Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

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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.

What is 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.

What is Exforge HCT used for?

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.

How is Exforge HCT used?

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.

How does Exforge HCT work?

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.

How has Exforge HCT been studied?

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.

What benefit has Exforge HCT shown during the studies?

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.

What is the risk associated with Exforge HCT?

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.

Why has Exforge HCT been approved?

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.

Other information about Exforge HCT:

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.

Name Language First published Last updated
Exforge HCT : EPAR - Summary for the public BG = bălgarski 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public ES = español 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public CS = čeština 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public DA = dansk 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public DE = Deutsch 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public ET = eesti keel 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public EL = elliniká 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public EN = English 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public FR = français 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public IT = italiano 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public LV = latviešu valoda 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public LT = lietuvių kalba 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public HU = magyar 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public MT = Malti 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public NL = Nederlands 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public PL = polski 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public PT = português 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public RO = română 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public SK = slovenčina 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public SL = slovenščina 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public FI = suomi 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public SV = svenska 2009-11-12 2013-12-12
Exforge HCT : EPAR - Summary for the public HR = Hrvatski 2009-11-12 2013-12-12

This EPAR was last updated on 20/04/2017 .

Authorisation details

Product details

Product details for Exforge HCT
NameExforge HCT
Agency product numberEMEA/H/C/001068
Active substance

amlodipine besylate / valsartan / hydrochlorothiazide

International non-proprietary name (INN) or common name

amlodipine besylate / valsartan / hydrochlorothiazide

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09DX01

Publication details

Publication details for Exforge HCT
Marketing-authorisation holder

Novartis Europharm Ltd

Revision11
Date of issue of marketing authorisation valid throughout the European Union16/10/2009

Contact address:

Novartis Europharm Ltd
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

23/02/2017  Exforge HCT -EMEA/H/C/001068 -WS/1080

Name Language First published Last updated
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20
Exforge HCT : EPAR - Product Information HR = Hrvatski 2009-11-12 2017-04-20

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.


Name Language First published Last updated
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  
Exforge HCT : EPAR - All Authorised presentations HR = Hrvatski 2009-11-12  

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

Name Language First published Last updated
Exforge HCT : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2010-08-26 2017-04-20
Exforge HCT-H-C-1068-A31-0029 : EPAR - Assessment Report - Article 31 HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
Exforge HCT-H-C-1068-WS-0359 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-12-12  
CHMP post-authorisation summary of positive opinion for Exforge HCT HR = Hrvatski 2013-06-28  

Initial marketing-authorisation documents

Name Language First published Last updated
Exforge HCT : EPAR - Public assessment report HR = Hrvatski 2009-11-12  
Committee for medicinal products for human use summary of positive opinion for Exforge HCT HR = Hrvatski 2009-07-23  

Authorised

This medicine is approved for use in the European Union

Related information on Exforge HCT