POWERGEL 2.5% gel

Powergel contains ketoprofen BP 2.5g/100g.

For a full list of excipients, see section 6.1.

A colourless, non-greasy, non-staining gel with an aromatic fragrance for topical application.

For local relief of pain and inflammation associated with soft tissue injuries and acute strains and sprains.

Powergel should be applied topically to the affected area two or three times daily. Maximum duration of use should not exceed 10 days. Powergel should be applied with gentle massage only.

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 of treated skin 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.

Do not use with occlusive dressing.

Topical application of large amounts may result in systemic effects, including hypersensitivity and asthma.

Ketoprofen gel should be used with caution in patients with serious kidney failure.

The use of topical products, especially if it is prolonged, may give rise to phenomena of sensitisation or local irritation.

Keep out of the reach and sight of children.

No interactions of Powergel with other drugs have been reported. It is, however, advisable to monitor patients under treatment with coumarinic substances.

Powergel should not be used during pregnancy and lactation.

No embryopathic effects have been demonstrated in animals but epidemiological data give no clear evidence of the safety of ketoprofen in human pregnancy.

Clinical data show that the use of NSAIDs during the final three months of pregnancy may cause pulmonary and cardiac toxicity in the foetus. NSAIDs can also delay birth when administered during pregnancy.

Lactation:

After systemic administration, traces of ketoprofen have been detected in mothers' milk.

No effects on the ability to drive and use machinery have been reported.

The most common adverse reactions are photosensitive reactions (phototoxic and photosensitivity allergic reactions), the majority of which occurs after an incorrect use of the product (exposure of the skin to sunlight or solarium before 15 days from the last application, see sections 4.3 and 4.4). There have been reports of localised skin reactions due to photosensitivity, including erythema, pruritis and burning sensations, which might spread beyond the area of application. 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: hypersensitivity, gastrointestinal and renal disorders (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 intactness of the skin, on the duration of the treatment and on the use of occlusive bandages).

The below mentioned adverse reactions have been collected in the post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which, therefore is not known.

Infections and infestations

Secondary impetigo

Blood and lymphatic system disorders

Eosinophilia

Immune system disorders

Hypersensitivity

Eye disorders

Eyelid oedema

Vascular disorders

Vasculitis

Gastrointestinal disorders

Diarrhoea, Lip oedema

Skin and subcutaneous tissue disorders

Angioedema, burning sensation, dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, photosensitivity allergic reaction, skin exfoliation, rash (erythematous, generalised, maculo-papular, papular, pruritic, pustular, vesicular), pruritus, skin oedema, application site burn

Renal and urinary disorders

Acute renal failure

General disorders and administration site Conditions

Pyrexia

Injury, poisoning and procedural complications

Wound complication

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.

ATC code: MO2AA10

Ketoprofen is an inhibitor of both the cyclo-oxygenase and lipoxygenase pathways. Inhibition of prostaglandin synthesis provides for potent anti-inflammatory, analgesic and antipyretic effects. Lipoxygenase inhibitors appear to attenuate cell-mediated inflammation and thus retard the progression of tissue destruction in inflamed joints. In addition, Ketoprofen is a powerful inhibitor of bradykinin (a chemical mediator of pain and inflammation), it stabilises lysosomal membranes against osmotic damage and prevents the release of lysosomal enzymes that mediate tissue destruction in inflammatory reactions.

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.

Powergel allows the site specific topical delivery of ketoprofen with very low plasma concentrations of drug. Therapeutic levels in the affected tissues provide relief from pain and inflammation, yet will satisfactorily overcome the problem of significant systemic unwanted effects.

In animal trials no embryopathic effects have been found, while there is no epidemiological evidence of the safety of ketoprofen in human pregnancy. In preclinical and clinical trials on Ketoprofen no serious adverse effects have been observed, although anecdotal cases of systemic adverse reactions have been described. There are no preclinical data of relevance to the prescriber which are additional to that already included in other parts of the SPC.

Powergel contains the following excipients: carbomer 940, ethanol, neroli essence, lavender essence, trolamine, purified water.

Not applicable.

Tube and dispenser: 60 months.

Store below 25°C.

Soft aluminium tube, treated inside with non-toxic epoxy resin. The tubes are packed in cardboard together with a package insert. The following pack sizes are approved:

30g sample pack, 50g pack, 2x50g twin pack, 100g pack

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

Not all pack sizes may be marketed.

Not applicable.

A Menarini Industrie Farmaceutiche Ruinite S.r.l.

Via Sette Santi, 3

50131 Florence

Italy

PL 10649/0001.

28 January 1993/1 May 2008

25 January 2012