Each 5 ml of oral solution contains:
active ingredient: Acetaminophen (paracetamol) – 120 mg;
excipients: Sodium saccharin, propylene glycol, glycerin, aroma orange, sunset yellow FCF (E110), water purified.
Drug formLiquid (for oral use)
ATC categoryNon steroidal antiinflammatory drugs
ATC subcategoryNSAIDs for systemic use
Brand nameParacetamol
Generic nameAcetaminophen (Paracetamol)
Each 5 ml of oral solution contains:
active ingredient: Acetaminophen (paracetamol) – 120 mg;
excipients: Sodium saccharin, propylene glycol, glycerin, aroma orange, sunset yellow FCF (E110), water purified.
Paracetamol has analgesic, antipyretic and weak inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis and the influence on the thermoregulation center in the hypothalamus.
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.
Age: 2–3 months
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Dose
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1. Post-vaccination fever | One 2.5 mL (0.5 teaspoonful);If necessary, after 4-6 hours, give a second 2.5 mL dose. |
2. Other causes of pain and fever only if • Weighs over 4 kg • Born after 37 weeks |
• Do not give to babies less than 2 months of age
• Do not give more than 2 doses
• Leave at least 4 hours between doses
• If further doses are needed, talk to your doctor or pharmacist.
Child’s Age
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How Much
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How often (in 24 hours)
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3 – 6 months | One 2.5 mL (0.5 teaspoonful) | 4 times |
6 – 24 months | One 5 mL (1 teaspoonful) | 4 times |
2 – 4 years | One 5ml (1 teaspoonful) and one 2.5 mL (0.5 teaspoonful) | 4 times |
4 – 8 years | Two 5mL (2 teaspoonfuls) | 4 times |
8 – 10 years | Three 5mL (3 teaspoonfuls) | 4 times |
10 – 12 years | Four 5mL (4 teaspoonfuls) | 4 times |
• Do not give more than 4 doses in any 24 hour period
• Leave at least 4 hours between doses
• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist
If your baby was born prematurely and is less than 3 months old consult your doctor prior to use.
Method of Administration
Paracetamol oral solution is for oral administration only.
There have been rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
The frequency of adverse events associated with paracetamol are tabulated below.
Blood and lymphatic system disorders: Very rare – Thrombocytopaenia, agranulocytosis.
Immune System disorders: Very rare – anaphylaxis, cutaneous hypersensitivity reactions, angiodema, Stevens Johnson syndrome.
Respiratory, thoracic and mediastinal disorders: Very rare – bronchospasm in patients sensitive to aspirin and other NSAIDs.
Hepatobiliary disorders: Very rare -hepatic dysfunction.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with noncirrhotic alcoholic liver disease.
Do not give with any other paracetamolcontaining products.
Never give more medicine than shown in the table.
Use the teaspoonful.
Do not give to babies less than 2 months of age.
For infants 23 months no more than 2 doses should be given.
Do not give more than 4 doses in any 24 hour period.
Leave at least 4 hours between doses.
Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.
As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.Keep out of the reach and sight of children.
If symptoms persist, consult your doctor.
Prolonged use except under medical supervision may be harmful.
If your baby was born prematurely and is less than 3 months old consult your doctor prior to use.
Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of irreversible liver damage.
Contains Propylen glycol, which at 200mg/kg children may cause alcohol-like symptoms.
Contains colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Effects on ability to drive and use machines: none.
Biochemical evidence of maximal damage, however, may not be attained until 7296 hours after ingestion of the overdose.
Intravenous Nacetylcysteine (NAC) is effective when initiated within 8 hours of the overdose. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12 g or 150 mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose. There is little evidence that undertaking gastric lavage will be of benefit to a patient in whom paracetamol is known to have been the only substance ingested.
Symptoms of paracetamol overdose in the first 24 hours may include pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death.
Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; Occasional doses have no significant effect.
Oral solution with orange flavour.
A clear orange colored, orange flavored oral solution.
Glass bottle with 60 ml oral solution and insert-leaflet in cardboard box.
Glass bottle with 100 ml oral solution and insert-leaflet in cardboard box.
3 years. Do not use the medicine for more than 6 months after opening.
To be dispensed without prescription.
Store at a temperature 15-250C, in a cool and dry place, out of the reach of children. Protect from light.