DAWA TATU (Aspirin, Paracetamol and Caffeine)
Paracetamol, Aspirin and Caffeine tablets is indicated for the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, influenza, feverishness and feverish colds.
Posology and method of administration
Adults, the elderly and young person aged 16 and over, 2 tablets every 4 hours to a maximum of 8 tablets in 24 hours. Do not exceed 8 tablets a day. Do not give to children under 12 years, unless specifically indicated (for e.g. Kawasaki’s disease)
- Hypersensitivity to the active ingredients or any of the excipients (Pre-gelatinised starch,, purified water, microcrystalline cellulose, crosspovidone, maize starch, colloidal anhydrous silica and stearic acid)
- Peptic ulceration and those with a history of peptic ulceration
- Concurrent anti-coagulant therapy
- Children under 12 years and when breast feeding because of possible risk of Reyes syndrome
Special warnings and precautions for use
Caution should be exercised in patients with asthma, allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration. The hazards of overdose are greater in those with non-cirrhotic liver disease
- Do not take if you have a stomach ulcer
- Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
- Do not take anything else containing paracetamol when taking this medicine.
Talk to your 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.
There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children under 12 years unless specifically indicated (Kawasaki’s disease)
Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.
Pregnancy and lactation
There are no adequate data available from the use of tablets in pregnant women. Animal studies have not been performed with Aspirin, paracetamol and caffeine in combination.
Aspirin: due to the presence of Aspirin, its use is contraindicated in the 3rd trimester of pregnancy and caution should be exercised when used in the first 2 terms of pregnancy
Paracetamol: epidermiological studies indicate that under normal therapeutically conditions paracetamol can be used during pregnancy. Nevertheless, it should be used only after a careful benefit risk assessment has been done.
Caffeine: pregnant women are advised to limit their intake of caffeine to aminimum as the available data on the effect of caffeine on the human fetus suggests a potential risk.
Aspirin appears in breast milk, and regular high doses may affect neonatal clotting. Not recommended while breast feeding due to possible risk of Reye’s syndrome as well as neonatal bleeding due to hypoprothrombinaemia.
Paracetamol is excreted in breast milk but not in significant amount.
Caffeine appears in breast milk. Irritability and poor sleeping pattern in the infant have been reported.
Effects on ability to drive and use machines
No studies on the effects of the ability to drive and use machines have been performed. If you notice undesirable effects such as dizziness or drowsiness, you should not drive or use machines.
Side effects are mild and infrequent, but there is a high incidence of gastro-intestinal irritation with slight asymptomatic blood loss. Increased bleeding time. Aspirin may precipitate broncho spasm and induce asthma attacks or other hypersensitivity reactions, such as skin reactions (including angioedema and face oedema) in susceptible individuals.
Aspirin may induce gastro-intestinal haemorrhage, occasionally major. It may precipitate gout in susceptible individuals. Possible risk of Reye’s syndrome in children under 12 years.
Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura and agranulocytosis, but these were not necessarily causality related to paracetamol.
High doses of paracetamol can cause tremor and palpitations.