Paracetamol 500 mg Film Coated Tablets

  • Name:

    Paracetamol 500 mg Film Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Paracetamol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/06/18

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Summary of Product Characteristics last updated on medicines.ie: 4/10/2018

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Pfizer Consumer Healthcare

Pfizer Consumer Healthcare

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1 - 0 of 14 items.Total: Infinity pages

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 4 October 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through general sale

Updated on 8 June 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 4 June 2018

Updated on 13 July 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

 

 

Posology

Adults:

1-2 tablets 3-4 times daily.
A maximum of 8 tablets should not be exceeded in any 24-hour period.

 

Paediatric Population

For children 6 to 9 years of age:

Give ½ a tablet with a drink of water, every 4 to 6 hours as required.

 

For children 10 to 11 years of age:

Give 1 tablet with a drink of water, every 4 to 6 hours as required.

 

For adolescents 12 to 15 years of age:

Give 1 to 1 ½ a tablet with a drink of water, every 4 to 6 hours as required.

 

A maximum of 4 doses should not be exceeded in any 24 hour period.  

 

Children under 6 years:

Not recommended


10. DATE OF REVISION OF THE TEXT

 

             July 2017

 

Updated on 13 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 11 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - use in children/adolescents

Updated on 24 June 2015 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 27 November 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

4.8 Undesirable effects

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.

10. DATE OF REVISION OF THE TEXT

November 2014

Updated on 25 November 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 10 June 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

7. MARKETING AUTHORISATION HOLDER

Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland.

8. MARKETING AUTHORISATION NUMBER

PA 822/167/1

10. DATE OF REVISION OF THE TEXT

May 2014

Updated on 5 June 2014 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 August 2013 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

3. PHARMACEUTICAL FORM

Film-coated Tablet.
White capsule shaped film coated tablets embossed on one face with “P-500” and with a break bar on the reverse. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal halves.



6.5 Nature and contents of container

uPVC hard tempered aluminium foil blister packs containing 6, 8, 12, 16, 24 and 32 tablets.

Not all pack sizes may be marketed.

Updated on 22 June 2013 SmPC

Reasons for updating

  • 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 general sale

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

• Consult the doctor if there is no improvement
• Caution should be exercised in patients with impairment of hepatic or renal function (avoid if severe). The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
• Do not take other Paracetamol containing products
• If symptoms persist for more than 3 days, consult your doctor
• Prolonged use without medical supervision may be harmful

4.9 Overdose

Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage.

Symptoms

Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion and this may be manifested in increasing pro-thrombin time, which is a reliable indicator of deteriorating liver function. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, coma and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage.

Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is likely in adults who have taken 10g or more of Paracetamol. Acute or chronic ingestion of Paracetamol above the recommended dose may lead to liver damage particularly if the patient has risk factors.

Risk Factors

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b) Regularly consumes ethanol in excess of recommended amounts.
Or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

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.

Management Treatment

Immediate treatment is essential in the management of Paracetamol overdose. Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).

Or and any patient who have ingested about 7.5g or more of Paracetamol in the preceding 4 hours should undergo gastric lavage. Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).

Treatment with N-Acetylcysteine may be used up to 24 hours after ingestion of paracetamol however, the maximum protective effect is obtained up to 8 hours post indigestion.


Intravenous N-Acetylcysteine or oral methionine protects the liver if administered within 8 to 12 hours of ingesting the overdose. N-Acetylcysteine is effective up to and possibly beyond 24 hours, but expert advice is essential. If required the patient should be given intravenous-N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. General supportive measures must be available.

Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

10. DATE OF REVISION OF THE TEXT

June 2013

Updated on 10 August 2010 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

7. MARKETING AUTHORISATION HOLDER

Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.

(formally Wyeth Consumer Healthcare)

Updated on 24 June 2010 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

During the renewal assessment the following changes were made; 

Section 3, clarified function of the scoreline, to break the tablet in half for ease of swallowing.
Section 4.2, a separate paediatric dosing section was included. 
Section 4.4 overdosage section brought in line with current information.  
Section 5.1 addition of ATC CODE, Pharmacotherapeutic group.      

Updated on 5 September 2005 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through general sale

Updated on 31 March 2005 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category: Supply through general sale

Updated on 11 February 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Supply through general sale

Updated on 17 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale