Refain®
Diclofenac Sodium

COMPOSITION
Refain®: Each Enteric Coated tablet contains Diclofenac Sodium USP 50mg.
Refain®TR: Each Timed Release capsule contains Diclofenac Sodium BP 100mg.

PHARMACOLOGICAL INFORMATION
Pharmacological Action
Diclofenac sodium is a non-steroidal compound, a phenylacetic acid derivative, with analgesic, antipyretic and anti-inflammatory effects. Diclofenac sodium inhibits the biosynthesis and release of prostaglandins, which are known to be implicated in the pathogenesis of inflammation, pain and fever. Diclofenac tablets are enteric-coated so that absorption occurs in the gastrointestinal tract to give peak plasma concentrations approximately 2 hours after ingestion. There is at least 99% binding to plasma-proteins and excretion of metabolites is mainly in the urine.

Mechanism of Action
Diclofenac sodium works by blocking the action of a substance (enzyme) in the body called cyclo-oxygenase. Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced in response to injury or certain diseases and would otherwise go on to cause pain, swelling and inflammation.

CLINICAL INFORMATION
Therapeutic Indications:
Inflammatory and degenerative forms of

• Rheumatism
• Rheumatoid arthritis
• Ankylosing spondylitis
• Osteoarthritis
• Painful post-operative and post-traumatic inflammation and swelling and dysmenorrhoea.

Use in Children
Diclofenac sodium is not recommended for use in children as safety and efficacy have not been established.

ContraindicationsDiclofenac sodium is contraindicated in patients with known hypersensitivity to diclofenac and in patients who respond to aspirin and aspirin-type drugs with sensitivity reactions like asthma, acute rhinitis and urticaria. Diclofenac sodium is absolutely contraindicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.

Use in patients with impaired hepatic function
Elevations of one or more liver tests may occur during the therapy.

Use in patients with impaired renal function
Long term administration of NSAIDs may result in renal papillary necrosis and other renal injury.

Elderly Patients
No significant difference in use between patients above 65 years and younger patients.

Drug Interactions
Serious interactions have been reported after the use of high dose methotrexate with diclofenac.
Blood concentrations of lithium are increased when Diclofenac is administered concommitantly.

Use in Pregnancy & Lactation
The safe use of Diclofenac in pregnancy has not been demonstrated. Regular use of NSAID's during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.

Undesirable Effects
In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Gastric or intestinal ulceration with associated bleeding has been reported - Diclofenac therapy should be discontinued immediately in such cases. Skin rashes and gastro-intestinal disturbances may occur. Headache, dizziness, oedema, nervousness, pruritus, tinnitus, insomnia, blurred vision and other ocular reactions, peripheral oedema, malaise, jaundice, elevated transaminase levels, drowsiness and hypersensitivity reactions (eg. bronchospasm) have occurred. Diclofenac should be given with care to patients with bleeding disorders, cardiovascular disease, and in those who are receiving coumarin anticoagulants. Patients who are sensitive to aspirin generally should not be given Diclofenac.

PHARMACEUTICAL INFORMATION
Storage & Conditions
Store in cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Refain®(Diclofenac Sodium) Tablet: Each commercial box contains 10 x10's tablets in Alu-PVC blister pack.
Refain®TR (Diclofenac Sodium) Capsule: Each commercial box contains 12 x 4's capsules in Alu-Alu blister pack.