Panadol  is a mild analgesic and antipyretic. The tablets are recommended for use in the short-term management of
headaches, musculoskeletal disorders, menstrual pain, toothache and for symptoms of common colds and flu. Panadol Original
may also be used in the symptomatic relief of mild to moderate pain associated with osteoarthritis as diagnosed by a doctor.

Panadol is for oral administration.

Adults (including the elderly) and children aged 16 years and over:
One or two tablets up to four times daily as required.

Children aged 10-15 years:
One tablet up to four times daily as required. Children should not be given Panadol Original Tablets for more than 3 days
without consulting a doctor.

Panadol Original tablets are not recommended for children under 10 years of age.
These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24
hour period.
The lowest dose necessary to achieve efficacy should be used.

Contains paracetamol. Do not use 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.

kidney impairment must seek medical advice before taking this medication.
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.
Caution in patients with glutathione depleted states such as sepsis; the use of paracetamol may increase the risk of metabolic
acidosis.
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap
metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of
glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring,
including measurement of urinary 5-oxoproline, is recommended.
Do not exceed the stated dose.
If symptoms persist, consult your doctor. Prolonged use except under medical supervision may be harmful.
This product should only be used when clearly necessary. Keep out of sight and reach of children.

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. Caution should be taken when
paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic
acidosis, especially in patients with risks factors (see section 4.4)

Pregnancy
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies
on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol
can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the
lowest possible frequency.

Lactation
Paracetamol is excreted in breast milk. However, the level of paracetamol present is not considered to be harmful. Available
published data do not contraindicate breastfeeding.

None.

There have been rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but there were not
necessarily casually related to paracetamol.
The frequency of adverse events associated with paracetamol are tabulated below:

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected
adverse reactions via HPRA Pharmacovigilance website: www.hpra.ie.
Kingdom of Saudi Arabia
-National Pharmacovigilance center (NPC)
• Fax: +966-11-205-7662
• Reporting Hotline: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa
Other GCC States
Please contact the relevant competent authority

Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Acute pancreatitis has been observed,
usually with hepatic dysfunction and liver toxicity.
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
cause 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 of liver 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 >150mg/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.

Paracetamol has analgesic and antipyretic actions.

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Concentration in plasma reaches a
peak in 30 - 60 minutes.
Plasma half-life is 1 - 4 hours.
Paracetamol is relatively uniformly distributed throughout most body fluids.
Plasma protein binding is variable.
Excretion is almost exclusively renal, in the form of conjugated metabolites.

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development
are not available.

Maize starch
Potassium sorbate
Talc
Stearic acid
Povidone
Starch, Pregelatinised
Hypromellose
Triacetin
Carnauba wax

Not applicable.

Store below 30°C

Panadol Tablets are packed in:
• Blister packs packed either into cardboard cartons containing 12, 24, 48 or 96 tablets, or into cardboard wallets
containing 12 tablets:
- Blister packs comprising polyvinyl chloride (PVC) laminate heat-sealed with hard tempered aluminium foil.
- Child resistant blister packs comprising PVC laminate heat sealed to bilayer of aluminium and polyethylene terephthalate.
- Blister packs compromising polypropylene (PP) thermoforming foil heat sealed to PP push through lidding film.
• HDPE bottles fitted with screw closure or ‘Clik Lok’ caps containing 100 tablets
Not all pack sizes may be marketed.

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.