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Paraeze Hard Capsules

*
General Sale: Non-prescription

  • Company:

    Haleon Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Supply through general sale

  • Active Ingredient(s):

    CaffeineParacetamol

    *Additional information is available within the SPC or upon request to the company

Updated on 16 January 2024

File name

working-ie-spc-Paraeze Hard Capsules-Proposed-clean-230724SKDJ Approved 9th Jan 2024.pdf

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Consolidation of the Pfizer and Haleon safety positions following the joint venture

Updated on 16 January 2024

File name

working-ie-pl-paraeze-500mg-32mg-Proposed-clean-230724SKDJ Approved 9th Jan 2024.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Consolidation of the Pfizer and Haleon safety positions following the joint venture

Updated on 12 May 2023

File name

working-ie-text leaflet-paraeze-PA0678-151-001-Separation-clean-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 12 May 2023

File name

Working-ie-spc-paraeze-Haleon Name change-clean-230413RE.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 from GSK to Haleon

Updated on 20 September 2022

File name

PARAEZE_12 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-paraeze-Prac update-clean-RFI1-220511SKDJ.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

1511_Paraeze_SmPC_20_024_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

1511_Paraeze_PIL_20_024_PAA148213_Oct 2020.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 05 November 2019

File name

1681_Paraeze SmPC August 2019.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 04 November 2019

File name

1681_Paraeze_PIL_19-102_v2_August 2019.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 11 March 2019

File name

1681_PIL_18 023_v5 - PAA112337.pdf

Reasons for updating

  • Change to name of medicinal product

Updated on 11 March 2019

File name

1681_SmPC_18_024_v1 - Approved Jun 2018.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Supply through general sale

Updated on 04 October 2018

File name

1681_SmPC_17 002_v3 .pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through general sale

Updated on 22 June 2018

File name

1681_SmPC_18_024_v1 - Approved Jun 2018.docx

Reasons for updating

  • Previous version of SPC reinstated

Legal category:Supply through general sale

Updated on 21 June 2018

File name

1681_SmPC_18_024_v1 - Approved Jun 2018.docx

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Supply through general sale

Updated on 16 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 16 November 2017

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

Adolescents aged 12 to 15 years take 1 capsule every 4 to 6 hours. A maximum of 4 doses in any given 24 hour period.   

Updated on 15 November 2017

File name

PIL_9029_753.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017

Reasons for updating

  • Change to section 3 - dose and frequency

Updated on 24 June 2015

Reasons for updating

  • Change to name of manufacturer

Updated on 06 January 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • 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

3. PHARMACEUTICAL FORM

Capsules, hard

Size 0, hard gelatin capsules with an opaque blue cap and an opaque yellow body, imprinted on both sections with “500/32”, containing a white, free flowing granule mix.

4.4 Special Warnings and Special Precautions for Use

• 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.
• If symptoms persist, consult your doctor.
• Prolonged use without medical advice may be harmful.
• Do not exceed the stated dose.
• Do not take this medicine with other Paracetamol containing products.
• Immediate medical advice should be sought in the event of overdosage even if you feel well.
• Use only when clearly necessary.

Patients should be advised that Paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.


4.8 Undesirable Effects

Skin and subcutaneous tissue disorders 

Very Rare

Serious skin reactions (including severe cutaneous reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Acute Generalised Exanthematous Pustulosis) have been reported.


10. DATE OF (PARTIAL) REVISION OF THE TEXT

December 2014

Updated on 31 December 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 26 August 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

3. PHARMACEUTICAL FORM

Capsules, hard (capsule)

Size 0, hard gelatin capsules with an opaque blue cap and an opaque yellow body, imprinted longitudinally on both sections with “500/32”, containing a white, free flowing granule mix.

Updated on 20 August 2013

Reasons for updating

  • Change to further information section

Updated on 26 March 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

P.A. 822/168/1


Updated on 20 March 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 14 June 2012

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

6.1       List of Excipients

 

Maize Starch

Magnesium Stearate

Sodium Laurilsulfate

Croscarmellose Sodium

 

Capsule Shell

 

Gelatin

Purified water

Erythrosine

Patent blue V

Titanium dioxide

Quinoline Yellow

 

Printing Ink

Shellac

Titanium dioxide

Propylene glycol

Ammonium hydroxide

Simeticone

Iron oxide black (E172)

Updated on 11 June 2012

Reasons for updating

  • Change to further information section

Updated on 24 October 2011

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

6.1 List of Excipients

Maize Starch
Magnesium Stearate
Sodium Laurilsulfate
Croscarmellose Sodium

Capsule Shell

Gelatin
Erythrosine
Patent blue V
Titanium dioxide
Quinoline Yellow

Printing Ink
Shellac
Titanium dioxide
Propylene glycol
Iron oxide black (E172)

Updated on 20 October 2011

Reasons for updating

  • Change to further information section

Updated on 11 March 2011

Reasons for updating

  • Change to improve clarity and readability
  • Change due to user-testing of patient information

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)

Updated on 09 August 2010

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 October 2008

Reasons for updating

  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to instructions about overdose

Updated on 18 September 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

During recent renewal assessment Section 1, 4.4 and 4.9 of the SmPC were updated in line with EU guidance and current safety information.  

Updated on 13 September 2006

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

Update section 4.8: Delete 'any unexplained bruising or bleeding more easily than usual' and include 'High caffeine intake can result in tremor and palpitations'.

Updated on 15 March 2006

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Updated on 23 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 September 2003

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Supply through general sale

Updated on 20 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale