ara sezzjoni 3 “ Id- doża fi gruppi speċjali ”), • jekk int magħruf li għandek tidjieq jew sadd fil- vażi tad- demm li jwasslu fil- kliewi jew jekk kellek trapjant ta ’ kilwa riċentement, • jekk il- funzjoni tal- fwied tiegħek hi indebolita (ara sezzjonijiet 2 “ Tieħux Cozaar ”, u 3, “ Id- doża di gruppi speċjali ”). • jekk tbati minn insuffiċjenza kardijaka bi jew mingħajr indeboliment fil- kliewi jew arritmiji kardijaċi severi li jkunu ta ’ theddida għal.
Special caution is necessary when you are treated with a ß-blocker concomitantly, • if you have problems with your heart valves or heart muscle, • if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain), • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).
Attenzjoni speċjali hi meħtieġa meta inti qed tiġi trattat b’ ß- blocker fl- istess waqt, • jekk għandek problemi bil- valvi tal- qalb tiegħel jew bil- muskolu tal- qalb, • jekk tbati minn mard koronjarju tal- qalb (li jiġi kkaġunat minn influss imnaqqas ta ’ demm fil - vażi tad- demm tal- qalb) jew minn mard ċerebrovaskulari (ikkaġunat minn tnaqqis fiċ - ċirkolazzjoni għall- moħħ), • jekk tbati minn iperaldosteroniżmu primarja (sindromu assoċjat ma ’ żieda fil- produzzjoni ta ’ l - ormon aldosterone mill- glandola adrenali, ikkawżata minn abnormalità ġewwa l- glandola).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, li jinkludi mediċini minn ħxejjex u prodotti naturali.
Take particular care if you are taking the following medicines while under treatment with Cozaar: • other blood pressure lowering medicines as they may additionally reduce your blood pressure.
Oqgħod attent jekk qed tieħu il- mediċini li ġejjin waqt li tkun qed tieħu Cozaar: • mediċini oħra li jbaxxu l- pressjoni peress li dawn jistgħu ibaxxu aktar il- pressjoni tiegħek.
Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine, • medicines which retain potassium or may increase potassium levels (e. g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparine), • non-steroidal anti-inflammatory drugs such as indomethacin, including cox-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood lowering effect of losartan.
Il - pressjoni tad- demm tissta ’ wkoll tiġi mnaqqsa b’ xi waħda mill- mediċini/ kategorija ta ’ mediċini li ġejjin: mediċini ta ’ kontra d- dipressjoni triċikliċi, mediċini kontra l- psikosi, baclofene, amifostine, • mediċini li jżommu l- potassju jew li jistgħu jżidu l- livelli ta ’ potassju (eż. supplimenti tal- potassju, sostituti ta ’ l- imluħa li fihom il- potassju, jew mediċini li jirristrinġu l- potassju fl - urina bħal ċertu dijuretiċi [amiloride, triamteren, spironolactone] jew eparina), • mediċini mhux sterojdi u mhux infjammatorji bħal indomethacin, li jinkludu impedituri ta ’ cox- 2 (mediċini li jnaqqsu l- infjammazzjoni, u li jistgħu jintużaw biex ittaffu l- uġigħ) peress li jistgħu jnaqqsu l- effett fuq id- demm ta ’ losartan.
If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
Jekk il- funzjoni tal- kliewi tiegħek hija indebolita l- użu konġunt ta ’ dawn il- mediċini jista ’ jwassal għal tiħżin tal- funzjoni tal- kliewi.
Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor.
Mediċini li fihom il- litju m’ għandhomx jittieħdu f’ kombinazzjoni ma ’ losartan mingħajr superviżjoni mill- qrib mit- tabib tiegħek.
Special precautionary measures (e. g. blood tests) may be appropriate.
Miżuri speċjali ta ’ prekawzjoni (eż. testijiet tad- demm) għandhom mnejn jkunu xierqa.
Taking Cozaar with food and drink
Meta tieħu Cozaar ma ’ l- ikel u x- xorb
Cozaar may be taken with or without food.
Cozaar jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Pregnancy and breast-feeding 69 You should not take losartan 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.
66 M’ għandekx tieħu Cozaar fl- ewwel 12- il ġimgħa ta ’ tqala, u mgħandekx teħodhom għall- ebda raġuni wara t- 13- il ġimgħa peress li l- użu tagħhom waqt it- tqala jista ’ jkun ta ’ ħsara għat- tarbija.
If you become pregnant while on losartan, tell your doctor immediately.
Jekk tinqabad tqila waqt li qed tieħu Cozaar, għid lit- tabib tiegħek minnufih.
