Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ketotifen fumarate
CD Pharma Srl
R06AX17
Ketotifen fumarate
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5013054260028
Zaditen tablets 1 mg (ketotifen) This medicine will usually be referred to as Zaditen WHAT YOU NEED TO KNOW ABOUT ZADITEN TABLETS Your doctor has decided that you need this medicine to help treat your condition. START TO TAKE YOUR MEDICINE. IT CONTAINS IMPOR- TANT INFORMATION. because you may want to read it again. If you have any other questions, or if there is some- thing you don’t understand, please ask your doctor or pharmacist. This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours. please tell your doctor or pharmacist. 1. What Zaditen Tablets are and what they are used for 2. Things to consider before you start to take Zaditen Tablets 3. How to take Zaditen Tablets 5. How to store Zaditen Tablets 6. Further information 1. WHAT ZADITEN TABLETS ARE AND WHAT THEY ARE USED FOR Zaditen Tablets contains the active ingredient, ketotifen. Ketotifen is an antihistamine with anti-allergy properties. In allergic conditions certain substances are released in the body. Tablets act to dampen down these responses and can therefore be used to treat various allergic mucous membranes in the nose) and conjunctivi- eye). 2. THINGS TO CONSIDER BEFORE YOU START TO TAKE ZADITEN TABLETS SOME PEOPLE MUST NOT TAKE ZADITEN TABLETS. TALK TO YOUR DOCTOR IF: • You think you may be allergic to ketotifen or to any of the other ingredients of Zaditen Tablets. • You are pregnant, or planning to become pregnant. Tell your doctor straight away if you become pregnant whilst taking Zaditen Tablets. • You are breast-feeding. YOU SHOULD ALSO ASK YOURSELF THESE QUESTIONS BEFORE TAKING ZADITEN TABLETS. IF THE ANSWER TO ANY OF THESE QUESTIONS IS YES, TELL YOUR DOCTOR OR PHARMACIST BECAUSE ZADITEN TABLETS MIGHT NOT BE THE RIGHT MEDICINE FOR YOU. • Do you have epilepsy? • Do you have an inherited intolerance to some sugars? (The tablets contain a small amount of lactose.) ARE YOU TAKING OTHER MEDICINES? Some medicines can inter Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ZADITEN Tablets 1mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ketotifen hydrogen fumarate 1.38mg (equivalent to 1 mg ketotifen base). For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM White tablets, 7 mm diameter, with break-line on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults 1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily. Children (From 3 years of age): 1 mg twice daily with food. For patients for whom a tablet form may not be suitable, an alternative dosage form should be considered. Use in the elderly No evidence exists that elderly patients require different dosages or show different side-effects from younger patients. Patients known to be easily sedated should be given 0.5 -1 mg at night for the first few days. 4.3 CONTRAINDICATIONS Hypersensitivity to ketotifen or any of the excipients. A reversible fall in the thrombocyte count in patients receiving ZADITEN® concomitantly with oral anti-diabetic agents has been observed in a few cases. This combination of drugs should therefore be avoided until this phenomenon has been satisfactorily explained. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Zaditen Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption should not take this medicine. Convulsions have been reported very rarely during ZADITEN® therapy. As ZADITEN® may lower the seizure threshold it should be used with caution in patients with a history of epilepsy. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION ZADITEN® may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol. Patients should be warned not to take charge of vehicles or machinery until the effect of ZADITEN® treatment on the individu Διαβάστε το πλήρες έγγραφο