Diclofenac Epolamine 65 mg (Corresponding to Diclofenac Sodium 50 mg).
Flector Capsule is prescribed for:
• Rheumatic inflammatory and degenerative diseases such as rheumatoid arthritis, ankylosing spondylitis, arthrosis, non-articular rheumatism, inflammatory pains of non-rheumatic origin or following a trauma.
• In the treatment of menstrual pains.
Dosage and Administration
- In General: the initial daily dosage is two to three capsules.
- For less serious cases as well as for prolonged treatments: One to Two capsules per day.
- With menstrual pains: the daily dosage, which must be individually tailored, is one to three capsules.
- The treatment should begin when the first symptoms appear and continue for some days according to symptoms.
- The daily dosage must be divided in two or three administrations.
- In patients suffering from any ulcer and/ or serious stomach or intestinal diseases, serious liver or kidneys diseases, are undergoing intensive diuretic therapy, having ongoing or probable haemorrhages suffer from serious blood diseases and patients who are undergoing anticoagulant treatments.
- As for other non-steroidal anti-inflammatory drugs, Diclofenac is contraindicated for those subjects, who registered asthmatic attacks, urticaria, or acute rhinitis after taking acetylsalicylic acid or other drugs that inhibit the prostaglandin synthetase.
- Cases of hypersensitivity to the active ingredient or to any of the components in the formulation.
- Should not be administered to children under 14 years old.
- If administered together with other preparations containing digoxin, diclofenac can raise plasmatic concentration, but in such case no clinical indications of over dosage have yet been observed.
- Several non-steroidal anti-inflammatory drugs could inhibit the activity of diuretic drugs and boost the effect of the potassium-saving diuretics, making it necessary to control the serum potassium levels.
- We do not recommend the concomitant administration of lithium salt as this could bring about an increase of serum lithium levels.
- Even though clinical studies did not suggest that Flector has any effects on anticoagulants, rare cases of increase in the risk of haemorrhage were observed with the combined use of Diclofenac and an anticoagulant therapy.
Pregnancy and Lactation
- We do not recommend the administration of Diclofenac in the first three months of pregnancy, because of the possible teratogenic risks.
- During the third quarter, all inhibitors of prostaglandin synthetase could expose the foetus to cardio-pulmonary (pulmonary hyper-tension due to the early closure of the arterial duct) and renal toxicity.
- Furthermore, toward the end of the pregnancy, it could expose both the mother and the child to an extension of the period in labour. Therefore, none of the inhibitors of prostaglandin synthetase should be taken in the third quarter of pregnancy.
Warning and Precaution
Flector Capsule must be taken whole capsule, with some liquid, during or after meals. Due to the interaction with the metabolism of arachidonic acid, the drug can determine crises and possibly shocks and other allergic phenomena in asthmatic people and subjects predisposed to bronchial spasm.
Package and Storage
Package: Carton Box containing 30 soft gastro-resistant capsules of 50 mg
, Under licence from IBSA