Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOCETIRIZINE DIHYDROCHLORIDE
IDAMAN PHARMA MANUFACTURING SDN BHD
LEVOCETIRIZINE DIHYDROCHLORIDE
10x 10 Tablets; 50x10 Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
_Consumer Medication Information Leaflet (RiMUP) _ LEVOZAL TABLET 5MG Levocetirizine dihydrochloride (5mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Levozal Tablet 5mg is used for 2. How Levozal Tablet 5mg works 3. Before you use Levozal Tablet 5mg 4. How to use Levozal Tablet 5mg 5. While you are using Levozal Tablet 5mg 6. Side effects 7. Storage and disposal of Levozal Tablet 5mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT LEVOZAL TABLET 5MG IS USED FOR Levozal Tablet 5mg is used to treat the symptoms: • 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 LEVOZAL TABLET 5MG WORKS Levozal Tablet 5mg contains the active ingredient levocetirizine dihydrochloride. Levozal Tablet 5mg is an antiallergic medication. It works by blocking a certain natural substance (histamine) that your body makes during allergic reaction. BEFORE YOU USE LEVOZAL TABLET 5MG _-When you must not use it _ Do not take Levozal Tablet 5mg if you are: - • Allergy (hypersensitive) to the active substance levocetirizine dihydrochloride,cetirizine,hydr -oxyzine,piperazine derivatives or any of the excipients listed contains in the product • Severe renal impairment at less than 10 ml/min creatinine clearance. The use of Levozal Tablet 5mg 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 or have any of the following medical conditions: - • If you have difficulties emptying your bladder due to factors such as spinal cord lesion or prostatic hyperplasia (enlargement of t Прочитать полный документ
CONTRAINDICATIONS Levocetirizine is contraindicated in: • hypersensitivity to levocetirizine, to cetirizine, to hydroxyzine, to any piperazine derivatives or any of the excipients contained in the product. • severe renal impairment at less than 10 ml/min creatinine clearance. • rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. WARNINGS AND PRECAUTIONS Do not exceed the stated dose. _ALCOHOL_ Precaution is recommended with intake of alcohol. _RISK OF URINARY RETENTION_ Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention. _RISK OF SEIZURE AGGRAVATION_ Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation. _ALLERGY SKIN TESTS_ Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. _WITHDRAWAL SYNDROME_ Pruritus may occur when levocetirizine is stopped even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted. _EXCIPIENT: LACTOSE_ This medical product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. INTERACTIONS WITH OTHER MEDICAMENTS No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions antipyrine (with antipyrine pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). _THEOPHYLLINE_ A small decrease in the clearance of cetiri Прочитать полный документ