Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mibe Pharma UK Ltd, 4 Coleman Street, 6th Floor; London, United Kingdom, EC2R 5AR
For the cutaneous treatment of actinic keratoses (AKs) with a severity grade of 1 or 2 (according to Olsen), preferably on the face or scalp.
Solacutan gel should be applied to the affected skin areas twice daily and smoothed into the skin gently. The amount used depends on the size of the area to be treated.
Usually 0.5 g of gel (about the size of a pea) is applied to a 5x5 cm lesion site. The usual duration of treatment is 60 to 90 days. Maximum effect has been observed with treatment durations at the upper end of this time range.
Complete healing of the lesion(s) or optimal therapeutic effect may not be seen for up to 30 days after completion of therapy. A maximum dose of 8 g daily should not be exceeded.
Nothing is known about the long-term effect.
The normal dosage can be used.
Dosage recommendations and indications for the use of Solacutan gel in the paediatric population have not been established.
Cutaneous use.
The low systemic absorption of topical diclofenac renders overdose very much unlikely. However, the skin should be rinsed with water. There have been no reports of clinical cases of overdosage from ingestion of diclofenac-containing gel.
However, undesirable effects similar to those observed following an overdose of diclofenac tablets can be expected if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 3,000 mg 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 medicinal products should be used.
Supportive and symptomatic treatments should be administered for the management of complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion. Specific treatments (such as forced diuresis and dialysis) will probably not be effective at eliminating NSAIDs because of the high rate of protein binding of NSAIDs.
3 years.
After first opening: 6 months.
Do not store above 25°C.
Aluminium tube with original sealing membrane and internal protective lacquer and HDPE screw cap.
10 g gel
25 g gel
26 g gel
30 g gel
50 g gel
60 g gel
90 g gel
Not all pack sizes may be marketed.
No special requirements.
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