Ketonal, gel 2.5% 100 g

Symptomatic therapy of painful and inflammatory processes of different genesis, including:

– rheumatoid arthritis and periarthritis;

– ankylosing spondylitis (Bechterew’s disease);

– psoriatic arthritis;

– reactive arthritis (Reiter’s syndrome);

– osteoarthritis of various localizations;

– tendinitis, bursitis;

– myalgia; <

– neuralgia;

– sciatica;

– musculoskeletal injuries (including sports.

– injuries of the musculoskeletal system (including sports), muscle and ligament contusions, sprains, tears of ligaments and tendons of muscles.

Indications

Symptomatic treatment of painful and inflammatory processes of various origins, including:

– rheumatoid arthritis and periarthritis;

— ankylosing spondylitis (ankylosing spondylitis);

– psoriatic arthritis;

– reactive arthritis (Reiter’s syndrome);

— osteoarthritis of various localizations;

– tendinitis, bursitis;

– myalgia;

– neuralgia;

– radiculitis;

– injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and tendons.

Pharmacological effect

Pharmacological action

Special instructions

It is necessary to avoid getting the gel in the eyes, on the skin around the eyes, and mucous membranes.

If any side effects occur, you should stop using the drug and consult a doctor.

If the patient forgets to apply the gel, it should be used at the time the next dose is due, but not doubled.

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

If skin reactions occur, incl. developed during combined use with octocrylene-containing drugs, treatment should be stopped immediately.

To reduce the risk of developing photosensitivity, it is recommended to protect the skin areas treated with the gel with clothing from exposure to ultraviolet radiation throughout the entire treatment period and for another 2 weeks after stopping use of the gel.

Do not use as occlusive dressings.

You should wash your hands thoroughly after each application of the drug.

Impact on the ability to drive vehicles and operate machinery

There is no data on the negative effect of the drug Ketonal® gel on the ability to drive vehicles and other potentially hazardous activities that require concentration and speed of psychomotor reactions.

Active ingredient

Ketoprofen

Composition

Active substances:

ketoprofen 25 mg

Excipients:

(carbomer – 20 mg, trolamine (triethanolamine) – 37 mg,

ethanol 96% – 285 mg,

lavender oil (lavender essential oil) – 0.28 mg,

water – 632.72 mg) – 1 g.

Pregnancy

The drug is contraindicated for use in the third trimester of pregnancy.

Use in the first and second trimesters is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk for the fetus.

The use of Ketonal® during lactation (breastfeeding) is not recommended.

Contraindications

– hypersensitivity to the components of the drug;

– hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate, UV blockers, fragrances;

— violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound);

– history of attacks of bronchial asthma caused by taking NSAIDs and salicylates;

– history of photosensitivity reactions;

— exposure to sunlight, incl. indirect sunlight and UV irradiation in a solarium throughout the entire treatment period and for another 2 weeks after stopping treatment;

— III trimester of pregnancy;

– children under 15 years of age.

With caution: impaired liver and/or kidney function, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, bronchial asthma, chronic heart failure.

Side Effects

Local reactions occur most often.

Determination of the frequency of adverse reactions: very often (≥1/10), often (≥1/100 and

Allergic reactions: very rarely – angioedema, anaphylaxis.

From the skin and skin appendages: infrequently – erythema, itching, burning, eczema, mild transient dermatitis; rarely – urticaria, rash, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely – a single case of severe contact dermatitis (due to 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 – a single case of deterioration of renal function in a patient with chronic renal failure; in isolated cases – interstitial nephritis.

Interaction

Since the concentration of the drug in the blood plasma is extremely low, symptoms of interaction with other drugs (similar symptoms with systemic use) are possible only with frequent and prolonged use.

The simultaneous use of other forms for external and local use (ointments, gels) containing ketoprofen or other NSAIDs is not recommended.

Simultaneous administration of acetylsalicylic acid reduces the degree of binding of ketoprofen to plasma proteins.

Ketoprofen reduces the excretion of methotrexate and increases its toxicity.

Interaction with other drugs and the effect on their elimination are not significant.

Patients taking coumarin-containing anticoagulant drugs are advised to undergo treatment under medical supervision.

Overdose

Symptoms: irritation, erythema, itching.

Treatment: stop using the drug, rinse the skin thoroughly with running water. The patient needs to see a doctor.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life

3 years.

Manufacturer

Salutas Pharma GmbH, Germany