Страна: Мальта
мова: англійська
Джерело: Medicines Authority
Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland
R06AX13
LORATADINE 10 mg
TABLET
LORATADINE 10 mg
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2012-11-27
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER LORATADINE CHEFARO, 10 MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. WHAT LORATADINE CHEFARO IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORATADINE CHEFARO 3. HOW TO TAKE LORATADINE CHEFARO 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LORATADINE CHEFARO 6. CONTENTS OF THE PACK AND OTHER INFORMATION. 1. WHAT LORATADINE CHEFARO IS AND WHAT IT IS USED FOR Loratadine Chefaro contain loratadine, which belongs to a group of drugs called antihistamines. These medicines help to relieve the symptoms of some allergies. Loratadine Chefaro is used to relieve: • symptoms of hayfever and other allergies such as sneezing, runny nose and burning, itchy eyes. • Symptoms of chronic urticaria of unknown origin (itching and redness) which is often known as hives or nettle rash. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORATADINE CHEFARO Loratadine Chefaro can be taken by adults, and children aged 2 years and over PROVIDED THEY WEIGH OVER 30 KG . Some people should not take this medicine or should talk to their pharmacist or doctor first. Suitable for people with coeliac disease. DO NOT TAKE LORATADINE CHEFARO: • If you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your pharmacist or doctor before taking if you: • Have liver problems. You may need to take a lower dose. Page 2 of 4 OTHER ME Прочитайте повний документ
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Loratadine Chefaro, 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of loratadine. Excipients with known effect: The quantity of lactose monohydrate in the loratadine 10 mg tablet composition is 62.50 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, oval tablets, scored on one side and plain on the other side, debossed “L” on one side of the scoreline and “10” on the other side of the scoreline. The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loratadine tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children 12 years of age and over: _ 10mg daily (one tablet once daily). The tablets may be taken without regard to mealtime. _Children aged 2 to under 12 years with:_ Body weight more than 30 kg: 10mg daily (one tablet once daily). Body weight 30 kg or less: The 10mg strength tablet is not appropriate in children with a body weight less than 30 kg. Page 2 of 6 Efficacy and safety of Loratadine tablets in children under 2 years of age have not been established. Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of one tablet every other day is recommended for adults and children weighing more than 30 kg. No dosage adjustments are required in the elderly or in patients with renal insufficiency. Suitable for people with coeliac disease. 4.3 CONTRAINDICATIONS Loratadine tablets are contraindicated in patients who are hypersensitive to loratadine or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Loratadine should be administered with caution in the treatment of patients with severe liver impairment (see Section 5.2). This medicinal product conta Прочитайте повний документ