A.Menarini Pharmaceuticals Ltd

Fastum 2.5% w/w Gel

Fastum Gel contains Ketoprofen 2.5% w/w.

For a full list of excipients, see section 6.1.

Gel.

A colourless, non-greasy, non-staining gel with an aromatic fragrance for cutaneous use.

For local relief of pain and inflammation associated with rheumatic and muscular disorders and soft tissue injuries such as acute strains and sprains.

Fastum Gel should be applied topically to the affected area two or three times daily. Maximum duration of use should not exceed 10 days. After application gel should be rubbed well to ensure local absorption of ketoprofen.

Adults and elderly:

Tube or dispenser: Apply 5 to 10cm of gel, for the pump dispenser push the pump 3-6 times (100-200mg ketoprofen) with each application.

Children under 12 years of age:

Not recommended as experience in children is limited.

The lowest dose compatible with adequate safe clinical control should be employed in the elderly, who are more prone to adverse events.

History of any photosensitivity reaction.

Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs.

History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes.

Sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation.

Hypersensitivity to any of the excipients of the product.

Ketoprofen gel should not be applied to open wounds or lesions of the skin, or near the eyes.

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 avoid exposure to direct sunlight including solarium (sunbeds), and to protect treated areas by wearing clothing during treatment with the product and for two weeks following its discontinuation to avoid the risk of photosensitisation.

Not for use with occlusive dressing.

Topical application of large amounts may result in systemic effects, including hypersensitivity and asthma. Although systemic effects should be low, ketoprofen should be used with caution in patients with severe renal impairment, cardiac or hepatic impairment, history of peptic ulceration or inflammatory bowel disease or bleeding diathesis.

Keep out of the reach and sight of children.

Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. The total dose of product should not exceed 25g daily.

If there is no improvement, or the condition is aggravated the doctor should be consulted.

Interactions are unlikely as serum concentrations following topical administration are low. Serious interactions have been recorded after use of high dose methotrexate with non-steroidal anti-inflammatory agents, including ketoprofen, when administered by the systemic route. It is advisable to monitor patients under treatment with coumarinic substances.

No embryopathic effects have been demonstrated in animals, but there is no epidemiological evidence of the safety of ketoprofen in human pregnancy. During the last trimester of pregnancy the use of NSAIDs may result in pulmonary and cardiac toxicity in the foetus. Therefore, it is recommended that ketoprofen should be avoided during pregnancy. Non-steroidal anti-inflammatory drugs may also delay labour.

Trace amounts of ketoprofen are excreted in breast milk after systemic administration.

None known.

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

Other systemic effects of anti-inflammatory drugs: these depend on the transdermic spreading of the active ingredient, hence on the amount of gel applied, on the surface involved, on the degree of the intactness of the skin, on the duration of the treatment and on the use of an occlusive bandage (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.

Considering the low blood levels of ketoprofen by the percutaneous route, no overdosage phenomena have been described yet.

Pharmacotherapeutic category: non-steroid anti-inflammatory drug for topical use. It has anti-inflammatory and analgesic actions.

ATC code: MO2AA10

After oral administration of a single dose, maximum blood concentrations are achieved within 2 hours.

Ketoprofen plasma half-life ranges from 1 to 3 hours. Plasma protein binding is 60%-90%. Elimination is mainly by urinary route and in glucuronated form; approximately 90% of the amount administered is excreted within 24 hours.

By cutaneous route, absorption is instead very low. In fact the percutaneous application of 50-150 mg of ketoprofen produces plasma levels of the active ingredient of 0.08-0.15 μg/mL approx. 5-8 hours after application.

Preclinical safety studies suggest that Fastum Gel is irritant to mucosae and should not be applied to open wounds or lesions of the skin. By single or repeated applications Fastum Gel is well tolerated by the intact skin, although repeated application may locally increase sensitivity to UV light. Fastum Gel has negligible systemic toxicity.

Carbomer 940

Ethanol

Neroli essence

Lavender essence

Trolamine

Purified water.

Not applicable.

i) Five years in aluminium tube

ii) Two years in polypropylene container.

Store below 25°C.

Replace the cap after use.

Keep the gel away from naked flames.

Soft aluminium tube, treated inside with non-toxic epoxyresin, containing 30g, 50g, 100g, or 2x50g twinpack.

Or

Pump dispenser: rigid polypropylene dispenser containing 50g or 100g gel.

Not all pack sizes may be marketed.

No special requirements.

A Menarini Srl

1-3 via Sette Santi

Florence

Italy

PA 512/1/1

Date of first authorisation: 19th August 1992

Date of last renewal: 19th August 2007

June 2011