Composition :
Each hard gelatin capsule contains:
Paracetamol BP………………300mg
Chlorzoxazone USP…………250mg
Excipients………………………Q.S.
Approved colour used in hard gelatin capsule shells
Pharmaceutical form :
Capsule for oral administration
Therapeutic indications : Paracetamol capsules are recommended for the treatment of headaches including migraine and tension headaches; also for backache, rheumatic and muscle pains, ‘nerve pains’, toothache, dysmenorrhoea, sore throat and for relieving the fever, aches and pains of colds and flu. Chlorzoxazone is particularly effective in treating pain and spasm of the skeletal muscles arising in Sprains and strains, Myalgia, Torticollis ,Tension headache ,Traumatic muscle damage , Lumbago .
Posology and method of administration :
Adults, Elderly and Children over 16 years Two capsules up to 4 times a day. Do not take for more than 3 days without consulting your doctor.These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period.
Paediatric population :
Not recommended for children under 10 years of age.
2 capsules 3 times daily after meals (unless otherwise prescribed by the physician) This dosage is sufficient to maintain an adequate myotonolytic and analgesic effect throughout the day. Method of administration Capsule for oral administration.
Contraindications :
Hypersensitivity to the active substance or to any of the excipients
Special warnings and precautions for use :
Not recommended for children under 10 years of age. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the recommended dose.
Do not take with any other paracetamol-containing products.
If symptoms persist, consult your doctor.
Keep out of the reach of children.
Interaction with other medicinal products and other forms of interaction :
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Pregnancy and lactation :
Pregnancy
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Breasffeeding Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
Undesirable effects :
Immune system disorders
Hypersensitivity including skin rash may occur.
Not known: Anaphylactic shock, Angioedema Blood and lymphatic system disorders Not known : blood dyscrasias including hrombocytopenia and agranulocytosis
Skin and subcutaneous disorders Very rare cases of serious skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption have been reported.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away : •Feeling sleepy. Dizziness, Feeling tired or weak. Feeling nervous and excitable. change in color of urine.
Overdose:
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:
If the patient is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’s Wort or other drugs that induce liver enzymes, or regularly consumes ethanol in excess of recommended amounts, or s likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Pharmacological properties : Pharmacodynamic properties :
ATC code : NO2B E01, Other analgesics and antipyretics.
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar
to that of aspirin and dependent on the inhibition of prostaglandin synthesis. The inhibition appears, however, to be on a selective basis.
Pharmacokinetic properties :
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the half life in plasma is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day.
However, practically no paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation.
Special precautions for storage :
Store below 30°C. Protect from light and moisture.
Keep the medicine out of reach of children.
Presentation
30 Capsules
Marketed by:
PYXUS PHARMACEUTICALS PVT. LTD.
