We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

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: medinfo@menarini.ie
Medical Information Direct Line: 1800 283 045

Summary of Product Characteristics last updated on medicines.ie: 29/10/2015
SPC Fastum 2.5% w/w gel

Go to top of the page

Fastum 2.5% w/w Gel

Go to top of the page

Fastum Gel contains Ketoprofen 2.5% w/w.

For the full list of excipients, see section 6.1.

Go to top of the page


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

Go to top of the page

Go to top of the page
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.

Fastum Gel is indicated in adults.

Go to top of the page
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.

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

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

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. After application gel should be rubbed well to ensure local absorption of ketoprofen

Go to top of the page
4.3 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.

• 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).

Go to top of the page
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 sight and reach 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.

Go to top of the page
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.

4.6 Fertility, pregnancy and lactation

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


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.


No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

Go to top of the page
4.7 Effects on ability to drive and use machines

Not known.

Go to top of the page
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



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.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Go to top of the page
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.

Go to top of the page

Go to top of the page
5.1 Pharmacodynamic properties

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

ATC code: MO2AA10

Go to top of the page
5.2 Pharmacokinetic properties


By cutaneous route, absorption is 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.


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.

Go to top of the page
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.

Go to top of the page

Go to top of the page
6.1 List of excipient(s)

Carbomer 940


Neroli essence

Lavender essence


Purified water

Go to top of the page
6.2 Incompatibilities

Not applicable.

Go to top of the page
6.3 Shelf life

i) Five years in aluminium tube

ii) Two years in polypropylene container.

Go to top of the page
6.4 Special precautions for storage

Store below 25°C.

Replace the cap after use.

Keep the gel away from naked flames.

Go to top of the page
6.5 Nature and contents of container

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


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

Not all pack sizes may be marketed.

Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements for disposal.

Go to top of the page

A Menarini Industrie Farmaceutische Riunite S.r.l.

1-3 via Sette Santi



Go to top of the page

PA 512/1/1

Go to top of the page

Date of first authorisation: 19th August 1992

Date of last renewal: 19th August 2007

Go to top of the page

October 2015

Link to this document from your website:

Document Links

  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Active Ingredients