Panadol Extra Film-coated tablets, Paracetamol 500mg, Caffeine 65mg
*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 21 July 2023
File name
working-ie-spc-panadolextra-27-clean-230713RE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Updated on 21 July 2023
File name
ie-pil-mockup-Haleon-230713RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 21 September 2022
File name
PANADOL_EXTRA_1224 pc_Leaflet.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 16 September 2022
File name
ie-spc-Panadol Extra-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 28 February 2022
File name
ie-spc-panadolextra-210709bc-approved-clean-jul2021.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- 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
Section 2
Deleted
Excipients: Each tablet contains: Parahydroxybenzoates 1.35mg [(Sodium methyl parahydroxybenzoate (E219), Sodium ethyl parahydroxybenzoate (E215) and Sodium propyl parahydroxybenzoate (E217).
Each tablet contains 0.446mg of sodium.
Section 3
Added
, "- -" on the other side.
Section 6.1
Deleted
Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Sodium propyl parahydroxybenzoate (E217)
Added
Microcrystalline cellulose
Updated on 28 February 2022
File name
ie-mockup-pl-panadolextra-210709bc-approved-clean-jul2021.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Deleted "contains parahydroxybenzoates which may cause allergic reaction (possibly delayed)
Replaced sodium methyl parahydroxybenzoate (E219), Sodium ethyl parahydroxybenzoate (E215), Sodium propyl parahydroxybenzoate (E217) with microcrystalline cellulose
Updated on 23 June 2020
File name
ie-spc-panadolextra-27-1-GDSv7-180302EK 19-Jun-20.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 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through general sale
Updated on 23 June 2020
File name
ie-mockup-pl-panadolextra-27-1-GDSv7-180302EK.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
Updated on 29 May 2020
File name
ie-mockup-pl-panadolextra-200320em.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 15 July 2019
File name
m1-3-2-mockup-pl-171207LC_2.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
Updated on 19 September 2018
File name
PIL_8680_371.pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
Updated on 03 September 2018
File name
PIL_8680_371.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 03 September 2018
File name
ie-spc-678-27-1-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Paediatric posology changes
Updated on 21 July 2017
File name
PIL_8680_371.pdf
Reasons for updating
- New PIL for new product
Updated on 21 July 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 21 July 2017
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 general sale
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
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 18 April 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
New Text
Underlying liver disease increases the risk of paracetamol related liver damage .
10. Date of Revision of the Text
April 2017
Next >>
Updated on 25 April 2016
Reasons for updating
- Change to MA holder contact details
Updated on 10 July 2015
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
Section 7
Marketing Authorisation Holder address updated to:
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 12 December 2013
Reasons for updating
- Change to packaging
Updated on 13 June 2012
Reasons for updating
- Change of inactive ingredient
Updated on 13 October 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- 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
2. Qualitative and Quantitative Composition
Excipients: Each tablet contains: Parahydroxybenzoates 1.35mg [(Sodium methyl parahydroxybenzoate (E219), Sodium ethyl parahydroxybenzoate (E215) and Sodium propyl parahydroxybenzoate (E217)].
3. Pharmaceutical Form
White, capsule shaped film-coated tablet with ‘Panadol Extra’ embossed on one side of the tablet.
White to off white oval shaped coated tablets debossed “xPx” with P inside a circle on one side.
4.4. Special Warnings and Precautions for Use
Contains Sodium methyl parahydroxybenzoate (E219), Sodium ethyl parahydroxybenzoate (E215) and Sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).
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.
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Caffeine is absorbed readily after oral administration
New Panadol Extra Tablets contain a disintegrant system that accelerates tablet dissolution compared to a standard paracetamol-caffeine combination tablet.
Human pharmacokinetic data demonstrate that with new Panadol Extra, the time to reach minimum therapeutic paracetamol concentration in the plasma (4μg/ml) is 10 minutes in the fasted state, and 22 minutes in the fed state.
The time to reach maximum plasma concentration (Tmax) of paracetamol is 15 minutes faster for new Panadol Extra compared to a standard paracetamol-caffeine combination tablet.
Human pharmacokinetic data demonstrate that with new Panadol Extra, the time to reach minimum therapeutic paracetamol concentration in the plasma (4μg/ml) is approximately 50% faster compared to a standard paracetamol-caffeine combination tablet.
Human pharmacokinetic data demonstrate that with new Panadol Extra, the paracetamol exposure in the first 30 minutes (AUC0-30) is increased 3-fold compared to a standard paracetamol-caffeine combination tablet; however, total exposure to both paracetamol and caffeine are no different from the standard paracetamol-caffeine combination tablet.
The total extent of absorption of both paracetamol and caffeine with new Panadol Extra is equivalent to that from a standard paracetamol-caffeine combination tablet.
Paracetamol is relatively uniformly distributed throughout most body fluids. It is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates. The half-life is 1 to 4 hours. Binding to the plasma proteins is minimal at therapeutic concentrations.
The plasma half life of caffeine is about 4-5 hours. Metabolized in liver and excreted in urine as various xanthine derivatives
6.1. List of Excipients
Core
Pregelatinised starch
Maize starch
Povidone
Potassium sorbate
Purified Talc
Stearic acid
Croscarmellose sodium
Film coating
Hypromellose
Triacetin
Starch Pregelatinized
Povidone
Calcium carbonate
Crospovidone
Sodium methyl parahydroxybenzoate (E219)
Sodium ethyl parahydroxybenzoate (E215)
Sodium propyl parahydroxybenzoate (E217)
Alginic Acid
Magnesium Stearate
Carnauba Wax
Purified Water
Opadry white (YS-1-7003) containing:
Titanium dioxide (E171), Hypromellose, Macrogol, Polysorbate 80
6.3. Shelf Life
4 years. 2 years
10. Date of Revision of the Text
September 2011
Updated on 14 June 2011
Reasons for updating
- Change to improve clarity and readability
Updated on 11 April 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 18 August 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 09 August 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
- Change of special precautions for disposal
- Change due to user-testing of patient information
Updated on 10 May 2010
Reasons for updating
- 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 general sale
Free text change information supplied by the pharmaceutical company
Addition of the warning in relation to excessive intake of caffeine and update of the warning in relation to people who have been diagnosed with liver and kidney imparament.
Section 4.6
Update of the information in relation pregnancy and breastfeeding related to both actives, paracetamol and caffeine.
Section 4.8
Adverse events shown in the table by System Organ Class and frequencies.
Section 4.9
Addition of the information related to overdose with caffeine.
Updated on 22 October 2008
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 20 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 18 August 2008
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 20 December 2006
Reasons for updating
- Change of inactive ingredient
Updated on 03 February 2006
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Updated on 06 July 2005
Reasons for updating
- Change of active ingredient
- Change of inactive ingredient
Updated on 12 May 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 24 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 05 August 2004
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 12 August 2003
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 25 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale