PACIMOL Uncoated tablet Ref.[50222] Active ingredients: Paracetamol

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2021  Publisher: Ipca Pharma (NZ) Pty Limited, PO Box 74509, Auckland 1546 +64 2136 0880 in New Zealand or +61 3 98856172 in Australia

4.1. Therapeutic indications

For the temporary relief of pain & discomfort, in headaches, colds and flu symptoms, rheumatic. muscular and neuralgic conditions and dental pain. Assist in reducing fever.

4.2. Posology and method of administration

Adults and children aged 12 years and over: 1 to 2 tablets every four to six hours as required. Maximum of 8 tablets in 24 hours.

Maximum daily dose: 4000 mg.

Children 7 to 11 years: ½ to 1 tablet every four to six hours as required. Maximum of 4 tablets in 24 hours. Do not exceed the stated dose.

Adults: Do not take this medicine for longer than a few days at a time unless advised by a doctor.

Children and Adolescence: Do not take this medicine for longer than 48 hours at a time unless advised by a doctor.

Not suitable for children under seven years of age.

Take orally with water or other fluid. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. Should not be used with other paracetamol‐containing products.

Minimum dosing interval: 4 hours.

4.9. Overdose

Experience following overdose with paracetamol indicates that the clinical signs of liver injury occur usually after 24 to 48 hours and have peaked after 4 to 6 days.

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.

Immediate medical management is required in the event of an overdose, even if the symptoms of overdose are not present.

If an overdose is taken or suspected, contact the Poisons Information Centre immediately for advice (0800 764 766), or the patient should go to the nearest hospital straight away. This should be done even if they feel well because of the risk of delayed, serious liver damage.

Administration of N‐acetylcysteine may be required.

In cooperative adults, activated charcoal may reduce absorption of the medicine if given within one hour after ingestion.

6.3. Shelf life

60 months from date of manufacture.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Blister pack of 1000 tablets.

6.6. Special precautions for disposal and other handling

No special requirements.

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