Dafiro 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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its 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 for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

: Dafiro 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.

: Dafiro 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.

: Dafiro 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 Dafiro 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 Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.

: The three active substances in Dafiro HCT are antihypertensive 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 Dafiro HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide). Patients received either Dafiro 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 Dafiro 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 Dafiro 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 Dafiro 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 Dafiro HCT, see the package leaflet.
Dafiro 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 Dafiro 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, Dafiro 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.
Dafiro 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 Dafiro HCT which combines the three substances in a single tablet. The main study showed the benefit of the highest strength of Dafiro HCT in lowering the blood pressure. For all doses, Dafiro HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately. The CHMP therefore decided that Dafiro 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 Dafiro HCT on 4 November 2009.

List item

Dafiro HCT : EPAR - Summary for the public (PDF/75.98 KB)

First published: 12/11/2009
Last updated: 12/12/2013
- Bulgarian
  (PDF/104.3 KB)
- Croatian
  (PDF/93.81 KB)
- Czech
  (PDF/103.51 KB)
- Danish
  (PDF/76.17 KB)
- Dutch
  (PDF/76.53 KB)
- Estonian
  (PDF/75.71 KB)
- Finnish
  (PDF/75.93 KB)
- French
  (PDF/77.85 KB)
- German
  (PDF/77.87 KB)
- Greek
  (PDF/125.58 KB)
- Hungarian
  (PDF/119.69 KB)
- Italian
  (PDF/98.62 KB)
- Latvian
  (PDF/99 KB)
- Lithuanian
  (PDF/102.58 KB)
- Maltese
  (PDF/125.73 KB)
- Polish
  (PDF/126.08 KB)
- Portuguese
  (PDF/98.97 KB)
- Romanian
  (PDF/98.53 KB)
- Slovak
  (PDF/101.04 KB)
- Slovenian
  (PDF/92.69 KB)
- Spanish
  (PDF/76.71 KB)
- Swedish
  (PDF/99.21 KB)

This EPAR was last updated on 20/12/2022

Authorisation details

Product details
Name	Dafiro HCT
Agency product number	EMEA/H/C/001160
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	25
Date of issue of marketing authorisation valid throughout the European Union	03/11/2009
Contact address	Vista Building Elm Park Merrion Road Dublin 4 Ireland

Product information

15/12/2022 Dafiro HCT - EMEA/H/C/001160 - WS/2373

List item

Dafiro HCT : EPAR - Product Information (PDF/760.39 KB)

First published: 12/11/2009
Last updated: 20/12/2022
- Bulgarian
  (PDF/899.4 KB)
- Croatian
  (PDF/824.57 KB)
- Czech
  (PDF/824.27 KB)
- Danish
  (PDF/828.77 KB)
- Dutch
  (PDF/808.27 KB)
- Estonian
  (PDF/774.11 KB)
- Finnish
  (PDF/744.02 KB)
- French
  (PDF/841.15 KB)
- German
  (PDF/735.64 KB)
- Greek
  (PDF/880.16 KB)
- Hungarian
  (PDF/841.27 KB)
- Icelandic
  (PDF/774.43 KB)
- Italian
  (PDF/805.3 KB)
- Latvian
  (PDF/820.16 KB)
- Lithuanian
  (PDF/830.51 KB)
- Maltese
  (PDF/880.11 KB)
- Norwegian
  (PDF/777.48 KB)
- Polish
  (PDF/852.32 KB)
- Portuguese
  (PDF/796.71 KB)
- Romanian
  (PDF/834.79 KB)
- Slovak
  (PDF/858.79 KB)
- Slovenian
  (PDF/808.55 KB)
- Spanish
  (PDF/738.17 KB)
- Swedish
  (PDF/851.3 KB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Dafiro HCT : EPAR - All Authorised presentations (PDF/21.51 KB)

First published: 12/11/2009
Last updated: 12/11/2009
- Bulgarian
  (PDF/91.61 KB)
- Croatian
  (PDF/69.64 KB)
- Czech
  (PDF/89.42 KB)
- Danish
  (PDF/23.98 KB)
- Dutch
  (PDF/22.7 KB)
- Estonian
  (PDF/24.63 KB)
- Finnish
  (PDF/24.71 KB)
- French
  (PDF/24.63 KB)
- German
  (PDF/23.86 KB)
- Greek
  (PDF/90.57 KB)
- Hungarian
  (PDF/93.79 KB)
- Icelandic
  (PDF/44.42 KB)
- Italian
  (PDF/23.91 KB)
- Latvian
  (PDF/91.74 KB)
- Lithuanian
  (PDF/92.27 KB)
- Maltese
  (PDF/88.4 KB)
- Norwegian
  (PDF/48.08 KB)
- Polish
  (PDF/54.99 KB)
- Portuguese
  (PDF/22.55 KB)
- Romanian
  (PDF/88.17 KB)
- Slovak
  (PDF/87.21 KB)
- Slovenian
  (PDF/22.77 KB)
- Spanish
  (PDF/23.76 KB)
- Swedish
  (PDF/21.74 KB)

