Ketogel - zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KETOGEL-ZDOROVYE (KETOGEL-ZDOROVYE)

Composition:

Active ingredient: ketoprofen;

1 g of the preparation contains 25 mg of ketoprofen;

Excipients: carbomer, diisopropanolamine, ethanol 96%, peppermint oil, purified water.

Pharmaceutical form. Gel.

Main physico-chemical properties: viscous gel, colorless, transparent or almost transparent, with a characteristic odor.

Pharmacotherapeutic group. Topical non-steroidal anti-inflammatory drugs. 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 reach the site of inflammation, thereby enabling local treatment of joints, tendons, ligaments, and muscles affected by painful conditions.

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 amounts to only 0.08–0.15 μg/mL.

Clinical characteristics.

Indications.

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

Contraindications.

The medicinal product 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, for example asthma symptoms, allergic rhinitis, and urticaria, previously occurring in the patient upon administration of ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs).
• History of skin allergic reactions upon use of ketoprofen, tiaprofenic acid, fenofibrate, ultraviolet (UV) light blockers, or perfumed products.
• Exposure to sunlight (even diffused light) or UV irradiation in solarium during treatment with the gel and within 2 weeks after discontinuation of the gel (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 breastfeeding").

Interaction with other medicinal products and other types of interactions.

No interactions of the medicinal product with other drugs have been observed. Interaction is unlikely due to low serum concentration following topical application. However, monitoring of patients receiving treatment with coumarin derivatives is recommended.

Special precautions for use.

The medicinal product 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 kidney 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.

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

Use, especially prolonged, of topical medicinal products may cause sensitization or local irritation.

If redness occurs, treatment should be discontinued.

If any skin reactions develop, including those related to concomitant use of medicinal products containing octocrylene, treatment with the gel should be discontinued immediately (octocrylene is 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 sprays).

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 medicinal product does not develop.

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

Use during pregnancy or breastfeeding.

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

Pregnancy.

First and second trimesters of 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, the medicinal product 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 synthesis inhibitors, including ketoprofen, may cause toxic effects on the cardiovascular system and kidneys of the fetus. At the end of pregnancy, prolonged bleeding time may occur in both mother and child. Therefore, the use of ketoprofen is contraindicated during the third trimester of pregnancy.

The use of NSAIDs may also delay the onset of labor.

Period of breastfeeding.

There are no data on the passage of ketoprofen into breast milk following topical application.

After systemic administration, traces of ketoprofen have been detected in breast milk. Ketoprofen should not be used during breastfeeding.

During the first and second trimesters of pregnancy and during breastfeeding, the medicinal product should be used only after consultation with a physician and after joint assessment of the benefit-risk ratio in each individual case. In case of probable or planned pregnancy, a physician should be consulted before using this medicinal product.

Ability to influence reaction speed when driving or operating machinery.

Unknown.

Dosage and Administration.

For external use only.

Apply a 3-5 cm strip of gel as a thin layer to the skin over the affected area and gently rub in to facilitate absorption, 1–3 times daily. The duration of treatment should be determined individually by a physician.

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 dermal application, overdose symptoms are negligible. However, if the gel is accidentally ingested, systemic adverse effects may occur, the severity of which depends on the amount swallowed. In such cases, symptomatic and supportive treatment should be administered, as in overdose with orally administered anti-inflammatory agents.

Side effects

Like all medicinal products, ketoprofen may cause adverse reactions, although they do not occur in everyone.

Skin reactions are possible. There have been reports of local skin reactions (e.g., erythema, itching, and burning sensation), which may subsequently spread beyond the application site 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 discontinuation of treatment.

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

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), 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 disorders: frequency not known: anaphylactic reactions, including anaphylactic shock, angioedema, hypersensitivity reactions.

Gastrointestinal disorders: very rare: gastrointestinal bleeding, diarrhea, peptic ulcer.

Skin and subcutaneous tissue disorders: uncommon: local skin reactions such as erythema, eczema, itching, and burning sensation; rare: dermatological reactions: photosensitization, bullous rash, urticaria; very rare: contact dermatitis; frequency not known: bullous dermatitis. Severe adverse reactions such as bullous or vesicular eczema, which may spread and become generalized, occur very rarely.

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

Elderly patients are more susceptible to developing adverse reactions to NSAIDs.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after a medicinal product is authorized 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.

Shelf life. 2 years.

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

Keep out of the reach of children.

Packaging. 50 g or 100 g of gel in a tube, tube in a carton.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of its business operations.

22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.