País: Malta
Idioma: inglés
Fuente: Medicines Authority
BENZYDAMINE HYDROCHLORIDE
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
M01AX07
BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)
OROMUCOSAL SPRAY
BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2006-03-29
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER DIFFLAM SPRAY 0.15% W/V, OROMUCOSAL SPRAY benzydamine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use 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. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. The name of your medicine is Difflam spray 0.15% w/v, oromucosal spray, which will be called Difflam spray throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Difflam spray is and what it is used for 2. What you need to know before you use Difflam spray 3. How to use Difflam spray 4. Possible side effects 5. How to store Difflam spray 6. Contents of the pack and other information 1. WHAT DIFFLAM SPRAY IS AND WHAT IT IS USED FOR Difflam spray contains the active ingredient benzydamine, which belongs to a group of medicines called local analgesics and anti-inflammatories. Difflam spray is used along with other treatments to relieve painful inflammatory conditions of the mouth and throat. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM SPRAY DO NOT USE DIFFLAM SPRAY: - if you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. WARNINGS OR PRECAUTIONS Talk to your doctor or pharmacist before using Difflam spray. Try not to get Difflam spray in your eyes. If you do, wash them thoroughly with clean water. Stop using if the cond Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Difflam Spray, 0.15% w/v, Oromucosal Spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each puff (175 microlitres) contains 262. 5 micrograms of benzydamine hydrochloride (0.15% w/v). Excipients: Each puff contains 0.17 mg of Methyl parahydroxybenzoate (E218), 14 mg of Ethanol and mint flavour (contains the allergens benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene and linalool). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal spray. Difflam Spray is a metered dose pump oromucosal spray solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS As an adjunct in the symptomatic relief of painful inflammatory conditions of the throat and mouth. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oromucosal administration. ADULTS AND ELDERLY: 4 to 8 puffs, 1½-3 _ _ hourly. CHILDREN (6-12): 4 puffs, 1½- 3 _ _ hourly. CHILDREN UNDER 6: One puff to be administered per 4 kg body weight, up to a maximum of 4 puffs, 1½-3 _ _ hourly. Because of the small amount of drug applied, elderly patients can receive the same dose as adults. The spray should be directed onto the affected area. Uninterrupted treatment should not exceed seven days, except under medical supervision. 4.3. CONTRAINDICATIONS Use in patient with a known hypersensitivity (e.g. bronchospasm, rhinitis, urticaria) to this product. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with the eyes. If the condition is aggravated or not improved use should cease. This medicinal product contains: • 14 mg of alcohol (ethanol) in each puff. The small amount of alcohol in this medicine will not have any noticeable effects. • less than 1 mmol sodium (23 mg) per dose of 8 puffs, that is to say essentially ‘sodium-free’. • methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) • mint flavour with benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, is Leer el documento completo