Kidz PCM

Paracetamol.

Active Ingredient: Each 5 ml contains Paracetamol 250 mg.
Excipients/Inactive Ingredients: Preservatives: Methyl Hydroxybenzoate 0.1% w/v, Propyl Hydroxybenzoate 0.01% w/v, Sodium Benzoate 0.1% w/v.

Pharmacology: Paracetamol produces analgesia and antipyresis by a mechanism similar to that of salicylates. There is some evidence that Paracetamol has weak anti-inflammatory activity in some nonrheumatoid conditions (e.g., in patients who have had oral surgery). Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilatation and increased peripheral blood flow.
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses.
Paracetamol is distributed in most body tissues. It crosses the placenta and is present in breast milk.
Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
The elimination half-life of Paracetamol varies from about 1 to 3 hours.
Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged Paracetamol.

For the relief of fever and mild to moderate pain in children, including headache and toothache.

For fever and pain: Children 6 to 12 years: Give 5-10 ml 3 to 4 times a day.
Children 1 to 6 years: Give 2.4-5 ml 3 to 4 times a day.
Babies 3 to 12 months: Give 1.2-2.4 ml 3 to 4 times a day.
Babies 1 to 3 months: Give 0.6-1.2ml 3 to 4 times a day.
For post-immunization fever in babies: Babies 2 to 3 months: Give 1.2 ml as a single dose. A second dose can be repeated after 6 hours if necessary.
Do not give more than 4 doses in 24 hours.
Do not give more than the recommended dose unless advised by a doctor.
Can be administered or mixed with water or fruit juice if needed.
SHAKE WELL BEFORE USE.

In case of overdose, seek emergency medical attention immediately or call the National Poison Centre at 1800-888-099 for advice.
Symptoms: Symptoms of Paracetamol overdosage in the first 24 hours are diarrhea, sweating, loss of appetite, nausea or vomiting, stomach cramps or pain. Persistence beyond this time, pain, swelling or tenderness in the upper abdomen or stomach area, usually indicates development of hepatic necrosis. Liver damage may be apparent with 12 to 48 hours overdosage.
Treatments: Despite a lack of significant early symptoms, patients who have taken an overdose of Paracetamol should be admitted to hospital immediately.
1. Induction of vomiting may reduce absorption if 100 - 150 mg/kg or greater of Paracetamol is ingested.
2. Administration of activated charcoal should be considered if Paracetamol in excess of 150 mg/kg or 12 g whichever is smaller, is thought to have been ingested within the previous hour.
3. Gastric lavage is indicated if the patient is unwilling or unable to take the activated charcoal.
4. Dextrose and blood infusion.
5. Antidote such as acetylcysteine and methionine protect the liver if given within 10 - 12 hours of ingestion and other supportive treatments may be provided in the hospital.
6. Haemoperfusion may be worthwhile if too much time has elapsed since the poisoning to allow the use of antidote.

Patients with known hypersensitivity to Paracetamol.
Not recommended for babies less than 1 month old.

Patients with impaired liver or kidney functions should take the medication with caution.
Patients should seek medical consultation if pain persists for more than 5 days for children (10 days for adults) or if the pain gets worse, new symptoms occur or the painful area is inflamed or swollen.
Patients should seek medical consultation if fever lasts for more than 3 days or recurs, and if the fever gets worse or extremely high.
This preparation contains Paracetamol. Do not take any other Paracetamol-containing medicines at the same time.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.

Pregnancy: Category A: Paracetamol has been taken by large number of pregnant women and women of childbearing age without any proven increase in frequency of malformations or other direct or indirect harmful effects on the foetus having been observed. Children under 12 years are not likely to become pregnant.
Lactation: Paracetamol is excreted in breast milk in less than 1% of the dose ingested by lactating women. Therefore, maternal ingestion of therapeutic doses does not present a risk to the baby. Children under 12 years are not likely to breastfeed.

Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.

Caution should be taken when Paracetamol are administered concurrently with these medications: Paracetamol may increase Chloramphenicol concentrations.
Prolonged use or high doses of Paracetamol may increase the effects of oral anticoagulant (eg. Warfarin).
Paracetamol absorption is increased by drugs which increase gastric emptying (eg. Metoclopramide).
Paracetamol absorption is decreased by drugs which decrease gastric emptying (eg. Propantheline or narcotic analgesics, Pethidine).
Paracetamol toxicity may be increased by the concomitant use of enzyme-inducing agents (eg. alcohol or Phenytoin).

Store below 30°C. Protect from light. Keep cap tightly closed after opening.
Shelf Life: 3 years from the date of manufacture.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

NP