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A. Menarini Pharmaceuticals Ireland Ltd

2nd Floor, Castlecourt, Monkstown Farm, Monsktown, Glenageary, Co. Dublin, Ireland
Telephone: +353 1 284 6744
Fax: +353 1 284 6769
E-mail: ireland@menarini.ie
Medical Information Direct Line: 1800 283 045


Summary of Product Characteristics last updated on medicines.ie: 12/03/2013
SPC Fastum gel



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1. NAME OF THE MEDICINAL PRODUCT

Fastum 2.5% w/w Gel


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Fastum Gel contains Ketoprofen 2.5% w/w.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Gel.

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


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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4.2 Posology and method of administration

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.


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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 pathological skin changes such as eczema or acne or on infected skin, open wounds, lesions of the skin, or near the eyes.

• Third trimester of pregnancy (see section 4.6).


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4.4 Special warnings and precautions for use

• Although systemic effects should be low, ketoprofen should be used with caution in patients with severe renal impairment, or reduced cardiac, hepatic or renal function, history of peptic ulceration or inflammatory bowel disease or bleeding diathesis. Isolated cases of systemic adverse reactions consisting of renal dysfunction have been reported.

• Topical application of large amounts may result in systemic effects, including 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 increasing over time.

• Duration of treatment should be kept to a minimum as 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 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.

• 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.

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.

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


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4.5 Interaction with other medicinal products and other forms of interaction

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.


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4.6 Pregnancy and lactation

As there has been no such experience with the topical formulation, the following is stated according to the systemic formulation:

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.


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4.7 Effects on ability to drive and use machines

Not known.


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4.8 Undesirable effects

There have been reports of localised skin reactions which might subsequently 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: 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.

System Organ Class

Uncommon

Rare

Very rare

Immune system disorders

 

 

Anaphylactic reaction, Hypersensitivity reaction

Gastrointestinal disorders

 

 

Peptic ulcer, Gastrointestinal bleeding, Diarrhoea

Skin and subcutaneous tissue disorders

Erythema, Pruritus, Eczema, Burning sensation

Photosensitivity reaction, Dermatitis Bullous, Urticaria

Dermatitis contact, Angioedema

Renal and urinary disorders

 

 

Renal failure or insufficiency aggravated

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


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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 antiphlogistics.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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

ATC code: MO2AA10


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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 μg/mL approx. 5-8 hours after application.


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5.3 Preclinical safety data

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.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Carbomer 940

Ethanol

Neroli essence

Lavender essence

Trolamine

Purified water


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

i) Five years in aluminium tube

ii) Two years in polypropylene container.


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6.4 Special precautions for storage

Store below 25°C.

Replace the cap after use.

Keep the gel away from naked flames.


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6.5 Nature and contents of container

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.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

A Menarini Srl

1-3 via Sette Santi

Florence

Italy


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8. MARKETING AUTHORISATION NUMBER(S)

PA 512/1/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19th August 1992

Date of last renewal: 19th August 2007


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10. DATE OF REVISION OF THE TEXT

February 2013



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Active Ingredients

 
   Ketoprofen