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

Dafiro HCT : EPAR - Procedural steps taken and scientific information after authorisation (PDF/390.19 KB)

First published: 26/08/2010
Last updated: 20/12/2022
List item

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Adopted

First published: 05/07/2021
- Bulgarian
  (PDF/145.18 KB)
- Croatian
  (PDF/142.87 KB)
- Czech
  (PDF/139.02 KB)
- Danish
  (PDF/126.81 KB)
- Dutch
  (PDF/127.53 KB)
- Estonian
  (PDF/123.85 KB)
- Finnish
  (PDF/125.84 KB)
- French
  (PDF/127.12 KB)
- German
  (PDF/131.05 KB)
- Greek
  (PDF/139.5 KB)
- Hungarian
  (PDF/137.17 KB)
- Italian
  (PDF/126.56 KB)
- Latvian
  (PDF/147.7 KB)
- Lithuanian
  (PDF/148.34 KB)
- Maltese
  (PDF/151.21 KB)
- Polish
  (PDF/137.7 KB)
- Portuguese
  (PDF/128.87 KB)
- Romanian
  (PDF/143.59 KB)
- Slovak
  (PDF/135.07 KB)
- Slovenian
  (PDF/149.74 KB)
- Spanish
  (PDF/125.85 KB)
- Swedish
  (PDF/126.99 KB)
List item

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Adopted

First published: 02/03/2021
EMA/47245/2021
List item

Dafiro HCT : EPAR - Scientific conclusions (PDF/99.42 KB)

First published: 04/06/2019
- Bulgarian
  (PDF/136.15 KB)
- Croatian
  (PDF/125.02 KB)
- Czech
  (PDF/131.08 KB)
- Danish
  (PDF/96.12 KB)
- Dutch
  (PDF/99.3 KB)
- Estonian
  (PDF/94.4 KB)
- Finnish
  (PDF/97.12 KB)
- French
  (PDF/97.56 KB)
- German
  (PDF/100.2 KB)
- Greek
  (PDF/142.79 KB)
- Hungarian
  (PDF/119.82 KB)
- Italian
  (PDF/95.54 KB)
- Latvian
  (PDF/130.68 KB)
- Lithuanian
  (PDF/130.84 KB)
- Maltese
  (PDF/133.78 KB)
- Polish
  (PDF/130.65 KB)
- Portuguese
  (PDF/96.47 KB)
- Romanian
  (PDF/128.25 KB)
- Slovak
  (PDF/119.14 KB)
- Slovenian
  (PDF/124.14 KB)
- Spanish
  (PDF/98.31 KB)
- Swedish
  (PDF/96.85 KB)
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
List item

Dafiro HCT-H-C-1160-A31-0030 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 01/10/2014
Last updated: 01/10/2014
List item

Dafiro HCT-H-C-1160-A31-0030 : 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 recomm... (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

Dafiro HCT-H-C-1160-WS-0359 : EPAR - Assessment Report - Variation (PDF/446.66 KB)

Adopted

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

CHMP post-authorisation summary of positive opinion for Dafiro HCT (PDF/68.38 KB)

Adopted

First published: 28/06/2013
Last updated: 28/06/2013
EMA/CHMP/397292/2013

Dafiro HCT

Table of contents

Overview

Dafiro HCT : EPAR - Summary for the public (PDF/75.98 KB)

Authorisation details

Product information

Dafiro HCT : EPAR - Product Information (PDF/760.39 KB)

Dafiro HCT : EPAR - All Authorised presentations (PDF/21.51 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Dafiro HCT : EPAR - Procedural steps taken and scientific information after authorisation (PDF/390.19 KB)

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Dafiro HCT : EPAR - Scientific conclusions (PDF/99.42 KB)

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

Dafiro HCT-H-C-1160-A31-0030 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Dafiro HCT-H-C-1160-A31-0030 : 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 recomm... (PDF/48.81 KB)

Dafiro HCT-H-C-1160-WS-0359 : EPAR - Assessment Report - Variation (PDF/446.66 KB)

CHMP post-authorisation summary of positive opinion for Dafiro HCT (PDF/68.38 KB)

Initial marketing-authorisation documents

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

Committee for medicinal products for human use summary of positive opinion for Dafiro HCT (PDF/34.15 KB)

News

More information on Dafiro HCT

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?