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

Logo PAINAMOL® TABLETS
SCHEDULING STATUS:
Not scheduled: All pack sizes containing less than 25 tablets.
Schedule 1: All pack sizes containing more than 25 tablets.

PROPRIETARY NAME
(and dosage form):

PAINAMOL® TABLETS

COMPOSITION:
Each tablet contains:
Paracetamol: 500 mg
Preservatives: Nipastat 0,1% m/m
Benzoic Acid 0,06% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
Painamol tablets have analgesic and antipyretic actions.

INDICATIONS:
For the relief of mild to moderate pain, and fever.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage. Do not use continually for more than 10 (ten) days without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE:
Children under 6 years: not recommended.
Children 6 to 12 years –half to one tablet every 6 hours.
Children over 12 years –one tablet every four to six hours.
Adults: one to two tablets every four to six hours. (Do not exceed 8 tablets in 24 hours).

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Sensitivity reactions resulting in reversible skin rashes or blood disorders may occur, but these are rare.

SPECIAL PRECAUTIONS:
1. Consult your doctor if no relief is obtained with the recommended dosage.
2. Do not use continuously for longer than ten days without consulting your doctor.
3. Store in a safe place, out of reach of children.
4. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre. 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.

IDENTIFICATION:
A flat, round, white tablet, 12,7 mm in diameter, scored on one side and "Painamol" imprinted on the other side.

PRESENTATION:
Containers of 20, 24, 100, 500, 1000 and 5000 tablets.
Patient ready packs of different pack sizes. Blister packs of 10 and 20 tablets.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
E/2.7/105 (S.A.)
B 9314900 (Botswana)

NAME AND BUSINESS ADDRESS OF APPLICANT:
BE-TABS PHARMACEUTICALS (PTY) LTD.
14 Lautre Road
Stormill, Ext. 1
Roodepoort 1724

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 June 1974

CODE: IPM/10

                        JET PRINTERS 8/2002

Updated on this site: May 2004
Source: Community Pharmacy

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