Storage:
active substance: sodium diclofenac;
1 g of gel contains diclofenac sodium 50 mg;
excipients: trometamol, macrogol 400, methyl parahydroxybenzoate (E 218), carbopol Ultrez 21, ethyl alcohol 96%, glycerin, purified water.
Medicinal form. Gel.
Main physicochemical properties: homogeneous white or almost white gel.
Pharmacotherapeutic group.
Means used locally for joint and muscle pain. Nonsteroidal anti-inflammatory drugs for local use. Diclofenac.
Clinical characteristics.
Indication.
Local treatment of pain and inflammation of joints, muscles, ligaments and tendons of rheumatic or traumatic origin.
Contraindication.
Hypersensitivity to diclofenac or other non-steroidal anti-inflammatory drugs, isopropyl alcohol or other components of the drug. Presence in the anamnesis of attacks of bronchial asthma, urticaria, acute rhinitis, nasal polyps, angioedema caused by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. The last trimester of pregnancy. Children’s age.
Interaction with other medicinal products and other types of interactions.
Since the systemic absorption of diclofenac due to local application of the drug is very low, the occurrence of interactions is unlikely.
Method of application and dosage.
Apply diclofenac 3-4 times a day, rubbing it lightly into the skin. The amount of the drug used depends on the size of the affected area (so, 2-4 g of gel, the size of which corresponds to the size of a cherry or a 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.
If the drug is not prescribed by a doctor, it is necessary to consult him for advice, if after 7 days of treatment the patient’s condition has not improved or worsened.
Elderly patients (over 65 years old)
There is no reason to believe that elderly patients require a special adjustment of the dose or that they may experience adverse reactions different from other patients.
Patients with renal failure
There is no reason to believe that patients with renal insufficiency require special selection of the dose.
Patients with liver failure
There is no reason to believe that patients with hepatic insufficiency require special selection of the dose.
Children.
There are no dosage recommendations and therapeutic indications for the use of Diclofenac 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, it should be taken into account that 1 tube of the drug of 100 g contains the equivalent of 1 g of diclofenac sodium; at the same time, the development of systemic adverse reactions is possible.
In case of accidental ingestion of the drug, the stomach should be emptied immediately and an adsorbent should be applied. Symptomatic treatment with the use of therapeutic measures, which should be used in poisoning with non-steroidal anti-inflammatory drugs, is indicated.
ermine of fitness.3 years.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging.
40 g or 50 g or 100 g of gel in a tube in a pack or without a pack.
Leave category.
Without a prescription.
Producer.
PrJSC Pharmaceutical factory “Viola”.
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