Benzydamine Hydrochloride 0.30 % w/v Oromucosal Spray Prescribing Information. |
Spray Prescribing Information. Prescribers should consult the SmPC before prescribing. Presentation: 1 ml contains 3 mg of benzydamine hydrochloride. Each spray is equal to 0.18 ml solution. Excipients with known effect: Benzyl alcohol 0.0648 mcg in spearmint flavor per spray and Methyl parahydroxybenzoate 0.18 mg as per spray. Indications: Symptomatic treatment of painful inflammatory and swelling conditions of the mouth and throat. Dosage and administration: Generally used 2-6 times daily (every 1 ½ -3 hours). Adults and adolescents over 12 years: 2-4 sprays, 1 ½ -3 hourly. Method of administration: spray for mouth and throat. See the SmPC for the instructions for use. Special Populations: Paediatric Population: Children between 6 and 12 years: 2 sprays, 1 ½ -3 hourly. Children under 6 years with bw over 8 kg: 1 spray per 8 kg body weight, maximum 2 sprays, 1 ½ -3 hourly. Elderly: Same as adults Fertility, pregnancy and lactation: Pregnancy: should not be used in pregnancy unless the clinical condition of the woman requires treatment. Breastfeeding: Should not be used unless considered essential by the physician. Fertility: Not known Contraindications: Hypersensitivity to active substance or any of the excipients. Should not be used in infants and children up to 2 years due to content of menthol. Special warnings and precautions: Prolonged use can lead to sensitisation. Patients who do not get better within 3 days must contact their doctor or dentist. Not recommended in patients who are hypersensitive to salicylic acid or other NSAIDs. The indications do not justify long-term treatment, as this could affect the normal bacterial flora of the oral cavity. Should be used with caution in patients with a history of bronchial asthma, since bronchospasm may occur. Methyl p-hydroxybenzoate may cause allergic reactions. Benzyl alcohol may cause mild local irritation. |
Drug Interactions: No studies were conducted to assess interactions. Effects on ability to drive/use machines: No influence on the ability to drive and operate machines. Undesirable effects: hypersensitivity reactions, anaphylactic reactions, respiratory, thoracic and mediastinal disorders, laryngospasm, mouth burn, mouth dryness, numbness in the mouth and throat, nausea, vomiting, photosensitivity and angioedema. See SmPC for full list of adverse events. Pack size and UK list price: Benzydamine Hydrochloride 0.30 % w/v Oromucosal Spray (PL 56740/0034) pack size: 1 x 15 ml, £ 4.60 Legal category: POM Marketing Authorisation Holder: Abdi Farma GmbH, Donnersbergstraße 4, 64646, Heppenheim, Germany Distributor: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Date of Preparation: May 2025 Ref: 000757366 |