Exforge HCT

amlodipine besilate / valsartan / hydrochlorothiazide

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 Exforge HCT. 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 Exforge HCT.

: Exforge HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide. It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg.

: Exforge HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

: Exforge HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning. The dose of Exforge HCT to be used is the same as the doses of three individual active substances that the patient was taking before. The daily dose of Exforge HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.

: The three active substances in Exforge HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
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 helps the blood vessel walls to relax and widen, thereby reducing blood pressure.
Valsartan is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a body hormone 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 and blood pressure to reduce.
Hydrochlorothiazide is a diuretic. It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.
The combination of the three active substances has an additive effect, reducing the blood pressure more than the individual medicines alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

: Because the combination of the three active substances has been in use for a number of years, the company presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Exforge HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide). Patients received either Exforge HCT or one of the three combinations containing only two of the active substances for eight weeks. The main measure of effectiveness was the average change in the blood pressure.

: Treatment with the highest strength of Exforge HCT was more effective at treating hypertension than dual combinations containing any of the two active substances. The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Exforge HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.

: The most common side effects with Exforge HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention). For the full list of all side effects reported with Exforge HCT, see the package leaflet.
Exforge HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Exforge HCT. It must not be used in women who are more than three months pregnant. It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique). Finally, Exforge HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Exforge HCT 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.

: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Exforge HCT which combines the three substances in a single tablet. The main study showed the benefit of the highest strength of Exforge HCT in lowering the blood pressure. For all doses, Exforge HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken seperately. The CHMP therefore decided that Exforge HCT’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 European Union for Exforge HCT on 16 October 2009.
For more information about treatment with Exforge HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Exforge HCT : EPAR - Summary for the public (PDF/75.96 KB)

First published: 12/11/2009
Last updated: 12/12/2013
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More detail is available in the summary of product characteristics

This EPAR was last updated on 07/07/2020

Authorisation details

Product details
Name	Exforge HCT
Agency product number	EMEA/H/C/001068
Active substance	valsartan hydrochlorothiazide Amlodipine besilate
International non-proprietary name (INN) or common name	amlodipine besilate valsartan hydrochlorothiazide
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DX01

Publication details
Marketing-authorisation holder	Novartis Europharm Limited
Revision	17
Date of issue of marketing authorisation valid throughout the European Union	15/10/2009
Contact address	Vista Building Elm Park Merrion Road Dublin 4 Ireland

Product information

23/06/2020 Exforge HCT - EMEA/H/C/001068 - IG/1255

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Exforge HCT : EPAR - Product Information (PDF/689.35 KB)

First published: 12/11/2009
Last updated: 07/07/2020
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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.

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Exforge HCT : EPAR - All Authorised presentations (PDF/20.81 KB)

First published: 12/11/2009
Last updated: 12/11/2009
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  (PDF/90.38 KB)
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Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.

Assessment history

Changes since initial authorisation of medicine

List item

Exforge HCT : EPAR - Procedural steps taken and scientific information after authorisation (PDF/406.69 KB)

First published: 26/08/2010
Last updated: 07/07/2020
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Exforge HCT : EPAR - Scientific conclusions - Annex IV (PDF/99.42 KB)

First published: 16/08/2019
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  (PDF/136.15 KB)
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List item

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Adopted

First published: 02/05/2019
EMA/217823/2019
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Exforge HCT-H-C-1068-A31-0029 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 01/10/2014
Last updated: 01/10/2014
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Exforge HCT-H-C-1068-A31-0029 : 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 recom... (PDF/48.81 KB)

First published: 01/10/2014
Last updated: 01/10/2014
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  (PDF/87.49 KB)
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List item

Exforge HCT-H-C-1068-WS-0359 : EPAR - Assessment Report - Variation (PDF/446.67 KB)

Adopted

First published: 12/12/2013
Last updated: 12/12/2013
EMA/CHMP/356309/2013
List item

CHMP post-authorisation summary of positive opinion for Exforge HCT (PDF/68.44 KB)

Adopted

First published: 28/06/2013
Last updated: 28/06/2013
EMA/CHMP/388293/2013

Exforge HCT

Table of contents

Overview

Exforge HCT : EPAR - Summary for the public (PDF/75.96 KB)

Authorisation details

Product information

Exforge HCT : EPAR - Product Information (PDF/689.35 KB)

Contents

Exforge HCT : EPAR - All Authorised presentations (PDF/20.81 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Exforge HCT : EPAR - Procedural steps taken and scientific information after authorisation (PDF/406.69 KB)

Exforge HCT : EPAR - Scientific conclusions - Annex IV (PDF/99.42 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Exforge HCT-H-C-1068-A31-0029 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Exforge HCT-H-C-1068-A31-0029 : 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 recom... (PDF/48.81 KB)

Exforge HCT-H-C-1068-WS-0359 : EPAR - Assessment Report - Variation (PDF/446.67 KB)

CHMP post-authorisation summary of positive opinion for Exforge HCT (PDF/68.44 KB)

Initial marketing-authorisation documents

Exforge HCT : EPAR - Public assessment report (PDF/1.23 MB)

Committee for medicinal products for human use summary of positive opinion for Exforge HCT (PDF/34.3 KB)

News

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

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