1. Name Of The Medicinal Product
Difflam Spray
2. Qualitative And Quantitative Composition
Each metered dose pump spray delivers Benzydamine hydrochloride 0.15% w/v, approximately 175 microlitres per puff.
3. Pharmaceutical Form
Difflam Spray is a metered dose pump throat spray.
4. Clinical Particulars
4.1 Therapeutic Indications
Difflam 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.
4.2 Posology And Method Of Administration
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.
4.3 Contraindications
Difflam Spray is contra-indicated in patients with known hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Avoid contact with the 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
None.
4.8 Undesirable Effects
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.
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 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
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
Glycerol Ph. Eur.
Saccharin FU
Sodium Bicarbonate Ph. Eur.
Ethanol FU
Methylhydroxybenzoate Ph. Eur.
Mouthwash Flavour
Polysorbate 20 Ph. Eur.
Purified Water Ph. Eur.
6.2 Incompatibilities
None.
6.3 Shelf Life
The shelf life expiry date for this product shall not exceed 3 years from the date of its manufacture.
6.4 Special Precautions For Storage
Do not store above 30°C, do not refrigerate or freeze. Keep out of the reach of children.
6.5 Nature And Contents Of Container
Difflam Spray is presented in a 30 ml HDPE bottle with 170 μl valve pump spray.
6.6 Special Precautions For Disposal And Other Handling
The patient should read the instruction leaflet before 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 15142/0046
9. Date Of First Authorisation/Renewal Of The Authorisation
30th November 1984 / 05th March 2004
10. Date Of Revision Of The Text
17th June 2011
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