Fort-gel 2.5% tube 50 g

1 g of gel contains (active ingredient) 0.025 g of ketoprofen.

Excipients: ethanol 96%, carbomer, triethanolamine, lavender oil, purified water.

1. Hypersensitivity to ketoprofen or to any other excipients of the drug, salicylates and other NSAIDs.
2. Known hypersensitivity reactions, e.g. symptoms of bronchial asthma, allergic rhinitis or urticaria after the use of ketoprofen, other non-steroidal anti-inflammatory drugs, acetylsalicylic acid, fenofibrate, tiaprofenic acid. Exacerbation of gastric or duodenal ulcer. History of gastrointestinal bleeding. Chronic dyspepsia (discomfort and pain in the upper abdomen). Severe renal failure. Damage and diseases of the skin, skin injuries, irritation, itching, acne, burns (rash, eczema, skin infections). The gel should not be applied to damaged skin (dermatoses, open and infected wounds). Do not use airtight dressings.
3. Any photosensitivity reactions in history. History of skin allergic reactions to ketoprofen, other excipients of the drug, fenofibrate, tiaprofenic acid, ultraviolet (UV) blockers or perfumes. Exposure to sunlight (even on a foggy day), including indirect sunlight and UV exposure in a solarium during the entire treatment period and for two weeks after stopping treatment.
4. Pregnancy (III trimester), breastfeeding period.

Gel for external use. The drug is applied in a thin layer (3-5 cm of gel), gently rubbed until completely absorbed 2 times a day. The duration of the course of treatment is determined by the doctor individually, but it is recommended to use the drug for no more than 10 days.

“Fort-gel” can be combined with other dosage forms of ketoprofen (capsules, tablets, rectal suppositories). The total maximum daily dose of ketoprofen should not exceed 200 mg, regardless of the dosage form used.

After applying the gel, hands should be washed, except when applying the gel directly to the hands. If prolonged rubbing into the skin is necessary, protective gloves should be used.

Pregnant women

In the I and II trimesters, the use of the gel is possible only as prescribed by a doctor if the expected benefit to the mother outweighs the potential risk to the fetus.

Children

The safety and efficacy of the drug for this age group have not been established.

In case of accidental oral administration of ketoprofen, the drug may cause drowsiness, dizziness, nausea, vomiting, and epigastric pain. These symptoms usually disappear after appropriate symptomatic treatment. High doses of ketoprofen when administered systemically may cause bradypnea, coma, convulsions, gastrointestinal bleeding, acute renal failure, and increased or decreased blood pressure.

Systemic side effects may occur with prolonged use of the drug “Fort-gel”, when used in high doses or when applied to large areas of skin.

Symptoms: irritation, erythema and itching or increased manifestations of other adverse reactions.

Since the level of ketoprofen, which penetrates the skin, in the blood plasma is low, overdose is unlikely. The development of systemic adverse reactions is possible when using the drug for a long time, in high doses or on large areas of skin. If a lot of gel is applied to the skin, it should be washed with water.

Possible side effects typical of nonsteroidal anti-inflammatory drugs: heartburn, nausea, discomfort in the epigastric region, headache, dizziness.

Treatment: There is no specific antidote, symptomatic treatment is recommended along with maintaining vital body functions. Gastric lavage and administration of activated charcoal (the first dose should be administered together with sorbitol) are recommended, especially in the first 4 hours after overdose or when using a dose that is 5-10 times higher than the recommended dose. In case of irritation, erythema and itching, the skin surface should be thoroughly washed with running water.

Skin and subcutaneous tissue disorders: skin irritation, allergic skin reactions, flushing, erythema, burning sensation, itching, swelling, urticaria, contact dermatitis, rash, eczema, including vesicular, bullous and phlyctenular, which can spread and become generalized, bullous dermatitis, exfoliative dermatitis, Stevens-Johnson syndrome, increased sweating; photosensitivity, including serious skin reactions from exposure to the sun (photosensitization); purpura, erythema multiforme, dermatitis resembling lichen, skin necrosis.

On the part of the immune system: hypersensitivity reactions, anaphylactic reactions, including angioedema, and anaphylaxis, observed with systemic and local use of ketoprofen, bronchospasm, attacks of bronchial asthma.

From the respiratory system: asthmatic attacks.

From the urinary system: renal dysfunction, rarely interstitial nephritis.

Gastrointestinal: vomiting, dyspepsia, nausea, constipation, diarrhea, heartburn, peptic ulcers, bleeding or perforation.

Neurological disorders: headache, dizziness, mood changes, drowsiness or insomnia.

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 3 years.