Aprovel 75mg film-coated tablets
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 May 2021
File name
1.3.2.1 Mock-up Leaflet - IE Aprovel 75mg.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 75mg (1).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 75mg (2).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 75mg.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 75mg (1).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 75mg.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 75mg.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 75mg (2).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 10 December 2019
File name
Aprovel 75mg SmPC.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 75mg PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 January 2019
File name
PIL Aprovel 75mg.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 75mg fc tablets.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 75mg PIL 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 - 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 75mg SPC.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
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.
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
Updated on 21 December 2016
File name
PIL_15721_979.pdf
Reasons for updating
- New PIL for new product
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
- 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
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
Updated on 09 July 2014
Reasons for updating
- Change to marketing authorisation holder
Updated on 25 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
Updated on 23 October 2013
Reasons for updating
- Change to marketing authorisation holder
Updated on 14 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
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
Updated on 08 May 2013
Reasons for updating
- New individual PIL (was previously included in a combined PIL)