SUMMARY OF PRODUCT CHARACTERISTICS

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.

Also contains ethanol (96%) and methyl parahydroxybenzoate. For a 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.

For oromucosal administration.

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 1% to 3 hours as required for pain relief.

The solution should be expelled from the mouth after use.

CHILDREN: Not suitable for children aged 12 years or under.

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.

4.3 Contraindications

Oroeze/Benzydamine 0.15% w/v Mouthwash is contra-indicated in patients with known hypersensitivity to any of the ingredients; see section 4.4 and 6.1 for further information.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

Oroeze/Benzydamine 0.15% w/v Mouthwash should not be used in pregnancy or lactation unless considered essential by the physician. 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 ranked under the heading of the frequency:

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. Respiratory, thoracic and mediastinal disorders Very rare: Laryngospasm or bronchospasm.

Gastrointestinal disorders

Uncommon: Oral numbness (hypoesthesia) 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.

Frequency not known: Angioedema

Immune system disorders

Frequency not known: Anaphylactic reaction which can be potentially life-threatening.

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.

Overdose

Oroeze/Benzydamine 0.15% w/v Mouthwash is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. 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.

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 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: A01A D02

Benzydamine exerts an anti-inflammatory and analgesic action by stabilising the cellular membrane and inhibiting prostaglandin synthesis.

5.2 Pharmacokinetic properties

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. 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 water

6.2    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.

Special precautions for disposal