Local treatment of painful and inflammatory conditions of rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
ACTIVE INGREDIENTS
1 g of gel contains: etofenamate 50 mg. For a full list of excipients, see section 6.1.
EXCIPIENTS
Oleylcetyl polyglycol ether alcohol, macrogol 400, carbomer, isopropyl alcohol, sodium hydroxide, purified water.
DOSAGE
Unless otherwise prescribed by your doctor, apply 2-3 times a day in sufficient quantity to cover the painful area with a light layer of gel (for an extension of 5-10 cm corresponding to approximately 1.7 - 3.3 grams of gel) and massage thoroughly to facilitate penetration. In most cases, a treatment lasting 1-2 weeks is sufficient. If after this period the symptoms persist, consult your doctor to assess whether to continue the treatment or whether it is necessary to consider any therapeutic alternatives.
CONSERVATION
This medicinal product does not require any special storage conditions.
CONTRAINDICATIONS / SIDE EFFECTS
Hypersensitivity to the active substance or to any of the excipients, as well as to flufenamic acid or other non-steroidal anti-inflammatory drugs. Third trimester of pregnancy, breastfeeding and paediatric age (see paragraph 4.6).
WARNINGS
The use, especially if prolonged, of products for skin use may give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute an appropriate therapy. In case of a history of allergies, the product should be used with the usual precautions. • The gel should not be applied to open wounds or to skin affected by eczematous alterations. The gel should not be applied to open wounds or to skin affected by eczematous alterations. Hands must be washed after applying the product and contact with these parts of the body must be avoided. • Do not expose the treated area to the sun and/or solarium during treatment and for the following two weeks. • In patients with asthma, chronic obstructive respiratory diseases, hay fever or chronic swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive airway diseases or chronic airway infections, especially if combined with manifestations of hay fever, all formulations of etofenamate should be used only after taking certain precautions and under strict medical supervision. • Systemic absorption increases if the medicinal product is used for a longer period and/or applied over a large surface area. Therefore, this should be avoided. • Children should not come into contact with areas of skin treated with the medicinal product. Avoid contact with mucous membranes and eyes. Do not swallow. In case of a history of allergies, the product should be used with the usual caution. Avoid contact with mucous membranes and eyes. Do not swallow.
INTERACTIONS
In light of current knowledge, no pharmacological interactions can be hypothesised between etofenamate administered epicutaneously and other preparations taken at the same time.
SIDE EFFECTS
Local skin reactions may occur in the treated areas, in the form of erythema, irritation and itching, rash, edema and vesicles. These effects resolve quickly after stopping treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
OVERDOSE
There are no reports in the literature of effects attributable to overdose, which can also be excluded based on the route of administration. In case of incorrect use : if the contents of one tube or more of BRUFEN ANTI-INFLAMMATORY LOCAL 5% gel are applied to the entire body surface in a short period of time, headache, dizziness or epigastric discomfort may occur. The recommended countermeasure is to remove the product with water. There is no specific antidote.
PREGNANCY AND BREASTFEEDING
There are no adequate data on the use of etofenamate in pregnant women. Since the effect of prostaglandin synthesis inhibition on human pregnancy has not yet been investigated, etofenamate should only be used in the first and second trimester of pregnancy after careful risk/benefit assessment. The use of etofenamate formulations is contraindicated in the third trimester of pregnancy. During the last three months of pregnancy, the mechanism of action of this medicinal product may lead to suppression of labor, prolongation of pregnancy and the birth process. It may also cause cardiovascular toxicity (with early closure of the ductus arteriosus and pulmonary hypertension) and renal toxicity (with oliguria and oligoamniosis) in the child, increased bleeding tendency in the mother and child, as well as an increased risk of edema formation in the mother. Since etofenamate passes into breast milk to a minimal extent, breastfeeding mothers should avoid the use of etofenamate-containing formulations.
