|Dosage and administration||
Hypersensitivity to diclofenac, aspirin, other non-steroidal anti-inflammatory drugs (asthma, rhinitis, urticaria after taking aspirin) or any of the excipients of the drug.
|Warnings and precautions for use||
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
Diclofenac can cause headache, drowsiness, somnolence, visual disturbance. Therefore, caution should be taken when driving or operating machinery.
|Interactions, incompatibilities of medicine||
Diclofenac may enhance or inhibit the effects of other medications.
|Undesirable effects (ADRs)||
Side effects in the digestive tract occurred in about 5 – 15% of patients treated with diclofenac.
|Overdose and management||
Diclofenac, a phenylacetic acid derivative, is a non-steroidal anti-inflammatory drug with marked anti-inflammatory, analgesic and antipyretic activities.
Diclofenac is absorbed easily from the gastrointestinal tract after oral administration. The absorption is more rapid if it is taken on an empty stomach. As with oral preparations the AUC is approximately a half of the value obtained from a parenteral dose. Diclofenac binds extensively to plasma proteins, mainly with albumin (99%). Approximately 50% of an oral dose undergoes hepatic first-pass metabolism. Peak plasma concentrations occur two hours after oral administration, the peak levels in synovial fluid achieve after 4 to 6 hours. Effects of the drug occur 60 to 120 minutes after oral administration.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each enteric film-coated tablet contains:
Diclofenac sodium. . . . . . . . . . . . . . . . . . .50 mg
Cardboard box containing 10 blisters of 10 enteric film-coated tablets.
Symptomatic treatment of chronic forms of arthritis including: Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis.
Symptomatic treatment of acute attack of periarthritis (frozenshoulder, tendinitis, tenosynovitis, bursitis).
Symptomatic treatment of acute pain (post-traumatic inflammation, back pain, sprain, dislocation) and chronic pain.