PARAEXTRA Hard Capsules
*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 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
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
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
Updated on 09 October 2013
Reasons for updating
- New PIL for new product