PARAEXTRA Hard Capsules

*
General Sale: Non-prescription
  • Company:

    Haleon Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Supply through general sale
  • Active Ingredient(s):

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

Updated on 16 January 2024

File name

working-ie-spc-paraextra-500mg-32mg-Proposed-RFI2-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 position following the joint venture

Updated on 16 January 2024

File name

working-ie-pl-paraextra-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 - dose and frequency
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Update to safety information to consolidate the safety positions between Pfizer consumer healthcare and Haleon

Updated on 12 May 2023

File name

working-ie-spc-paraextra-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 12 May 2023

File name

working-ie-mockup leaflet-Paraextra-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

PARA EXTRA_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-paraextra-PRAC update-RFI1-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

1521_Paraextra_PIL_20_023_PAA148217_Oct 2020.pdf

Reasons for updating

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

Updated on 30 November 2020

File name

1521_Paraextra_SmPC_20_023_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 04 November 2019

File name

1691_Paraextra_SmPC_19_102_v2_August 2019_clean.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

1691_Paraextra_PIL_19_102_v2_August 2019_clean.pdf

Reasons for updating

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

Updated on 08 October 2018

File name

1691_PIL_18 022_v2 - PAA112472.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 04 October 2018

File name

1691_SmPC_17 005_v3.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through general sale

Updated on 07 June 2018

File name

1.3 1691_PIL_18 022_v2_cropped.pdf

Reasons for updating

  • Improved presentation of PIL

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 (12-15 years) to take 1 capsule repeated every 4 to 6 hours. A maximum of 4 doses in any given 24 hours period.  

Updated on 15 November 2017

File name

PIL_15861_990.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 4.4 - Special warnings and precautions for use
  • 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

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 date of revision
  • Change to improve clarity and readability

Updated on 11 October 2013

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided

Updated on 09 October 2013

Reasons for updating

  • New PIL for new product