FLOGOPROFEN Gel / Cutaneous spray solution Ref.[51140] Active ingredients: Etofenamate

• Use only on intact skin. Do not apply to open wounds, mucous membranes or eczematous skin.
• Avoid contact with the eyes and mucous membranes. In the event of contact with the eyes or mucous membranes, wash thoroughly with water.
• Do not apply to large areas or for an extended period of time. Apply to the affected area only.
• Do not use occlusive dressings.
• Do not apply simultaneously to the same area as other topical products.
• Do not expose the treated area to the sun to reduce the risk of photosensitivity reactions (lesions such as eczema or vesicular bullous rash. etc., could manifest).
• Frequent application can cause skin irritation and dryness.
• Although local administration minimises risks derived from its systemic use, it is important to remember the following precautions in the event of any significant absorption:
  • Medical history of gastroduodenal ulcer, ulcerative colitis, coagulopathy or haemorrhage.
  • Patients with hypertension or heart failure due to fluid retention or oedema.
  • Patients with renal failure or hepatic failure.
• Not suitable for children under 12 years.
• Flogoprofen solution must be kept away from excessive heat sources. Due to the high flammability of the excipients of the solution, it should not be used near incandescent sources or sprayed onto an open flame.

If symptoms persist for more than 7 days or irritation occurs or worsens, asses the clinical situation of the patient.

Warning about excipients:

Flogoprofen 50 mg/g Gel can cause skin irritation because it contains dimethyl sulfoxide.

Flogoprofen 50 mg/ml Solution can cause skin irritation because it contains dimethyl sulfoxide and propylene glycol.

Simultaneous use with topical anti-infective medication is not recommended. The feasibility of using any other analgesic during the treatment with this medicinal product will be assessed.

Pregnancy

Unless prescribed by the doctor. Flogoprofen Gel and Flogoprofen Cutaneous spray solution should not be used during pregnancy.

Systemic NSAIDs are not indicated during pregnancy, particularly during the third trimester, as they inhibit prostaglandins synthesis which can lead to dystocia or affect or postpone labour, as well as lead to adverse effects in the foetal cardiovascular system, such as, for example, the premature closing of the ductus arteriosus.

Breast-feeding

During breast-feeding, this medicinal product should only be applied to small areas and for a short period of time.

Flogoprofen has no or negligible influence on ability to drive and use machines.

Undesirable effects are listed in decreasing order of seriousness in each frequency grouping.

Skin and subcutaneous tissue disorders

Common (≥1/100 to <1/10): reddening of the skin, contact dermatitis and allergic skin reactions (such as: intense pruritus, rash, erythema, eczema, swelling or blisters) which normally disappear quickly when the treatment is withdrawn.

Rare (≥1/10.000 to <1/1.000): photodermatitis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the National Competent Authority.

Not applicable.