Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
BENZYDAMINE HYDROCHLORIDE
Meda Pharmaceuticals Limited
A01AD02
BENZYDAMINE HYDROCHLORIDE
OROMUCOSAL SPRAY
BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)
OTC
STOMATOLOGICAL PREPARATIONS
Authorised
2006-03-29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DIFFLAM 0.15% 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, pharmacist or nurse have told you. • This medicine is available without prescription. However, you still need to use it carefully to get the best results. • Keep this leaflet. You may need to read it again. • Ask your doctor or pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Difflam Spray is and what it us 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 substance benzydamine hydrochloride and belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS. Difflam Spray works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the mouth or throat including: • Mouth ulcers • Teething • Sore throat • Sore tongue or gums • Discomfort associated with dentures or dental work. 2. What you need to know before you take Difflam Spray Do not use Difflam Spray if: • You are allergic to benzydamine hydrochloride • You are allergic to any of the other ingredients in Difflam Spray (listed in section 6). Warnings and precautions: Talk to your doctor, pharmacist or nurse before using Difflam Spray: • If you have a history of asthma • If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory (NSAID) drugs If any of these apply, talk to your d Citiți documentul complet
1 NAME OF THE MEDICINAL PRODUCT Difflam 0.15% w/v Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose pump spray delivers Benzydamine hydrochloride 0.15% w/v, approximately 175 microlitres per puff. Contains methyl parahydroxybenzoate and Ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Difflam Spray is a metered dose pump throat spray. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Difflam Spray is a locally acting analgesic and anti-inflammatory treatment for the throat and mouth. It is especially useful for the relief of pain in traumatic conditions such as following tonsillectomy or the use of a naso-gastric tube; dental surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, adolescents and elderly:_ 4 to 8 puffs every 1½-3 hourly. _Children(6-12):_ 4 puffs every 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. _Elderly: _ Because of the small amount of drug applied, elderly patients can receive the same dose as adults. Method of administration For oral administration 4.3 CONTRAINDICATIONS Difflam Spray is contra-indicated in patients with known hypersensitivity to the active substance benzydamine hydrochloride or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs. Page 1 of 5 Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients. Avoid contact with the eyes. If the condition is aggravated or not improved use should cease. This medicinal product contains 10 vol % ethanol. Methyl hydroxybenzoate may cause allergic reactions (possibly delayed) 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy Difflam Spray should not be used in pregnancy unle Citiți documentul complet