Difflam Oral Rinse

1. Name Of The Medicinal Product

Difflam Oral Rinse

2. Qualitative And Quantitative Composition

A pleasant tasting, clear, green solution, containing benzydamine hydrochloride 0.15% w/v.

3. Pharmaceutical Form

Liquid for use as mouthwash/gargle.

4. Clinical Particulars

4.1 Therapeutic Indications

Difflam Oral Rinse is 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

Adults: 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.

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

Elderly: No special dosage recommendations are made for elderly patients.

Difflam Oral Rinse 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

Difflam Oral Rinse is contra-indicated in patients with known hypersensitivity to any of the ingredients

4.4 Special Warnings And Precautions For Use

Difflam Oral Rinse should generally be used undiluted, but if 'stinging' occurs the rinse may be diluted with water.

Avoid contact with eyes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Side-effects are minor. Occasionally, oral tissue numbness or 'stinging' sensations may occur. Hypersensitivity reactions occur very rarely but may be associated with pruritus rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.

4.9 Overdose

Difflam 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

Benzydamine exerts an anti-inflammatory and analgesic effect 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 metabolized primarily by oxidation, conjugation and dealkylation.

5.3 Preclinical Safety Data

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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol (96% v/v) BP

Glycerol Ph Eur

Saccharin Sodium BP

Mouthwash flavour, 52 503/T

Polysorbate 20 Ph Eur

Methyl Hydroxybenzoate Ph Eur

Quinoline Yellow (E104)

Patent Blue V (E131)

Purified Water Ph Eur

6.2 Incompatibilities

None known

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not leave the uncartonned bottle in direct sunlight. Store between 5°C and 30°C. Do not freeze.

6.5 Nature And Contents Of Container

Clear glass bottle with screwcap containing 300 ml.

6.6 Special Precautions For Disposal And Other Handling

The solution should be expelled from the mouth after use.

7. Marketing Authorisation Holder

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

8. Marketing Authorisation Number(S)

PL 15142/0045

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation 11 June 1981

Date of last renewal 6 September 2002

10. Date Of Revision Of The Text

17^th June 2011