VOLTAREN EMULGEL 12 HOUR Gel Ref.[115936] Active ingredients: Diclofenac

Posology

Use the lowest effective dose for the shortest possible duration of treatment.

Method of administration

For the flip-top cap:

Use a finger, thumb, side of your hand or even edge of a table against the underside of the cap lid to open the flip-top cap easily. Tamper evident tabs located on each side of the flip-top cap will break when the cap is opened for the first time. Before first use check if the tamper evident tabs are not broken.

For the screw cap:

To remove the seal before first use, unscrew and remove the cap. Use the reverse side of the cap to insert, twist and remove the seal from the tube.

Adults and children 14 years and over

The gel should be rubbed gently into the skin. Depending on the size of the affected site to be treated, 2-4 g (a circular shaped mass approximately 2,0–2,5 cm in diameter) should be applied 2 times a day (preferably morning and evening). The maximum daily dose is 8 g.

Therefore, the maximum weekly dose is 56 g.

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. 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.

The low systemic absorption of topical diclofenac renders overdose very unlikely.

Undesirable effects, similar to those observed following an overdose of Voltaren tablets, can be expected if Voltaren Emulgel 12 Hour is inadvertently ingested (e.g. 1 tube of 50 g contains the equivalent of 1 g 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. The use of activated charcoal should be considered, especially within a short time of ingestion.

Three years.

All presentations: Store at or below 30°C.

Voltaren Emulgel 12 Hour should be kept out of sight and reach of children.

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. 30 g and 50 g Laminated aluminium tube with white cap 100 g Laminated aluminium tube with white cap or Laminated aluminium tube with white triangular cap

Pack sizes: 50 g and 100 g.

Not all pack sizes may be marketed.

None.