Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
BENZYDAMINE HYDROCHLORIDE
Mylan IRE Healthcare Limited
A01AD; A01AD02
BENZYDAMINE HYDROCHLORIDE
0.15 percent weight/volume
Gargle
Product not subject to medical prescription
Other agents for local oral treatment; benzydamine
Marketed
2008-04-18
PACKAGE LEAFLET: INFORMATION FOR THE USER DIFFLAM ORAL RINSE 0.15% W/V, GARGLE benzydamine hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take 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. - 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. The name of your medicine is Difflam Oral Rinse 0.15% w/v gargle, which will be called Difflam rinse throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Difflam rinse is and what it is used for 2. What you need to know before you use Difflam rinse 3. How to use Difflam rinse 4. Possible side effects 5. How to store Difflam rinse 6. Contents of the pack and other information 1. WHAT DIFFLAM RINSE IS AND WHAT IT IS USED FOR Difflam rinse contains the active ingredient benzydamine, which belongs to a group of medicines called local analgesics and anti-inflammatories. Difflam rinse is used to relieve painful inflammatory conditions of the mouth and throat including: - Pharyngitis (sore throat) caused by removal of the tonsils or use of naso-gastric tube (feeding tube). - Pharyngitis, and mouth ulcers caused by radiation therapy - After dental operations. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM RINSE DO NOT USE DIFFLAM RINSE: - 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 AND PRECAUTIONS Talk to your doctor or pharmacist before using Difflam rinse. Try not to get Difflam rinse in your eyes. If you do, rinse thoroughly with clean water. Take special care w Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 24 November 2020 CRN00C1SP Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difflam Oral Rinse 0.15% w/v, gargle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15ml contains 22.5mgbenzydamine hydrochloride equivalent to 0.15% w/v Excipients: Each 15ml dose contains 15mg of methyl parahydroxybenzoate (E218), 1126 mg of ethanol, mint flavour (contains allergens including 2 mg benzyl alcohol) and <1mmol of sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gargle. Clear, green solution with pleasant taste. 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. Benzydamine exerts an anti-inflammatory and analgesic action by stabilising the cellular membrane and inhibiting prostaglandin synthesis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1.5 to 3 hours as required for pain relief. Not suitable for children aged 12 years or under. 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. ELDERLY: No special dosage recommendations are made for elderly patients. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to the active ingredient, benzydamine hydrochloride, or to any of the other ingredients. Health Products Regulatory Authority 24 November 2020 CRN00C1SP Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with eyes. Difflam Διαβάστε το πλήρες έγγραφο