מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
DIMETINDENE MALEATE
Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece
D04AA13
DIMETINDENE MALEATE 1 mg/g
GEL
DIMETINDENE MALEATE 1 mg/g
OTC
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Authorised
2007-04-19
PACKAGE LEAFLET: INFORMATION FOR THE USER FENISTIL 0,1% GEL, Dimetindene maleate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use Fenistil gel 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. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET: 1. What Fenistil gel is and what it is used for 2. What you need to know before you use Fenistil gel 3. How to use Fenistil gel 4. Possible side effects 5. How to store Fenistil gel 6. Contents of the pack and other information 1. WHAT FENISTIL GEL IS AND WHAT IT IS USED FOR WHAT FENISTIL GEL IS Fenistil gel contains dimetindene maleate, an active ingredient that belongs to the group of medicines called antihistamines, which are used for relief from skin allergies, as well as different types of itching. HOW FENISTIL GEL ACTS Dimetindene maleate (the active substance of Fenistil gel) stops itching by blocking the effect of histamine, which is released into the body through contact with an allergen and causes the allergic reaction. As the gel penetrates effectively into the skin, it provides immediate relief from itching and irritation in just a few minutes. Fenistil gel also has local anesthetic action. WHAT FENISTIL GEL IS USED FOR Fenistil gel is used in the relief from itching due to limited and mild symptoms of urticaria, dermographism and dermatitis from natural causes such as insect or jellyfish bites or contact with plants and for the relief of pruritus associated with sunburn and superficial burns. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fenistil 0,1% w/w Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 g of gel contains 1 mg of dimetindene maleate. Excipients with known effect: Each 1 g of gel contains 150 mg propylene glycol and 0,1 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Odourless and colourless gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief from itching due to limited and mild symptoms of urticaria, demographism and dermatitis from natural causes such as insect or jellyfish bites or contact with plants and from pruritus associated with sunburn and superficial burns. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Apply small quantity of gel 2-4 times a day to affected area of the skin. Maximum duration of use: If no improvement is seen after 7 days of gel use, the patient should consult the physician. Special use instructions In case of very severe urticaria events or extensive skin lesions, doctor’s or pharmacist’s advice should be asked for the topical application of Fenistil to be supplemented by a systemic therapy with an oral form of antihistamine. PAEDIATRIC POPULATION Fenistil gel should be used on children below 2 years of age only after doctor’s advice. Do not use on premature or newborn infants below 4 weeks of age. In small children and infants, do not use on extensive areas of the skin, particularly on open wounds or inflamed skin (see 4.4 Special warnings and precautions for use) _Μethod of administration _ For dermatological use on intact skin without injuries. Αpply small quantity on the affected area. Then, gently massage with your hand to facilitate penetration of the medicine into the skin. Do not cover with bandages that do not allow air to pass through and do not apply on extensive areas of the skin. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In cas קרא את המסמך השלם