Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LORATADINE
KOTRA PHARMA (M) SDN. BHD.
LORATADINE
60 ml; 100 ml
KOTRA PHARMA (M) SDN. BHD.
AXCEL LORATADINE SYRUP Loratadine (5mg/5ml) _ _ 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What Axcel Loratadine Syrup is used for. 2. How Axcel Loratadine Syrup works. 3. Before you use Axcel Loratadine Syrup. 4. How to use Axcel Loratadine Syrup. 5. While you are using it. 6. Side effects. 7. Storage and disposal of Axcel Loratadine Syrup. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT AXCEL LORATADINE SYRUP IS USED FOR Axcel Loratadine Syrup is used for the relief of symptoms associated with allergic rhinitis (inflammation of the mucous membrane inside the nose) for example sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular (eye) itching burning, chronic urticaria (a raised, itchy rash on the skin) and other allergic dermatologic (skin) disorders. HOW AXCEL LORATADINE SYRUP WORKS Loratadine is a long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonist activity. It works by blocking the action of one of the body's natural chemicals known as histamine. Histamine is responsible for many of the symptoms caused by allergies. BEFORE YOU USE AXCEL LORATADINE SYRUP _When you must not use it _ Do not take Axcel Loratadine Syrup if: • If you are allergic or hypersensitive to any ingredients in Axcel Loratadine Syrup. • If it is not prescribed by a qualified doctor or pharmacist for you. • Do not take Axcel Loratadine Syrup if you are pregnant, trying to get pregnant or think you may be pregnant. • Do not take Axcel Loratadine Syrup if you are breast-feeding. Loratadine is excreted in breast milk. Ask your doctor or pharmacist for advice before taking any medicine. _Before you start to use it _ Tell your doctor if you: • If you are allergic to any medicines, food and dyes. • If you are taking any other medicines (including those not prescribed by your doctor). • If you have severe liver impairment. Use in children: Safety and efficacy of loratadine in children be Прочитать полный документ
PRECAUTION: Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 5mg once daily or 10mg every other day is recommended. Unsuitable for phenylketonurics. _Use in Pregnancy and Lactation:_ Safe use of loratadine during pregnancy has not been established; therefore use only if potential benefit justifies potential risk to the fetus. Since loratadine is excreted in breast milk and because of the increased risk of loratadine for infants, particularly newborns and premature infants, a decision should be made whether to discontinue nursing or discontinue the drug. _Use in Children:_ Safety and efficacy of loratadine in children < 2 years have not yet been established. SIDE EFFECTS: The incidence of adverse effects associated with loratadine has been comparable to that of placebo. In controlled paediatric clinical trials, the incidence of treatment-related headache, sedation and nervousness, which were rarely reported events, was similar to placebo. DRUG INTERACTIONS: When administered concomitantly with alcohol, loratadine has no potential effects as measured by psychomotor performance studies. Increase in plasma concentrations of loratadine has been reported with concomitant use of ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other drugs known to inhibit hepatic metabolism should be co-administered with caution until definitive interaction studies can be completed. Plasma concentration for loratadine may be increased by amprenavir. OVERDOSAGE AND TREATMENT: To date overdosage has not occurred with loratadine. A single acute ingestion of 160mg produced no adverse effects. In the event of overdosage, treatment which should be started immediately, is symptomatic and supportive. The patients should be induced to vomit even if emesis has occurred spontaneously. Pharmacologically-induced vomiting by the administration of Прочитать полный документ