Audited Supplier
The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium).
Each suppository contains 25mgdiclofenac sodium Ph.Eur.
Therapeutic indications
Diclofenac sodium 25mg suppositories
Adults and Elderly:
Relief of all grades of pain and inflammation in a wide range of conditions, including:
(i) | arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout,
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(ii) | acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis, |
(iii) | other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. |
Children (aged 1-12 years): Juvenile chronic arthritis
Children (aged 6 years and above): As monotherapy or as adjunct therapy with other opiates (due to its opiate-sparing effect) for the relief of acute post-operative pain.
Posology and method of administration
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.
Cardiovascular and significant cardiovascular risk factors
Diclofenac is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease .
Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. Since cardiovascular risks with diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used and for the shortest duration possible (see section 4.4 Special warnings and precautions for use)
