Paracetamol 500 mg Film Coated Tablets
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 May 2023
File name
working-ie-spc-Paracetamol 500mg film coated tablets-Haleon Ireland Limited-clean-230413RE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Updated on 12 May 2023
File name
ie-spc-Paracetamol 500mg film coated tablets-PRAC update-clean-220511SKDJ.pdf
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
Change to MAH name
Updated on 12 May 2023
File name
working-ie-mockup leaflet-Paracetamol 500 mg-proposed-230413RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Change from GSK to Haleon
Updated on 20 September 2022
File name
PARACETAMOL_500mg_Leaflet (1).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 16 September 2022
File name
ie-spc-Paracetamol 500mg film coated tablets-PRAC update-clean-220511SKDJ.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Supply through general sale
Updated on 30 November 2020
File name
1501_Paracetamol_SmPC 20_025_ v1_August 2020_clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 30 November 2020
File name
1501_Paracetamol_PIL_20_025_PAA153642_Oct 2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 June 2020
File name
1671_Paracetamol_SmPC 19_102_ v6_Jan 2020.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 23 June 2020
File name
1671_Paracetamol Tablets_PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 04 October 2018
File name
1671 SmPC 16 060 v4_clean.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through general sale
Updated on 08 June 2018
File name
1671_PIL_Paracetamol _18 021.pdf
Reasons for updating
- Improved presentation of PIL
File name
PIL_16020_380.pdf
Updated on 13 July 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 13 July 2017
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 11 July 2017
File name
PIL_16020_380.pdf
Reasons for updating
- New PIL for new product
Updated on 11 July 2017
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
Reasons for updating
- Change to name of manufacturer
Updated on 27 November 2014
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
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
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
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
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 05 June 2014
Reasons for updating
- New PIL for medicines.ie
Updated on 12 August 2013
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.
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
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
• 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
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)
Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.
(formally Wyeth Consumer Healthcare)
Updated on 24 June 2010
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.
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 September 2005
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
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Supply through general sale
Updated on 11 February 2005
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
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale