Active substanceKetoprofenKetoprofen
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  • Pharmacotherapeutic group:non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    M.02.A.A.10   Ketoprofen

    Contraindications:

    - Hypersensitivity to ketoprofen or other components of the drug, as well as to salicylates, tiaprofenic acid or other non-steroidal anti-inflammatory drugs, fenofibrate, blockers of UV rays, fragrances;

    - an indication in an anamnesis for seizures of bronchial asthma after the application of NSAIDs and salicylates;

    - III trimester of pregnancy;

    - Children's age (up to 15 years);

    - violation of the integrity of the skin (eczema, dandruff, open or infected wound);

    - photosensitivity reaction in the anamnesis;

    - exposure to sunlight, incl. indirect sunlight and ultraviolet irradiation in the solarium throughout the treatment period and 2 more weeks after discontinuation of treatment with the drug.

    Side effects:

    Side effect

    The most frequent manifestations associated with the use of a cream containing ketoprofen, are local manifestations.

    Classification of adverse reactions by the frequency of their detection: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000).

    Allergic reactions: very rarely - angioedema, anaphylaxis.

    From the skin and skin appendages: infrequently - erythema, itching, burning, eczema, transient dermatitis of mild severity; rare - hives, rashes, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely - a single case of severe contact dermatitis (against a background of poor hygiene and insolation), a single case of severe generalized photodermatitis, toxic epidermal necrolysis.

    From the respiratory system: very rarely - asthmatic attacks as a variant of an allergic reaction.

    From the urinary system: very rarely - deterioration of kidney function in patients with chronic renal failure.

    Special instructions:

    You should avoid getting the cream in the eyes, on the skin around the eyes, mucous membranes.

    If any side effects occur, discontinue use and consult a doctor.

    If you forget to apply the cream, apply it at the time when the next dose should be applied, but do not double it.

    Cream for external use Ketonal® can be used in combination with other dosage forms of Ketonal®(capsules, tablets, candles). The total daily dose, regardless of the dosage form, should not exceed 200 mg.

    When skin reactions appear, including those that develop when combined with octocrylene-containing drugs, treatment should be discontinued immediately.

    To reduce the risk of photosensitivity, it is recommended to protect the creamy areas of the skin with clothing from exposure to UV radiation throughout the treatment period and for another 2 weeks after discontinuation of use. Do not use in the form of occlusive dressings.

    Wash hands thoroughly after each application.

    Effect on the ability to drive transp. cf. and fur:

    Data on the negative effect of Ketonal® cream on the ability to drive vehicles and engage in other potentially dangerous activities that require concentration and speed of psychomotor reactions are not present.

    Form release / dosage:Cream for external use 5%.
    Packaging:Tubes of 30 or 50 g in a cardboard bundle.
    Terms of leave from pharmacies:Without recipe
    Registration number:P N 013942/04
    Date of registration:19.11.2007
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    LEK d.d. Slovenia
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp22.05.2015
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