ETOFLAM Gel Ref.[9350] Active ingredients: Etofenamate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath

Therapeutic indications

For the treatment of inflammatory disorders of the musculo-skeletal system.

Posology and method of administration

Recommended dosage

Adults (including the elderly)

Etoflam 5% w/w gel is applied topically. A 5-10cm strip of gel (according to the area affected) should be rubbed in gently. This may be repeated up to 4 times daily.

Clinical studies in patients with impaired renal function or undergoing anti-coagulant therapy have not indicated a need to change the recommended dosage in these patients.

Children and infants

The use of Etoflam 5% w/w gel is not recommended in children or infants.

It is recommended that treatment should be reviewed after 14 days. Treatment should not extend beyond 6 weeks. In symptomatic treatment of osteoarthritis, therapy should be reviewed after 4 weeks.

Overdose

In view of the topical route of administration overdosage is not considered a practical possibility.

Shelf life

5 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Collapsible aluminium tube with an internal coating with polyethylene screw cap. Tubes contain either 20g or 100g of gel product.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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