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Aprovel 300mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Irbesartan

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

Updated on 01 March 2023

File name

63ff60092cf08.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 14 February 2023

File name

63eb680a91cfd.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 28 March 2022

File name

1.3.2.1 Mock-up Leaflet - IE Aprovel 300mg (1)_1648463375.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 03 March 2022

File name

1.3.2.1 Mock-up Leaflet - IE Aprovel 300mg_1646311716.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 03 March 2022

File name

1.3.2.1 Mock-up Leaflet - IE Aprovel 300mg_1646310670.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 May 2021

File name

1.3.2.1 Mock-up Leaflet - IE Aprovel 300mg_1620892748.pdf

Reasons for updating

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

Updated on 08 April 2021

File name

1.3.2.1 Leaflet text - IE Aprovel 300mg (1)_1617881878.pdf

Reasons for updating

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

Updated on 08 April 2021

File name

1.3.1.1 IE SmPC Aprovel 300mg (2)_1617881739.pdf

Reasons for updating

  • 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 07 April 2021

File name

1.3.2.1 Leaflet text - IE Aprovel 300mg_1617802417.pdf

Reasons for updating

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

Updated on 07 April 2021

File name

Clean 1.3.1.1 IE SmPC Aprovel 300mg (1)_1617802035.pdf

Reasons for updating

  • 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 11 March 2021

File name

1.3.2.1 Leaflet text - IE Aprovel 300mg (1)_1615475716.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 10 February 2021

File name

1.3.1.1 IE SmPC Aprovel 300mg_1612973665.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
  • 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 14 April 2020

File name

1.3.2.1 Mock-up Leaflet - IE Aprovel 300mg (1)_1586853500.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 10 December 2019

File name

Aprovel 300mg SmPC_1575995934.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 10 December 2019

File name

Aprovel 300mg PIL_1575995896.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 January 2019

File name

PIL Aprovel 300mg fc tablets_1547464292.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 14 January 2019

File name

SPC Aprovel 300mg fc tablets_1547464135.pdf

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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)

Free text change information supplied by the pharmaceutical company

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Based on its

pharmacodynamic properties, irbesartan is unlikely to affect theis ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.

 

Blood and lymphatic system disorders

Not known:      thrombocytopenia

Immune system disorders:

 Not known:      hypersensitivity reactions such as angioedema, rash, urticarial, anaphylactic reaction, anaphylactic shock

Metabolism and nutrition disorders:

Not known:      hyperkalaemia

Nervous system disorders:

Common:         dizziness, orthostatic dizziness*

Not known:      vertigo, headache

Ear and labyrinth disorder:

Not known:      tinnitus

Cardiac disorders:

Uncommon:     tachycardia

Vascular disorders:

Common:         orthostatic hypotension*

Uncommon:     flushing

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Updated on 18 September 2018

File name

APROVEL 300 mg PIL text_1537185318.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 2018

File name

APROVEL 300 mg SPC_1537185396.pdf

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.7

4.7 Effects on ability to drive and use machines

 

No studies on the effects on the ability to drive and use machines have been performed. Based on its

pharmacodynamic properties, irbesartan is unlikely to affect theis ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment

 

section 4.8

Reporting of suspected adverse reactions

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

Updated on 11 December 2017

File name

PIL_15723_258.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 21 December 2016

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 July 2016

Reasons for updating

  • New SPC for new product

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

Updated on 14 July 2016

Reasons for updating

  • 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

Blood and lymphatic system disorders

Not known:                  thrombocytopenia.

Updated on 29 October 2014

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 02 October 2014

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Article 31 on RAS Acting Agents

Updated on 09 September 2014

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 October 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Type IA-IN Bulk variation to change the name of the MAH form the current one "Sanofi Pharma Bristol-Myers Squibb SNC" to the new one "Sanofi Clir SNC". The current address of the MAH remains unchanged "54, rue La Boetie - 75008 Paris".

Updated on 11 October 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

MAH name change: Sanofi Clir SNC

Updated on 16 August 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Type IIC Aliskiren contra-indication CCDS v27 (WS 148)

Updated on 10 May 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Product moved from under Sanofi/BMS umbrella to Sanofi only

Updated on 08 May 2013

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)