VOLTAROL PAIN-EZE EMULGEL Gel for topical administration Ref.[6789] Active ingredients: Diclofenac

Adults and children aged 14 years and over

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

A period of at least 4 hours should be left between applications. The dose should not be applied more than 4 times in a 24 hour period.

If symptoms persist after 7 days or get worse at any time, medical advice should be sought.

Not to be used for more than 7 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.

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 Topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1000 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 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.

Shelf life: Three years.

Do not store above 30°C.

This medicine should be kept out of the sight and reach of children.

Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap.

Packaging available in packs of 10g, 30g, 40g and 50g.

Aluminium laminated tube (low density polyethylene/aluminium/high density polyethylene (internal layer)) fitted with a high density polyethylene shoulder and closed by a moulded seal. The tube is closed with a polypropylene screw cap, incorporating a moulded feature used to insert, twist and remove the seal before first use or a push/pull cap applicator, which is designed to facilitate hand-free application of the product, available for 100g pack only

Packaging available in packs of 30g, 50g, 60g, 100g and 120g.

None.