Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
UNIMED SDN BHD
DESLORATADINE
1 X 10 Tablets
Zydus Lifesciences Limited
NEOLOR 5 Desloratadine Tablet USP 5mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET: 1. What is used for NEOLOR 5 2. How NEOLOR 5 works 3. Before you use NEOLOR 5 4. How to use NEOLOR 5 5. While you are using it 6. Side effects 7. Storage and Disposal of NEOLOR 5 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT NEOLOR 5 IS USED FOR: NEOLOR 5 relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes). NEOLOR 5 is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. HOW NEOLOR 5 WORKS NEOLOR 5 is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU USE NEOLOR 5 - _When you must not use it_ _ _ Do not take NEOLOR 5 if you: Have • If you are allergic to Desloratadine or any of the other ingredients of this medicine (listed in section “Ingredients”) _ _ - Before you start to use it Do not take NEOLOR 5 if: • If you have medical or family history of seizures. • Efficacy and safety of NEOLOR 5 in children under 12 years of age have not been established. - _Pregnancy and Lactation _ _ _ • Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast- feeding. • If you are pregnant or nursing a baby, taking NEOLOR 5 is not recommended - _Taking other medicines _ _ _ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines and supplements. However, there are no known interactions of NEOLOR 5 with other medicines. HOW TO USE NEOLOR 5 - _How much to use _ Adults and adolescents (12 years of age and older): ta Citiți documentul complet
1. NAME OF THE MEDICINAL PRODUCT NEOLOR 5 Desloratadine Tablets USP 5mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains: Desloratadine USP 5mg Excipients q.s. Colours: Iron Oxide Yellow, Iron Oxide Red, Titanium Dioxide For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film Coated Tablet DESLORATADINE TABLETS USP 5MG: Pink colored, biconvex, round shaped, film coated tablet plain on both side. The tablet should be free of all physical defects. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desloratadine tablets are indicated for the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching, congestion/ stuffiness, as well as ocular itching, tearing and redness. Desloratadine tablets for the relief of symptoms associated with chronic idiopathic urticaria such as the relief of itching and the size and number of hives. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and Adolescents (12 years of age and older): One Desloratdine 5 mg film coated tablet once a day regardless of mealtime. METHOD OF ADMINISTRATION For oral use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Efficacy and safety of Desloratadine tablets in children under 12 years of age have not been established. Desloratadine should be administered with caution in patients with a medical or family history of seizures. In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No clinically relevant interactions with Desloratadine tablets were observed in clinical trials. There was no effect of food or grapefruit juice on the disposition of desloratadine. Desloratadine tablets taken concomitantly with alcohol d Citiți documentul complet