About
This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
- What is CoAprovel?
CoAprovel is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as oval tablets (peach: 150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink: 300 mg irbesartan and 25 mg hydrochlorothiazide).
- What is CoAprovel used for?
CoAprovel is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
- How is CoAprovel used?
CoAprovel is taken by mouth, with or without food. The dose of CoAprovel to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended. CoAprovel may be added to other treatments for hypertension.
- How does CoAprovel work?
CoAprovel contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
- How has CoAprovel been studied?
Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel. It can be used with hydrochlorothiazide to treat hypertension. The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of CoAprovel. Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
- What benefit has CoAprovel shown during the studies?
CoAprovel was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure. Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.
- What is the risk associated with CoAprovel?
The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle). For the full list of all side effects reported with CoAprovel, see the Package Leaflet.
CoAprovel should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. CoAprovel must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high. Care must be taken when using CoAprovel with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in the Package Leaflet.
- Why has CoAprovel been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that CoAprovel’s benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. The Committee recommended that CoAprovel be given marketing authorisation.
- Other information about CoAprovel
The European Commission granted a marketing authorisation valid throughout the EU for CoAprovel to Sanofi Pharma Bristol-Myers Squibb SNC on 15 October 1998. The marketing authorisation was renewed on 15 October 2003 and on 15 October 2008.
| Name | Language | First published | Last updated |
|---|---|---|---|
| CoAprovel : EPAR - Summary for the public | 04/05/2009 |
This EPAR was last updated on 10/10/2011 .
More detail is available in the Summary of Product Characteristics
Authorisation details
Product information
Product information
02/09/2011 CoAprovel -EMEA/H/C/000222 -WS/0147
| Name | Language | First published | Last updated |
|---|---|---|---|
| CoAprovel : EPAR - Product Information | BG = bălgarski | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | ES = español | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | CS = čeština | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | DA = dansk | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | DE = Deutsch | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | ET = eesti keel | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | EL = elliniká | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | EN = English | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | FR = français | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | IT = italiano | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | LV = latviešu valoda | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | LT = lietuvių kalba | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | HU = magyar | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | MT = Malti | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | NL = Nederlands | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | PL = polski | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | PT = português | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | RO = română | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | SK = slovenčina | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | SL = slovenščina | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | FI = suomi | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | SV = svenska | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | IS = Islenska | 19/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Product Information | NO = Norsk | 19/10/2009 | 10/10/2011 |
Contents
- Annex I - Summary of product Characteristics
- Annex IIA - Manufacturing Authorisation Holder responsible for Batch Release
- Annex IIB - Conditions of the Marketing Authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package Leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmaco-therapeutic Group
Agents acting on the renin-angiotensin system
Therapeutic Indication
Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| CoAprovel : EPAR - Procedural steps taken and scientific information after authorisation | EN = English | 25/10/2009 | 10/10/2011 |
| CoAprovel : EPAR - Steps taken after authorisation when a cutoff date has been used | EN = English | 17/10/2006 |
Initial Marketing authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| CoAprovel : EPAR - Scientific Discussion | EN = English | 17/10/2006 | |
| CoAprovel : EPAR - Procedural steps taken before authorisation | EN = English | 17/10/2006 |
Authorised
This medicine is approved for use in the European Union
Patient safety
More information on CoAprovel
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011 (21/10/2011)
- European Medicines Agency concludes that benefit-risk balance of angiotensin II receptor antagonists remains positive (20/10/2011)
- European Medicines Agency recommendation on use of angiotensin II receptor antagonists during pregnancy (24/04/2008)