Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CETIRIZINE HYDROCHLORIDE
Hovid Pharmacy Sdn. Bhd.
CETIRIZINE HYDROCHLORIDE
10 x 10 Tablets
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PRESMEDIC CETIRIZINE 10MG TABLET Cetirizine Hydrochloride (10mg) 1 WHAT IS IN THIS LEAFLET 1. What Presmedic Cetirizine 10mg is used for 2. How Presmedic Cetirizine 10mg works 3. Before you use Presmedic Cetirizine 10mg 4. How to use Presmedic Cetirizine 10mg 5. While you are using Presmedic Cetirizine 10mg 6. Side effects 7. Storage and Disposal of Presmedic Cetirizine 10mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT PRESMEDIC CETIRIZINE 10MG IS USED FOR Presmedic Cetirizine 10mg is used for adults and children of 2 years and above to treat seasonal allergic rhinitis (pollen allergic), perennial allergic rhinitis (hay fever) and urticaria (hives) of allergic origin. HOW PRESMEDIC CETIRIZINE 10MG WORKS Presmedic Cetirizine 10mg contains Cetirizine Hydrochloride which is an antihistamine agent. Antihistamine can help to relieve the symptoms of some allergies and itchy skin rashes. BEFORE YOU USE PRESMEDIC CETIRIZINE 10MG _- When you must not use it _ Do not take this medicine if: • You have ever had an allergic reaction to antihistamines or to any of the other ingredients (listed in later part of this leaflet). • You have severe kidney problems. If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor. _- Before you start to use it _ Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may interact with Presmedic Cetirizine 10mg. _ _ _- Taking other medicines_ Consumption of alcohol at the same time may reduce the alertness and impairment of performance. Other interactions not stated may occur. Talk to your doctor or pharmacist if you have any other concerns. HOW TO USE PRESMEDIC CETIRIZINE 10MG _- How much to use_ Swallow Presmedic Cetirizine 10mg with water at the recommended dose as follows: • _Adult: _ 10 mg (1 tablet) once daily. A 5 mg starting dose (hal Læs hele dokumentet
MEDDRA SOC ADVERSE REACTION FREQUENCY Blood and lympha�c disorders Thrombocytopenia Very rare Metabolism and nutri�on disorders Increased appe�te Not known Agita�on Uncommon Aggression, confusion, depression, hallucina�ons, insomnia Rare Tic Very rare Suicidal idea�on, nightmare Not known Psychiatric disorders Nervous system disorders Paraesthesia Uncommon Convulsions, movement disorders Rare Dysgeusia, syncope, tremor, dystonia, dyskinesia Very rare Amnesia, memory impairment Unknown Eye disorders Accommoda�on disorder, blurred vision, oculogyra�on Very rare Skin and subcutaneous �ssue disorders Pruritus, rash Uncommon Ur�caria Rare Angioneuro�c oedema, fixed drug erup�on Very rare Acute generalized exanthematous pustulosis (AGEP) Unknown Ear and labyrinth disorders Ver�go Not known Cardiac disorders Tachycardia Rare Gastro-intes�nal disorders Diarrhoea Uncommon Hepatobiliary disorders Hepa�c func�on abnormal (increased transaminases, alkaline phosphates, γ -GT and bilirubin) Rare Hepa��s Unknown VICETxx-0 694 DESCRIPTION Oblong, white to off-white film-coated tablet, bevel-edged, shallow convex and scored on one face. COMPOSITION Each tablet contains Cetirizine HC _l_ 10 mg. PHARMACODYNAMICS Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1-receptors. In vitro receptor binding studies have shown no measurable affinity for receptors other than H1-receptors. In addition to its anti-H1 effect, cetirizine was shown to display anti-allergic activities at a dose of 10 mg once or twice daily, it inhibits the late phase recruitment of eosinophils, in the skin and conjunctiva of atopic subjects submitted to allergen challenge. At the recommended dosage, cetirizine has demonstrated that it improves the quality of life of patients with perennial and seasonal allergic rhinitis. PHARMACOKINETICS Peak blood levels in the order of 0.3μg/ml are reached within about one hour after the oral administration of cetirizine. The terminal half-li Læs hele dokumentet