TRAXAM Cutaneous foam Ref.[27616] Active ingredients: Felbinac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London, EC4N 7BL, UK

4.1. Therapeutic indications

This medicine is a topical anti-inflammatory and analgesic. It is indicated for the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injury such as sprains, strains and contusions.

4.2. Posology and method of administration

Posology

Prescription Only Medicine

Adult population

The foam should be dispensed onto the hand and rubbed lightly into the affected area(s). This medicine is formulated to break down into a clear liquid when warmed by contact with the skin.

Gently rub one golf-ball sized quantity of foam (one and a half inches (4cm) in diameter) into the affected area(s) 2 to 4 times a day.

The total daily dose should not exceed 25g of foam irrespective of the number of affected areas; a golf-ball size aliquot of foam weighs approximately 1 gram.

Hands should be washed following application of this medicine, unless they are the treatment site.

If symptoms do not resolve, it is advisable to review the patient to assess whether continued treatment is appropriate. Treatment should not extend beyond 6 weeks.

Elderly

No special dosage recommendations are made for elderly patients.

Paediatric population

Safe use of felbinac in early childhood has not been established.

Pharmacy medicine

Adult population

The foam should be dispensed onto the hand and rubbed lightly into the affected area(s).

This medicine is formulated to break down into a clear liquid when warmed by contact with the skin.

Gently rub one golf ball sized (one and a half inches (4cm) in diameter) quantity of foam into the affected area(s) 2 to 4 times a day.

The total daily dose should not exceed 25g of foam irrespective of the number of affected areas; a golf ball size aliquot of foam weighs approximately 1 gram.

Hands should be washed following application of this medicine, unless they are the treatment site.

Do not use for longer than 7 days.

Elderly

No special dosage recommendations are made for elderly patients.

Paediatric population

Not recommended for use in children under 12 years of age.

4.9. Overdose

It is unlikely that this medicine could cause adverse systemic effects even if accidental ingestion should occur. Consult a doctor if ingestion is suspected.

6.3. Shelf life

12 months.

6.4. Special precautions for storage

This medicine is packed in a Pressurised container. Protect the canister from sunlight and do not expose to temperature above 50°C. Extremes of temperature can occur in motor cars. Do not pierce or burn canister even when empty. Do not refrigerate. Do not spray or use near any ignition source (e.g. naked flame, open fire) or while smoking.

This medicine should be stored below 25°C.

6.5. Nature and contents of container

Aluminium monobloc can with white enamel body, double grinded microflex internal lacquer and colourless overlacquer. Cans are fitted with a valve made of aluminium microflex and diptube and shave foam actuator.

Pack sizes: 25g, 30g, (Pharmacy)

Pack sizes: 50g, 100g, (Prescription Only)

6.6. Special precautions for disposal and other handling

Not applicable.

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