REMETHAN Gel Ref.[28322] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

For the local symptomatic relief of pain and inflammation in:

  • trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises
  • localised forms of soft tissue rheumatism

For the relief of pain of non-serious arthritic conditions.

4.2. Posology and method of administration

Posology

Adults and children 14 years and over

Remethan Gel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) should be applied 3-4 times a daily. The maximum daily dose is 16g. Therefore the maximum weekly dose is 112g.

For arthritis pain it may be necessary to apply the gel for up to 7 days (to allow its effect to build up on the joint) before an improvement in pain is noticed. The gel can be used for up to 14 days under pharmacy supervision.

After application, the hands should be washed unless they are the site being treated.

If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Consultation with a doctor is recommended if more than two major joints in the body are affected. Do not use for more than 14 days unless recommended by a doctor.

Use in the elderly

The usual adult dosage may be used.

Children and adolescents

There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3). In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.

Method of administration

For external use only.

4.9. Overdose

Signs and symptoms

The low systemic absorption of topical diclofenac renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if diclofenac gel is inadvertently ingested (1 tube of 100g contains the equivalent of 1000mg of diclofenac sodium). In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicines should be used. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.

Treatment

Management of overdosage with NSAIDs essentially consists of supportive and symptomatic measures. There is no typical clinical picture resulting from diclofenac overdosage. Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C. Replace cap tightly after use.

6.5. Nature and contents of container

Aluminium tube. Pack-sizes of 20 g, 50 g and 100 g.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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