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Bristol-Myers Squibb Pharmaceuticals Ltd
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Telephone: +44 (0)1895 523 000
Fax: +44 (0)1895 523 010
Medical Information Direct Line: +44 (0)1895 523 740
Medical Information e-mail: medical.information@bms.com
Medical Information Fax: +44 (0)1895 523 677
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Summary of Product Characteristics last updated on the eMC: 07/09/2009
SPC CoAprovel 150/12.5 mg, 300/12.5 mg and 300/25 mg Film-Coated Tablets (Bristol-Myers Squibb)

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 07/09/2009 and displayed until Current
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:   31-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


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.
Updated on 04/12/2008 and displayed until 07/09/2009
Reasons for adding or 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2 Posology and method of administration
(...) Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of CoAprovel.

 

Children and adolescents: there

Paediatric patients: CoAprovel is no experiencenot recommended for use in children and adolescents due to a lack of data on safety and efficacy.

 

 


4.4 Special warnings and precautions for use

General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke. Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
Cases of photosensitivity reactions have been reported with thiazides diuretics (see section 4.8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.

 

4.8 Undesirable effects

 

 

Irbesartan/hydrochlorothiazide combination: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials in which 898 hypertensive patients received various doses (range: 37.5 mg/6.25 mg to 300 mg/25 mg irbesartan/hydrochlorothiazide

Undesirable effects Tabulised
Updated on 23/07/2008 and displayed until 04/12/2008
Reasons for adding or updating:
  • 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


4.6         Pregnancy and lactation

 

Pregnancy:   

Thiazides cross the placental barrier and appear in cord blood.   They may cause a decrease in placental perfusion, foetal electrolyte disturbances and possibly other reactions that have occurred in the adults.   Cases of neonatal thrombocytopenia, or foetal or neonatal jaundice have been reported with maternal thiazide therapy.   Since CoAprovel contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.   A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.

CoAprovel is contraindicated in the second and third trimesters of pregnancy (see section 4.3). 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. If pregnancy is diagnosed, CoAprovel 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 AIIR

As 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).

 

Thiazides cross the placental barrier and appear in cord blood. They may cause a decrease in placental perfusion, foetal electrolyte disturbances and possibly other reactions that have occurred in the adults. Cases of neonatal thrombocytopenia, or foetal or neonatal jaundice have been reported with maternal thiazide therapy. Since CoAprovel contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.

 

Lactation: CoAprovel is contraindicated during breast-feeding.
Updated on 21/09/2007 and displayed until 23/07/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 23/02/2007 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
  • Improved Electronic Presentation
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4:
Addition of:
  Lactose:   This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
 
Section 5.1:
Addition of:

Efficacy and safety of CoAprovel as initial therapy for severe hypertension (defined as SeDBP ¡Ý 110 mmHg) was evaluated in a multicentre, randomised, double-blind, active-controlled, 8‑week, parallel-arm study. A total of 697 patients were randomised in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.

 

The study recruited 58% males. The mean age of patients was 52.5 years, 13% were ¡Ý 65 years of age, and just 2% were ¡Ý 75 years of age. Twelve percent (12%) of patients were diabetic, 34% were hyperlipidaemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5% of the participants.

 

The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at week 5 of treatment. Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005). The mean baseline blood pressure was approximately 172/113 mmHg in each treatment group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for irbesartan/hydrochlorothiazide and irbesartan, respectively (p < 0.0001).

 

The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy. During the 8‑week treatment period, there were no reported cases of syncope in either treatment group. There were 0.6% and 0% of patients with hypotension and 2.8% and 3.1% of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
 
Section 10
Changed from '28 August 2006' to 'January 2007'
Updated on 20/11/2006 and displayed until 23/02/2007
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • 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
  • Addition of joint SPC covering all presentations
  • Correction of spelling/typing errors
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes due to addition of new CoAprovel 300/25 mg strength in the following sections:
1.
CoAprovel 300/25 mg film-coated tablets
2. Addition of excipient details for all three strengths.
3.

300 mg/25 mg film-coated tablets:

Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.

4.2
Children and adolescents:   there is no experience in children and adolescents.
4.3
Hypersensitivity to the active substances, to any of the excipients (see section 6.1), or to other sulfonamide-derived substances (hydrochlorothiazide is a sulphonamide-derived substance).
4.8. Re-grouping os side efccects in order of decreasing seriousness.
6.1
Addition of CoAprovel 300/25 mg film-coated tablets
6.3 Addition of CoAprovel 300/25 mg film-coated tablets
6.5 Cartons of  28 film-coated tablets; 2 blister cards of 14 film-coated tablets
6.6

Any unused product or waste material should be disposed of in accordance with local requirements.

8.  

CoAprovel 300/12.5mg film-coated tablets:

EU/1/98/086/017

CoAprovel 300/25mg film-coated tablets:

EU/1/98/086/024
9.

Date of first authorisation: 15 October 1998

Date of last renewal: 15 October 2003

 

10.

28 August 2006
Updated on 15/12/2004 and displayed until 20/11/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 27/09/2004 and displayed until 15/12/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  hydrochlorothiazide
  irbesartan


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