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Plaquenil Tablets

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Hydroxychloroquine Sulfate

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

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Updated on 07 April 2025

File name

1.3.1 Plaquenil 200mg Tablets PIL Text IE (2).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 07 April 2025

File name

1.3.1 Plaquenil 200mg Tablets PIL Text IE (1).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 25 March 2025

File name

1.3.1 Plaquenil 200mg tablets SmPC IE.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 March 2025

File name

1.3.1 Plaquenil 200mg Tablets PIL Text IE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 12 July 2024

File name

SmPC Clean - IE S23.470 - Plaquenil 200mg tablets.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 12 July 2024

File name

1.3.2- Plaquenil IE PIL.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 27 March 2024

File name

1.3.1 - Plaquenil SmPC IE_ IE S23 178 WS 219 _CCDS 19 Phospholipidase_clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 March 2024

File name

1.3.2- Plaquenil IE PIL (1).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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 23 February 2024

File name

1.3.1 - Plaquenil SmPC IE.pdf

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 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 February 2024

File name

1.3.2- Plaquenil IE PIL.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 27 November 2023

File name

S22.344 Plaquenil IE SmPC WS317 Macrolides DDI (1).pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 November 2023

File name

S22 .344 - plaquenil IE PL text WS317 Macrolides DDI.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 27 November 2023

File name

S22 .344 - plaquenil IE PL text WS317 Macrolides DDI.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 03 March 2023

File name

S22 410 - plaquenil IE PL text_article 61.3 update_clean final text (1).pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 20 September 2022

File name

S21-298 - plaquenil IE PL text_CCDS 16 - IEHxxxxWS160_clean.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 20 September 2022

File name

S21-298 Plaquenil IE smpc WSC CDSv16 - IEHxxxxWS160_clean.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 01 June 2022

File name

IES22-078 plaquenil IE smpc WS CCDS 17_Clean_April 2022.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 April 2022

File name

PIL S22-078 - plaquenil IE PL text_CCDS 17 _ Clean.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 22 April 2022

File name

SPC IES22-078 plaquenil IE smpc WS CCDS 17_Clean (1).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 November 2021

File name

S21. 1232 plaquenil IE smpc WS CCDS 14 clean.pdf

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 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 September 2021

File name

S21.067 - plaquenil IE PL text.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 17 September 2021

File name

S21.067 plaquenil IE smpc.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2020

File name

IE1169- Clean Final Approved IE SmPC CCDS v13.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2020

File name

IE1169 - Clean Approved IE PIL -clean18june2020.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 06 July 2020

File name

778254 PRO PLAQUENIL 200MG IE.pdf

Reasons for updating

  • XPIL Removed

Updated on 30 March 2020

File name

778254 PRO PLAQUENIL 200MG IE.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 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 30 March 2020

File name

1.3.1 Plaquenil 200mg SPC IE720 CCDSv12 clean including CCDSv11 March 2020.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.3, 4.4, 4.5, 4.6, 4.8, 5.3 and 10 have been updated.

Updated on 13 February 2020

File name

1.3.1.1 Plaquenil 200mg SmPC.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Pharmacovigilance reporting details was updated

Updated on 13 February 2020

File name

1.3.2.1 Plaquenil 200mg PIL.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

 

Updated on 05 June 2019

File name

1.3.1 Plaquenil 200mg SPC IE589.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update from Word to PDF doc

Updated on 11 July 2018

File name

Plaquenil 200mg Film-coated Tablets SPC .docx

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

6.4          Special precautions for storage

 Wording changed to:-

This medicinal product does not require any special storage conditions

 

Updated on 11 July 2018

File name

Plaquenil 200mg film-coated Tablets PIL.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 06 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 March 2018

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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 added:-

Concomitant use of hydroxychloroquine with drugs known to induce retinal toxicity, such as tamoxifen, is not recommended

Updated on 05 March 2018

File name

PIL_9119_593.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 15 December 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4

Addition of Extrapyramidal disorders may occur with Plaquenil

Section 4.8

Nervous system disorders

Common: Headache

Uncommon: Dizziness

Not known: Convulsions have been reported with this class of drugs.
Extrapyramidal disorders such as dystonia, dyskinesia,

Updated on 22 May 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II No. C.I.4 to update SPC sections 4.4 & 4.8 following the publication of Hydroxychloroquine CCDS version 8 in Dec 2013. This change concerns a minor update to the wording related to cardiomyopathy, following on from the submission and approval of CCDS version 7 and the recommended wording of PRAC meeting in September 2013. The CCDS version 8 mandated the additional warning that “cardiomyopathy may result in cardiac arrest, in some cases with fatal outcome”.

Updated on 19 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 17 January 2014

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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II No. C.I.4 to update SPC sections 4.4, 4.5 & 4.8 following the publication of Hydroxychloroquine CCDS version 7 in April 2013. Administrative/editorial updates to the SPC and required text following publication of the latest QRD template (including PV legislation wording) are also included.

Updated on 15 January 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 12 June 2013

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II C.I.4 safety variation application to update the current SPC and PIL for Plaquenil 200mg tablets, following an update of the Company Core Safety Information

Updated on 07 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to dosage and administration

Updated on 07 September 2012

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated SPC.

Updated on 25 February 2010

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update Section 4.3
Contraindicated in persons under 6 years of age.
Update Section 4.4
Addition of excipient warning

Updated on 22 February 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 September 2007

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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 
The changes are to the following sections:
7    Change name and address of MAH
8    Change MA number from PA 77/21/1
10    Updated to August 2007

Updated on 10 September 2007

Reasons for updating

  • Change to marketing authorisation holder

Updated on 21 June 2007

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 6.2 - Incompatibilities
  • 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
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1:    Name updated to Plaquenil 200 mg Film-coated Tablets.
Section 2:    Pharmacopoeial designation deleted and sentence revised. Included a quantitative description of lactose monohydrate and updated reference to Section 6.1.
Section 3:    Updated to 'Film-coated Tablets' and inserted a visual description of the tablets.
Section 6.2: Updated to 'Not applicable'
Section 6.4: Updated to 'Do not store above 25°C'
Section 6.5: Included statement that 'Not all pack sizes may be marketed'
Section 6.6: Updated heading in line with IMB schedule received. Text updated to 'No special requirements'.
Section 9:    Updated to specify dates of first authorisation and date of last renewal.
Section 10:  Updated to May 2007

Updated on 19 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 13 December 2005

Reasons for updating

  • Improved electronic presentation

Updated on 30 August 2005

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 30 June 2005

Reasons for updating

  • Improved electronic presentation

Updated on 16 May 2005

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 December 2004

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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

SANOFI

SANOFI