GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Panadol Cold and Flu Relief 500mg/65mg Film Coated Tablets

Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.

For excipients, see section 6.1.

Film coated tablet.

White, capsule shaped, film coated tablet printed on one side with 'Panadol Relief'.

The tablets are recommended for use as an analgesic in the relief of mild to moderate pain such as is associated with rheumatism, neuralgia, musculoskeletal disorders, and headache and of discomfort associated with influenza, feverishness and feverish colds, toothache and dysmenorrhoea.

For oral administration.

Adults (including the elderly)

2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours.

Children

Not recommended for children under 12 years of age.

Minimum dosing interval: 4 hours.

Should not be used with other paracetamol-containing products.

Known hypersensitivity to paracetamol.

Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Prolonged use except under medical supervision may be harmful.

Do not exceed stated dose.

Take only when necessary.

If symptoms persist, consult your doctor.

Keep out of reach and sight of children.

Paracetamol may increase the elimination half-life of chloramphenicol. The absorption of paracetamol may be increased by metaclopramide and decreased by cholestyramine. Oral contraceptives may increase the rate of clearance of paracetamol.

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

Paracetamol

Human and animal studies have not identified any risk of paracetamol in pregnancy or embryo-foetal development.

Caffeine

Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion associated with caffeine consumption.

Lactation

Paracetamol and caffeine are excreted in breast milk.

Paracetamol

Human studies with paracetamol at the recommended doses have not identified any risk to lactation or the breast-fed offspring.

Caffeine

Caffeine in breast milk may potentially have a stimulating effect on breast fed infants but significant toxicity has not been observed.

None.

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.

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

Paracetamol

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, can cause severe liver damage. 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.

Caffeine

Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity. No specific antidote is available, but supportive measures such as beta adrenoreceptor antagonists to reverse the cardiotoxic effects may be used

The combination of paracetamol and caffeine is a well established analgesic combination.

Paracetamol is well absorbed from the gastrointestinal tract, peak plasma concentrations occurring 0.5 – 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates – less than 5% is excreted as unmodified paracetamol. The half-life is 1 to 4 hours. Binding to the plasma proteins is minimal at therapeutic concentrations.

Caffeine is absorbed readily after oral administration, maximal plasma concentrations are achieved after approximately 20 – 60 minutes and the plasma half-life is about 4 hours. Over 48 hours, 45% of a dose is excreted in the urine as l-methyluric acid and l-methylxanthine.

Preclinical safety data on paracetamol in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not been mentioned elsewhere in this Summary.

Core

Pregelatinised starch

Maize starch

Povidone

Potassium sorbate

Purified talc

Stearic acid

Croscarmellose sodium

Film-coating

Hypromellose

Triacetin

Printing Ink

Shellac

Brilliant blue (E133)

Sodium lactate

Silicone antifoam emulsion

Not applicable.

4 years.

Store below 25°C.

Opaque PVC/Aluminium foil blister strips packed into cardboard cartons containing 4, 6, 12, 24, 30, 48, 60 and 96 tablets or into cardboard wallets containing 12 tablets.

Not all pack sizes may be marketed.

No special requirements.

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/105/1

Date of First Authorisation: 25^th May 2007

March 2010