PARACETAMOL WINTHROP Tablet

Symptomatic treatment of mild to moderated pain and/or febrile states.

Method of administration

Oral administration

Swallow the tablets with a large glass of water, milk or fruit juice.

Dosage

THIS DOSAGE FORM IS ONLY FOR USE IN ADULTS AND CHILDREN WEIGHING 27KG OR MORE, (i.e. from approximately 8 years of age).

In adults and children weighing more than 50kg (i.e. approximately 15 years of age and older):

The usual dosage is 1-2 500mg tablets taken in one dose, repeated as needed at intervals of not less than 4 hours. It is generally not necessary to take more than 3g of paracetamol (i.e. 6 tablets) per day. However, in patients experiencing more intense pain, and on your doctor’s advice, the total dose can be increased to 4g of paracetamol (i.e. 8 tablets) per day.

However:

- Dosages greater than 3g of paracetamol per day require medical advice.

- Never take more than 4g of paracetamol per day (taking into consideration all medicines containing paracetamol).

Always take doses at least 4 hours apart.

In Children: The dosage of paracetamol depends on the child’s weight; ages are provided as an indication; and more appropriate pharmaceutical forms used.

The recommended daily dose of paracetamol is approximately 60mg/kg/day, given in 4 or 6 divided doses, i.e. approximately 15mg/kg every 6 hours or 10mg/kg every 4 hours.

Children weighing 27-40kg (approximately 8-13 years of age); the dosage is one 500mg tablet per dose, repeated, if necessary, every 6 hours, without exceeding 4 tablets per day.

Children weighing 41-50kg (approximately 12-15 years of age): the dosage is one 500mg tablet per dose, repeated, if necessary, every 4 hours, without exceeding 6 tablets per day.

Administration frequency

Following a regular dose schedule makes it possible to avoid fluctuations in pain or fever.

Intervals between doses should be:

* Children should be given doses, including during the night, at regular intervals of at least 4 hours, and preferably 6 hours.

* Adults should take doses at least 4 hours apart.

Impaired renal function

In case of severe renal impairment (creatinine clearance less than 10mL/min), the minimum interval between doses should be preferably 8 hours and at least 4 hours. Paracetamol dose should not exceed 3g (i.e. 6 tablets) per day.

Allergy to paracetamol or any excipients

Patients with anemia, or heart, lung, liver, or kidney insufficiency, Glucose-6- phosphate dehydrogenase deficiency.

In certain rare cases, skin rash or redness, or an allergic reaction appearing as sudden swelling of the face and neck, or sudden malaise with a fall in blood pressure may occur. You must stop treatment immediately and inform your physician.

Very rare instances of thrombocytopenia have been reported.

The safe use or paracetamol in pregnancy has not been established. Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in recommended dosage. Paracetamol can be used throughout pregnancy under normal conditions of use if necessary.

Maternal ingestion of paracetamol in usual therapeutic doses does not appear to present a risk to the breastfed infants.

To avoid risk of overdosage, make sure that concomitant medications are paracetamol-free. Alcohol consumption should be limited or avoided.

Paracetamol is rapidly and almost completely absorbed after oral administration. The plasma concentration reaches a maximum within 30-60 minutes. Paracetamol is rapidly distributed to all tissues. Low binding to plasma protein.