Difflam Cream

or

Difflam-P Cream

Each tube of Difflam Cream/ Difflam-P Cream contains Benzydamine Hydrochloride 3% w/w.

Cream.

Difflam Cream/ Difflam-P Cream is a topical analgesic and non-steroidal anti-inflammatory agent.

It is recommended as a short-term treatment for the relief of symptoms associated with painful inflammatory conditions of the musculo-skeletal system, including:

Acute inflammatory disorders such as myalgia and bursitis.

Traumatic conditions such as sprains, strains, contusions and the after-effects of fractures.

Difflam Cream/ Difflam-P Cream is well absorbed through the skin and has been shown to have anti-inflammatory and local anaesthetic actions.

Difflam Cream/ Difflam-P Cream should be massaged lightly into the affected area. Depending on the size of the site to be treated, 35 - 85 mm (1 - 2 g) should be applied three times daily and at the discretion of the doctor, up to six times daily in more severe conditions. It is recommended that treatment be limited to not more than ten days.

ELDERLY:

No special dosage recommendations are made for elderly patients.

Difflam Cream is contraindicated in patients with known hypersensitivity to any of the ingredients.

To avoid possible irritation, Difflam Cream/ Difflam-P Cream should be kept away from eyes and mucosal surfaces.

None.

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.

Photosensitivity reactions have been reported and local skin reactions which have varied from erythema to papular eruption. The skin returned to normal on stopping treatment.

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 topical administration, benzydamine is absorbed through intact skin and reaches peak levels between 24 - 32 hours, amounting to about 20 - 25% of the plasma levels obtained after the oral administration of the same dose.

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.

'Cutina' MD

Cetyl Alcohol USNF

'Cetiol' V

'Eumulgin' B1

Propylene Glycol Ph Eur

Perfume, 'Crematest' 0/064060

Methyl Hydroxybenzoate Ph Eur

Propyl Hydroxybenzoate Ph Eur

Purified Water Ph Eur

None known.

3 years.

Store between 5 - 30°C. Do not freeze.

Collapsible Aluminium tube closed with plastic screwcap

or

Laminate tube closed with plastic screwcap.

Contents: 35 g, 50 g or 100 g

Not applicable.

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 15142/0044

6 March 1980/ 6 September 2002

17^th June 2011