Kinzalkomb

telmisartan / hydrochlorothiazide

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This is a summary of the European public assessment report (EPAR) for Kinzalkomb. 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 Kinzalkomb.

What is Kinzalkomb?

Kinzalkomb is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. It is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).

What is Kinzalkomb used for?

Kinzalkomb is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘Essential’ means that the hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is Kinzalkomb used?

Kinzalkomb is taken by mouth once a day with liquid, with or without food. The dose of Kinzalkomb 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 Kinzalkomb.

How does Kinzalkomb work?

Kinzalkomb 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 blood pressure.

The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has Kinzalkomb been studied?

Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension. In four of these studies, Kinzalkomb was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients. The fifth study compared the effects of remaining on the 80/12.5-mg tablet with switching to the 80/25-mg tablet in 713 patients who had not responded to the 80/12.5-mg tablet. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

What benefit has Kinzalkomb shown during the studies?

Kinzalkomb was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo. In patients who were not controlled on the 80/12.5-mg tablet, switching to the 80/25-mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.

What is the risk associated with Kinzalkomb?

The most common side effect with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with Kinzalkomb, see the Package Leaflet.

Kinzalkomb 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. Kinzalkomb must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high. In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Kinzalkomb must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension). For the full list of restrictions, see the package leaflet.

Care must be taken when using Kinzalkomb with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in the package leaflet.

Why has Kinzalkomb been approved?

The CHMP decided that Kinzalkomb’s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone. The Committee recommended that Kinzalkomb be given marketing authorisation.

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

A risk management plan has been developed to ensure that Kinzalkomb is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kinzalkomb, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Kinzalkomb

The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalkomb on 19 April 2002.

For more information about treatment with Kinzalkomb, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Kinzalkomb : EPAR - Summary for the public BG = bălgarski 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public ES = español 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public CS = čeština 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public DA = dansk 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public DE = Deutsch 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public ET = eesti keel 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public EL = elliniká 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public EN = English 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public FR = français 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public IT = italiano 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public LV = latviešu valoda 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public LT = lietuvių kalba 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public HU = magyar 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public MT = Malti 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public NL = Nederlands 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public PL = polski 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public PT = português 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public RO = română 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public SK = slovenčina 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public SL = slovenščina 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public FI = suomi 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public SV = svenska 2009-05-28 2015-11-06
Kinzalkomb : EPAR - Summary for the public HR = Hrvatski 2009-05-28 2015-11-06

This EPAR was last updated on 08/05/2018 .

Authorisation details

Product details

Product details for Kinzalkomb
NameKinzalkomb
Agency product numberEMEA/H/C/000415
Active substance

telmisartan / hydrochlorothiazide

International non-proprietary name (INN) or common name

telmisartan / hydrochlorothiazide

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09DA07

Publication details

Publication details for Kinzalkomb
Marketing-authorisation holder

Bayer AG

Revision33
Date of issue of marketing authorisation valid throughout the European Union19/04/2002

Contact address:

Bayer AG
51368 Leverkusen
Germany

Product information

Product information

12/04/2018  Kinzalkomb -EMEA/H/C/000415 -T/0105

Name Language First published Last updated
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb : EPAR - Product Information HR = Hrvatski 2009-11-26 2018-05-08

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
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  
Kinzalkomb : EPAR - All Authorised presentations HR = Hrvatski 2008-05-06  

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.

Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients 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
Kinzalkomb : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-11-26 2018-05-08
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
Kinzalkomb-H-C-415-A31-0084 : 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 2014-10-03  
CHMP post-authorisation summary of positive opinion for Kinzalkomb HR = Hrvatski 2013-04-26  
Kinzalkomb-H-C-415-X-0039 : EPAR - Scientific Discussion - Extension HR = Hrvatski 2008-06-04  
Kinzalkomb : EPAR - Steps taken after authorisation when a cutoff date has been used HR = Hrvatski 2005-10-21  

Initial marketing-authorisation documents

Name Language First published Last updated
Kinzalkomb-H-C-415-A31-0084 : EPAR - Assessment Report - Article 31 HR = Hrvatski 2014-10-03  
Kinzalkomb : EPAR - Scientific Discussion HR = Hrvatski 2008-06-04  
Kinzalkomb : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21  

Authorised

This medicine is approved for use in the European Union

More information on Kinzalkomb