Adolescents over 14 years of age (short-term treatment):local symptomatic treatment of pain in acute strains, sprains or bruises caused by blunt injuries.Adults: post-traumatic inflammation of tendons, ligaments, muscles and joints resulting from sprains, strains or bruises; backache; limited inflammation of soft tissues, e.g. tendinitis or tennis elbow; limited and benign forms of osteoarthritis.
Composition:
1 g of gel contains 11.6 mg of diethylammonium Diclofenac, equivalent to 10 mg of Diclofenac sodium. The preparation contains propylene glycol.
Action:
A non-steroidal anti-inflammatory drug for topical use with analgesic and anti-inflammatory effects. The mechanism of action is based on inhibition of prostaglandin synthesis. Due to the hydro-alcoholic substrate, the gel also has a soothing and cooling effect. After topical administration, the amount of diclofenac absorbed by the skin depends on the size of the place to be treated, the time of contact with the skin, the amount of gel used and the degree of skin hydration. The relative bioavailability after topical application to the skin relative to oral administration was about 6%. Diclofenac is 99.7% bound to plasma proteins (mainly albumin). It is metabolized mainly to the 4-hydroxy derivative and other phenolic derivatives and then coupled with glucuronic acid. T0,5 in the phase of elimination in the plasma is 1-2 hours. It is excreted in the urine and to a lesser extent in the bile, mainly as conjugated and non-conjugated metabolites.
Contraindications:
Hypersensitivity to the active substance, propylene glycol or any of the excipients. Hypersensitivity to Acetylsalicylic acid or other NSAIDs manifested by attacks of asthma, urticaria or acute rhinitis. Children and youth under 14 years. Third trimester of pregnancy.
Precautions:
The drug should be used only on the intact skin surface (it should not be used on damaged skin, damaged, with wounds). The preparation can be used simultaneously with air-permeating non-occlusive dressings, but it should not be used with air-tight occlusive bandages. Avoid contact of the gel with eyes and mucous membranes, do not swallow. Due to the propylene glycol content, the drug may cause skin irritation.
Pregnancy and lactation:
Diclofenac should not be used during the first and second trimesters of pregnancy unless clearly necessary. If diclofenac is used by women planning pregnancy and during the first and second trimester of pregnancy, the lowest dose should be used and the duration of therapy should be the shortest. In the third trimester of pregnancy, the drug is contraindicated. Due to the lack of controlled studies on breastfeeding women, the drug should be used during lactation only on the recommendation of a physician. In such cases, the preparation should not be used on breasts of breastfeeding women, or on large skin surfaces or long-term.
Side effects:
Common: rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus. Rare: vesicular dermatitis. Very rare: lumpy rash, hypersensitivity (including urticaria), angioneurotic edema, asthma, hypersensitivity reactions to light. In cases of application to large areas of the skin or during long-term use, systemic side effects may occur (in the gastrointestinal area, such as stomach ulcers or nervous system disorders, such as dizziness or headaches).
Dosage:
For topical application to the skin. Adults and adolescents over 14 years old: the gel should be applied 3-4 times a day by rubbing gently. The amount of gel used should be adjusted to the size of the affected area, e.g. 2 - 4 g of gel (the amount corresponding to the size of the cherry fruit to the size of a walnut) is sufficient to coat the surface approx. 400 cm2 up to 800 cm2. After applying the gel, wash your hands if your hands are not being treated. The duration of treatment depends on the indications and on the response to treatment.Without consulting a doctor, the drug should not be used for more than 14 days in the case of post-traumatic inflammation and rheumatism of soft tissue and not longer than 4 weeks in the case of osteoarthritis. A medical check-up is recommended after 7 days of use in the event of ineffective treatment or when the disease symptoms worsen.
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