Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOCETIRIZINE DIHYDROCHLORIDE
Md Healthcare Sdn Bhd
LEVOCETIRIZINE DIHYDROCHLORIDE
500 Tablets; 10 Tablets; 100 Tablets
STANDARD CHEM & PHARM CO LTD
_Consumer Medication Information Leaflet (RiMUP) _ ALLERZAL F.C. TABLET 5MG Levocetirizine dihydrochloride 5mg 1 WHAT IS IN THIS LEAFLET 1. What Allerzal F.C. Tablet 5mg is used for 2. How Allerzal F.C. Tablet 5mg works 3. Before you use Allerzal F.C. Tablet 5mg 4. How to use Allerzal F.C. Tablet 5mg 5. While you are using it 6. Side effects 7. Storage and Disposal of Allerzal F.C. Tablet 5mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT ALLERZAL F.C. TABLET 5MG IS USED FOR Levocetirizine 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 ALLERZAL F.C. TABLET 5MG WORKS Allerzal contains the active ingredient, levocetirizine dihydrochloride. Allerzal is an anti- allergic medication. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. BEFORE YOU USE ALLERZAL F.C. TABLET 5MG _When you must not use it _ Do not use Allerzal: • If you are allergic (hypersensitive) to levocetirizine dihydrochloride, any other related substance, or any of the other ingredients of Allerzal (refer to PRODUCT DESCRIPTION section); • If you have a severe kidney impairment with creatinine clearance below 10 ml/min. The use of Allerzal is not recommended for children under 6 years. Pregnancy and lactation 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 _ You should tell your doctor if: • You have difficulties emptying your bladder due to factors such as spinal cord or prostatic hyperplasia (enlargement of the prostate gland); • You have been told by your doctor that you have an intol Baca dokumen lengkap
_ALLERZAL F.C. TABLET 5MG _ _Proposed package Insert (PI) _ 1. NAME OF THE MEDICINAL PRODUCT Allerzal F.C. Tablet 5mg 2. PHARMACEUTICAL FORM AND STRENGTH Film-coated tablet: White to off-white, oblong and biconvex tablet; engraved with “293” on one surface and “STD” on the other surface, containing 5mg of Levocetirizine Dihydrochloride. List of excipients include: microcrystalline cellulose, lactose (spray-dried), magnesium stearate, hydroxypropylmethyl cellulose, polyethylene glycol 400, and titanium dioxide. 3. THERAPEUTIC INDICATION Levocetirizine is indicted for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria. 4. POSOLOGY AND METHOD OF ADMINISTRATION It must be taken orally, swallowed whole with liquid and may be taken with or without food. _Adults and adolescents 12 years and above: _ The recommended dose is 5mg once daily (1 film-coated tablet). _Children aged 6 to 12 years: _ The recommended dose is 5mg once daily (1 film-coated tablet). _Elderly: _ Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below). _Adult patients with renal impairment: _ The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CL cr ) in ml/min is needed. The CL cr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: CL cr = [140 – age (years)] x weight (kg) (x 0.85 for women) 72 x serum creatinine (mg/dl) Dosing Adjustments for Patients with Impaired Renal Function: GROUP CREATININE CLEARANCE (ML/MIN) DOSAGE AND FREQUENCY Normal ≥ 80 1 tablet once daily Mild 50 – 79 1 tablet once daily Moderate 30 – 49 1 tablet once every 2 days Severe < 30 1 tablet once every 3 days End-stage renal disease - Patients undergoing dialysis < 10 Contra-indicated In paediatric pa Baca dokumen lengkap