Powergel 2.5% Gel
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
POWERGEL 2.5% gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Powergel contains ketoprofen BP 2.5g/100g.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A colourless, non-greasy, non-staining gel with an aromatic fragrance for topical application
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For local relief of pain and inflammation associated with soft tissue injuries and acute strains and sprains.
4.2 Posology and method of administration
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.
Adults and elderly: Tube or dispenser: Apply 5 to 10cm of
gel (100-200mg ketoprofen) with each application; for the pump dispenser push the pump 3-6 times.
Children under 12 years of age: Not recommended as experience in
children is limited.
4.3
Contraindications
• 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 or infected wounds or lesions of the skin, such as occurs, for example, with eczema or acne, or near the eyes.
• Third trimester of pregnancy (see section 4.6).
4.4 Special warnings and precautions for use
• The gel should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions affecting renal function have been reported.
• The topical use of large amounts of product may give rise to systemic effects such as hypersensitivity and asthma.
• The treatment should be interrupted if rash appears.
• The recommended length of treatment should not be exceeded due to the risk of developing contact dermatitis and photosensitivity reactions increases over time.
• 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 dressings.
• The gel must not come into contact with mucous membranes.
• 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 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.
Paediatrics: The safety and efficacy of ketoprofen gel in children have not
been established.
4.5 Interaction with other medicinal products and other forms of interaction
Interactions are unlikely as serum concentrations following topical administration are low. It is, however, advisable to monitor patients under treatment with coumarinic substances.
4.6 Fertility, pregnancy and lactation
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.
Lactation
No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.
4.7 Effects on ability to drive and use machines
Not known.
4.8 Undesirable effects
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, pruritus 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.
The following CIOMS frequency rating is used: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Not known: Secondary impetigo
Blood and lymphatic system disorders Not known: Eosinophilia
Immune system disorders
Not known: Anaphylactic reaction, angioedema, hypersensitivity Eye disorders
Not known: Eyelid oedema
Vascular disorders Not known: Vasculitis
Gastrointestinal disorders
Not known: Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema Skin and subcutaneous tissue disorders
Uncommon: Rash (erythematous, generalised, maculo-papular, papular, pruritic, pustular, vesicular), eczema, pruritus, burning sensation, application site burn
Rare: Dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, photosensitivity allergic reaction, skin exfoliation, skin oedema,
Renal and urinary disorders
Very rare: Acute renal failure, insufficiency aggravated
General disorders and administration site Conditions
Not known: Pyrexia
Injury, poisoning and procedural complications Not known: Wound complication
Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs.
4.9 Overdose
Overdose is unlikely to be caused by topical administration. If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be symptomatic and supportive in accordance with overdosage of oral anti-inflammatories.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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 antiinflammatory, 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.
5.2 Pharmacokinetic properties
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 pg/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.
5.3 Preclinical safety data
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Powergel contains the following excipients: carbomer 940, ethanol, neroli essence, lavender essence, trolamine, purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Tube and dispenser: 60 months.
6.4 Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
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.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
A Menarini Industrie Farmaceutiche Ruinite S.r.l.
Via Sette Santi, 3 50131 Florence Italy
8 MARKETING AUTHORISATION NUMBER(S)
PL 10649/0001.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/05/2008
10 DATE OF REVISION OF THE TEXT
26/02/2013