Instructions Fastum gel 2.5% tube 100 g
Composition
active ingredient: ketoprofen;
1 g of gel contains ketoprofen 0.025 g;
excipients: carbomer, ethanol 96%, neroli flavoring, lavandin flavoring, triethanolamine, purified water.
Dosage form
Gel.
Main physicochemical properties: gel of mucous consistency, colorless or almost transparent, with a fragrant odor.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs for topical use. ATC code M02A A10.
Pharmacological properties
Pharmacodynamics.
Ketoprofen has anti-inflammatory and analgesic effects.
Ketoprofen, contained in the appropriate filler, reaches the area of inflammation through the skin and thus provides the possibility of local treatment of lesions of the joints, tendons, ligaments and muscles, accompanied by pain syndrome.
Pharmacokinetics.
Absorption of the drug applied to the skin into the general bloodstream is very slow. When applying 50 to 150 mg of ketoprofen, the concentration of the active substance in the blood plasma after 5–8 hours is only 0.08–0.15 μg/ml.
Indication
Post-traumatic pain in muscles and joints, tendon inflammation.
Contraindication
FASTUM® GEL is contraindicated in the following cases:
History of hypersensitivity to any of the excipients of the drug.
History of photosensitivity reaction.
Hypersensitivity reactions, such as asthma symptoms, allergic rhinitis and urticaria, have been reported with the use of ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers, or other perfume products.
Exposure to sunlight, even in the form of diffused light or UV radiation in a solarium, during treatment and for two weeks after its cessation (see section "Special precautions for use").
Application to skin with pathological changes, such as dermatosis, eczema or acne, to infected skin or to open wounds.
Application to the skin around the eyes.
Third trimester of pregnancy (see section "Use during pregnancy or breastfeeding").
Interaction with other medicinal products and other types of interactions
No interactions of FASTUM® GEL with other drugs have been observed. Interactions are unlikely, since serum concentrations after topical application are low. However, it is recommended to monitor the condition of patients receiving treatment with coumarin derivatives.
Application features
FASTUM® GEL should be used with caution in patients with cardiac, hepatic or renal insufficiency. Isolated cases of systemic adverse reactions associated with renal damage have been reported.
The use of the gel should not be combined with wearing an occlusive dressing.
The gel should not come into contact with mucous membranes and eyes.
Local application of large amounts of the drug may lead to systemic effects such as hypersensitivity and bronchial asthma.
The use, especially over a long period of time, of topical preparations may cause sensitization or local irritation.
If redness appears, treatment should be discontinued.
If any skin reactions develop, including those associated with concomitant use of products containing octocrylene, treatment with the gel should be discontinued immediately (octocrylene is an excipient used to prevent photodegradation of cosmetics and personal care products such as shampoos, aftershaves, shower and bath gels, skin creams, lipstick, anti-aging creams, makeup removers and hairsprays).
During treatment and for 2 weeks after its completion, it is recommended to wear clothing that covers the application area to avoid photosensitivity.
Hands should be washed thoroughly after each application of the medicinal product. The recommended duration of treatment should not be exceeded, as the risk of developing contact dermatitis and photosensitivity reactions increases over time.
Patients who have asthma in combination with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of developing an allergy to aspirin and/or nonsteroidal anti-inflammatory drugs than the rest of the population.
Habituation to the drug FASTUM® GEL does not develop.
Pediatric patients: The safety and efficacy of ketoprofen gel in children have not been established.
Use during pregnancy or breastfeeding
Clinical data are not available for the topical formulation. The following recommendations are based on data for the systemic formulation.
Pregnancy.
First and second trimester of pregnancy.
Since safety studies of ketoprofen in pregnant women have not been conducted, its use should be avoided during the first and second trimesters of pregnancy.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors, including ketoprofen, may cause toxic damage to the cardiovascular system and kidneys in the fetus.
At the end of pregnancy, bleeding time may be prolonged in both the mother and the child. Therefore, the use of ketoprofen is contraindicated during the third trimester of pregnancy.
The use of NSAIDs can also cause delayed labor.
