Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
For local symptomatic relief of pain and inflammation in:
It is recommended that treatment should be reviewed after 14 days in these indications.
These indications should not warrant treatment for more than 6 weeks.
Almiral 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 daily. After application, the hands should be washed unless they are the site being treated.
It is recommended that treatment be reviewed after 14 days. These indications should not warrant treatment for more than 6 weeks.
The usual adult dose may be used.
There are insufficient data on efficacy and safety available for children and adolescents below 14 years of age (see 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.
Topical application.
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 Almiral 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.
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.
Two (2) years.
Store below 25°C, in the original package.
Lacquered aluminium tubes sealed with polypropylene screw cap of 25g, 50g and 100g gel. Polyethylene plastic jars of 250g.
Not all pack sizes may be marketed.
No special requirements.
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