Indications

– Long– terms treatment of joint degeneration, chronic rheumatoid polyarthritis, spondyloarthritis,…
– Short– terms treatment of acute painful conditions in ear– nose– throat, gyneco– obstetrics, menstrual pain, post– traumatic or postoperative, bursitis,…

Present

Blister of 10 enteric– coated tablets. Box of 3 blisters.

Composition

Diclofenac sodium ………………………………75mg
Excipients s.q. for……………………..……1 tablet
(Lactose, cassava starch, povidone, microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer, talc, polyethylene glycol 6000, erythrosine lake, red ferric oxide, yellow ferric oxide, ethanol 96%).

Pharmacology

Diclofenac has pharmacologic actions similar to those of other prototypical NSAIDs. The drug exhibits anti– inflammatory, analgesic, and antipyretic activity. Diclofenac, a potent inhibitor of cyclooxygenase, reduces considerably the synthesis of prostaglandins, prostacyclins, and thromboxanes that play important roles in inflammatory process.

Pharmacokinetics

Diclofenac is rapidly absorbed when given orally on empty stomach. It is subject to first– pass metabolism by 50% in liver. It is excreted in the form of somehow less active metabolites, mainly in urine (about 60%) and less than 1% is excreted as unchanged, the remaining amounts are excreted in the bile and feces.

Contra-Indications

– Hypersensitivity to any ingredient of the medicine or other nonsteroidal anti– inflammatory drug.
– Active gastric ulcer.
– Patients with asthma or bronchospasm.
– Severe hepatic impairment, renal impairment, and cardiovascular disease.
– Patients who are taking anticoagulant coumarin.
– Patients with congested heart failure.
– Patients with collagen disease or wearing contact lenses.
– Pregnant women.

Side effect

– Common: headache, epigastric pain, nausea, vomiting, diarrhea, tinnitus, elevation of transaminase,…
– Rare: bronchial spasm in patients with asthma, drowsiness, somnolence, urticaria,…
Inform your doctor about side– effects when using this medicine.

Precaution

– In patients with gastrointestinal disorders, a history of peptic ulcer, ulcerative colitis. In the rare cases where gastrointestinal bleeding or ulceration occur during treatment, diclofenac should be discontinued.
– In patients with hemorrhagic disorders, asthma or bronchospasm, a history of hypersensitivity reactions to aspirin or other NSAIDs, hypertension, impaired renal, hepatic, cardiac function and elderly.
– Hepatic function should be checked during prolonged treatment with diclofenac.
– If there are visual disturbances associated with diclofenac the patient should be advised to have ophthalmological check.
– Caution should be exercised when it is given to patients who are driving or operating machinery.
PREGNANCY AND LACTATION:
– Pregnant women should not use this drug.
– Caution should be exercised when it is given to nursing mothers.

Interaction

– Diclofenac may increase risk of quinolone antibacterials adverse effects on CNS, aspirin and glucocorticoid ulcerogenic effect on gastric mucosa, oral anticoagulants and heparin hypothrombinemic effect that lead to prolonged bleeding time.
– Diclofenac increases plasma concentrations of lithium, digoxin.
OVERDOSAGE & MANAGEMENT:
– Manifestation: acute diclofenac overdosage produces manifestations that are mainly extensions of adverse effects of the drug.
– Management: immediate induced emesis or gastric lavage, administration of activated charcoal may be useful in minimizing absorption of diclofenac and reabsorption of enterohepatically recirculated drug.
Should overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 30^oC. Protect from light.

Dosage

This drug should not be chewed or crushed, best taken before meals.
– As prescribed by the physician.
– Recommended dosage for adults: inflammation & acute pain: 1 – 2 tablets daily; mild & maintenance: 1 tablet daily.