Difflam Spray

Each metered dose pump spray delivers Benzydamine hydrochloride 0.15% w/v, approximately 175 microlitres per puff.

Difflam Spray is a metered dose pump throat spray.

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

It is used to treat various painful oropharyngeal conditions such as mouth ulcers, sore throat, sore mouth or gums, dental pain

For oral administration.

Adults, adolescents and elderly: 4 to 8 puffs every 1½-3 hourly.

Children(6-12): 4 puffs every 1½-3 hourly.

Children under 6: One puff to be administered per 4 kg body weight, up to a maximum of 4 puffs, 1½-3 hourly.

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

Difflam Spray is contra-indicated in patients with known hypersensitivity to any of the ingredients.

Avoid contact with the eyes.

None known.

Difflam 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.

None.

Side-effects are minor. Occasionally, oral tissue numbness or 'stinging' sensations may occur. The stinging has been reported to disappear upon continuation of the treatment, however if it persists it is recommended that treatment be discontinued. Hypersensitivity reactions occur very rarely but may be associated with pruritus rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.

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

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

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.

Non-Clinical Data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated toxicity, genotoxicity, cardiogenic potential, and toxicity to reproduction.

Glycerol Ph. Eur.

Saccharin FU

Sodium Bicarbonate Ph. Eur.

Ethanol FU

Methylhydroxybenzoate Ph. Eur.

Mouthwash Flavour

Polysorbate 20 Ph. Eur.

Purified Water Ph. Eur.

None.

The shelf life expiry date for this product shall not exceed 3 years from the date of its manufacture.

Do not store above 30°C, do not refrigerate or freeze. Keep out of the reach of children.

Difflam Spray is presented in a 30 ml HDPE bottle with 170 μl valve pump spray.

The patient should read the instruction leaflet before use.

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

PL 15142/0046

30^th November 1984 / 05^th March 2004

17^th June 2011