Febrofid (Gel) Instructions for Use

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Manufactured By

Pharmaceutical Works “Polpharma” SA Medana Branch In Sieradz (Poland)

Contact Information

AKRIKHIN JSC (Russia)

ATC Code

M02AA10 (Ketoprofen)

Active Substance

Ketoprofen (Rec.INN registered by WHO)

Dosage Form

Febrofid

Gel for external use 2.5%: tubes 30 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use transparent or slightly opalescent, from colorless to light yellow.

Excipients : macrogol 200 – 5 g, methylparahydroxybenzoate – 0.15 g, propylparahydroxybenzoate – 0.05 g, carbomer 980 – 1.5 g, trolamine – 2.5 g, purified water – up to 100 g.

30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID for external use. It has anti-inflammatory, anti-exudative, and analgesic effects.

It is used for lesions of joints, tendons, ligaments, muscles, skin, veins, lymphatic vessels, and lymph nodes. In joint syndrome, it leads to a reduction of joint pain at rest and during movement, reduces morning stiffness and joint swelling.

Pharmacokinetics

Ketoprofen penetrates well through the skin, providing local analgesic and anti-inflammatory effects. The bioavailability of the gel is about 5%. Plasma protein binding is 99%. It does not accumulate in the body.

It is metabolized in the liver. About 80% of the administered dose is excreted in the urine as metabolites, less than 10% is excreted unchanged.

Indications

As a drug for external use in the symptomatic treatment of

• Back pain;
• Neuralgia;
• Myalgia;
• Inflammatory and degenerative diseases of the musculoskeletal system (including arthritis, bursitis, synovitis, tendinitis, lumbago);
• Uncomplicated injuries (including sports injuries, dislocations, sprains or ruptures of ligaments and tendons, contusions, post-traumatic pain);
• As part of combination therapy for inflammatory diseases of the veins (phlebitis, periphlebitis), lymphatic vessels, lymph nodes (lymphangitis, superficial lymphadenitis).

ICD codes

Dosage Regimen

Apply the gel externally only.

Use a small amount, equivalent to a 3-5 cm strip, on the affected skin area.

Gently rub the gel into the skin until fully absorbed.

Apply the gel two to three times daily.

The maximum daily dose should not exceed the amount applied to a body surface area of 1000 cm².

Do not apply the gel to open wounds, abrasions, or mucous membranes.

Avoid contact with eyes; if contact occurs, rinse thoroughly with water.

Wash hands immediately after application, unless the hands are the treated area.

Do not use with occlusive dressings.

The duration of treatment depends on the indication and clinical response.

For uncomplicated injuries, treatment is typically short-term.

For chronic conditions, treatment duration should be reassessed periodically.

Discontinue use if a skin rash or other signs of hypersensitivity occur.

Do not expose treated areas to direct sunlight or UV rays due to risk of photosensitivity.

Use with caution in patients with severe hepatic or renal impairment during long-term therapy.

Adverse Reactions

Possible allergic reactions, skin hyperemia, photosensitization, skin exanthema, purpura.

Contraindications

• Weeping dermatoses, eczema;
• Infected abrasions, wounds, burns;
• Third trimester of pregnancy;
• Lactation period (breastfeeding);
• Hypersensitivity to ketoprofen and/or other components of the drug;
• Hypersensitivity to other NSAIDs (Ketoprofen may cause bronchospasm in individuals sensitive to acetylsalicylic acid and other NSAIDs).

Use in Pregnancy and Lactation

The drug can be used in the first and second trimesters of pregnancy only if necessary. The use of the drug is contraindicated in the third trimester of pregnancy.

It is not recommended to use the drug during breastfeeding.

Use in Hepatic Impairment

Caution is necessary with long-term use in patients with severe hepatic insufficiency.

Use in Renal Impairment

Caution is necessary with long-term use in patients with severe renal insufficiency.

Special Precautions

Avoid contact of the gel with mucous membranes and eyes.

The drug should not be applied to damaged areas of the skin.

Caution is necessary with long-term use in patients with severe hepatic or renal insufficiency.

If a rash appears, it is necessary to discontinue the use of the drug and carry out appropriate therapy.

Overdose

Due to low systemic absorption, an overdose of Febrofid is unlikely.

Drug Interactions

With frequent and prolonged use, symptoms of interaction with other drugs may appear (the same as with systemic use).

Concomitant use with other NSAIDs, glucocorticosteroids, ethanol, and corticotropin may lead to ulcer formation and the development of gastrointestinal bleeding.

Concomitant use with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandole increases the risk of bleeding.

Ketoprofen reduces the effect of antihypertensive drugs and diuretics (inhibition of prostaglandin synthesis).

It enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose adjustment is necessary). Concomitant use with sodium valproate causes impaired platelet aggregation. It increases the plasma concentration of verapamil and nifedipine.

Storage Conditions

The drug should be stored in a place protected from light and out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.