PAINAMOL PLUS Tablet Ref.[50534] Active ingredients: Codeine Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext.1, Roodepoort, 1724, South Africa

4.1. Therapeutic indications

PAINAMOL PLUS tablets are indicated for the relief of mild to moderate pain and for the reduction of temperature in febrile conditions.

4.2. Posology and method of administration

Posology

Adults: One or two tablets every four to six hours.

Children over 12 years: One tablet every four to six hours.

Children 6 to 12 years: Half to one tablet every six hours.

Do not exceed an adult dose of 8 tablets per day.

Do not use continuously for longer than ten (10) days without consulting your doctor.

Method of Administration

For oral use.

4.9. Overdose

Paracetamol: Symptoms 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 overdosage, consult your 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.

Codeine: Symptoms include restlessness, excitement, respiratory depression and hypotension with circulatory failure and coma. In children convulsions may occur. The specific antagonist, naloxone hydrochloride is used to counteract the severe respiratory depression.

In the event of overdosage, consult a doctor or take the patient to the nearest hospital immediately.

Treatment is supportive and symptomatic.

6.3. Shelf life

24 Months: 20, 100, 500, 1000 and 5000 tablets.

15 Months: Patient ready packs of different pack sizes.

6.4. Special precautions for storage

Store at or below 25°C.

Protect from strong light in a well-closed container.

Protect from moisture.

Exposure to air should be minimum.

6.5. Nature and contents of container

Cartons with 2 X 10 tablets in push through blister packs.

Containers with 100, 500 and 1000 tablets.

Blue/green plastic buckets containing 5000 tablets.

Patient ready packs of different pack sizes.

6.6. Special precautions for disposal and other handling

Not applicable.

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