GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Panadol Advance 500 mg Film Coated Tablets

Each tablet contains 500 mg paracetamol.

For full list of excipients, see section 6.1.

Film-coated tablet

White, capsule shaped film coated tablets with convex edges and debossed with a “P” within a circle on one face and a breakline on the other. The tablet can be divided into equal halves.

Panadol Advance 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 Advance may also be used in the symptomatic relief of mild to moderate pain associated with osteoarthritis, as diagnosed by a doctor.

Panadol Advance is for oral administration.

Adults (including the elderly)

2 tablets repeated if necessary 3-4 times a day to a maximum of 8 tablets in any 24 hour period.

Children 6-12 years:

½ - 1 tablet repeated if necessary 3-4 times a day to a maximum of 4 tablets in any 24 hour period.

Panadol Advance tablets are not suitable for children under 6 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.

Maximum duration of continued use without medical advice: 3 days.

Hypersensitivity to paracetamol or any of the other constituents.

Use in children under 6 years of age.

Caution is advised in the administration of paracetamol to patients with moderate or severe renal or severe hepatic impairment. The hazard of overdose is greater in those with moderate and severe liver disease.

Do not exceed the stated dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist, consult your doctor. Prolonged use except under medical supervision may be harmful.

This product should only be used when clearly necessary.

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.

Pregnancy

There is epidemiological evidence of the safety of paracetamol in human pregnancy. Paracetamol is the mild analgesic of choice during pregnancy. However as with all drugs, caution should be exercised in its use during the first trimester.

Lactation

Paracetamol is excreted in breast milk. However the level of paracetamol present is not considered to be harmful.

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.

Immediate medical attention (in-hospital, if possible) is required in the event of overdose, even if there are no significant early symptoms. There may be no early symptoms following a life-threatening overdose. Ingestion of more than 12 g paracetamol (24 standard 500 mg tablets) or more than 150 mg paracetamol per kg bodyweight (9 g paracetamol in a 60 kg individual), whichever is the smaller, may cause liver failure. Liver damage (as demonstrated by a rise in plasma transaminase levels) may be apparent between 8 and 36 hours following overdose. Biochemical evidence of maximal damage, however, may not be attained until 72-96 hours after ingestion of the overdose. Intravenous N-acetylcysteine (NAC) is effective when initiated within 8 hours of the overdose. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12 g or 150 mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose. There is little evidence that undertaking gastric lavage will be of benefit to a patient in whom paracetamol is known to have been the only substance ingested.

Symptoms of paracetamol overdose in the first 24 hours may include pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

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 Advance compared to standard paracetamol tablet (p<0.0001) and less within-subject variability (p<0.0001) in early absorption of paracetamol from Panadol Advance compared to standard paracetamol tablets.

Human pharmacokinetic data demonstrate that maximum plasma concentration of paracetamol is reached at least 25% faster for Panadol Advance compared to standard paracetamol tablets in fasted and fed states (p < 0.01).

Total extent of absorption of paracetamol from Panadol Advance is equivalent to that from standard paracetamol tablet.

Human scintigraphy data demonstrate that Panadol Advance generally start to disintegrate by 5 minutes post dose. Human pharmacokinetic 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 Advance 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.

There are no pertinent data not already described elsewhere in this SPC.

Pregelatinised starch

Calcium carbonate

Alginic acid

Crospovidone

Povidone (K-25)

Magnesium stearate

Colloidal anhydrous silica

Sodium methyl parahydroxybenzoate (E219)

Sodium ethyl parahydroxybenzoate (E215)

Sodium propyl parahydroxybenzoate (E217)

Carnauba wax

Opadry white (YS-1-7003) containing:

Titanium dioxide (E171), Hypromellose, Macrogol, Polysorbate 80

Not applicable.

3 years.

This medicinal product does not require any special storage precautions.

Opaque or clear 250 or 300 micron poly vinyl chloride (PVC)/Aluminium foil blister strips packed into cardboard cartons containing 6, 12, 24, 48 or 96 tablets or into cardboard wallets containing 12 tablets.

Polyethylene sachet pack of 2 tablets (6 tablets in carton).

HDPE bottle containing 100 tablets.

No all pack sizes may be marketed.

No special requirements.

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/107/1

Date of first authorisation: 11 August 2006

December 2009