- Each film coated tablet contains
- Active ingredients: Paracetamol 500 mg and caffeine 85mg
- Inactive ingredients: Maize starch, potassium sorbate, talc,
stearic acid, povidone, pregetatinised starch and croscarmellose sodium (type A)
Film coat: hypromellose, triacetin
- The tablets are recommended for use as an analgesic in the relief of mild to moderate pain such as is associated with rheumatism (ie, joint pain), neuralgia, musculoskeletal disorders, headache including Migraine, backache and symptoms of colds, influenza, sore throat, feverishness, feverish colds, toothache and dysmenorrhoea
Posology and method of administration
For oral administration
- Adults (including the elderly) and children 16 years and over
- 2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours
- Children aged 12 – 15 years:
- 1 tablet up to four times daily. Do not exceed 4 tablets in 24 hours,
- Not recommended for children under 12 years of age.
Minimum dosing interval: 4 hours.
The lowest dose necessary to achieve efficacy should be used.
- Should not be used with other paracetamol-containing products.
- Known hypersensitivity to paracetamol, caffeine or any of the other ingredients
- Special warnings and precautions for use
- 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
can lead to liver transplant or death.
- Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
- Cases of hepatic dysfunction Mailure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol Caution in patients with glutathione depleted states such as sepsis:
- 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.
- Prolonged use except under medical supervision may be harmful.
- Do not exceed the stated dose. Take only when necessary.
- If symptoms persist, consult your doctor.
- Keep out of the sight and reach of children.
Interaction with other medicinal products and other forms of interaction
- Paracetamol may increase the elimination half-life of chloramphenicol.
- The absorption of paracetamol may be increased by metaclopramide and decreased by cholestyramine. Oral contraceptives may increase the rate of clearance of paracetamol The anticoagulant effect of Warfarin and other Coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occassional doses have no significant effect.
- Fertility, pregnancy and lactation Pregnancy Paracetamol
- Human and animal studies have not identified any risk of paracetamol in pregnancy or embryo-foetal development Caffeine
- Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion associated with caffeine
consumption Lactation Paracetamol and caffeine are excreted in breast milk.
- Human studies with paracetamol at the recommended doses have notidentified any risk to lactation or the breast-fed offspring, Caffeine
- Caffeine in breast milk may potentially have a stimulating effect on breast fed infants but significant toxicity has not been observed.
- Effects on ability to drive and use machines None
Undesirable effects Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by
System organ Class and frequency.
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