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5th May 2009
Dolphin has added seven more formulations to its growing Sri Lanka Portfolio

28th April 2009
The Board of Directors of the Company in its 154th meeting held on Tuesday, 28 April, 2009 has recommended 50% cash and 25% stock dividend (bonus share)

Voltadol Tablet
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 DESCRIPTION

Voltadolis a preparation of diclofenac sodium. It is a non-steroidal agent with marked analgesic/anti- inflammatory properties. It is an inhibitor of prostaglandin synthetase, (cyclo-oxygenase).

 INDICATIONS

Voltadolis indicated for the treatment of:
• Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis,     osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism
• Post-traumatic and post-operative pain, inflammation and swelling (eg: following dental or orthopaedic surgery)
• Painful and/or inflammatory conditions in gynaecology (eg: primary dysmenorrhoea or adnexitis)

 DOSAGE AND ADMINISTRATION

Adults:
The recommended daily dose is 100-200 mg, in 1 or 2 divided doses. In milder cases, as well as for long-term therapy, 75-100 mg daily is usually sufficient.

Children (aged 1-12 years):
1-3mg/kg per day in divided doses. Children (aged 6-12 years) with acute post-operative pain: 1-2mg/kg per day in divided doses. Treatment of acute post-operative pain should be limited to 4 days treatment.

 CONTRAINDICATIONS

• Known hypersensitivity to the active substance, diclofenac, or any other ingredient in Volmax® SR
• Active gastric or intestinal ulcer, bleeding or perforation
• Last trimester of pregnancy
• Severe hepatic, renal or cardiac failure
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltadolis also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.

 SIDE-EFFECTS

The side effects of diclofenac correspond to those from ibuprofen, however the substance is, compared with others not opioiden pain means somewhat to be better compatible.

 USE IN PREGNANCY AND LACTATION

The use of diclofenac in pregnant women has not been studied. Therefore, Voltadolshould not be used during the first two trimesters of pregnancy unless the potential benefit to the mother outweighs the risk to the foetus. As with other NSAIDs, use during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus. Animal studies have not shown any directly or indirectly harmful effects on pregnancy, embryonal/foetal development, parturition or postnatal development

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltadolshould not be administered during breast-feeding in order to avoid adverse effects in the infant.

 OVERDOSE

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism. Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.

 PRECAUTIONS

Renal:
As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause (eg: before or after major surgery). Monitoring of renal function is recommended as a precautionary measure when using Voltadolin such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Hepatic:
If As with other NSAIDs, values of one or more liver enzymes may increase. During prolonged treatment with Volmax® SR, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (eg: eosinophilia, rash), Voltadolshould be discontinued. Hepatitis may occur without prodromal symptoms.
Caution is called for when using Voltadolin patients with hepatic porphyria, since it may trigger an attack.

Haematological:
During prolonged treatment with Volmax® SR, as with other NSAIDs, monitoring of the blood count is recommended. Like other NSAIDs, Voltadolmay temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

 PHARMACEUTICAL PRECAUTIONS

Store in a dry place, protected from moisture. Keep out of reach of children.

 PACKAGING

Voltadol Tablet: Box containing 10 strips of 10 tablet each. Each capsule contains Diclofenac sodium USP 50 mg.


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