CoAprovel 300 mg/12.5 mg film-coated tablets * Pharmacy Only: Prescription
Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 08 April 2022
File name
1.3.2.1 Mock-up Leaflet (IE-NL joint pack) - CoAprovel 300mg-12.5mg_1649425950.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 08 April 2022
File name
1.3.1.1 IE SmPC CoAprovel 300mg12.5mg (4)_1649425035.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 not be renewed (A)
Updated on 28 March 2022
File name
1.3.2.1 Mock-up Leaflet (IE-NL joint pack) - CoAprovel 300mg-12.5mg_1648463428.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 May 2021
File name
1.3.2.1 Leaflet text - IE CoAprovel 300 mg12.5 mg (2)_1621413804.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 12 May 2021
File name
1.3.2.1 Mock-up Leaflet (IENL joint pack) - CoAprovel 300mg12.5mg_1620830645.pdf
Reasons for updating
- 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 08 April 2021
File name
1.3.2.1 Leaflet text - IE CoAprovel 300 mg12.5 mg (1)_1617880413.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 CoAprovel 300mg12.5mg (3)_1617880254.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 not be renewed (A)
Updated on 07 April 2021
File name
1.3.2.1 Leaflet text - IE CoAprovel 300 mg12.5 mg_1617802985.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 CoAprovel 300mg12.5mg (1)_1617802793.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 not be renewed (A)
Updated on 07 April 2021
File name
1.3.2.1 Leaflet text - IE CoAprovel 300 mg12.5 mg_1617801358.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 CoAprovel 300mg12.5mg (1)_1617800976.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 March 2021
File name
1.3.2.1 Leaflet text - IE CoAprovel 300 mg12.5 mg_1615458324.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 19 February 2021
File name
1.3.2.1 CoAprovel 300mg-12.5mg_1613733462.pdf
Reasons for updating
- 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 10 February 2021
File name
1.3.1.1 IE SmPC CoAprovel 300mg12.5.g (2)_1612971715.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 not be renewed (A)
Updated on 27 November 2020
File name
1.3.1.1 IE SmPC CoAprovel 300mg12.5.g (1)_1606480313.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 not be renewed (A)
Updated on 27 November 2020
File name
1.3.2.1 Mock-up Leaflet - CoAprovel 300mg-12.5mg (3)_1606480269.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 01 September 2020
File name
1.3.1.1 IE SmPC CoAprovel 300mg12.5.g_1598965408.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 not be renewed (A)
Updated on 06 July 2020
File name
1.3.2.1 Mock-up Leaflet - CoAprovel 300mg-12.5mg_1581335468.pdf
Reasons for updating
- XPIL Removed
Updated on 10 February 2020
File name
1.3.1.1 SmPC CoAprovel 300mg-12.5.g_1581335511.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Ireland – Centralised packs split to remove UK details due to Brexit
Updated on 10 February 2020
File name
1.3.2.1 Mock-up Leaflet - CoAprovel 300mg-12.5mg_1581335468.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
Free text change information supplied by the pharmaceutical company
Ireland – Centralised packs split to remove UK details due to Brexit
Updated on 10 February 2020
File name
1.3.1.1 SmPC CoAprovel 300mg-12.5.g_1581335366.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
MAH address name change from Sanofi Clir SNC to sanofi-aventis groupeMAH address name change from Sanofi Clir SNC to sanofi-aventis groupe
Updated on 10 February 2020
File name
1.3.2.1 Mock-up Leaflet - CoAprovel 300mg-12.5mg_1581335244.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 16 January 2019
File name
PIL Coaprovel 300mg.12.5mg_1547646826.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 16 January 2019
File name
SPC Coaprovel 300mg.12_1547647198.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
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Non-melanoma skin cancer
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC.
Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8).
4.5 Interaction with other medicinal products and other forms of interaction
|
Hepatobiliary disorders: |
Not known: |
jaundice (intrahepatic cholestatic jaundice) |
|
Psychiatric disorders: |
Not known: |
depression, sleep disturbances |
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
Not known: |
non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) |
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Non-melanoma skin cancer:
Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed. One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively. High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC. A clear cumulative dose response relationship was observed for both BCC and SCC. Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy. A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
5.2 Pharmacokinetic properties
Updated on 14 January 2019
File name
PIL Coaprovel 300mg.12.5mg_1547464710.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 Coaprovel 300mg.12.5mg_1547464568.
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 not be renewed (A)
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, CoAprovel is unlikely to affect theis ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
4.8 Undesirable effects
Irbesartan/hydrochlorothiazide combination
|
Table 2: Adverse reactions reported with the use of irbesartan alone |
||
|
Blood and lymphatic system disorders: |
Not known: |
thrombocytopenia |
|
General disorders and administration site conditions: |
Uncommon: |
chest pain |
|
Immune system disorders: |
Not Known: |
Anaphylactic reaction including anaphylactic shock |
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 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
CO APROVEL 300 mg 12 5 mg PIL text_1537185848.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 17 September 2018
File name
CO APROVEL 300 mg 12 5 mg SPC_1537185923.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 not be renewed (A)
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, CoAprovel is unlikely to affect theis ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
4.8 Undesirable effects
|
Hepatobiliary disorders: |
Uncommon: Not known: |
jaundice hepatitis, abnormal liver function |
|
Reproductive system and breast disorders: |
Uncommon: |
sexual dysfunction, libido changes |
|
Immune system disorders: |
Not Known: |
Anaphylactic reaction including anaphylactic shock |
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with CoAprovel. Tables 2 and 3 below detail the adverse reactions reported with the individual components of CoAprovel.
Updated on 12 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 December 2017
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 added to table:-
|
Table 2: Adverse reactions reported with the use of irbesartan alone |
||
|
Blood and lymphatic system disorders: |
Not known: |
thrombocytopenia |
Updated on 11 December 2017
File name
PIL_15556_85.pdf
Reasons for updating
- New PIL for new product
Updated on 11 December 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 April 2015
Reasons for updating
- Change to information about pregnancy or lactation
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 4.2 - 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 09 September 2014
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 October 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 August 2013
Reasons for updating
- 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 - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type IIC Aliskiren contra-indication CCDS v27 (WS 155)
Updated on 08 May 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 November 2012
Reasons for updating
- New PIL for medicines.ie