TRAUMON Gel Ref.[51169] Active ingredients: Etofenamate

Traumon Gel 10% may only be used under certain precautionary measures and under direct medical supervision in

• Patients suffering from asthma, hay fever, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive respiratory diseases or chronic respiratory infections (especially coupled with hay fever-like symptoms). When using Traumon Gel 10%, these patients are more at risk of asthma attacks (so-called analgesic intolerances/analgesic asthma), localised swelling of the skin and mucous membranes (so-called Quincke’s edema) or urticaria than other patients;
• Patients who are also hypersensitive (allergic) to other substances, such as skin reactions, itching or hives.

Direct sunlight and solarium visits should be avoided during treatment and 2 weeks thereafter.

The occurrence of systemic side effects from the use of Traumon Gel 10% cannot be excluded if the medicine is used on large skin areas over a long period of time.

Children should not come into contact with the skin areas where the medicine has been applied.

Traumon Gel 10% can cause discolouration or changes in the surface of polished furniture or plastics. Therefore, if necessary, wash your hands after rubbing the gel or avoid contact with the above-mentioned objects.

No interactions are known with the intended use of Traumon Gel 10%.

Pregnancy

There is insufficient experience in humans regarding the safety of using etofenamate during pregnancy. Since the influence of prostaglandin synthesis inhibition during pregnancy is unclear, Traumon Gel 10% should only be used in the 1st and 2nd trimesters of pregnancy after careful consideration of the benefit-risk balance. The maximum daily dose should not be exceeded. (See section 4.2)

In the last trimester of pregnancy, the use of Traumon Gel 10% is contraindicated.

During the last trimester of pregnancy, the mechanism of affection could inhibit labour, prolong pregnancy and childbirth, cardiovascular (premature occlusion of the ductus Botalli, pulmonary hypertension) and renal (oliguria, oligoamnion) toxicity in the child, increased tendency of bleeding in the mother and child and increased edema formation in the mother.

Lactation

Since etofenamate passes into breast milk, prolonged use of Traumon Gel 10% during breastfeeding should be avoided if possible, and the daily dose should not be exceeded. Breastfeeding women should not use the medication in the breast area, so as to avoid ingestion by the infant.

Wash hands after applying Traumon Gel 10% to avoid the infant coming in contact with the medication.

Traumon Gel 10% has very little to no influence on the ability to drive and to operate machines.

The following categories are used for the frequency of side effects: Very frequent ≥1/10, Frequent ≥1/100 to <1/10, Occasional ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Very rare <1/10,000, Unknown Frequency cannot be estimated from the available data.

Description of selected side effects

Hypersensitivity reactions have been reported after systemic use of NSAIDs. These can be (a) non-specific allergic reactions and anaphylaxis (b) respiratory reactivity with asthma, increased asthma, bronchospasms or dyspnea, or © various skin reactions, including rashes of various types, pruritus, urticaria, purpura, angioedema and on rare occasions exfoliative and bullous dermatoses (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme). Seek immediate medical attention if any one of these symptoms arise, which could be possible after the first application.

If Traumon Gel 10% is applied over a large skin area and used over a longer period of time, there is a possibility of experiencing side effects after the systemic use of medicines containing etofenamate that affect a certain organ system or the entire being.

Report suspicion of side effects

The reporting of suspected adverse reactions that should occur after authorisation of the medicine is important, because this enables continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.medicinesauthority.gov.mt/adrportal

There are no known incompatibilities.