Breast-feeding.
There are no data on the penetration of ketoprofen into breast milk after topical application. Traces of ketoprofen have been detected in breast milk after systemic application. The use of ketoprofen in breastfeeding mothers is not recommended.
During the first and second trimesters of pregnancy and during breastfeeding, FASTUM® GEL should be used only after consultation with a doctor and after a joint assessment of the benefit/risk ratio in each individual case. In case of probable or planned pregnancy, seek medical advice before using this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
The gel should be applied in a thin layer (3–5 cm) to the affected areas 1 to 3 times a day, and for better penetration, use light massage movements.
Children
The safety and effectiveness of ketoprofen gel for children have not been established.
Special precautions for disposal and other use.
Opening the soft aluminum tube: unscrew the cap and pierce the aluminum membrane with the tip located on the outside of the cap.
Preparing the tube with a dispenser for use: press the dispenser cap several times or press the base of the tube inward until the gel appears. When using, it is recommended to hold the tube in a horizontal position.
Overdose
With topical application, overdose is unlikely. Given the low level of ketoprofen in the blood plasma when applied to the skin, overdose phenomena can be excluded. In case of accidental ingestion of the gel, systemic side effects may develop, the severity of which depends on the amount of the drug swallowed. In these cases, symptomatic and supportive treatment should be carried out, as in the case of overdose with anti-inflammatory drugs used orally.
Side effects
Like all medicines, FASTUM® GEL can cause side effects, although not everybody gets them.
As with other topical medicinal products, undesirable effects may occur on the skin. Local skin reactions (e.g. erythema, itching and burning sensation) have been reported, which may extend beyond the application site and in some cases may be severe and generalised (e.g. bullous or phlyctenular eczema), in addition to hypersensitivity reactions and skin reactions (photosensitivity).
The frequency and severity of these effects are significantly reduced if exposure to sunlight, including solariums, is avoided during treatment and for two weeks after treatment.
Other systemic effects of NSAIDs: their development depends on the transdermal diffusion of the active substance and, therefore, on the amount of gel applied, the area of the lesion, the degree of skin integrity, the duration of treatment and the use of occlusive dressings (reactions from the digestive system and kidneys).
When analyzing adverse effects, the frequency of adverse reactions was determined as follows: very common (≥ 10%), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), unknown (frequency cannot be estimated from the available data).
Immune system disorders
Not known: anaphylactic reactions, including anaphylactic shock, angioedema, hypersensitivity reactions.
Gastrointestinal disorders
Very rare: peptic ulcer, gastrointestinal bleeding, diarrhea.
Skin and subcutaneous tissue disorders
Sometimes: local skin reactions such as erythema, eczema, itching and burning sensation.
Rare: Dermatological reactions (photosensitivity, bullous eruptions and urticaria). More severe adverse reactions such as bullous or phlyctenular eczema, which may spread or become generalized, develop extremely rarely.
Very rare: contact dermatitis.
Not known: bullous dermatitis.
Renal and urinary disorders
Very rare: renal failure or worsening of existing renal failure. Isolated cases of systemic adverse reactions such as renal impairment have been reported.
Elderly patients are particularly susceptible to developing adverse reactions to NSAIDs.
Reporting possible adverse reactions
Post-marketing adverse reaction reporting is very important. It allows for continued monitoring of the benefit-risk balance of a medicinal product. Healthcare professionals are encouraged to report any suspected adverse reactions.
Expiration date
5 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
No special storage conditions are required. Keep out of the reach of children.
Packaging
Tube containing 20 g or 30 g, or 50 g, or 100 g of gel; container with a mechanical dispenser containing 100 g of gel; 1 tube or 1 container in a cardboard box.
Vacation category
According to the recipe.
Producer
A. Menarini Manufacturing Logistics and Services S.r.L.
Location of the manufacturer and its business address
Via Sete Santi 3, 50131 Florence (FI), Italy.
Applicant
A. MENARINI Industrie Farmaceutiche Riunite S.r.L.
Location of the applicant and address of its place of business
Via Sete Santi 3, 50131 Florence, Italy.
