Description
Composition:
Each enteric coated tablet contains:
Sodium(2,6-dichlorophenyl)-amino – phenyl – acetate = diclofenac sodium 50 mg and excipients.
Therapeutic Indications: Treatment of:
- inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis, painful syndromes of the vertebral coulmn, non-articular rheumatism.
- acute attacks of gout.
- post-traumatic and postoperative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery.
- painful and/or inflammatory conditions in gynaecology , e.g. primary dysmenorrhoea or adnexitis.
- as an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otits.
- In keeping with standard therapeutic principles, the underlying disease should be treated with specific therapy, as appropriate.
- Fever alone is not an indication.
Psology and method of administration:
- Adults: The recommended initial daily dosage is 100-150 mg. In milder cases, as well as for long-term therapy, 75-100 mg daily
- is usually sufficient. The total daily dosage should be divided into 2-3 doses. To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a maximum
- daily dose of 150 mg).
- In primary dysmenorrhoea the daily dosage should be individually adjusted and is generally 50-150 mg.
- Initially a dose of 50-100 mg should be given and, if necessary, raised in the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started upon appearance of the first symptoms and depending on the symptomatology, continued for a few days.
- The tablets should be swallowed whole with liquid, preferably before meals.
- Children: Children aged 1 year and over should be given 0.5-2 mg/kg body weight daily, in 2-3 divided doses, depending on the severity of the disorder.
- to the treatment of juvenile rheumatoid arthritis the daily dosage can be raised up to a maximum of 3 mg/kg in divided doses.
- Voltaren tablets of 50 mg are not recommended for use in children.
Contraindications:
- Gastric or intestinal ulcer.
- Known hypersensitivity to the active substance and any of the excipients.
- Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other drugs with prostaglandin-synthetase inhibiting activity.
- To be used under medical supervision.
- To be swallowed whole.
- Protect from light and heat (Store below 30 degrees C).
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