Antirheumatic, anti-inflammatory, analgesic

Composition
Active substance: Diclofenac sodium.
Enteric coated tablets of 25 mg and 50 mg.
Suppositories of 50 mg and 100 mg.

Properties / Effects
VOLTAREN is a non-steroidal substance with pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic effects. Inhibition of prostaglandin biosynthesis, which has been demonstrated in experiments, is considered to be fundamental to the mechanism of action of Diclofenac. In rheumatic diseases, the anti-inflammatory and analgesic properties of VOLTAREN elicit a clinical response characterized by marked relief of signs and symptoms such as pain upon movement, morning stiffness, and swelling of the joints, and by improvement in function. In post-traumatic and postoperative inflammatory conditions, VOLTAREN rapidly relieves both spontaneous pain and pain upon movement, and reduces inflammatory swelling and wound oedema. In primary dysmenorrhea, VOLTAREN can relieve pain and reduce the extent of bleeding. In clinical trials, VOLTAREN has also been found to exert a pronounced analgesic effect in moderate and severe pain of non-rheumatic origin.

Pharmackinetics
Diclofenac is rapidly and completely absorbed from the enteric coated tablets after passage through the stomach. Peak plasma concentrations are reached within 2 hours. Plasma concentrations are in linear proportion to the size of the dose. Approximately 60 % of the dose administered is excreted via the kidneys in the form of metabolites, less than 1% is excreted as unchanged substance. The rest of the dose is eliminated in the form of metabolites through the bile in the faeces.

Indications
- Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis.
- Painful syndromes of the vertebral column.
- Non-articular rheumatism.
- Acute attacks of gout.
- Painful post-traumatic and postoperative inflammation and swelling.
- Painful and/or inflammatory conditions in gynaecology e.g. primary dysmenorrhea or adenexitis.
- As an adjuvant in severe painful inflammatory infections of the ear, nose or throat.
Fever alone is not an indication.

Dosage
Adults: The initial daily dose is usually 100-150 mg. In milder cases, as well as in prolonged therapy 75-100 mg. daily is usually sufficient. The daily dosage is generally given in 2-3 divided doses. To prevent nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by a suppository taken at bedtime (up to maximum daily dose of 150 mg.). Treatment should be started as soon as symptoms begin and continued for several days, depending on the symptomatology. The tablets should be swallowed whole with liquid, preferably before meals.

Contraindications
Peptic ulcer, known hypersensitivity to the active substance like other non-steroidal anti-inflammatory agents. VOLTAREN is contraindicated in patients whom the attacks of asthma, urticaria, or acute rhinitis have been precipitated by acetylsalicylic acid or other prostaglandin synthetase inhibitors.

Precautions / Warning
Symptoms/history of gastrointestinal diseases, impaired hepatic, cardiac, or renal function. Pregnancy and lactation. Porphyria. Caution should be taken in elderly patient. Extra-cellular volume depletion. Central nervous disturbances can influence the ability to drive and use machines. During prolonged treatment, periodic monitoring of liver function and blood counts is recommended.

Interactions
Diclofenac may raise plasma concentrations of lithium or digoxin. Concomitant treatment with potassium-sparing diuretics may raise serum potassium levels. An increase risk of haemorrhage in patients receiving Diclofenac and anticoagulants concomitantly has been reported in isolated cases although this has not been confirmed in clinical studies.

Storage
- Protect enteric coated tablets from heat and moisture.
- Protect the suppositories from heat.
- The preparation should not be used after the date marked “EXP” on the pack.

Packs
20 coated tablets of 25 mg
20 coated tablets of 50 mg
5 suppositories of 50 mg
5 suppositories of 100 mg