Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOCETIRIZINE DIHYDROCHLORIDE
MEDISPEC (M) SDN.BHD
LEVOCETIRIZINE DIHYDROCHLORIDE
10x10 Tablets
Unison Laboratories Co. Ltd.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CETIZAL 5MG TABLET Levocetirizine dihydrochloride (5 mg) 1 WHAT IS IN THIS LEAFLET 1. What Cetizal is used for 2. How Cetizal works 3. Before you use Cetizal 4. How to use Cetizal 5. While you are using it 6. Side effects 7. Storage and Disposal of Cetizal 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CETIZAL IS USED FOR Cetizal is used to treat the symptoms of: • Allergic rhinitis (inflammation of the mucous membrane inside the nose) including persistent allergic rhinitis • Chronic idiopathic urticaria (a raised, itchy rash of unknown cause) HOW CETIZAL WORKS Cetizal contains the active ingredient levocetirizine dihydrochloride. Cetizal is an antiallergic medication. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. BEFORE YOU USE CETIZAL _- When you must not use it _ Do not take Cetizal: • if you are allergic (hypersensitive) to the active substance, levocetirizine dihydrochloride, cetirizine, hydroxyzine or to an antihistamine, or any of the other ingredients of Cetizal • if you have a severe kidney impairment with creatinine clearance below 10 ml/min. The use of Cetizal is not recommended for infants and children under 6 years. _Pregnancy and breastfeeding _ Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant, trying to get pregnant or breastfeeding. Levocetirizine is excreted in human milk. Talk to your doctor or pharmacist before taking this medicine if you are breastfeeding. _- Before you start to use it _ Tell your doctor if you have any of the following conditions: • If you have difficulties emptying your bladder due to factors such as spinal cord lesion or prostatic hyperplasia (enlargement of the prostate gland). • If you have been told by your doctor that you have an intolerance to some sugars. This tablet contains lactose. • If you have e Soma hati kamili
-1- -2- -3- ANTIHISTAMINE FOR SYSTEMIC USE 19 cm. 26 cm. CETIZAL 5 _Insert_ICMY 0081 By...DA 12/05/2023 Product CETIZAL 5 ICMY 0081 Code No. Dimension W 26 x L 19 cm. Packaging Type Thickness 60 g (0.08 mm.) Designed by: (PDM, ASPD, PDC-M, PDC-A, PDO-M, PDO-A) Checked by: (PDM/ASPD) Approved by: PLC: (Date) LRA: (Date) Approved by: (MD (Only Pattern and Colors) ) IRA: (Date) QCC-PM: (Date) CUSTOMER/SALES DEPT.: (Date) Wood Free Paper (กระดาษปอนด‹) Each film coated tablet contains: LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG PRODUCT DESCRIPTION: White, oblong, biconvex, film coated tablet with engraved LC on one side and 5 on the left of the scored side MECHANISM OF ACTION: Pharmacotherapeutic group: Antihistamine for systemic use, piperazine derivative _PHARMACOLOGY_ Levocetirizine, the (R) enantiomer of Cetirizine, is a potent and selective antagonist of peripheral H 1 -receptors. Levocetirizine has high affinity for human H 1 -receptors. Levocetirizine dissociates from H 1 -receptors with a half-life of 115 ± 38 min. After single administration, Levocetirizine shows a receptor occupancy of 90% at 4 hours and 57% at 24 hours. _PHARMACOKINETICS_ The pharmacokinetics of Levocetirizine are linear with dose- and time-independent with low inter-subject variability. The pharmacokinetic profile is the same when given as the single enantiomer or when given as Cetirizine. No chiral inversion occurs during the process of absorption and elimination. Absorption Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, peak plasma concentrations are achieved 0.9 hour after dosing. The extent of absorption is dose-independent and is not altered by food, but the peak concentration is reduced and delayed. Distribution No tissue distribution data are available in humans, neither concerning the passage of Levocetirizine through the blood-brain-barrier. Levocetirizine is 90% bound to plasma proteins. The distribution of Levocetirizine is restrictive, as the volume of distribution i Soma hati kamili