429871

SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT

Fastum Gel
QUALITATIVE AND QUANTITATIVE COMPOSITION

Fastum gel contains Ketoprofen BP 2.5g/100g.
PHARMACEUTICAL FORM
A colourless, almost transparent, non greasy, non staining gel, with an aromatic fragrance
for topical application.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the local relief of pain and inflammation associated with soft tissue injuries and acute
strains and sprains.
4.2
Posology and method of administration

Fastum gel should be applied to the affected area two or three times daily. Maximum
duration of use should not exceed 10 days. Fastum gel should be applied with gentle
massage only.
Adults and elderly: Tube or dispenser: Apply 5-10cm 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
4.4
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).
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).
Infections and infestations

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.
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
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.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Fastum gel contains the following excipients: carbomer 940, ethanol, neroli
essence, lavender essence, triethanolamine, purified water.
6.2
Incompatibilities
Not applicable.
6.3
Shelf life
Tube:
60 months.
Dispenser:
6.4
24 months
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 gel.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal

Not applicable.
MARKETING AUTHORISATION HOLDER

A Menarini Industrie Farmaceutiche Ruinite srl
Via Sette Santi, 3
50131 Florence
Italy
MARKETING AUTHORISATION NUMBER(S)

PL 10649/0006
DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION
10/09/2007
10
DATE OF REVISION OF THE TEXT

26/02/2013

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SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

QUALITATIVE AND QUANTITATIVE COMPOSITION

Posology and method of administration

History of any photosensitivity reaction.

Special warnings and precautions for use

Interaction with other medicinal products and other forms of interaction

Fertility, pregnancy and lactation

Effects on ability to drive and use machines

Infections and infestations

Not known: Eosinophilia

Not known: Anaphylactic reaction, angioedema, hypersensitivity

Not known: Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema

Uncommon: Rash (erythematous, generalised, maculo-papular, papular, pruritic,

Not known: Wound complication

Preclinical safety data

Special precautions for storage

Nature and contents of container

Special precautions for disposal

MARKETING AUTHORISATION HOLDER

MARKETING AUTHORISATION NUMBER(S)

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

DATE OF REVISION OF THE TEXT

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