VOLTAROL Suppositories Ref.[6795] Active ingredients: Diclofenac

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).

Not to be taken by mouth, as per rectal administration only.

The suppositories should be inserted well into the rectum. It is recommended to insert the suppositories after passing stools.

Adults

75-150mg daily, in divided doses (25mg, 50mg and 100mg suppositories only).

The recommended maximum daily dose of Voltarol is 150mg. This may be administered using a combination of dosage forms, e.g. tablets and suppositories. (25mg and 50mg suppositories only).

100mg suppositories may also be given as a once daily treatment, usually at night. Where necessary, therapy may be combined with 25mg or 50mg tablets or suppositories up to the maximum dose of 150mg per day.

Special populations

Elderly

Although the pharmacokinetics of Voltarol are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also Precautions) and the patient should be monitored for GI bleeding during NSAID therapy.

Renal impairment

Diclofenac is contraindicated in patients with severe renal impairment (see section 4.3). No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment (see section 4.3 and 4.4).

Hepatic impairment

Diclofenac is contraindicated in patients with severe hepatic impairment (see section 4.3). No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment (see section 4.3 and 4.4).

Paediatric population

Children (aged 1-12 years) with juvenile chronic arthritis: 1-3mg/kg per day divided into 2 or 3 doses (12.5mg and 25mg suppositories only).

Children (aged 6-12 years) with acute post-operative pain: 1-2mg/kg per day in divided doses.

Treatment of acute post-operative pain should be limited to 4 days treatment (12.5mg and 25mg suppositories only).

Symptoms

There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the case of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measures

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults gastric lavage should be considered within one hour of ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patients clinical condition.

Shelf life: Three years.

Protect from heat (store below 30°C).

Medicines should be kept out of the reach of children.

The suppositories are white to yellowish, torpedo-shaped, with smooth or slightly rough surfaces and a slightly fatty odour, and are sealed in a composite foil made of polyvinylchloride (PVC) laminated with low-density polyethylene (LD-PE).

They come in packs of 10.

For rectal use only.