A mild analgesic and antipyretic recommended in the short-term management of the symptoms of headaches, musculoskeletal disorders, menstrual pains, toothache and for relieving fever, aches and pains of common colds and flu.

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 12-15 years:
One tablet up to four times daily as required.
Children should not be given Panadol ActiFast for more than 3 days without consulting a doctor.

Not recommended for children under 12 years of age.

Minimum dosing interval: 4 hours.
Not more than 4 doses should be taken in any 24-hour period.
Do not exceed the stated dose.
Should not be used with other paracetamol containing products.
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.
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.

This medicinal product contains 352 mg of sodium per dose, equivalent to 17.6% of the WHO recommended maximum daily
intake for sodium. The maximum daily dose of this product is equivalent to 70.4% of the WHO recommended maximum daily
intake for sodium. Panadol ActiFast is considered high in sodium. This should be particularly taken into account for those on a
low salt diet.
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.
If symptoms persist, seek medical advice. Prolonged use except under medical supervision may be harmful. 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.

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 ai1d considered attributable are tabulated below by System Organ Class and frequency .

Frequencies are defined as: very common ('.2=1  / 10),      common (2:1/100, < l/1 0), uncommon (2:1/1,000  <1/l  00 ), rare (2! 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)
Fax: +966-11-205-7662
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
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 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.
High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea.
Gastric rupture has rarely been reported. In addition, high doses of sodium bicarbonate may cause hypernatraemia;
hyperosmolarity and metabolic alkalosis, particularly in patients with renal disease. Electrolytes should be monitored and if
abnormalities occur, the patient should be managed appropriately after seeking expert advice

Paracetamol is an analgesic and antipyretic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central 11ervous system. The lack of peripheral prostaglandin inhibition confers important pharmacological properties such as the maintenance of the protective prostaglandins within the gastrointestinal tract Paracetamol is, therefore, particularly suitable fr)r patients with a history of disease or on concomitant medicaion where peripheral prostaglandin inhibition would be undesirable (such as, for example, those with a history of GI bleeding or the elderly).

Sodium bicarbonate has no known analgesic activity.

Clinical data showed PANADOL Actifast to provide faster onset of analgesia than standard paracetamol tablets. Onset of pain relief for PANADOL Actifast showed no difference in both fasted and fed states in an acute pain study.

Paracetamol is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates                                                                                                              less than 5 % is excreted as unmodified paracetamol. Binding to the plasma proteins is minimal at therapeutic concentrations.

Sodium bicarbonate speeds up tablet dissolution in the stomach and enhances gastric emptying of paracetamol into the small intestine where it is absorbed.

In human volunteer phannacokinetic studies, mean maximum plasma concentrations were reached at leasttwice as for PANADOL Actifast tablets compared to standard paracetamol tablets at both a one and two tablet dose and these were statistically significant.

The extent of absorption for PANADOL Actifast tablets is equivalent to that for standard paracetamol tablets as shown by AUC at both a one and two tablet dose.

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

Tablet core:
Sodium hydrogen carbonate Pregelatinised starch Povidone
Maize starch Microcrystalline cellulose Magnesium stearate Carnauba wax
Sodium starch glycolate Colloidal anhydrous silica
The tablets are coated with Opadry II Y-22-7719 White which contains: Titanium dioxide (E171)
Polydextrose Hypromellose Triacetin Macrogol

Not applicable.

Do not store above 30°C.

Opaque PVD/Aluminium foil blister strips packed into cardboard cartons containing 4, 6, 8, 10, 12, 16, 20, 24 or 32 tablets or
into cardboard wallets containing 10 or 12 tablets.

Not all pack sizes may be marketed.

No special requirements.