Plot 3c, blk A, Aswani Market Road, Isolo,Oshodi, Lagos, Nigeria
Tel: 234-1-8105555,234-1-4523570, 4523721, 4527160, 4529288.
Fax: 234-01-4525288, 2693531
Emzor Pharmaceutical Industries Ltd. Plot 3C, Block A, Aswani Market Road, Off Oshodi-Apapa Express Way, Isolo, Lagos.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Caplet (NRN: 04-0261): Paracetamol BP 500 mg.
Pack size: 10 x 10's.
The mechanism of action of Paracetamol is not fully understood. The main mechanism proposed is the inhibition of cyclooxygenase (COX), and recent findings suggest that it is highly selective for COX-2. Because of its selectivity for COX-2 it does not significantly inhibit the production of the pro-clotting thromboxanes.
While it has analgesic and antipyretic properties comparable to those of Aspirin or other NSAIDs, its peripheral anti-inflammatory activity is usually limited by several factors, one of which is the high level of peroxides present in inflammatory lesions. However, in some circumstances, even peripheral anti-inflammatory activity comparable to NSAIDs can be observed.
Emcap is suitable for fast relief from headaches, backaches, joint and muscular pain, pains associated with common cold or "Flu", sorethroat, menstrual pains and to reduce fever.
Any known hypersensitivity to the paracetamol or any of the formulating ingredients.
It is also contraindicated in paracetamol-induced liver failure.
Do not exceed the stated dose. If symptoms persist after 3 days, consult your doctor.
Keep all medicines out of the reach of children.
The hepatotoxicity of Paracetamol, particularly after overdosage, may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants, and alcohol.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Antivirals: Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).
The use of drugs that induce hepatic microsomal enzymes such as anticonvulsants and oral contraceptives may increase the extent of metabolism of paracetamol resulting in reduced plasma concentrations of the drug and a faster elimination rate.
The adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Cases of acute pancreatitis have been reported. Paracetamol has been widely used and reports of adverse reactions are rare, and are generally associated with overdosage.
Allergic reactions occur occasionally.
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.
Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except after prolonged administration.
Dosage & Administration
Children (up to 1 year): ½ teaspoonful or 2.5 mL
1 - 6 years: 1 teaspoonful or 5 mL
6 - 12 years: 2 teaspoonful or 10 mL
Doses may be given 4-6 hourly but not more than 4 times in any 24 hours.
Store in a cool, dry place.
Keep out of the reach of children.