FASTUM Gel Ref.[28169] Active ingredients: Ketoprofen

• Hands should be washed thoroughly after each application of the product.
• Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene containing products.
• It is recommended to protect treated areas by wearing clothing during all the application of the product and two weeks following its discontinuation to avoid the risk of photosensitisation.
• Discontinue use if rash develops.
• Not for use with occlusive dressing.
• Topical application of large amounts may result in systemic effects, including hypersensitivity and asthma.
• The treated areas should not be exposed to sunlight, including sun beds during treatment or for the following 2 weeks.
• Keep out of the reach of children.
• The gel should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions consisting of renal affections have been reported.
• The recommended length of treatment should not be exceeded due to the risk of developing contact dermatitis and photosensitivity reactions increases over time.
• The gel must not come into contact with mucous membranes or the eyes.
• Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population.
• The excipients Citral, Citronellols, Coumarin, Farnesol, Geraniol, d-Limonene and Linalool may cause allergic reactions.

Paediatric population

The safety and efficacy of ketoprofen gel in children have not been established.

Interactions are unlikely as serum concentrations following topical administration are low. However, a close monitoring of patients treated with coumarins is recommended.

Pregnancy

During the first and second trimester

In mice and rats, there is no evidence of teratogenic or embryotoxicity. In the rabbit, slight embryotoxicity likely related to maternal toxicity has been reported.

As the safety of ketoprofen in pregnant women has not been evaluated, the use of ketoprofen during the first and second trimester of pregnancy should be avoided.

During the third trimester of pregnancy

All prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy, prolonged bleeding time in both the mother and child may occur. Therefore, ketoprofen is contraindicated during the last trimester of pregnancy.

Breast-feeding

No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

Fertility

If used according to dosage recommendations, no effects on fertility have been reported so far.

Fastum has negligible influence on the ability to drive and use machines.

There have been reports of localised skin reactions which may subsequently spread beyond the application area. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.

Other systemic effects of NSAIDs: they depend on the transdermic spreading of the active ingredient and thus on the quantity of gel applied, the surface treated, the degree of the cutaneous integrity, the treatment duration and on the use of an occlusive dressing (hypersensitivity, gastrointestinal and renal disorders).

Since marketing, the following adverse reactions have been reported. They have been listed according to classes of organ and system and classified according to their frequency as follows: very common (equal to or above 10%); common (ranging between 1% and 10 ), uncommon (ranging between 0.1 and 1%), rare (ranging between 0.01% and 0.1%); very rare (below 0.01%), including isolated reports.

Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs.

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 via the national reporting system listed below: Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Τel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.

Not applicable.