SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Oroeze Spray 0.15% w/v Oromucosal Spray Benzydamine 0.15% w/v Oromucosal Spray

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzydamine hydrochloride 0.15% w/v.

Each spray contains 262.5 micrograms of benzydamine hydrochloride.

Oroeze also contains ethanol (96%) and methyl parahydroxybenzoate. For a full list of excipients, see Section 6.1

3    PHARMACEUTICAL FORM

Oromucosal spray.

A clear solution with an odour of peppermint in a multidose spray container fitted with a metering pump and nozzle.

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

Oroeze Spray is a locally acting analgesic and anti-inflammatory treatment for the throat and mouth.

It is especially useful for the relief of pain in traumatic conditions such as following tonsillectomy or the use of a naso-gastric tube; dental surgery.

Posology and method of administration

For oromucosal administration.

ADULTS AND ELDERLY: 4 to 8 sprays, 1/ - 3 hourly.

CHILDREN (6-12): 4 sprays, 1/ - 3 hourly.

CHILDREN UNDER 6: One spray to be administered per 4 kg body weight, up to a maximum of 4 sprays, 1/ - 3 hourly.

Because of the small amount of drug applied, elderly patients can receive the same dose as adults.

4.3 Contraindications

Hypersensitivity to benzydamine hydrochloride or to any of the excipients, see section 4.4 and 6.1 for further information.

4.4 Special warnings and precautions for use

Avoid contact with the eyes.

Oroeze Spray/Benzydamine 0.15% w/v Oromucosal Spray 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.

Fertility, pregnancy and lactation

Oroeze Spray/Benzydamine 0.15% Oromucosal Spray 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

None.

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 the 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 and a stinging feeling in the mouth.

The stinging has been reported to disappear upon continuation of the treatment, however if it persists it is recommended that treatment be discontinued.

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 of 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 Spray is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. No special measures are required.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Non-steroidal anti-inflammatory drug.

ATC code: A01AD02 (Other agents for local oral treatment)

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

5.2 Pharmacokinetic properties

Following oral administration, benzydamine is rapidly absorbed from the gastrointestinal tract and maximum plasma levels reached after 2-4 hours. The most important aspect of the tissue distribution of benzydamine is its tendency to concentrate at the site of inflammation.

About half of the benzydamine is excreted unchanged via the kidney at a rate of 10% of the dose within the first 24 hours. The remainder is metabolised, mostly to N-Oxide.

5.3 Preclinical safety data

Not applicable.

6.1 List of excipients

Glycerol Ethanol (96%)

Methyl parahydroxybenzoate Saccharin sodium Polysorbate 20 Peppermint flavour Aniseed flavour Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years unopened.

Use within 6 months of opening.

6.4 Special precautions for storage

6.5 Nature and contents of container

White HDPE multidose spray container, fitted with a metering pump and nozzle, containing 30ml Oroeze.

6.6 Special precautions for disposal

None required

7. MARKETING AUTHORISATION HOLDER

Focus Pharmaceuticals Ltd Capital House,

85 King William Street,

London EC4N 7BL

United Kingdom.

8    MARKETING AUTHORISATION NUMBER(S)

PL 20046/0049

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/01/2010 29/04/2016