ROKIFEN [Ibuprofen] 50 mg Gel for external use

instructions for the medical use of the medicinal product

ROKIFEN

Tradename: Rokifen, Рокифен

International non-proprietary name or generic name: ibuprofen, ибупрофен

Dosage form: gel for external use.

Composition per 1 g of gel:

active substance: ibuprofen 50 mg, 

excipients: carbomer 940, glycerin, triethanolamine, polysorbate 80, ethyl alcohol, ethylparaben, aloe, purified water.

Pharmacotherapeutic group: Nonsteroidal anti-inflammatory drugs (NSAIDs) for external use

ATX code: M02A A13

Pharmacological properties

Pharmacodynamics

Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs. Has a double effect: analgesic and anti-inflammatory. Ibuprofen, being a derivative of propionic acid, indiscriminately blocks cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), as a result of which it inhibits the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction.

When applied to the skin, the gel has an additional cooling effect due to the rapid evaporation of the ethyl alcohol contained in the composition.

Pharmacokinetics

After application to the skin, ibuprofen is detected in the epidermis and dermis after 24 hours. The maximum plasma concentration of ibuprofen when applied topically is 5% of the maximum concentration level when using oral forms of ibuprofen. Clinically significant systemic absorption practically does not occur.

Metabolized in the liver. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.

Indications for use

As a local analgesic and anti-inflammatory agent for conditions such as muscle pain, back pain, arthritis, pain from ligament injuries and sprains, sports injuries and neuralgia.

Contraindications

• hypersensitivity to ibuprofen or other components included in the drug;

• a history of hypersensitivity reactions (bronchial asthma, rhinitis, Quincke's edema, urticaria) in response to the use of acetylsalicylic acid or other NSAIDs;

• violations of the integrity of the skin at the site of application of the drug (including infected wounds and abrasions, weeping dermatitis, eczema);

• pregnancy;

• breastfeeding period;

• children under 12 years of age.

Method of administration and dosage

For external use.

Squeeze 4-10 cm of the product onto your hand (corresponds to approximately 50-125 mg of ibuprofen) and gently rub the gel into the skin until completely absorbed.

Immediately after using the drug, you should wash your hands.

The drug should be reused no earlier than after 4 hours. The drug should not be used more than four times within 24 hours. The maximum daily dose is 500 mg.

If symptoms persist or worsen within two weeks of using the drug, you should stop treatment and consult a doctor.

Do not exceed the indicated dose.

Side effect

From the immune system: nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, Quincke's edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome (erythema multiforme).

From the digestive system: abdominal pain, dyspepsia.

From the kidneys and urinary tract: impaired renal function.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction with other medicinal products

Drug interactions between ibuprofen in the form of a gel for external use and other drugs have not been described. Use with caution simultaneously with the following drugs: anticoagulants and thrombolytic drugs, antihypertensive drugs, acetylsalicylic acid, other NSAIDs. It should be borne in mind that even with topical use of ibuprofen, its systemic effect cannot be completely excluded and, theoretically, side effects may increase when the drug is used simultaneously with other NSAIDs.

Special instructions and precautions

Before using the drug, consult your doctor.

Avoid contact with eyes, lips and other mucous membranes, inflamed or damaged areas of skin.

Do not use in combination with an occlusive (sealed) medical dressing.

Avoid excessive exposure to sunlight on the area of application of the drug.

Use with caution in case of: bronchial asthma or allergic diseases in the acute stage or in history - bronchospasm may develop; renal failure; liver failure; gastric ulcer, including a history of enteritis, colitis; hemorrhagic diathesis, pregnancy I-II trimester; breastfeeding.

Overdose

The likelihood of an overdose of the drug in gel form is minimal. If the drug is accidentally taken orally, the following symptoms may occur: headache, vomiting, decreased blood pressure.

Treatment: gastric lavage (only within an hour after administration), taking activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy.

Release form

50 g each in an aluminum tube with a polypropylene cap. One tube along with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 30°C.

Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiration date stated on the package.

Vacation conditions

By prescription.