PARAMED TABLETS

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

PARAMED TABLETS

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME:
(and dosage form)

PARAMED TABLETS

COMPOSITION:
Each tablet contains:

Paracetamol

500 mg

PHARMACOLOGICAL CLASSIFICATION:
A2.7 - Antipyretics or antipyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION :
Paracetamol has analgesic and antipyretic actions.

INDICATIONS:
Paramed Tablets are recommended for the relief of mild to moderate pain and fever such as headache, toothache, pain and fever associated with colds and flu.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.

WARNINGS:

1.	Dosages in excess of those recommended may cause severe liver damage.
2.	Do not use continuously for longer than 10 days without consulting your doctor.

In the event of overdosage and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Control Centre must be contacted immediately.

Do not exceed the recommended daily dose.

DOSAGE AND DIRECTIONS FOR USE:
ADULTS: Take one to two tablets every four hours if necessary. Do not take more than 8 tablets per 24 hours.

CHILDREN: 6 - 12 years: Take half to one tablet every four hours, if necessary. Do not take more than 4 tablets per 24 hours.

It symptoms persist, consult your doctor. Do not use continuously for longer than 10 days without consulting your doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SPECIAL PRECAUTIONS: Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for longer than ten days without consulting your doctor. Persons suffering from liver a kidney disease should take paracetamol under medical supervision. Store in a safe place out of the reach of children.
SIDE-EFFECTS: Sensitivity reactions resulting in skin rash or blood disorders may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include nausea and vomiting.
Liver damage which may be fatal may only appear after a few days.
Kidney failure has been described following acute intoxication.
In the event of an overdose, consult your doctor immediately or take the patient to the nearest hospital at once. Specialised treatment is essential as soon as possible.
The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
White, smooth round convex tablet with a breakline on one side and Paramed embossed on the other side.

PRESENTATION:
Packs of 2, blister packs of 10 and 20 tablets. Securitainers of 50 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in a well closed container protected from light.
Exposure to air should be kept to a minimum.
Keep out of reach a children.

REGISTRATION NUMBER:
R/2.8/263

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories SA (Pty) Ltd.,
21 Wrench Road,
Isando
Transvaal

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1984

809870101

Rosside 26612