Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
KETOTIFEN FUMARATE
Sigma-Tau Industrie Farmaceutiche Riunite S.p.a.
R06AX17
KETOTIFEN FUMARATE
1 MG/5ml
Oral Solution
Product subject to prescription which may be renewed (B)
Other antihistamines for systemic use
Authorised
2014-02-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZADITEN® 1 MG/5 ML ORAL SOLUTION Ketotifen (as Ketotifen hydrogen fumarate) READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must contact a doctor if your symptoms worsen or do not improve. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Zaditen is and what it is used for 2. Before you take Zaditen 3. How to take Zaditen 4. Possible side effects 5. How to store Zaditen 6. Further information 1. WHAT ZADITEN IS AND WHAT IT IS USED FOR The name of your medicine is Zaditen and it contains ketotifen. It belongs to a group of drugs which have anti-allergic activities and it is used to help prevent asthma attacks and treat allergic conditions such as rhinitis. 2. BEFORE YOU TAKE ZADITEN DO NOT TAKE ZADITEN - if you are allergic (hypersensitive) to ketotifen or any of the other ingredients (see section 6) of Zaditen. - if you have epilepsy. - if you are taking any oral medicines for diabetes. - if you are breast-feeding. TAKE SPECIAL CARE WITH ZADITEN - Zaditen is not effective in preventing or treating acute asthma attacks - Do not stop taking other asthma medications unless your doctor tells you to, however well you feel - During the first few days of treatment your reactions may be impaired (i.e. you may feel drowsy or your reactions may be slower than usual, even if you do not feel drowsy). You should not take charge of vehicles or machinery until the effect of your medicine on your reactions is Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zaditen 1mg/5ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of oral solution contains 1 mg Ketotifen (as the hydrogen fumarate). _Excipients_ Each 5 ml of oral solution contains 4,000 mg of maltitol liquid (hydrogenated glucose syrup), 1.655 mg of methyl parahydroxybenzoate (E218) 833 micrograms of propyl parahydroxybenzoate (E216) and 100 mg of ethanol (see section 4.4 special warnings and precautions for use). For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Oral Solution Clear, colourless syrup with a strawberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Preventative treatment of bronchial asthma, especially when associated with atopic symptoms. Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. ADULTS 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily. At the higher dose, an accelerated onset of efficacy may be expected. Special populations Pediatrics Children aged 2 to 3 years: 0.05mg (=0.25 ml Zaditen Oral Solution 1mg/5ml) per kilogram body weight twice daily (morning and evening). Pediatrics over 3 years of age and adolescents: 1 mg twice daily with food. Geriatrics (aged 65 years and above) No evidence exists that elderly patients require different dosages or show different side effects from younger patients. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days. Renal impairment No studies have been performed in renally impaired patients and hence no dosing recommendations can be provided for these patients (see section 5.2). HEALTH PRODUCTS R Leggi il documento completo