Analgesic and antipyretic

Age 3-9 months, average weight 5.5-8.3 kg, dose 0.8-l.2 ml
Age 9-12 months, average weight 8.3-10 kg, dose 1.2-l.5 ml
In each case, 3-4 times a day or as directed by physician. Do not take more frequently

than every 4 hours. Do not take more than 60mg/kg presented in divided doses of 15mg/kg throughout the 24 hour period. Always dose by body weight of child. Not to be administered without doctor's advice.

Route of Administration: Oral

• 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
• 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
• Check with your doctor before use if you have liver or kidney problems.
• Please see your doctor if your symptoms do not improve
• Keep out of the reach and sight of children.

Before taking this medicine, make sure you consult your doctor if you are taking warfarin or similar medicines used to thin the blood.

Not applicable

None

Stop taking this medicine and tell your doctor immediately if:

• you experience allergic reactions such as skin rash or itching, sometimes with
• breathing problems or swelling of the lips, tongue, throat or face.
• you experience a skin rash or peeling, or mouth ulcers.
• you have previously experienced breathing problems with aspirin or non-steroidal
• anti-inflammatories, and experience a similar reaction with this product.
• you experience unexplained bruising or bleeding.

lf you take more of the medicine, then you should seek medical advice immediately because of the risk of liver failure.

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulating centre to produce peripheral vaso dilation resulting in increased blood flow through the skin,

Oral absorption is rapid and almost complete, it may be decreased if Paracetamol is taken following a high carbohydrate meal.

There is no significant protein binding with doses producing plasma concentrations of below 60mcg (ug)/ml, but may reach moderate levels with high or toxic doses.

Approximately 90 - 95% of a dose is metabolised in the liver, primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. An intermediate metabolite, which may accumulate in overdosage after primary metabolic pathways become saturated, is hepatotoxic and possibly nephrotoxic.

Half life is 1 to 4 hours; does not change with renal failure but may be prolonged in acute overdosage, in some forms of hepatic disease, in the elderly, and in the neonate; may be somewhat shortened in children.

Time to peak concentration, 0.5 - 2 hours; peak plasma concentrations, 5 - 20mcg (ug)/ml (with doses up to 650mg); time to peak effect, 1- 3 hours; duration of action, 3- 4 hours.

Elimination is by the renal route, as metabolites, primarily conjugates, 3% of a dose may be excreted unchanged.

Peak concentration of 10 - 15mcg(ug)/ml have been measured in breast milk, 1 - 2 hours following maternal ingestion ofa single 650mg dose. Halflife in breast milk is 1.35 - 3.5 hours.

None stated

Methyl Paraben
Propyl Paraben
Polyethylene glycol
Sodium saccharine
Propylene glycol
Sorbitol liquid 70% Non-crystallizing
Citric acid anhydrous
Trisodium citrate dihydrate
Soluble color Carmosine
Flavour raspberry sweet
Flavor cherry
Flavor black current
Bitter taste masking flavour

None

Store below 25°C, protect from light.

20 ml amber glass bottle with plastic cap and dropper.

None