Naklofen

Carefully consider the potential benefits and risks of Naklofen^® (diclofenac sodium enteric-coated tablets) and other treatment options before deciding to use Naklofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).

Naklofen is indicated:

• For relief of the signs and symptoms of osteoarthritis
• For relief of the signs and symptoms of rheumatoid arthritis
• For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Rheumatoid arthritis

Osteoarthrosis

Low back pain

Migraine attacks

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

Ankylosing spondylitis

Acute gout

Control of pain and inflammation in orthopaedic, dental and other minor surgery

Pyrophosphate arthropathy and associated disorders

Carefully consider the potential benefits and risks of Naklofen^® (diclofenac sodium enteric-coated tablets) and other treatment options before deciding to use Naklofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).

After observing the response to initial therapy with Naklofen, the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day).

For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg three times a day. or four times a day, or 75 mg twice a day.).

For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg four times a day, with an extra 25-mg dose at bedtime if necessary.

Different formulations of diclofenac [Naklofen^® (diclofenac sodium enteric-coated tablets); Naklofen^®-XR (diclofenac sodium extended-release tablets); CATAFLAM^® (diclofenac potassium immediate-release tablets)] are not necessarily bioequivalent even if the milligram strength is the same.

For oral administration.

To be taken preferably with or after food.

The tablets should be swallowed whole with liquid

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults

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.

Paediatric population

For children over 14 years of age, the recommended daily dose is 75-100mg in two or three divided doses. Naklofen Potassium 25mg Tablets are not recommended for children under 14 years of age.

The use of Naklofen Potassium 25mg tablets in migraine attacks has not been established in children.

Elderly

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, it is recommended that the lowest effective dosage be used in frail elderly patient or those with low body weight, and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Renal impairment

No adjustment of the starting dose is required for renally impaired patients.

Hepatic impairment

No adjustment of the starting dose is required for hepatically impaired patients.