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Sanofi Pharma Bristol-Myers Squibb SNC
174 Avenue de France, F-75013 Paris, France,
Telephone: +44 (0)1483 505 515 Sanofi
Telephone: +44 (0)1895 52 3000 - BMS
Fax: +44 (0)1483 535 432 or +44 (0)1895 52 3010
Medical Information Direct Line: +44 (0)800 731 1736 BMS - Aprovel and CoAprovel
Medical Information e-mail: medical.information@bms.com
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com
Medical Information Fax: +44 (0)1895 52 3677 BMS

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Summary of Product Characteristics last updated on the eMC: 19/07/2011
SPC Aprovel Film-Coated Tablets (sanofi-aventis Bristol-Myers Squibb SNC)

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 19/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   17-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.6 and 5.3 of the SmPC have been updated to include information on fertility data.
Updated on 09/06/2011 and displayed until 19/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 4.8 (undesirable effects), jaundice has been added.
Updated on 15/02/2011 and displayed until 09/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Nervous system disorders:

Common:          dizziness, orthostatic dizziness

Not known:       vertigo, headache
Updated on 07/09/2009 and displayed until 15/02/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC has been updated to implement the CHMP recommendation on a harmonised labelling relating to the use of Angiotensin II Receptor Antagonists during pregnancy and lactation. Furthermore, minor typographical changes have been introduced in the SPC.


  • Change to section 4.3 - Contraindications - Lactation removed
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
    • Updated on 10/07/2008 and displayed until 07/09/2009
    Reasons for adding or updating:
    • Change to section 2 - Qualitative and quantitative composition
    • Change to section 4.6 - Pregnancy and Lactation
    Date of revision of text on the SPC:   26-Jun-2008
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company
    

    2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

    Aprovel 75 mg

     

    Each film-coated tablet contains 75 mg of irbesartan.

    Excipient: 25.50 mg of lactose monohydrate per film-coated tablet.

     

    Aprovel 150 mg

    Each film-coated tablet contains 150 mg of irbesartan.

    Excipient: 51.00 mg of lactose monohydrate per film-coated tablet.

     

    Aprovel 300 mg

    Each film-coated tablet contains 300 mg of irbesartan.

    Excipient: 102.00 mg of lactose monohydrate per film-coated tablet.



    4.6         Pregnancy and lactation

     

    Pregnancy: Aprovel is contraindicated (see section 4.3) in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death.

    As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.

     

    Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).

     

    Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.

    AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (see section 5.3).

    Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

    Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).

     

    Lactation: Aprovel is contraindicated (see section 4.3) during breast-feeding.It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats.
    Updated on 27/09/2006 and displayed until 10/07/2008
    Reasons for adding or updating:
    • Improved Electronic Presentation
    • 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 5.1 - Pharmacodynamic Properties
    • Change to section 5.2 - Pharmacokinetic Properties
    • Change to section 6. 5 - Nature and Contents of Container
    • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
    • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
    • Change to section 10 date of revision of the text
    Date of revision of text on the SPC:   05/2006
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company
    Section 4.2:
    Changed from: Children: Safety and efficacy of Aprovel have not been established in children.
    To:

    Paediatric patients: irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 5.1 and 5.2).

     
    Section 4.4:
    Addition of:

    Paediatric patients: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).

     
    Section 4.8:
    Changed from:
    Very rare: abnormal liver function, hepatitis
    To:

    Hepatitis, abnormal liver function

     
     
    Section 5.1:
    Addition of the following to clinical efficacy, hypertension section:

    Reduction of blood pressure with 0.5 mg/kg (low), 1.5 mg/kg (medium) and 4.5 mg/kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period. At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose). No significant difference was apparent between these doses. Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose). Over a subsequent two week period where patients were re-randomized to either active drug or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).

     
    Section 5.2:
    Addition of:

    The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks. Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years). Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily. A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.

     
    Section 6.5:
    Changed from:
     Aprovel film-coated tablets are packaged in blister packs containing 28 tablets in PVC/PVDC/Aluminium strips.

    To:

    14 tablets

    28 tablets

    56 tablets

    84 tablets

    98 tablets

    PVC/PVDC/Aluminium blisters

     

    56 x 1 tablets

    PVC/PVDC/Aluminium perforated unit dose blisters

     

    Not all pack sizes may be marketed.

     
    Section 8:
    Changed from:

     

    Aprovel 75 mg film-coated tablets: EU/1/97/046/17

     

    Aprovel 150 mg film-coated tablets: EU/1/97/046/22

     

    Aprovel 300 mg film-coated tablets: EU/1/97/046/27

    To:

    EU/1/97/046/016-020
    EU/1/97/046/021-025

    EU/1/97/046/026-030

    EU/1/97/046/031

    EU/1/97/046/032

    EU/1/97/046/033

     
     
    Section 9:
    Changed from: 02 March 2004
    To: 27 August 1997 / 29 October 2002
     
    Section 10:
    Changed from: 09 January 2006
    To: 31 May 2006
    Updated on 03/03/2006 and displayed until 27/09/2006
    Reasons for adding or updating:
    • Change to section 2 - qualitative and quantitative composition
    • Change to section 4.4 - Special Warnings and Precautions for Use
    • 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 6. 6 - Instruction for Use/Handling
    Updated on 27/09/2004 and displayed until 03/03/2006
    Reasons for adding or updating:
    • Pending awaiting re-submission
    • New SPC for new product

    Active Ingredients/Generics

     
      irbesartan