You must not take losartan if you are breast-feeding.
M’ għandekx tieħu Cozaar jekk qed tredda ’.
Cozaar has been studied in children.
Cozaar ġie studjat fi tfal.
For more information, talk to your doctor.
Għal aktar tagħrif, kellem lit- tabib tiegħek.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq u tħaddem inġenji.
Cozaar is unlikely to affect your ability to drive or use machines.
Cozaar mhux mistenni li jaffettwa l- ħila tiegħek biex issuq jew tħaddem inġenji.
However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people.
Madankollu, bħal fil- każ ta ’ ħafna mediċini oħra użati biex jittrattaw il- pressjoni għolja, losartan jista ’ jikkaġuna sturdamenti jew ħedla f’ xi persuni.
If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
Jekk tħossok sturduta jew mħedla, għandek tikkonsulta t- tabib tiegħek qabel ma tagħmel xi attivitajiet bħal dawn.
Important information about some of the ingredients of Cozaar
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Cozaar
Cozaar contains lactose monohydrate.
Cozaar fih lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li inti intolleranti xi tipi ta ’ zokkor kellem lit- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO TAKE Cozaar
KIF GĦANDEK TIEĦU Cozaar
Always take Cozaar exactly as your doctor has instructed you.
Dejjem għandek tieħu Cozaar skond il- parir tat- tabib.
Your doctor will decide on the appropriate dose of Cozaar, depending on your condition and whether you are taking other medicines.
It- tabib tiegħek ser jiddeċiedi dwar liema hi l- aħjar doża ta ’ Cozaar għalik, skond il- kundizzjoni u jekk intix tieħu mediċini oħra.
It is important to continue taking Cozaar for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Huwa importanti li tkompli tieħu Cozaar sakemm jibqa ’ jippreskrivih it- tabib tiegħek, peress li din il- mediċina tibqa ’ tikkontrolla l- pressjoni tiegħek.
Patients with High Blood Pressure Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg) once a day.
Pazjenti bi Pressjoni tad- Demm Għolja It- trattament ġeneralment jibda b’ pillola waħda ta ’ 50 mg losartan (pillola Cozaar 50 mg) darba kuljum.
The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment.
L- effett massimu għal tnaqqis ta ’ pressjoni għandu jintlaħaq fi żmien 3- 6 ġimgħat wara l- bidu tat- trattament.
In some patients the dose may later be increased to 100 mg losartan (two tablets Cozaar 50 mg) once daily If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Jekk inti għandek l- impressjoni li l- effett ta ’ losartan huwa qawwi wisq jew dgħajjef ħafna, jekk jogħġbok kellem lit- tabib jew spiżjar tiegħek.
Patients with high blood pressure and type 2 diabetes Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg) once a day.
Pazjenti bi pressjoni għolja tad- demm u dijabete ta ’ tip 2 It- trattament ġeneralment jibda b’ pillola waħda ta ’ 50 mg losartan (pillola Cozaar 50 mg) darba kuljum.
The dose may later be increased to 100 mg losartan (two tablets Cozaar 50 mg) once daily depending on your blood pressure response.
Id- doża tista ’ tiġi miżjuda aktar ’ il quddiem għal 100 mg losartan (żewġ pilloli Cozaar ta ’ 50 mg) darba kuljum skond ir- rispons għal pressjoni tad- demm tiegħek.
Losartan tablets may be administered with other blood pressure lowering medicines (e. g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e. g. sulfonylureas, glitazones and glucosidase inhibitors).
Il- pilloli Losartan jistgħu jingħataw ma ’ mediċini oħra li jnaqqsu l- pressjoni tad- demm (eż. dijuretiċi, imblokkaturi tal- kanal tal- kalċju, imblokkaturi alfa jew beta u mediċini li jaġixxu b’ mod ċentrali) kif ukoll ma ’ l- insulina u mediċini oħra li ġeneralment jingħataw għad- dijabete li jnaqqsu l- livell ta ’ glukosju fid- demm (eż. sulfonylureas, glitazones u impedituri ta ’ glucosidase).
Patients with Heart Failure Treatment usually starts with 12.5 mg losartan (one tablet Cozaar 12.5 mg) once a day.
Pazjenti b’ Insuffiċjenza tal- Qalb It- trattament ġeneralment jibda b’ pillola waħda ta ’ 12. 5 mg losartan (pillola Cozaar 12. 5 mg) darba kuljum.
70 Generally, the dose should be increased weekly step-by-step (i. e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week) up to the usual maintenance dose of 50 mg losartan (one tablet Cozaar 50 mg) once daily, according to your condition.
