Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
BENZYDAMINE HYDROCHLORIDE
Meda Pharmaceuticals Limited
A01AD02
BENZYDAMINE HYDROCHLORIDE
OROMUCOSAL SOLUTION
BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)
OTC
STOMATOLOGICAL PREPARATIONS
Authorised
2006-03-29
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, dentist 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 Oral Rinse is and what it is used for 2. What you need to know before you use Difflam Oral Rinse 3. How to use Difflam Oral Rinse 4. Possible side effects 5. How to store Difflam Oral Rinse 6. Contents of the pack and other information. 1. What Difflam Oral Rinse is and what it is used for Difflam Oral Rinse contains the active substance benzydamine hydrochloride and belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS. Difflam Oral Rinse works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the mouth or throat including: • Mouth ulcers • Sore throat • Discomfort associated with dentures or dental work. 2. What you need to know before you use Difflam Oral Rinse Do not use Difflam Oral Rinse if • you are allergic to benzydamine hydro chloride • you are allergic to any of the other ingredients of Difflam Oral Rinse (see section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Difflam Oral Rinse: • 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 to you, talk to your doctor, dentist or pharmacist. Other medicines and Difflam Oral R Izlasiet visu dokumentu
1 NAME OF THE MEDICINAL PRODUCT Difflam 0.15%w/v Oral Rinse 2 QUALITATIVE AND QUANTITATIVE COMPOSITION A pleasant tasting, clear, green solution, containing benzydamine hydrochloride 0.15% w/v. Contains methyl parahydroxybenzoate and Ethanol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Liquid for use as mouthwash/gargle. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Difflam Oral Rinse is a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat including: Traumatic conditions: Pharyngitis following tonsillectomy or the use of a naso-gastric tube. Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy. Dentistry: For use after dental operations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1 ½ to 3 hours as required for pain relief. _Children:_ Not suitable for children aged 12 years or under. _Elderly:_ No special dosage recommendations are made for elderly patients. Method of administration Rinse or gargle. The solution should be expelled from the mouth after use. Difflam Oral Rinse should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water. Uninterrupted treatment should not exceed seven days, except under medical supervision 4.3 CONTRAINDICATIONS Difflam Oral Rinse is contra-indicated in patients with known hypersensitivity to the active substance benzydamine hydrocholoride or to any of the excipients listed in section 6.1. Page 1 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benzydamine use is not advisible in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs. Difflam Oral Rinse should generally be used undiluted, but if ‘stinging’ occurs the rinse may be diluted with water. Avoid contact with eyes. This medicinal product contains 10 vol % ethanol. Methyl hydroxybenzoate may cause allergic reactions (possibly del Izlasiet visu dokumentu