Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
cetirizine dihydochloride
MEGA LIFESCIENCES SDN. BHD.
cetirizine dihydochloride
10 Capsules; 50 Capsules
Mega Lifesciences Public Company Limited
_Consumer Medication Information Leaflet (RiMUP) _ 1 ZIRIN (CAPSULE) Cetirizine dihydrochloride (10mg) WHAT IS IN THIS LEAFLET 1. What ZIRIN Capsules are and what they are used for 2. How ZIRIN Capsules works 3. Before you use ZIRIN Capsules 4. How to use ZIRIN Capsules 5. While you are using ZIRIN Capsules 6. Side effects 7. Storage and disposal of ZIRIN Capsules 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT ZIRIN CAPSULE ARE AND WHAT THEY ARE USED FOR The active ingredient in ZIRIN Capsule is cetirizine dihydrochloride, which belongs to a group of medicines called antihistamines. ZIRIN Capsule are used for symptomatic relief of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria in adults and children over 12 years of age. HOW ZIRIN CAPSULE WORKS Cetirizine dihydrochloride, the active ingredient of ZIRIN is an antihistamine. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions. Antihistamines like ZIRIN relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes. BEFORE YOU USE ZIRIN CAPSULE _When you must not use it _ • You are allergic (hypersensitive) to cetirizine dihydrochloride • You are allergic (hypersensitive) to any of the other ingredients of ZIRIN • You are breast-feeding • You have severe kidney failure (creatinine clearance less than 10 ml/min). • You have problems of urinary retention. If any of the above applies to you talk to your pharmacist. _Before you start to use it _ Check with your pharmacist before taking ZIRIN if • You have problems with your kidneys • You have predisposition factors of urinary retention (eg: spinal cord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention. • You suffer from epilepsy or are at risk of convulsions. • If you are pregnan Prečítajte si celý dokument
_PAGE 2/2 _ Drug Interactions : Due to the pharmacokinetic, pharmacodynamics and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day), _Alcohol and other CNS depressants _ In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance, although cetirizine does not potentiate the effect of alcohol (0.5 g/L blood levels). Pregnancy 8- Lactation _PREGNANCY _ Caution should be exercised when prescribing to pregnant women. For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. _LACTATION _ Caution should be exercised when prescribing cetirizine to lactating women. Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration. SIDE EFFECTS : _BLOOD AND LYMPHATIC DISORDERS: _ Thrombocytopenia _IMMUNE SYSTEM DISORDERS: _ hypersensitivity, anaphylactic shock _METABOLISM AND NUTRITION DISORDERS: _ increased appetite _PSYCHIATRIC DISORDERS: _ agitation, aggression, confusion, depression, hallucination, insomnia Tics, suicidal ideation, nightmare _NERVOUS SYSTEM DISORDERS: _ paraesthesia, convulsions, dysgeusia, dyskinesia, dystonia, syncope, tremor, amnesia, memory impairment _EYE DISORDERS: _ accommodation disorder, blurred vision, oculogyration _EAR AND LABYRINTH DISORDERS: _ vertigo _CARDIAC DISORDERS: _ tachycardia _GASTROINTESTINAL DISORDERS: _ diarrhoea _HEPATOBILIARY DISORDERS: _ hepatic function abnormal (transaminases increased, blood bilirubin increased, blood, a Prečítajte si celý dokument