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Pfizer Consumer Healthcare

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC Paracetamol 500 mg Film Coated Tablets

When a pharmaceutical company changes an SPC or PIL, 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 13/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04-Jul-2017
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 27/11/2014 and displayed until 13/07/2017
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Nov-2014
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 10/06/2014 and displayed until 27/11/2014
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-May-2014
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 12/08/2013 and displayed until 10/06/2014
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   02-Aug-2013
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 22/06/2013 and displayed until 12/08/2013
Reasons for adding or 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
Date of revision of text on the SPC:   12-Jun-2013
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 10/08/2010 and displayed until 22/06/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   30-Jun-2010
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 24/06/2010 and displayed until 10/08/2010
Reasons for adding or 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
Date of revision of text on the SPC:   15-Jun-2010
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 05/09/2005 and displayed until 24/06/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Updated on 31/03/2005 and displayed until 05/09/2005
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Updated on 11/02/2005 and displayed until 31/03/2005
Reasons for adding or 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
Updated on 17/06/2003 and displayed until 11/02/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Paracetamol