Copalia

amlodipine / valsartan

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Copalia. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Copalia.

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).

: Copalia is a medicine that contains two active substances, amlodipine and valsartan. It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).

: Copalia is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

: Copalia is taken by mouth as one tablet once a day with some water. The dose of Copalia to be used depends on the doses of amlodipine or valsartan that the patient was taking before. The patient may need to take separate tablets or capsules before switching to the combination tablet.

: Copalia contains two active substances, amlodipine and valsartan. Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Amlodipine is a calcium-channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood-vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Valsartan 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, valsartan stops the hormone having an effect, allowing the blood vessels to widen.

: Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out. Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment). Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan. The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats). The blood pressure was measured in ‘millimetres of mercury’ (mmHg).
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Copalia and people taking the separate medicines.

: The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone. In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively. Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.

: The most common side effects with Copalia (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes. For the full list of all side effects reported with Copalia, see the package leaflet.
Copalia must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives’ class, to valsartan, or to 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. Copalia must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure). Copalia must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment. For the full list of restrictions, see the package leaflet.

: The CHMP decided that Copalia’s benefits are greater than its risks and recommended that it be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the EU for Copalia on 16 January 2007.

List item

Copalia : EPAR - Summary for the public (PDF/74.95 KB)

First published: 05/05/2009
Last updated: 29/06/2015
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  (PDF/75.26 KB)
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  (PDF/97.76 KB)
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  (PDF/101.25 KB)
- Slovenian
  (PDF/91.91 KB)
- Spanish
  (PDF/76.72 KB)
- Swedish
  (PDF/75.84 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 11/12/2018

Authorisation details

Product details
Name	Copalia
Agency product number	EMEA/H/C/000774
Active substance	amlodipine (as besylate) valsartan
International non-proprietary name (INN) or common name	amlodipine / valsartan
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DB01

Publication details
Marketing-authorisation holder	Novartis Europharm Limited
Revision	22
Date of issue of marketing authorisation valid throughout the European Union	15/01/2007
Contact address	Elm Park, Merrion Road Dublin 4 Ireland

Product information

17/10/2018 Copalia - EMEA/H/C/000774 - IG/0986

List item

Copalia : EPAR - Product Information (PDF/680.06 KB)

First published: 05/05/2009
Last updated: 11/12/2018
- Bulgarian
  (PDF/801.99 KB)
- Croatian
  (PDF/761.13 KB)
- Czech
  (PDF/762.32 KB)
- Danish
  (PDF/729.91 KB)
- Dutch
  (PDF/708.16 KB)
- Estonian
  (PDF/684.4 KB)
- Finnish
  (PDF/945.35 KB)
- French
  (PDF/815.8 KB)
- German
  (PDF/812.33 KB)
- Greek
  (PDF/783.12 KB)
- Hungarian
  (PDF/746.94 KB)
- Icelandic
  (PDF/727.68 KB)
- Italian
  (PDF/702.66 KB)
- Latvian
  (PDF/851.08 KB)
- Lithuanian
  (PDF/751.55 KB)
- Maltese
  (PDF/822.6 KB)
- Norwegian
  (PDF/878.26 KB)
- Polish
  (PDF/839.52 KB)
- Portuguese
  (PDF/763.67 KB)
- Romanian
  (PDF/785.73 KB)
- Slovak
  (PDF/751.87 KB)
- Slovenian
  (PDF/721.63 KB)
- Spanish
  (PDF/697.81 KB)
- Swedish
  (PDF/756.6 KB)

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.

List item

Copalia : EPAR - All Authorised presentations (PDF/142.62 KB)

First published: 20/05/2008
Last updated: 06/08/2010
- Bulgarian
  (PDF/229.59 KB)
- Croatian
  (PDF/50.75 KB)
- Czech
  (PDF/181.96 KB)
- Danish
  (PDF/143.23 KB)
- Dutch
  (PDF/143.17 KB)
- Estonian
  (PDF/145.02 KB)
- Finnish
  (PDF/142.61 KB)
- French
  (PDF/143.69 KB)
- German
  (PDF/143.39 KB)
- Greek
  (PDF/225.01 KB)
- Hungarian
  (PDF/230.3 KB)
- Icelandic
  (PDF/36.56 KB)
- Italian
  (PDF/146.37 KB)
- Latvian
  (PDF/228.9 KB)
- Lithuanian
  (PDF/232.49 KB)
- Maltese
  (PDF/226.17 KB)
- Norwegian
  (PDF/40.4 KB)
- Polish
  (PDF/183.66 KB)
- Portuguese
  (PDF/142.45 KB)
- Romanian
  (PDF/225.12 KB)
- Slovak
  (PDF/181.54 KB)
- Slovenian
  (PDF/143.28 KB)
- Spanish
  (PDF/146.77 KB)
- Swedish
  (PDF/143.15 KB)

Pharmacotherapeutic group

Agents acting on the renin angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Assessment history

Changes since initial authorisation of medicine

List item

Copalia : EPAR - Procedural steps taken and scientific information after authorisation (PDF/293.88 KB)

First published: 05/05/2009
Last updated: 11/12/2018
List item

Copalia-H-C-774-A31-0069 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 01/10/2014
Last updated: 01/10/2014
EMA/PRAC/294920/2014
List item

Copalia-H-C-774-A31-0069: EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendat... (PDF/48.81 KB)

First published: 01/10/2014
Last updated: 01/10/2014
- Bulgarian
  (PDF/87.49 KB)
- Croatian
  (PDF/80.12 KB)
- Czech
  (PDF/82.81 KB)
- Danish
  (PDF/49.01 KB)
- Dutch
  (PDF/49.82 KB)
- Estonian
  (PDF/50.6 KB)
- Finnish
  (PDF/49.15 KB)
- French
  (PDF/51.91 KB)
- German
  (PDF/53.54 KB)
- Greek
  (PDF/89.54 KB)
- Hungarian
  (PDF/68.7 KB)
- Italian
  (PDF/51.13 KB)
- Latvian
  (PDF/81.63 KB)
- Lithuanian
  (PDF/82.54 KB)
- Maltese
  (PDF/84.23 KB)
- Polish
  (PDF/83.62 KB)
- Portuguese
  (PDF/49.74 KB)
- Romanian
  (PDF/88.19 KB)
- Slovak
  (PDF/81.5 KB)
- Slovenian
  (PDF/79.79 KB)
- Spanish
  (PDF/50.51 KB)
- Swedish
  (PDF/50.18 KB)
List item

Copalia-H-C-774-WS-0360 : EPAR - Assessment Report - Variation (PDF/329.42 KB)

Adopted

First published: 12/12/2013
Last updated: 12/12/2013
List item

CHMP post-authorisation summary of positive opinion for Copalia (PDF/68.51 KB)

Adopted

First published: 26/06/2013
Last updated: 26/06/2013
EMA/CHMP/397192/2013
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Copalia-H-C-774-WS-0100-G : EPAR - Assessment Report - Variation (PDF/636.9 KB)

Adopted

First published: 07/09/2011
Last updated: 07/09/2011

Copalia

Table of contents

Overview

Copalia : EPAR - Summary for the public (PDF/74.95 KB)

Authorisation details

Product information

Copalia : EPAR - Product Information (PDF/680.06 KB)

Contents

Copalia : EPAR - All Authorised presentations (PDF/142.62 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Copalia : EPAR - Procedural steps taken and scientific information after authorisation (PDF/293.88 KB)

Copalia-H-C-774-A31-0069 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Copalia-H-C-774-A31-0069: EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendat... (PDF/48.81 KB)

Copalia-H-C-774-WS-0360 : EPAR - Assessment Report - Variation (PDF/329.42 KB)

CHMP post-authorisation summary of positive opinion for Copalia (PDF/68.51 KB)

Copalia-H-C-774-WS-0100-G : EPAR - Assessment Report - Variation (PDF/636.9 KB)

Initial marketing-authorisation documents

Copalia : EPAR - Procedural steps taken before authorisation (PDF/21.39 KB)

Copalia : EPAR - Scientific Discussion (PDF/333.33 KB)

News

More information on Copalia

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

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Copalia

Table of contents

Overview

Copalia : EPAR - Summary for the public (PDF/74.95 KB)

Authorisation details

Product information

Copalia : EPAR - Product Information (PDF/680.06 KB)

Contents

Copalia : EPAR - All Authorised presentations (PDF/142.62 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Copalia : EPAR - Procedural steps taken and scientific information after authorisation (PDF/293.88 KB)

Copalia-H-C-774-A31-0069 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Copalia-H-C-774-A31-0069: EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendat... (PDF/48.81 KB)

Copalia-H-C-774-WS-0360 : EPAR - Assessment Report - Variation (PDF/329.42 KB)

CHMP post-authorisation summary of positive opinion for Copalia (PDF/68.51 KB)

Copalia-H-C-774-WS-0100-G : EPAR - Assessment Report - Variation (PDF/636.9 KB)

Initial marketing-authorisation documents

Copalia : EPAR - Procedural steps taken before authorisation (PDF/21.39 KB)

Copalia : EPAR - Scientific Discussion (PDF/333.33 KB)

News

More information on Copalia

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

Related content

How useful was this page?