Fastofen

INSTRUCTIONS FOR MEDICAL USE OF MEDICINAL PRODUCT

FASTOFEN (FASTOFEN)

Composition:

Active substance: ketoprofen;

1 g of gel contains 25 mg of ketoprofen;

Excipients: carbomer, 96% ethanol, lavender oil, neroli oil, diethanolamine, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: colorless, transparent or almost transparent gel with a specific odor. Opalescence and presence of a yellowish tint are permissible.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory drugs for topical use. ATC code M02A A10.

Pharmacological properties.

Pharmacodynamics.

Ketoprofen exerts anti-inflammatory and analgesic effects.

Ketoprofen contained in a suitable vehicle penetrates through the skin to the site of inflammation, thereby enabling local treatment of painful conditions affecting joints, tendons, ligaments, and muscles.

Pharmacokinetics.

Absorption of the drug applied to the skin into the systemic circulation occurs very slowly. When 50 to 150 mg of ketoprofen is applied, the plasma concentration of the active substance after 5–8 hours is only 0.08–0.15 μg/mL.

Clinical Characteristics.

Indications.

Post-traumatic pain in muscles and joints, tendon inflammation.

Contraindications.

The medicinal product Fastum gel is contraindicated in the following cases:

• History of hypersensitivity to any of the excipients of the medicinal product.
• History of photosensitivity reactions.
• Known hypersensitivity reactions, such as asthma symptoms, allergic rhinitis, and urticaria, occurring after intake of ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs).
• History of skin allergic reactions following the use of ketoprofen, tiaprofenic acid, fenofibrate, UV blockers, or other perfumery products.
• Exposure to sunlight, even in the form of diffused light, or UV irradiation in solarium during treatment and for 2 weeks after its discontinuation (see section "Special precautions").
• Application to skin with pathological changes, such as dermatosis, eczema, or acne, to infected skin, or to open wounds.
• Application to skin around the eyes.
• Third trimester of pregnancy (see section "Use during pregnancy or lactation").

Interaction with other medicinal products and other forms of interaction.

No interactions between Fastum and other medicinal products have been observed. Interaction is unlikely due to low plasma concentrations after topical application. However, monitoring of patients receiving treatment with coumarin derivatives is recommended.

Special precautions for use.

Fastum gel should be used with caution in patients with cardiac, hepatic, or renal impairment. There have been reports of isolated cases of systemic adverse reactions associated with renal damage.

Application of the gel should not be combined with the use of occlusive dressings.

The gel must not come into contact with mucous membranes or eyes.

Local application of large amounts of the drug may lead to systemic effects such as hypersensitivity and bronchial asthma.

Use of topical preparations, especially over prolonged periods, may lead to sensitization or local irritation.

If erythema occurs, treatment should be discontinued.

Treatment with the gel should be stopped immediately in case of any skin reactions, including those associated with concomitant use of medicinal products containing octocrylene (octocrylene – an excipient used to prevent photodegradation of cosmetic and personal hygiene products such as shampoos, after-shave lotions, shower and bath gels, skin creams, lipsticks, anti-aging creams, makeup removers, and hair lacquers).

During treatment and for 2 weeks after its completion, it is recommended to wear clothing covering the application site to avoid photosensitivity.

Hands should be thoroughly washed 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 suffering from asthma in combination with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of developing allergy to acetylsalicylic acid and/or NSAIDs than the general population.

Physical dependence on the drug does not develop.

Pediatric population: Safety and efficacy of ketoprofen in gel form have not been established in children.

Use during pregnancy or breastfeeding.

Clinical data on the topical formulation are lacking. The recommendations below are based on data concerning systemic formulations.

Pregnancy

First and second trimesters of pregnancy

There are no clinical data on the use of topical forms of ketoprofen during pregnancy. Even though systemic exposure is lower compared to oral administration, it is unknown whether the systemic exposure to ketoprofen achieved after topical application may be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, Fastum gel should not be used except in cases of extreme necessity. If used, the dose should be as low as possible and the duration of treatment as short as possible.

Third trimester of pregnancy

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including ketoprofen, may cause cardiovascular and renal toxicity in the fetus. Prolonged bleeding may occur in both mother and child towards the end of pregnancy, and labor may be prolonged. Therefore, Fastum gel is contraindicated during the last trimester of pregnancy (see section "Contraindications").

Breastfeeding period

There are no data on penetration of topically applied ketoprofen into breast milk. After systemic administration, traces of ketoprofen have been detected in breast milk. 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 physician and after individual benefit-risk assessment. In case of probable or planned pregnancy, medical advice should be sought before using this drug.

Ability to influence reaction rate when driving vehicles or operating machinery.

Unknown.

Method of Administration and Dosage

Apply a thin layer (3–5 cm) of the gel to the affected areas from 1 to 3 times daily. For better penetration, gently massage the area.

Children

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

Overdose

Overdose is unlikely with topical application. Given the low plasma levels of ketoprofen following skin application, overdose symptoms can be ruled out. However, if the gel is accidentally ingested, systemic adverse effects may develop, the severity of which depends on the amount ingested. In such cases, symptomatic and supportive treatment should be administered, as in overdose with orally administered anti-inflammatory medicinal products.

Side effects.

Like all medicinal products, Fastofen may cause adverse reactions, although they do not occur in every individual.

As with other topically applied medicinal products, undesirable effects may occur on the skin. Reports have been received of local skin reactions (e.g., erythema, pruritus, and burning sensation), which may subsequently spread beyond the site of application and, in some cases, may be severe and become generalized (e.g., bullous or vesicular eczema), in addition to hypersensitivity reactions and skin reactions (photosensitivity).

The frequency and severity of these adverse reactions are significantly reduced if exposure to sunlight, including visits to solariums, is avoided during treatment and for two weeks after treatment.

Other systemic effects of NSAIDs: their occurrence depends on transdermal diffusion of the active substance and thus on the amount of gel applied, the size of the affected area, the integrity of the skin, duration of treatment, and use of occlusive dressings (gastrointestinal and renal reactions).

When analyzing adverse reactions, the frequency of occurrence was defined 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), frequency not known (based on available data, frequency cannot be estimated).

Immune system

Frequency not known: anaphylactic reactions, including anaphylactic shock, angioedema, hypersensitivity reactions.

Gastrointestinal system

Very rare: peptic ulcer, gastrointestinal bleeding, diarrhea.

Skin and subcutaneous tissue

Uncommon: local skin reactions such as erythema, eczema, pruritus, and burning sensation.

Rare: dermatological reactions (photosensitization, bullous eruptions, urticaria). More severe adverse reactions such as bullous or vesicular eczema, which may spread or become generalized, occur very rarely.

Very rare: contact dermatitis.

Frequency not known: bullous dermatitis.

Renal and urinary system

Very rare: renal failure or worsening of pre-existing renal condition. Isolated cases of systemic adverse reactions, such as renal disorders, have been reported.

Elderly patients are particularly susceptible to adverse reactions following NSAID use.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 g in a tube, 1 tube per carton.

50 g in a tube, 1 tube per carton.

Prescription status.

Prescription only.

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and location of business activity.

1, Gordienkivska Street, Kharkiv, Kharkiv Oblast, Ukraine, 61010.