LOBAK Tablet

For the relief of mild to moderate pain and fever. Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, painful post-operative and post-traumatic inflammation and swelling and dysmenorrhoea and as an adjunct to physical therapy in the treatment of painful musculoskeletal disorders.

Dosage and Directions for use

Usual Adult Dose: 1 tablet 3 times daily, with or after meals or as directed by the Physician.

For muscle spasm: 1 tablet 3-4 times daily. The initial dosage for severe muscle spasm should be 2 tablets 3-4 times daily.

Sensitivity to any of the ingredients. It is contra-indicated in patients with known hypersensitivity to Diclofenac Sodium and in patients who respond to aspirin and aspirin-type drugs with sensitivity reactions like asthma, acute rhinitis and urticaria.

Diclofenac Sodium is absolutely contra-indicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.

Diclofenac Sodium:

Gastro-intestinal disorders including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side effects include vertigo, headache, skin rashes, pruritus, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, edema, palpitations, blurred vision and other ocular reactions. Hypersensitivity reactions may occur and include fever and rashes. Diclofenac Sodium may cause cystitis and haematuria as well as acute renal failure, interstitial nephritis and nephrotic syndrome.

Other adverse effects include anaemia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, and abnormalities in liver function tests. Patients with congestive heart failure, cirrhosis, diuretic induced volume depletion or renal insufficiency are at greater risk of developing renal dysfunction.

Paracetamol:

Skin rashes and other allergic reactions may occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions.

If few cases the use of Paracetamol has been associated with the occurrence of thrombocytopaenia, neutropaenia, pancytopaenia, leucopaenia and agranulocytosis. The dose should be reduced in renal functional impairment.

Paracetamol should also be given with care to patients taking other drugs that affect the liver such as the barbiturates.

The absorption of Acetaminophen (Paracetamol) may be accelerated by Metoclopramide. Excretion may be affected and plasma concentrations altered when administered with Probenecid.

Prolonged excessive use may cause irreversible kidney damage.

Chlorzoxazone:

Occasional patients may develop gastrointestinal disturbances. It is possible, in rare instances, that Chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, nausea, dizziness, lightheadedness, malaise or overstimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae or ecchymoses may develop during treatment. Angioneurotic oedema and anaphylactic reactions are extremely rare. Rarely, a patient may note discolouration of the urine resulting from a phenolic metabolite of Chlorzoxazone.

It should be used with caution in patients with known allergies or with a history of allergic reactions to medicines. If a sensitivity reaction occurs such as urticaria, redness or itching of the skin, the medicines should be stopped. If any or symptoms suggestive of liver dysfunction are observed the medicine should be discontinued.

Plasma concentrations are significantly decreased by the concomitant administration of therapeutic doses of Aspirin. When given together with preparations containing lithium or digoxin, Diclofenac Sodium may raise their plasma concentrations. Concomitant administration of glucocorticoids or other NSAIDs may aggravate gastro-intestinal side effects.

Concurrent administration with two or more NSAIDs may promote the occurrence of side effects.

Should be used with caution in patients with asthma. Use with care in elderly patients.

Dosage in excess of those recommended by the Physician may cause liver damage. Patients suffering from liver or kidney disease should take Paracetamol only under medical supervision. Consult your doctor if no relief is obtained from the recommended dosage.

Do not use continuously for more than 10 days without consulting your doctor.

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. 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.

Paracetamol has analgesic and antipyretic effects similar to those of Aspirin. However, it has no anti-inflammatory effect and does not share the antirheumatic properties of the salicylates. It is rapidly and practically completely absorbed from the gastro-intestinal tract. The concentration in plasma reaches a peak in 30-60 minutes and the plasma half-life is about 2 hours after therapeutic doses. It is distributed into most body tissues. It crosses the placenta and is present in breast milk.

Chlorzoxazone is a centrally acting muscle relaxant. Chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. Chlorzoxazone is rapidly absorbed from the gastrointestinal tract. It is metabolized to 6-hydrochlorzoxazone and then eliminated in the urine.