Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzydamine hydrochloride
Advanz Pharma
A01AD02
Benzydamine hydrochloride
1.5mg/1ml
Mouthwash
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12030100; GTIN: 5060064792377
OBJECT 1 BENZYDAMINE 0.15% W/V MOUTHWASH Summary of Product Characteristics Updated 12-Dec-2016 | Concordia International- formerly Focus Pharmaceuticals Ltd 1. Name of the medicinal product Oroeze 0.15% w/v Mouthwash Benzydamine 0.15% w/v Mouthwash 2. Qualitative and quantitative composition Benzydamine hydrochloride 0.15% w/v. Each 15ml dose contains 22.5mg benzydamine hydrochloride. Excipients with known effect Ethanol (96%) 8.1%w/v Methyl parahydroxybenzoate 0.1 %w/v It also contains propylene glycol. For the full list of excipients, see Section 6.1. 3. Pharmaceutical form Mouthwash. A clear green solution with an odour of peppermint 4. Clinical particulars 4.1 Therapeutic indications Oroeze/Benzydamine 0.15% w/v Mouthwash is indicated in adults and children aged 13 years and over. 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 PAEDIATRIC POPULATION Oroeze/Benzydamine 0.15% w/v Mouthwash should not be used in children aged 12 years or under. ADULTS AND ELDERLY: Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1½ to 3 hours as required for pain relief. The solution should be expelled from the mouth after use. Oroeze/Benzydamine 0.15% w/v Mouthwash 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. Method of administration: Oromucosal administration. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 4.4 Special warnings and precautions for use Oroeze/Benzydamine 0.15% w/v Mouthwash should generally be used undiluted, but i Прочитајте комплетан документ