Actelsar HCT

telmisartan / hydrochlorothiazide

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This is a summary of the European public assessment report (EPAR) for Actelsar HCT. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Actelsar HCT.

For practical information about using Actelsar HCT, patients should read the package leaflet or contact their doctor or pharmacist.

What is Actelsar HCT and what is it used for?

Actelsar HCT is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. It is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘Essential’ means that the hypertension has no obvious cause.

Actelsar HCT is a ‘generic medicine’. This means that Actelsar HCT is similar to a ‘reference medicine’ already authorised in the EU called MicardisPlus.

How is Actelsar HCT used?

Actelsar HCT is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid. The dose of Actelsar HCT to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5-mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5-mg tablets. The 80/25-mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5-mg tablets or who have been stabilised using the two active substances taken separately before switching to Actelsar HCT.

The medicine can only be obtained with a prescription.

How does Actelsar HCT work?

Actelsar HCT contains two active substances, telmisartan and hydrochlorothiazide.

Telmisartan 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, telmisartan 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 reducing 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 Actelsar HCT been studied?

Because Actelsar HCT is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Actelsar HCT?

Because Actelsar HCT is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Actelsar HCT approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus. Therefore, the CHMP’s view was that, as for MicardisPlus, the benefit outweighs the identified risk. The Committee recommended that Actelsar HCT be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Actelsar HCT?

Safety information has been included in the summary of product characteristics and the package leaflet for Actelsar HCT, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Actelsar HCT

The European Commission granted a marketing authorisation valid throughout the European Union for Actelsar HCT on 13 March 2013.

Name Language First published Last updated
Actelsar HCT : EPAR - Summary for the public BG = bălgarski 2013-03-26  
Actelsar HCT : EPAR - Summary for the public ES = español 2013-03-26  
Actelsar HCT : EPAR - Summary for the public CS = čeština 2013-03-26  
Actelsar HCT : EPAR - Summary for the public DA = dansk 2013-03-26  
Actelsar HCT : EPAR - Summary for the public DE = Deutsch 2013-03-26  
Actelsar HCT : EPAR - Summary for the public ET = eesti keel 2013-03-26  
Actelsar HCT : EPAR - Summary for the public EL = elliniká 2013-03-26  
Actelsar HCT : EPAR - Summary for the public EN = English 2013-03-26  
Actelsar HCT : EPAR - Summary for the public FR = français 2013-03-26  
Actelsar HCT : EPAR - Summary for the public IT = italiano 2013-03-26  
Actelsar HCT : EPAR - Summary for the public LV = latviešu valoda 2013-03-26  
Actelsar HCT : EPAR - Summary for the public LT = lietuvių kalba 2013-03-26  
Actelsar HCT : EPAR - Summary for the public HU = magyar 2013-03-26  
Actelsar HCT : EPAR - Summary for the public MT = Malti 2013-03-26  
Actelsar HCT : EPAR - Summary for the public NL = Nederlands 2013-03-26  
Actelsar HCT : EPAR - Summary for the public PL = polski 2013-03-26  
Actelsar HCT : EPAR - Summary for the public PT = português 2013-03-26  
Actelsar HCT : EPAR - Summary for the public RO = română 2013-03-26  
Actelsar HCT : EPAR - Summary for the public SK = slovenčina 2013-03-26  
Actelsar HCT : EPAR - Summary for the public SL = slovenščina 2013-03-26  
Actelsar HCT : EPAR - Summary for the public FI = suomi 2013-03-26  
Actelsar HCT : EPAR - Summary for the public SV = svenska 2013-03-26  

This EPAR was last updated on 19/05/2016 .

Authorisation details

Product details

Product details for Actelsar HCT
NameActelsar HCT
Agency product numberEMEA/H/C/002676
Active substance

telmisartan / hydrochlorothiazide

International non-proprietary name (INN) or common name

telmisartan / hydrochlorothiazide

Therapeutic area
Anatomical therapeutic chemical (ATC) code C09DA07
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Actelsar HCT
Marketing-authorisation holder

Actavis Group hf

Revision5
Date of issue of marketing authorisation valid throughout the European Union13/03/2013

Contact address:

Actavis Group hf
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland

Product information

Product information

20/04/2016  Actelsar HCT -EMEA/H/C/002676 -N/0013

Name Language First published Last updated
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19
Actelsar HCT : EPAR - Product Information SV = svenska 2013-03-26 2016-05-19

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
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23
Actelsar HCT : EPAR - All Authorised presentations SV = svenska 2013-03-26 2014-07-23

Pharmacotherapeutic group

Angiotensin-II-receptor antagonists and diuretics

Therapeutic indication

Treatment of essential hypertension.

Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.

Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.

Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately. 

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Actelsar HCT : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2014-07-23 2016-05-19
Actelsar HCT-H-C-2676-A31-0003 : EPAR - Assessment Report - Article 31 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  
Actelsar HCT-H-C-2676-A31-03 : 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 SV = svenska 2014-09-30  

Initial marketing-authorisation documents

Name Language First published Last updated
Actelsar HCT : EPAR - Public assessment report SV = svenska 2013-03-26  
CHMP summary of positive opinion for Actelsar HCT SV = svenska 2013-01-18  

Authorised

This medicine is approved for use in the European Union

More information on Actelsar HCT