Each film-coated tablet contains:
Active ingredient:
Paracetamol | 500 mg |
Caffeine | 65 mg |
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Adults (including the elderly), and children aged 16 years and over: Two tablets up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 tablets in 24 hours.
Children aged 12-15 years: One tablet up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 4 tablets in 24 hours.
Not recommended for children under 12 years
ADMINISTRATION
Oral route.
CONTRAINDICATIONS
Hypersensitivity to paracetamol, caffeine or any of the other constituents.
WARNINGS AND PRECAUTIONS
- Do not exceed stated dose.
- Do not use with any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose.
- Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
- Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease.
- Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis.
- Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
- Sodium methyl-, sodium ethyl- and sodium propyl- parahydroxybenzoates (E 219, E 215 and E 217) may cause allergic reactions (possibly delayed).
- This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
- If symptoms persist, medical advice must be sought.
- Keep out of the sight and reach of children.
- Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
PREGNANCY AND LACTATION
- Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
- Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.
- Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
STORAGE CONDITION
In a dry place, below 30°C, protect from light.
SHELF-LIFE
36 months from the manufacturing date. Do not use it after the expiry date.