Panadol Extra 500mg/65mg Soluble Effervescent Tablets

  • Name:

    Panadol Extra 500mg/65mg Soluble Effervescent Tablets

  • Company:
    info
  • Active Ingredients:

    Caffeine, Paracetamol

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/09/18

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Summary of Product Characteristics last updated on medicines.ie: 3/9/2018

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 3 September 2018 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 3 September 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Paediatric posology changes

Updated on 21 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 21 July 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

An update to section 4.4 to include a warnings and precautions statement concerning risk of metabolic acidosis in patients in glutathione depleted states, such as sepsis.

 

An update to sections 4.2, 4.4 and 4.9 to include further information relating to hepatotoxicity associated with overdose, and hepatic dysfunction in glutathione depleted states.

 

An update of the date of revision in section 10.

Updated on 21 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 April 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 10 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 3 December 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 June 2011 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 13 December 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2.      Posology and Method of Administration

 

For oral administration.

 

Panadol Extra Soluble should be dissolved in at least half a tumbler full of water.

 

Adults (including the elderly) and children aged 12 years and over:

 

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

 

Children under 12 years:

 

Not recommended for children under 12 years of age.½Not

 

 Minimum dosing interval: 4 hours.

           

Do not exceed the stated dose

 

Should not be used with other paracetamol-containing products.


Renal Impairment

Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol and caffeine products in patients with renal impairment are primarily a consequence of the paracetamol content of the drug.

 

Hepatic Impairment

Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol and caffeine products in patients with hepatic impairment are primarily a consequence of the paracetamol content of the drugs.

        

4.4.      Special Warnings or Precautions for Use


Paracetamol should only be used with caution in patients with liver or kidney impairment.

 

Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. Underlying liver disease increases the risk of paracetamol related liver damage.

 

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.


Each tablet contains sodium (425mg). Persons on a low sodium diet should not take this product unless advised by a doctor.

 

Each tablet contains 425 mg of sodium. per tablet. To be taken into consideration by patients on a controlled sodium diet.

 

Each tablet contains sorbitol powder (E 420) at 50 mg per tablet. Patients with rare hereditary problems of fructose intolerance should not take this medicine

 

Keep out of reach and sight of children.

 

4.6.      Pregnancy and Lactation

 

Epidemiological studies in human pregnancy have shown no ill effects due to caffeine or paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount.

 

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.

 

4.8.      Undesirable Effects

 

Adverse effects of paracetamol are rare but hypersensitivity including skin rashes may occur. The most common adverse effects associated with caffeine are nausea due to gastrointestinal irritation, insomnia and restlessness as a result of stimulation of the central nervous system.

           

Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by System Organ Class and frequency. The following convention has been utilised for the classification of undesirable effects: 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

Frequency

 

Paracetamol

 

Blood and lymphatic system disorders

 

 

Thrombocytopaenia

 

Very rare

 

Immune System disorders

Anaphylaxis

Cutaneous hypersensitivity

reactions including skin rashes,

angiodema, and Stevens

Johnson syndrome.

 

Very rare

 

Respiratory, thoracic and

mediastinal disorders

 

Bronchospasm in patients

sensitive to aspirin and other

NSAIDs

 

Very rare

 

Hepatobiliary disorders

Hepatic dysfunction

 

Very rare

 

Caffeine

Central Nervous System

Nervousness

 

Not known

 

 

 

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.

 

 

4.9.      Overdose 

 

Paracetamol

 

Symptoms and Signs

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.

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 overdoseBiochemical evidence of maximal damage, however, may not be attained until 72-96 hours after ingestion of the overdose.

 

Treatment

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.

High doses of caffeine may produce headache, tremor, nervousness and irritability.

 

High doses of sodium bicarbonate would be expected to induce gastrointestinal symptoms including belching and nausea.

 

Caffeine

 

Symptoms and Signs

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.

 

Treatment

No specific antidote is available, but supportive measures such as beta adrenceptor antagonists to reverse the cardiotoxic effects may be used.

 

Sodium bicarbonate

High doses of sodium bicarbonate would be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia, electrolytes should be monitored and patients managed accordingly.

 

Updated on 27 September 2010 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 September 2010 PIL

Reasons for updating

  • New PIL for new product