Storage:
active substance: diclofenac;
1 g of gel contains diclofenac sodium 50 mg;
auxiliary substances: methylparaben (E 218), peppermint oil, carbomer, glycerin, polyethylene glycol 400, ethanol 96%, dimethyl sulfoxide, concentrated ammonia solution, purified water.
Medicinal form. Gel.
Main physical and chemical properties: white gel, homogeneous consistency with a specific smell.
Pharmacotherapeutic group. Means used locally for joint and muscle pain. Nonsteroidal anti-inflammatory drugs for local use. Diclofenac.
ATX code M02A A15.
Pharmacological properties.
Pharmacodynamics.
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of prostaglandin biosynthesis.
In case of inflammation caused by injuries or rheumatic diseases, the drug reduces pain, tissue swelling and accelerates the recovery of damaged joints, ligaments, tendons and muscles. The drug reduces acute pain already 1 hour after the initial application. Due to the water-alcohol base, the medicine has a local anesthetic and cooling effect.
Indication.
Local treatment of pain and inflammation of joints, muscles, ligaments and tendons of rheumatic or traumatic origin.
Contraindication.
Hypersensitivity to diclofenac, other NSAIDs or other components of the medicinal product. History of attacks of bronchial asthma, angioedema, urticaria, or acute rhinitis caused by taking acetylsalicylic acid or other NSAIDs; the last trimester of pregnancy.
Method of application and dosage.
For adults, use 3-4 times a day, rubbing lightly into the skin. The amount of medicine used depends on the size of the affected area. Usually 2-4 g of gel, corresponding in volume to the size of a cherry or walnut, is enough to apply to an area of 400-800 cm2. After applying the drug, hands should be washed, except for those cases when this area is to be treated.
The duration of therapy depends on the nature of the disease and the effectiveness of treatment. The drug should not be used for longer than 14 days in a row.
Children. There are no dosage recommendations and therapeutic indications for the use of the drug in children.
Overdose.
Overdose is unlikely due to the low absorption of diclofenac into the systemic bloodstream when applied topically. In case of accidental ingestion, the possibility of developing systemic adverse reactions should be taken into account.
In case of accidental ingestion of the drug, the stomach should be emptied immediately and an adsorbent should be taken. Symptomatic treatment with therapeutic measures used in NSAIDs poisoning is indicated.
Adverse reactions.
The drug is usually well tolerated. Adverse reactions include mild, temporary skin reactions at the application site. In rare cases, allergic reactions may occur.
Infections and infestations: pustular rashes.
From the side of the immune system: hypersensitivity reactions (including urticaria), angioedema.
From the respiratory system: bronchial asthma.
From the side of the skin and connective tissues: rash, redness, eczema, exanthema, erythema, the appearance of swellings and vesicles, papules, pustules, peeling and dryness of the skin, dermatitis (including contact, bullous), photosensitivity reactions, burning, itching.
Expiration date. 3 years.
Storage conditions. Store in the original packaging at a temperature not higher than 25 oC.
Keep out of the reach of children.
Packaging. 50 g or 100 g in a tube in a box.
Release category. Without a prescription.
Manufacturer. Limited Liability Company “Pharmaceutical Company “Zdorovya”.
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