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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
E-mail: customer.relations@gsk.com
Medical Information Direct Line: 1800 441 442

Summary of Product Characteristics last updated on medicines.ie: 7/21/2017
SPC Panadol Cold and Flu Relief 500mg/65mg Film Coated Tablets

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

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Each tablet contains Paracetamol 500.0 mg and Caffeine 65 mg. For the full list of excipients, see section 6.1.

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White, film-coated capsule-shaped tablets with flat edges, with a triangular logo and a'+' symbol embossed on one side and blank on the other side.

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4.1 Therapeutic indications

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, headache and of discomfort associated with influenza, feverishness and feverish colds, toothache and dysmenorrhoea.

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4.2 Posology and method of administration

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.

The lowest dose necessary to achieve efficacy should be used.

Should not be used with other paracetamol-containing products.

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4.3 Contraindications

Known hypersensitivity to paracetamol.

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4.4 Special warnings and precautions for use

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.

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 the stated dose. Take only when necessary.

If symptoms persist, consult your doctor.

Keep out of the sight and reach of children.

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4.5 Interaction with other medicinal products and other forms of interaction

Paracetamol may increase the elimination half-life of chloramphenicol. The absorption of paracetamol may be increased by metoclopramide 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.

4.6 Fertility, pregnancy and lactation



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


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


Paracetamol and caffeine are excreted in breast milk.


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


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

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4.7 Effects on ability to drive and use machines


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4.8 Undesirable effects

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.

Body System

Undesirable Effect



Blood and lymphatic system disorders


Very rare

Immune System disorders


Cutaneous hypersensitivity reactions, including skin reactions, angioedema and Stevens Johnson syndrome.

Very rare cases of serious skin reactions have been reported

Very rare

Respiratory, thoracic and mediastinal disorders

Bronchospasm in patients sensitive to aspirin and other NSAIDs

Very rare

Hepatobiliary disorders

Hepatic dysfunction

Very rare


Central Nervous System

Nervousness, Dizziness

Not known

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.

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, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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4.9 Overdose


Paracetamol overdose may cause liver failure which can lead to liver transplant or death.

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.


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.

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5.1 Pharmacodynamic properties

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

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5.2 Pharmacokinetic properties

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.

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5.3 Preclinical safety data

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.

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6.1 List of excipient(s)


Pregelatinised starch

Maize starch


Potassium sorbate

Purified talc

Stearic acid

Croscarmellose sodium




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6.2 Incompatibilities

Not applicable

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6.3 Shelf life

4 years

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6.4 Special precautions for storage

Store below 25°C.

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6.5 Nature and contents of container

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.

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6.6 Special precautions for disposal and other handling

No special requirements.

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GlaxoSmithKline Consumer Healthcare (Ireland) Limited,

12 Riverwalk,

Citywest Business Campus,

Dublin 24,


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Date of first authorisation: 25th May 2007

Date of last renewal: 25th May 2012

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June 2017

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