BRUFEN ANTI-INFLAMMATORY GEL 40G 5% OTHER

BRUFEN ANTINFIAMMATORIAL LOCAL 5% GEL

active ingredients

1 g gel contains: hetofenamato 50 mg. For a complete list of excipients, see paragraph 6.1.

Excellent

Polyglycoltere oleylcetylic alcohol, macrogol 400, carbomer, isopropyl alcohol, sodium hydroxide, purified water.

Therapeutic indications

Local treatment of painful and phlogistic states of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients, as well as flufenamic acid or other non-steroidal anti-flogistics. Third trimester of pregnancy, breast milk and paediatric age (see paragraph 4.6).

Population

Save different prescription, apply 2-3 times a day in sufficient quantities to cover with a slight layer of gel the sore area (for an extension of 5-10 cm corresponding to about 1.7 - 3,3 grams of gel) and massage carefully to favor its penetration. In most cases a treatment of 1-2 weeks is sufficient. If after this period the symptoms persist, consult your doctor to assess whether to continue treatment or whether it is necessary to consider any therapeutic alternatives.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The use, especially if prolonged, of the products for skin use can give rise to phenomena of sensitization. In this case it is necessary to stop treatment and establish suitable therapy. In case of history of allergies, the product should be used with the usual cautele. • The gel should not be applied on open wounds or on skin affected by eczematous alterations. The gel should not be applied on open wounds or on skin affected by eczematous alterations. The hands should be washed after the application of the product and you should avoid contact with these parts of the body. • Do not expose the treated area to the sun and/or solarium during treatment and for the next two weeks. • In patients with asthma, chronic obstructive diseases of the respiratory system, hay fever or chronic swelling of the nasal mucosa (nasmal polyps) or chronic airway diseases or chronic airway infections, especially if combined with hay fever manifestations, all formulations of etofenmed must be used only after taking some precautions. • Systemic absorption increases if the medicinal product is used for a longer period and/or applied on a broad surface. Therefore, this must be avoided. • Children should not contact the skin areas treated with the medicine. Avoid contact with mucosa and eyes. Don't swallow. In case of history of allergies, the product should be used with the usual cautele. Avoid contact with mucosa and eyes. Don't swallow.

Interactions

In light of current knowledge, drug interactions between etofenamato by epicutanea and other preparations are not hypothesized.

Effects

It is possible the appearance of local skin reactions, dependent on treated areas, in the form of erythema, irritation and itching, rash, edema and vesicles. These effects are resolved in a short time with the interruption of treatment. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system to theindirizzowww.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

There are no reports of overdosing effects in literature, which can also be excluded according to the route of administration. In case of incorrect use: whether the content of a tube or more gel of BRUFEN LOCAL ANTINFIAMMATORIO 5% is applied on the entire body surface in a short time, cephalea, sturdiment or epigastric malaise may appear. The recommended countermeasure is to remove the product with water. There is no specific antidote.

No adequate data on the use of etofenamato in pregnant women are available. Since the effect of the inhibition of the synthesis of prostaglandin on human pregnancy has not yet been investigated, hetofenamato must be used only in the first and second trimester of pregnancy after having thoroughly evaluated the risk/benefit ratio. The use of formulations based on etofenamato is contraindicated in the third trimester of pregnancy. During the last three months of pregnancy the mechanism of action of this medicine can lead to the suppression of labor, to the prolongation of pregnancy and the birth process. It can also cause cardiovascular toxicity (with early closure of arteriosus and pulmonary hypertension) and kidney toxicity (with oliguria and oligoamnios) in the child, increased hemorrhagic tendency in the mother and son, as well as an increase in the risk of edema formation in the mother. Since hetofenamato passes minimally in breast milk, mothers nursing with breast milk must avoid the use of hetofenamato formulations.

Source: Farmadati