1 NAME OF THE MEDICINAL PRODUCT

Fastum 2.5% gel.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Fastum Gel contains ketoprofen BP 2.5g/100g.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

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

4.1    Therapeutic indications

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

Fastum Gel is indicated in adults.

4.2    Posology and method of administration

Posology

Fastum gel should be applied to the affected area two or three times daily.

Maximum duration of use should not exceed 10 days.

Paediatric population

Not recommended in children under 12 years of age. The safety and efficacy of ketoprofen gel in children have not been established.

Method of administration

Adults and older people

Fastum Gel should be applied with gentle massage only.

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.

Contraindications

•    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

•    History of any photosensitivity reaction.

•    Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to 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.

•    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 sight and reach of children.

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.

Breast-feeding

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.

System Organ Class	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).
Infections and infestations				Secondary impetigo
Blood and lymphatic system disorders				Eosinophilia
Immune system disorders				Anaphylactic reaction, angioedema, hypersensitivity
Eye disorders				Eyelid oedema
Vascular disorders				Vasculitis
Gastrointestinal disorders				Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema
Skin and subcutaneous tissue disorders	Rash (erythematous, generalised, maculo- papular, papular, pruritic, pustular, vesicular), eczema, pruritus, burning sensation, application site burn	Dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, photosensitivity allergic reaction, skin exfoliation, skin oedema

Renal and urinary disorders			Acute renal failure, insufficiency aggravated
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.

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 via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

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.

5.1 Pharmacodynamic properties

Pharmacotherapeutic category: non-steroid anti-inflammatory drug for topical use. ATC code: MO2AA10

Mechanism of action

Ketoprofen is an inhibitor of both the cyclooxygenase 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.

5.2 Pharmacokinetic properties

Fastum gel 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

There are no preclinical data of relevance to the prescriber which are additional to that already included in other parts of the SPC.

6.1 List of excipients

Carbomer 940 Ethanol Neroli essence Lavender essence Triethanolamine Purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Tube:    60 months.

Dispenser:    24 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: 30g sample pack, 50g pack, 2x50g twin pack, 100g pack

Dispenser: rigid polypropylene dispenser containing 50g gel.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements for disposal.

7    MARKETING AUTHORISATION HOLDER

A Menarini Industrie Farmaceutiche Ruinite srl Via Sette Santi, 3 50131 Florence

Italy

8    MARKETING AUTHORISATION NUMBER(S)

PL 10649/0006

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10/09/2007

10 DATE OF REVISION OF THE TEXT

14/12/2015