4.1 Therapeutic indications
Panadol is a mild analgesic and antipyretic. The tablets are recommended for use in the short-term management of headaches, musculoskeletal disorders, menstrual pains, toothache and for symptoms of common colds and flu. Panadol 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 500mg Tablets for more than 3 days without consulting a doctor

.
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.

Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver or
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 the 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.

No significant effect.

Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by System Organ Class and frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000,
<1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).
Adverse event frequencies have been estimated from spontaneous reports received through post marketing data.

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.

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. 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.

Pharmacotherapeutic group: Anilides.
ATC Code: N02B E01.
Paracetamol has analgesic and antipyretic actions.

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract.
Human pharmacokinetic data demonstrate that early absorption of paracetamol (fraction of dose over the first 60 minutes) is
32% greater from Panadol compared to standard paracetamol tablet (p<0.0001) and less between-subject and less
within-subject variability (p<0.0001) in early absorption of paracetamol from Panadol compared to standard paracetamol tablets.

Human pharmacokinetic data demonstrate that maximum plasma concentration of paracetamol is reached at least 25% faster
for Panadol compared to standard paracetamol tablets in fasted and fed states (p <0.01).
Total extent of absorption of paracetamol from Panadol is equivalent to that from standard paracetamol tablets.
Human scintigraphy data demonstate that Panadol generally start to disintegrate by 5 minutes post dose. Human
pharmaconkinetic data demonstrate that paracetamol can generally be detected in plasma by 10 minutes.

Concentration in plasma reaches a peak in 30 - 60 minutes. Plasma protein binding is variable. Plasma half-life is 1 - 4 hours.
Maximum plasma concentration of paracetamol is reached faster for Panadol compared to standard paracetamol tablet in fasted and fed states (p < 0.01).

Paracetamol is relatively uniformly distributed throughout most body fluids.

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.

6.1 List of excipients
Pregelatinised starch Calcium carbonate Alginic acid Crospovidone Povidone (K-25) Magnesium stearate
Colloidal anhydrous silica
Carnauba wax
Opadry white (YS-1-7003) containing:
Titanium dioxide (E171), Hypromellose, Macrogol, Polysorbate 80

Not applicable

Store below 30°C.

Opaque or clear 250 or 300 micron poly vinyl chloride (PVC)/Aluminium foil blister strips or blister packs comprised of clear
thermoformed polyethylene terephthalate (PET) film of 250 μm and CRSF polyethylene terephthalate (PET) lid of 30 μm, packed into cardboard cartons containing 6, 12, 24, 48 or 96 tablets or perforated opaque PVC/Aluminium foil blister strips packed into cardboard wallets containing 12 tablets.

Polyethylene sachet pack of 2 tablets (6 tablets in carton).
HDPE bottle containing 100 tablets.
Not all pack sizes may be marketed.

No special requirements.