Diclofenac Potassium 50 mg Tablets

Each film-     coated tablet contains 50 mg of diclofenac potassium

Also contains:

Lecithin Soya E322.

0.150(5.85mg) potassium per 50mg tablet.

0.73mg sodium per 50mg tablet.

For a full list of excipients, see section 6.1

3. Pharmaceutical form
Film-coated tablets

Reddish brown, circular, coated, biconvex tablets, diameter 9 mm

4. Clinical particulars
4.1 Therapeutic indications
Rheumatoid arthritis


Low back pain

Migraine attacks

Acute skeletal disorders and trauma such as  (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures

Ankylosing spondylitis

Acute gout

Control of pain an dental and other minor surgery

Pyrophosphate  and associated disorders

4.2 Posology and method of administration
Undesirable effects may  using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).

For oral administration

The tablets should be swallowed whole with liquid, preferably before meals, and must not be chewed or divided.


The recommended daily dose is 100-150mg in two or three divided doses. For milder cases, 75-100mg daily in two or three divided doses is usually sufficient.

In migraine an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50mg may be taken. If needed, further doses of 50mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200mg per day.

Special populations


For children over 14 years of age, the recommended daily dose is 75-100mg in two or three divided doses. Diclofenac Potassium Tablets are not recommended for children under 14 years of age.

The use of Diclofenac Potassium tablets in migraine attacks has not been established in children.


Although the pharmacokinetics of diclofenac 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 (see section 4.3 Contraindications).

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).

Renal impairment

Diclofenac Potassium Tablets are contraindicated in patients with renal failure (see section 4.3 Contraindications).

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 Diclof

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