Ġeneralment, id- doża għandha tiġi miżjuda pass, pass kull ġimgħa (i. e 12. 5 mg fl- ewwel ġimgħa, 25 mg matul it- tieni ġimgħa, 50 mg losartan matul it- tielet ġimgħa), sakemm tintlaħaq id - doża li ġeneralment tibqa ’ tingħata ta ’ 50 mg losartan (pillola Cozaar 50 mg) darba kuljum, skond il - kundizzjoni tiegħek.
In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/ or digitalis (medicine that helps to make the heart stronger and more efficient) and/ or a beta-blocker.
67 Fit- trattament ta ’ insuffiċjenza kardijaka, losartan ġeneralment jiġi kkombinat ma ’ dijuretiku (mediċina li żżid l- ammont ta ’ ilma li int tgħaddi mill- kliewi) u/ jew digitalis (mediċina li tgħin lil qalbek tkun aktar b’ saħħitha u aktar effiċjenti) u/ jew imblokkatur beta.
Dosage in special patient groups
Id- doża fi gruppi speċjali
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years.
It- tabib għandu mnejn jissuġerixxi doża aktar baxxa, speċjalment meta jibda l- kura fuq ċertu pazjenti bħal dawk ittrattati b’ dożi għoljin ta ’ dijuretiċi, f’ pazjenti b’ indeboliment fil- fwied, jew pazjenti li għandhom aktar minn 75 sena.
The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take losartan").
L- użu ta ’ losartan mhux rakkomandat f’ pazjenti li għandhom indeboliment epatiku sever (ara sezzjoni “ Tużax losartan ”.).
The tablets should be swallowed with a glass of water.
Il- pilloli għandhom jittieħdu ma ’ tazza ilma.
You should try to take your daily dose at about the same time each day.
Sabiex ma tinsiex, ipprova ħu d- doża ta ’ kuljum tiegħek fl- istess ħin kuljum.
It is important that you continue to take Cozaar until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Cozaar sakemm jgħidlek mod ieħor it- tabib tiegħek.
If you take more Cozaar than you should
Jekk tieħu Cozaar aktar milli suppost
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Jekk aċċidentalment tibla ħafna pilloli, jew tifel/ tifla tibla ’ xi ftit, ikkuntattja lit- tabib minnufih.
Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
Sintomi ta ’ doża eċċesiva huma pressjoni baxxa, żieda fit- taħbit tal- qalb, u possibilment tnaqqis fit- taħbit tal- qalb.
If you forget to take Cozaar
Jekk tinsa tieħu Cozaar
If you accidentally miss a daily dose, just take the next dose as normal.
Jekk aċċidentalment tinsa tieħu d- doża ta ’ kuljum tiegħek, ħu d- doża li jkun imissek tieħu bħas- soltu.
Do not take a double dose to make up for a forgotten tablet.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li nsejt tieħu.
Like all medicines, Cozaar can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Cozaar jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you experience the following, stop taking losartan 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.
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
Reazzjoni allerġikasevera (raxx, ħakk, nefħa fil- wiċċ, ix- xofftejn, il- ħalq jew il- griżmejn li jistgħu jikkawżaw diffikultàbiex tibla ’ jew tieħu n- nifs).
The side effects of medicines are classified as follows: very common: happening in more than 1 in 10 patients common: uncommon rare: very rare: not known
L- effetti sekondarji ta ’ mediċini huma kklassifikati kif ġej: komuni ħafna: li jseħħu f’ aktar minn pazjent 1 f’ kull 10 komuni:
happening in 1 in 100 to 1 in 10 patients happening in 1 in 1,000 to 1 in 100 patients happening in 1 in 10,000 to 1 in 1,000 patients happening in less than 1 in 10,000 patients (cannot be estimated from the available data)
mhux komuni li jseħħu f’ pazjent 1 f’ kull 1, 000 sa pazjent 1 f’ kull 100 pazjent rari: li jseħħu f’ pazjent 1 f’ kull 10, 000 sa pazjent 1 f’ kull 1, 000 pazjent rari ħafna:
71 The following side effects have been reported with Cozaar:
68 L- effetti sekondarji li ġejjin ġew irrapportati b ’ Cozaar:
Common: • dizziness, • low blood pressure, • debility, • fatigue, • too less sugar in the blood (hypoglycaemia), • too much potassium in the blood (hyperkalaemia).
Komuni: • sturdament, • pressjoni tad- demm baxxa, • tħossok ma tiflaħx, • għeja, • ftit wisq zokkor fid- demm (ipogliċemija), • wisq potassju fid- demm (iperkalemija).
