Benzydamine 0.15% w/v Mouthwash

Mouthwash. A clear green solution with an odour of peppermint

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** 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. *Paediatric population* Oroeze/Benzydamine 0.15% w/v Mouthwash should not be used in children aged 12 years or under. **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 Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs Caution should be exercised in patients suffering from or with a previous history of bronchial asthma. Oroeze/Benzydamine 0.15% w/v Mouthwash should generally be used undiluted, but if 'stinging' occurs the rinse may be diluted with water. Avoid contact with eyes. Oroeze/Benzydamine 0.15% w/v Mouthwash contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains propylene glycol which may cause skin irritation. The alcohol (ethanol) content in Benzydamine Mouthwash is 8.1% w/v. which is equivalent to 1215 mg per 15 ml of solution.4.5 Interaction with other medicinal products and other forms of interaction None known.4.6 Fertility, pregnancy and lactation **Pregnancy** Oroeze/Benzydamine 0.15% w/v Mouthwash should not be used in pregnancy **Breast-feeding** Oroeze/Benzydamine 0.15% w/v Mouthwash should not be used during lactation unless considered essential by the physician. **Fertility** There is no evidence of a teratogenic effect in animal studies.4.7 Effects on ability to drive and use machines Oroeze/Benzydamine 0.15% w/v Mouthwash has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects Adverse events are listed by System Organ Class: Frequencies are defined using the following convention: Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from available data). The most common side effects are numbness and a stinging feeling in the mouth. | | | | | --- | --- | --- | | System organ class | Frequency | Undesirable effects | | Immune system disorders | Not known | Anaphylactic reaction which can be potentially life-threatening and hypersensitivity reactionsi | | Respiratory, thoracic and mediastinal disorders | Very rare | Laryngospasm or bronchospasm | | Gastrointestinal disorders | Uncommon | Oral numbness (hypothesia) and a stinging feeling in the mouth (oral pain) | | Skin and subcutaneous tissue disorders | Very rare | Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash | | Not known | Angiodema | i) Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed). **Reporting of suspected adverse reactions** Reporting suspected adverse reactions after authorisations of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose Symptoms Oroeze/Benzydamine 0.15% w/v Mouthwash is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. Intoxication is only expected in case of accidental ingestion of large quantities of benzydamine (> 300 mg).Intoxication is only to be expected if large quantities of Oroeze/Benzydamine 0.15% w/v Mouthwash are swallowed. Symptoms associated with ingested overdose of benzydamine are mainly gastrointestinal symptoms and symptoms of the central nervous system. Most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and oesophageal irritation. Symptoms of the central nervous system include dizziness, hallucinations, agitation, anxiety and irritability. Management In acute overdose only symptomatic treatment is possible. Patients should be kept under close observation and supportive treatment should be given. Adequate hydration must be maintained.

5.1 Pharmacodynamic properties Pharmacotherapeutic group: Other agents for local oral treatment, ATC code: A01AD02. Benzydamine exerts an anti-inflammatory and analgesic action by stabilising the cellular membrane and inhibiting prostaglandin synthesis. **Mechanism of action** The indazole analogue benzydamine has physicochemical properties and pharmacological activities which differ from those of the aspirin-like NSAIDs. Unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is a weak base. In further contrast, benzydamine is a weak inhibitor of the prostaglandin synthesis. Only at concentration of 1mM and above benzydamine effectively inhibits cyclooxygenase and lipooxygenase enzyme activity. It mostly exerts its effects through inhibition of the synthesis of proinflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β) without significantly affecting other pro-inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist). Further mechanisms of action are hypothesised including the inhibition of the oxidative burst of neutrophils as well as membrane stabilisation as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels. **Pharmacodynamic effects** Benzydamine specifically acts on the local mechanisms of inflammation such as pain, oedema or granuloma. Benzydamine topically applied demonstrates anti-inflammatory activity reducing oedema as well as exudate and granuloma formation. Further, it exhibits analgesic properties if pain is caused by an inflammatory condition and local anaesthetic activity. Hyperthermia, which is indicative of systemic functional involvement, is poorly affected by benzydamine.5.2 Pharmacokinetic properties Absorption: Oral doses of benzydamine are well absorbed and plasma drug concentrations reach a peak fairly rapidly and then decline with a half-life of about 13 hours. Less than 20% of the drug is bound to plasma proteins. Although local drug concentrations are relatively large, the systemic absorption of mouthwash-gargle doses of benzydamine is relatively low compared to oral doses. This low absorption should greatly diminish the potential for any systemic drug side-effects when benzydamine is administered by this route. Biotransformation: Benzydamine is metabolised primarily by oxidation, conjugation and dealkylation.5.3 Preclinical safety data Not applicable.

6.1 List of excipients Glycerol Ethanol (96%) Methyl parahydroxybenzoate Saccharin sodium Polysorbate 20 Quinoline yellow (E104) Patent blue V (E131) Peppermint flavour (contains propylene glycol) Aniseed flavour (contains ethanol 95%) Purified water6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.6.3 Shelf life 3 years. Use within 6 months of opening.6.4 Special precautions for storage Do not store above 25°C.6.5 Nature and contents of container Clear type III glass bottle with child-resistant, tamper-evident cap containing 300ml of Mouthwash. Supplied with a measuring cup.6.6 Special precautions for disposal and other handling No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements