Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Mepyramine maleate
Sanofi-Aventis Ireland Limited T/A SANOFI
D04AA; D04AA02
Mepyramine maleate
2 percent weight/weight
Cream
Product not subject to medical prescription
Antihistamines for topical use; mepyramine
Marketed
1979-04-01
ANTHISAN ® _cream 2%w/w _ _mepyramine maleate_ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Anthisan Cream carefully to get the best results from it. – 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 after 3 days. – 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 Anthisan Cream is and what it is used for 2. What you need to know before you use Anthisan Cream 3. How to use Anthisan Cream 4. Possible side effects 5. How to store Anthisan Cream 6. Contents of the pack and other information 1. WHAT ANTHISAN CREAM IS AND WHAT IT IS USED FOR WHAT ANTHISAN CREAM IS AND WHAT IT IS USED FOR Anthisan Cream contains a medicine called mepyramine maleate. This belongs to a group of medicines called antihistamines. It worksby blocking a natural substance (histamine) that your body makes during an allergic reaction. ANTHISAN CREAM IS USED FOR TREATING: • Pain, itch and inflammation caused by insect stings, bites and nettle rash. 2. B 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANTHISAN CREAM EFORE YOU USE ANTHISAN CREAM DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR OR PHARMACIST IF: • You are allergic (hypersensitive) to mepyramine maleate or any of the other ingredients of Anthisan Cream (listed in Section 6 below). The signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • If you are pregnant, might become pregnant, or think you may be pregnant. • If you are breast feeding or planning to breast feed. DO NOT USE THIS MEDICINE: • In premature infants and neonates. • With adhesive dressings. DO NOT APPLY THE CR Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anthisan Cream 2% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mepyramine maleate 2% w/w Also contains Methyl Parahydroxybenzoate (E 218) and Cetostearyl Alcohol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. Smooth homogeneous cream of fairly firm consistency, off-white to pale in colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anthisan has analgesic, anti-histaminic and anti-pruritic properties. Symptomatic relief in insect bites, stings and nettle rash. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The route of administration is topical. Recommended Dosage Apply to affected area 2 to 3 times daily for up to 3 days or as directed by the physician. 4.3 CONTRAINDICATIONS Acute vesicular and exudative dermatoses. Use in eczematous conditions or on broken skin. Use with occlusive dressings. Use in patients hypersensitive to mepyramine maleate or any of the excipients of Anthisan Cream. Use in premature infants and neonates. Pregnancy and lactation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Repeated application for periods longer than a few days is not recommended and treatment should be discontinued immediately if skin sensitization occurs. If symptoms persist, consult a doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _ Soma hati kamili