Uncommon: • somnolence, • headache, • sleep disorders, • feeling of increased heart rate (palpitations), • severe chest pain (angina pectoris), • low blood pressure (especially after excessive loss of water from the body within blood vessels e. g. in patients with severe heart failure or under treatment with high dose diuretics), • dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position, • shortness of breath (dyspnoea), • abdominal pain, • obstipation, • diarrhoea, • nausea, • vomiting, • hives (urticaria), • itching (pruritus), • rash, • localised swelling (oedema).
Mhux komuni: • ngħas, • uġigħ ta ’ ras, • disturbi fl- irqad • tħoss li l- qalb qed tħabbat wisq jew tiġri (palpitazzjonijiet), • uġigħ fis- sider qawwi (anġina pectoris) • pressjoni baxxa tad- demm (speċjalment wara telf eċċessiv ta ’ ilma mill- ġisem ġewwa l- vażi tad- demm eż. f’ pazjenti b’ insuffiċjenza tal- qalb severa jew li huma taħt trattament b’ dijuretiċi ta ’ dożi għoljin), • effetti ortostatiċi relatati mad- doża bħal meta jkollok tqum minn bil- qiegħda jew tkun qed timtedd, • nifs qasir (dispnea), • uġigħ addominali, • stitikezza qawwija, • dijarea, • tqalligħ, • remettar, • ħorriqija (urtikarja), • ħakk (prurite), • nefħa lokalizzata (edema),
Rare: • inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura), • numbness or tingling sensation (paraesthesia), • fainting (syncope), • very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke), • inflammation of the liver (hepatitis), • elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Rari: • infjammazzjoni tal- vażi tad- demm (vaskulite li tinkludi purpura Henoch- Schonlein), • tirżiħ jew sensazzjoni ta ’ tnemnim (paraestesija) • ħass ħażon (sinkope) • qalb tħabbat bil- qawwi u b’ mod irregolari (fibrilazzjoni artrijali) attakk fil- moħħ (puplesija) • infjammazzjoni tal- fwied (epatite), • livelli elevati ta ’ alanine aminotransferase (ALT) fid- demm, li ġeneralment jirriżolvu rwieħom malli jieqaf it- trattament.
not known: • reduced number of red blood cells (anaemia), • reduced number of thrombocytes, • migraine, • cough, • liver function abnormalities, • muscle and joint pain, • changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure, • flu-like symptoms, • increase in blood urea, • serum creatinine and serum potassium in patients with heart failure, • back pain and urinary track infection.
mhux magħruf: • għadd imnaqqas ta ’ ċelluli tad- demm ħomor (anemija), • għadd imnaqqas ta ’ tromboċiti, • emikranja, • sogħla, • abnormalitajiet fil- funzjoni tal- fwied, • uġigħ fil- muskolu u fil- ġogi, • bidliet fil- funzjoni tal- kliewi (li jistgħu jkunu riversibbli mat- twaqqif ta ’ trattament) li jinkludi insuffiċjenza renali, • sintomi bħal ta ’ l- influwnza, • żieda ta ’ urea fid- demm, • Kreatinina fis- serum u potassju fis- serum f’ pazjenti b’ insuffiċjenza kardijaka, • uġigħ fid- dahar u infezzjoni fil- passaġġ ta ’ l- awrina
72 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
69 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
HOW TO STORE Cozaar
KIF TAĦŻEN Cozaar
Do not use Cozaar after the expiry date which is stated on the carton after EXP.
Tużax Cozaar wara d- data ta ’ skadenza li tidher fuq kartuna wara JIS.
Do not open the blister pack until you are ready to take the medicine.
Aħżen Cozaar fil- pakkett oriġinali Tiftakx il- folja qabel ma tkun lest biex tibda tieħu l- mediċina.
What Cozaar contains
X’ fih Cozaar
The active substance is losartan potassium.
Is- sustanza attiva hi losartan potassium.
Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
Kull pillola ta ’ 12. 5 mg Cozaar fiha 12. 5 mg ta ’ losartan potassium.
Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.
Kull pillola ta ’ 25 mg Cozaar fiha 25 mg ta ’ losartan potassium.
Each Cozaar 50 mg tablet contains 50 mg of losartan potassium.
Kull pillola ta ’ 50 mg Cozaar fiha 50 mg ta ’ losartan potassium.
Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Kull pillola ta ’ 100 mg Cozaar fiha 100 mg ta ’ losartan potassium.
The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
Is- sustanza l- oħra huma microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
The Cozaar 12.5 mg tablets also may contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
Il- pilloli ta ’ 12. 5 mg Cozaar jista ’ jkun fihom ukoll carnauba wax (E903), titanium dioxide (E171), indigo carmine aluminum lake (E132).
The Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Il- pilloli ta ’ 25 mg Cozaar jista ’ jkun fihom ukoll Carnauba wax (E903), Titanium dioxide (E171).
The Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Il- pilloli ta ’ 50 mg Cozaar jista ’ jkun fihom ukoll Carnauba wax (E903), Titanium dioxide (E171).
The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Il- pilloli ta ’ 100 mg Cozaar jista ’ jkun fihom ukoll Carnauba wax (E903), Titanium dioxide (E171).
What Cozaar looks like and contents of the pack
Id- dehra ta ’ Cozaar u l- kontenut tal- pakkett
Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
Cozaar hija fonuta bħala pillola miksija b’ rita u mhux mnaqqxa li fiha 12. 5 mg ta ’ losartan potassium.
Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium.
Cozaar hija fonuta bħala pillola miksija b’ rita u imnaqqxa li fiha 50 mg ta ’ losartan potassium.
Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Cozaar hija fonuta bħala pillola miksija b’ rita u mhux mnaqqxa li fiha 100 mg ta ’ losartan potassium.
Cozaar is supplied in the following pack sizes:
Cozaar hija fornuta fid- daqsijiet ta ’ pakketti li ġejjin:
73 Cozaar 12.5 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets.
Cozaar 12. 5 mg - folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7 pilloli, 14- il pillola, 21, 28, 50, 98 pillola, 210 pilloli jew 500 pillola.
A package containing 35 tablets (21 pcs of 12.5 mg tablet and 14 pcs of the 50 mg tablet) or 28 tablets (21 pcs of 12.5 mg tablet and 7 pcs of the 50 mg tablet) is available in a PVC/ PE/ PVDC titration blister package.
70 fih 35 pillola (21 biċċa b’ pilloli ta ’ 12. 5 mg u 14- il biċċa b’ pilloli ta ’ 50 mg) huwa disponibbli f’ pakkett ta ’ folji ttitrati tal- PVC/ PE/ PVDC.
Cozaar 25 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.
Cozaar 25 mg - folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7 jew 28 pillola.
Cozaar 50 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Cozaar 50 mg - folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7, 10 pilloli, 14, 15- il pillola, 20, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
Cozaar 100 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets.
Cozaar 100 mg - Folji tal- PVC/ PE/ PVDC b’ għotjien b’ fojl ta ’ l- aluminju f’ pakketti ta ’ 7, 10 pilloli, 14, 15- il pillola, 20, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
< To be completed nationally >
fil- pajjiż stess >
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Cosaar 12,5 mg - Filmtabletten Cosaar 50 mg - Filmtabletten Cosaar 100 mg - Filmtabletten COZAAR 100 mg COZAAR 50 MG COZAAR 12,5 mg COZAAR CARDIO START LOORTAN 100 mg LOORTAN 50 mg LOORTAN 12,50 mg LOORTAN CARDIO START Cozaar COZAAR Cozaar, Cozaar Startpakke Cozaar, Cozaar 12,5 mg Cozaar Cozaar 100 mg film-coated tablets Cozaar 50 mg scored coated tablets CARDOPAL START 12,5 mg Filmtabletten LORZAAR 100 mg Filmtabletten LORZAAR 50 mg Filmtabletten LORZAAR PROTECT 100 mg Filmtabletten LORZAAR PROTECT 50 mg Filmtabletten LORZAAR START 12,5 mg Filmtabletten
Cosaar 12, 5 mg - Filmtabletten Cosaar 50 mg - Filmtabletten Cosaar 100 mg - Filmtabletten COZAAR 100 mg COZAAR 50 MG COZAAR 12, 5 mg COZAAR CARDIO START LOORTAN 100 mg LOORTAN 50 mg LOORTAN 12, 50 mg LOORTAN CARDIO START Cozaar COZAAR Cozaar, Cozaar Startpakke Cozaar, Cozaar 12, 5 mg Cozaar Cozaar 100 mg film- coated tablets Cozaar 50 mg scored coated tablets CARDOPAL START 12, 5 mg Filmtabletten LORZAAR 100 mg Filmtabletten LORZAAR 50 mg Filmtabletten LORZAAR PROTECT 100 mg Filmtabletten LORZAAR PROTECT 50 mg Filmtabletten LORZAAR START 12, 5 mg Filmtabletten PINZAAR 100 mg Filmtabletten PINZAAR 50 mg Filmtabletten LORZAAR VARIPHARMSTART 12, 5 mg Filmtabletten
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