SERTOFEN

INSTRUCTIONS for medical use of the medicinal product SERTOFEN (SERTOFEN)

Composition:

Active substance: dexketoprofen;

1 g of gel contains dexketoprofen (in the form of trometamol) 12.5 mg;

Excipients: carbomer homopolymer, ethanol 96%, lavender oil, menthol, sodium hydroxide, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: opaque grayish-white homogeneous gel with the odor of lavender, mint, and alcohol.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory drugs for topical use. ATC code M02A A27.

Pharmacological properties.

Pharmacodynamics.

Dexketoprofen trometamol is the trometamol salt of (S)-(+)-2-(3-benzoylphenyl) propionic acid and the active enantiomer of the non-steroidal anti-inflammatory drug (NSAID) ketoprofen.

Its mechanism of action is based on reducing the synthesis of prostaglandins through inhibition of cyclooxygenase (COX). Specifically, the conversion of arachidonic acid into cyclic endoperoxides PGG2 and PGH2 is inhibited, from which prostaglandins PGE1, PGE2, PGF2α, PGD2, as well as prostacyclin PGI2 and thromboxanes TxА2 and TxВ2 are formed. In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators such as kinins, which may also indirectly influence the primary action of dexketoprofen.

It has been demonstrated that ketoprofen is an effective analgesic, anti-inflammatory, and antipyretic agent exclusively in the form of its enantiomer.

Studies on COX inhibition have shown that the R(-)-enantiomer is pharmacologically inactive, while the S(+)-enantiomer, or dexketoprofen, is responsible for the pharmacological activity of the racemate. In vivo studies in animals and humans confirm these findings.

Pharmacokinetics.

When the gel is applied topically, a high local concentration of dexketoprofen is achieved, while its plasma concentration remains very low. Clinical pharmacokinetic studies indicate that after application and absorption through the skin, the maximum plasma concentration of dexketoprofen is reached within 4 hours.

Therapeutically active concentrations have been detected in synovial fluid. It has been noted that the level of dexketoprofen (when applied at a concentration of 12.5 mg/g) in synovial fluid is equivalent to or higher than that of racemic ketoprofen (when applied at a concentration of 25 mg/g).

Inversion of the active (S)-enantiomer into the inactive (R)-enantiomer does not occur.

Dexketoprofen is eliminated from the body within 24 hours.

Clinical characteristics.

Indications.

Inflammation and pain in joints, tendons, ligaments, and muscles caused by injuries and degenerative diseases.

Contraindications.

• Hypersensitivity to the active ingredient or to any of the excipients of the medicinal product.
• Known hypersensitivity reactions, such as bronchial asthma symptoms or allergic rhinitis, occurring after administration of dexketoprofen, ketoprofen, tiaprofenic acid, acetylsalicylic acid, other NSAIDs, or other components of the medicinal product.
• History of photosensitization reactions.
• History of skin allergic reactions upon exposure to dexketoprofen, ketoprofen, tiaprofenic acid, fenofibrate, ultraviolet (UV) blockers, or perfumes.
• Exposure to sunlight (even diffused light) or UV irradiation in solariums during treatment with the medicinal product and within 2 weeks after discontinuation of therapy.
• Do not apply the medicinal product on open wounds, infected skin, mucous membranes, eczema, acne, genital areas, eyes, or periorbital area.

Interaction with other medicinal products and other types of interactions.

Interaction is unlikely, as plasma concentrations of dexketoprofen are negligible following topical application.

Special precautions for use

If any skin reactions occur, including those associated with concomitant use of products containing octocrylene, application of the medicinal product should be discontinued immediately.

To prevent the development of skin photosensitization reactions, it is recommended to protect with clothing the skin areas to which the medicinal product is applied, both during application and for 2 weeks after discontinuation.

After each application of the medicinal product, hands should be thoroughly washed to avoid transferring the gel to other areas of the body.

After application of the medicinal product, occlusive dressings should not be used and tight clothing should be avoided.

Cross-reactions may occur when dexketoprofen is used concomitantly with certain sunscreen creams, fenofibrate, and other products containing benzophenone in their chemical structure.

Warnings about excipients

This medicinal product contains alcohol (ethanol). Alcohol (ethanol) may cause a burning sensation on damaged skin.

This medicinal product contains lavender oil, which may cause allergic reactions.

Use during pregnancy or breastfeeding

Pregnancy

As the safety of using dexketoprofen in pregnant women has not been established, use of the medicinal product during pregnancy should be avoided.

Breastfeeding period

There are no data on the excretion of dexketoprofen into breast milk. The medicinal product is not recommended during breastfeeding.

Ability to affect reaction speed when driving or operating machinery

No data available.

Method of Administration and Dosage.

The medicinal product is intended for topical use. Generally, it is recommended to apply it 2–3 times daily. The amount of gel depends on the size of the affected area. The daily dose should not exceed 7.5 g, corresponding to approximately 14 cm of gel. The gel should be gently rubbed in to facilitate absorption. The duration of treatment should not exceed 7 days.

Children.

Indications and dosage of dexketoprofen in children under 18 years of age have not been established.

Overdose.

Overdose with topical application is unlikely. In case of accidental ingestion, gastric lavage and symptomatic therapy are indicated. Dexketoprofen may be removed by dialysis.

Side effects

Adverse reactions are classified by organ systems and frequency of occurrence: 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), unknown (frequency cannot be determined from available data).

Immune system disorders:

Very rare: systemic hypersensitivity reactions (urticaria, bronchospasm).

Skin and subcutaneous tissue disorders:

Uncommon: dermatitis (erythema, pruritus, inflammation, burning sensation); rare: serious skin reactions such as bullous dermatitis (including exfoliative), which may spread and become generalized; unknown: photosensitization reactions (erythema, inflammation, and in some cases mild vesiculation).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, 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.

Storage conditions

Store at temperatures not exceeding 25°C, in a place inaccessible to children.

Packaging

60 g in a tube; 1 tube in a cardboard box.

Prescription status

Prescription-only medicine.

Manufacturer

UORLД MEDICINE ILAC SAN. VE TIC. A.Ш./
WORLD MEDICINE ILAC SAN. VE TIC. A.S.

Manufacturer's address and location of business activity

15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey

Marketing Authorization Holder

LLC "WORLD MEDICINE", Ukraine
WORLD MEDICINE, LLC, Ukraine