4.1 Therapeutic indications
Panadol Baby and Infant Oral Suspension contains paracetamol which is an analgesic (a pain killer that reduces aches and shivers) and antipyretic (it reduces temperature when a child has fever).
Panadol Baby and Infant Oral Suspension relieves the pain of teething, toothache and sore throats and reduces the fever often associated with colds and flu and childhood infections such as chicken pox, whooping cough, measles and mumps.
Panadol Baby and Infant has a strawberry flavour specially formulated to be pleasant tasting and easy to administer to infants and children.
4.2 Posology and method of administration
This product is intended for oral use in children ages:

Maximum daily dose: 4000 mg.
For children above 6 years and adolescences, the maximum daily dose is 60 mg/kg given in divided doses of 10-15 mg/kg throughout the 24-hour period.
Not recommended for babies under 2 months except under medical advice. Do not exceed stated dose.
If symptoms persist, medical advice must be sought.
Prolonged use except under medical supervision may be harmful. This product should only be used when clearly necessary.
It is important to shake the bottle for at least 10 seconds before use

Method of Administration
Panadol Baby and Infant suspension is for oral administration only.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Contains paracetamol. Do not give 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.
Cases of hepatic dysfunction/failure 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.
Never give more medicine than shown in the table.
Always use the Measuring cup supplied with the pack.
For infants 2-3 months no more than 2 doses should be given.
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.

If your child has a known intolerance to some sugars, contact your doctor before use as this product contains maltitol syrup and sorbitol.
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 Hexacol Carmoisine Supra (El22) and parahydroxybenzoates (E219, E215 and E2 l 7) which may cause allergic reactions, possibly delayed.
Maltitol & Sorbitol liquid:
Patients with rare hereditary problems of fructose intolerance should not take this medicine. Each 120mg/5 ml suspension contains sorbitol (E 420) at 666.5 mg per 5 ml suspension.
Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Maltitol & Sorbitol liquid:
Patients with rare hereditary problems of fructose intolerance should not take this medicine. Each 120mg/5 ml suspension contains sorbitol (E 420) at 666.5 mg per 5 ml suspension.
Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).

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.

Talk to your doctor before taking Panadol Baby and Infant if you are pregnant.
• Paracetamol is excreted in breast milk. However, the level of paracetamol present is not considered to be harmful.
• Always seek medical advice before taking any medicine during pregnancy or lactation.

None.

4.8 Undesirable effects
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.

To report any side effect(s):
Kingdom of Saudi Arabia
-National Pharmacovigilance centre (NPC)
• Reporting Hotline: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa

Paracetamol overdose may cause liver failure which can lead to liver transplant or death.

There is a risk of poisoning with paracetamol particularly in elderly subjects, young children, patients with liver disease, cases of chronic alcoholism and in patients with chronic malnutrition. Overdosing may be fatal in these cases.

Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor, and abdominal pain, or patients may be asymptomatic.

Overdose of paracetamol in a single administration in adults or in children can cause liver cell necrosis likely to induce complete and irreversible necrosis,

resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.

Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Some patients may be at increased risk ofliver damage from paracetamol toxicity. Risk Factors include: If the patient;

•    Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

•  Regularly consumes ethanol in excess of recommended amounts

•   Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Emergency Procedure:

Immediate transfer to hospital.

Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol plasma concentration should be measured 4 hours post ingestion.

Administration of activated charcoal should be considered if > l 50mg/kg paracetamol has been taken within 1 hour.

The antidote N-acetylcysteine, should be administered as soon as possible in accordance with National treatment guidelines

Symptomatic treatment should be implemented.

ATC code/pharmacological group: N02BE01 Paracetamol has analgesic and antipyretic actions.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma generally reaches a peak in 30-60 minutes; plasma half-life is 1-4 hours. It is metabolised in the liver and excreted in the urine, mainly as the glucuronide and sulphate conjugates.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Ingredients: Hexacol Carmoisine Supra (E122), Malic Acid, Keltrol F (Xanthan Gum), Maltitol Syrup, Strawberry Flavour L10055, Sorbitol Liquid (Crystallising), Sodium methyl paraben (E219), Sodium ethyl paraben (E215), Sodium propyl paraben (E217), Sorbitol Powder, Citric Acid, Purified Water.

Panadol Baby is an opaque, pink liquid with an odour of strawberry. Panadol Baby suspension is contained in a 100mL amber glass bottle. and is supplied with a Measuring cup in the pack

Panadol Baby and Infant is an opaque, pink liquid with an odour and taste of strawberry. Panadol Baby and Infant suspension is contained in 100mL amber glass bottle. supplied with a Measuring cup in the pack.

Not applicable.

Store below 30°C. Protect from light.

Do not freeze. Keep out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) shown on the carton and bottle label. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Amber glass bottles fitted with Clic-loc closures with expanded polyethylene liners. Pack sizes: 100ml.

supplied with a Measuring cup in the pack.

No special requirements.