ETOFLAM Gel Ref.[9350] Active ingredients: Etofenamate

1. Etoflam 5% w/w gel contains alcohol and therefore contact with the eyes or the mucous membranes should be avoided.
2. Hands should be thoroughly washed after use of this product.
3. This product should not be applied to irritated or broken skin. If skin irritation develops, use of the product should be discontinued.
4. If there is no improvement or the condition is aggravated, the doctor should be consulted.

None known.

Etoflam 5% w/w gel is not recommended for use during pregnancy and lactation.

Etofenamate and some of its metabolites have been shown to cross the placenta in rats (oral and cutaneous) and rabbits (cutaneous). After 10, 30 and 100mg/kg BW per day (rabbits up to the 18th day of gestation) the concentrations in the placentas, uteri, foetuses, organs and bile decreased rapidly after stopping administration; they were below the per mille limit.

Elimination with the milk has been studied in goats and humans. After 65 mg/kg BW i.m., goats excreted 20-60 microg of etofenamate plus metabolites per litre of milk. After oral administration of 300 mg etofenamate the milk of lactating women contained no etofenamate but only main metabolite flufenamic acid. In total 1-14 microg flufenamic acid was excreted within 2 days. These concentrations have no practical meaning, since they are orders of magnitude below the therapeutic dose.

No teratogenic effects have been found in laboratory studies but the safety of etofenamate absorbed from Etoflam 5% w/w gel to the foetus, if used during pregnancy, or to the suckling infant if used during lactation, has not been established.

Not applicable.

The following undesirable effects have been reported through post-marketing use.

Undesirable effects listed in the table are grouped by MedDRA System Organ Classes and are ranked under heading of frequency, using the following convention, when applicable: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10, 000); not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorder

Rare: Contact dermatitis

Not applicable.