Kinzalkomb

telmisartan / 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 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.

: 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).

: 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.

: 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.

: 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.

: 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).

: 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.

: 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.

: 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.

: 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.

: 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.

List item

Kinzalkomb : EPAR - Summary for the public (PDF/76.09 KB)

First published: 28/05/2009
Last updated: 06/11/2015
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More detail is available in the summary of product characteristics

This EPAR was last updated on 08/05/2018

Authorisation details

Product details
Name	Kinzalkomb
Agency product number	EMEA/H/C/000415
Active substance	telmisartan hydrochlorothiazide
International non-proprietary name (INN) or common name	telmisartan / hydrochlorothiazide
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DA07

Publication details
Marketing-authorisation holder	Bayer AG
Revision	33
Date of issue of marketing authorisation valid throughout the European Union	19/04/2002
Contact address	51368 Leverkusen Germany

Product information

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

List item

Kinzalkomb : EPAR - Product Information (PDF/377.65 KB)

First published: 26/11/2009
Last updated: 08/05/2018
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  (PDF/410.15 KB)
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- Icelandic
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- Latvian
  (PDF/364.24 KB)
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- Maltese
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- Norwegian
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- Slovenian
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- Spanish
  (PDF/389.81 KB)
- Swedish
  (PDF/358.73 KB)

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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Kinzalkomb : EPAR - All Authorised presentations (PDF/25.76 KB)

First published: 06/05/2008
Last updated: 06/05/2008
- Bulgarian
  (PDF/113.91 KB)
- Croatian
  (PDF/28.12 KB)
- Czech
  (PDF/61.75 KB)
- Danish
  (PDF/26.35 KB)
- Dutch
  (PDF/23.58 KB)
- Estonian
  (PDF/26.35 KB)
- Finnish
  (PDF/26.82 KB)
- French
  (PDF/27.1 KB)
- German
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- Greek
  (PDF/112.64 KB)
- Hungarian
  (PDF/111.69 KB)
- Icelandic
  (PDF/28.14 KB)
- Italian
  (PDF/26.58 KB)
- Latvian
  (PDF/110.92 KB)
- Lithuanian
  (PDF/112.53 KB)
- Maltese
  (PDF/109.33 KB)
- Maltese
  (PDF/27.85 KB)
- Norwegian
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- Polish
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- Portuguese
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- Romanian
  (PDF/105.34 KB)
- Slovak
  (PDF/64 KB)
- Slovenian
  (PDF/26.03 KB)
- Spanish
  (PDF/23.54 KB)
- Swedish
  (PDF/22.08 KB)

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

List item

Kinzalkomb : EPAR - Procedural steps taken and scientific information after authorisation (PDF/240.86 KB)

First published: 26/11/2009
Last updated: 08/05/2018
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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 recomme... (PDF/48.81 KB)

First published: 03/10/2014
Last updated: 03/10/2014
- 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

CHMP post-authorisation summary of positive opinion for Kinzalkomb (PDF/66.65 KB)

Adopted

First published: 26/04/2013
Last updated: 26/04/2013
EMA/CHMP/261191/2013
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Kinzalkomb-H-C-415-X-0039 : EPAR - Scientific Discussion - Extension (PDF/383.69 KB)

Adopted

First published: 04/06/2008
Last updated: 04/06/2008
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Kinzalkomb : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/84.13 KB)

First published: 21/10/2005
Last updated: 21/10/2005

Kinzalkomb

Table of contents

Overview

Kinzalkomb : EPAR - Summary for the public (PDF/76.09 KB)

Authorisation details

Product information

Kinzalkomb : EPAR - Product Information (PDF/377.65 KB)

Contents

Kinzalkomb : EPAR - All Authorised presentations (PDF/25.76 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Kinzalkomb : EPAR - Procedural steps taken and scientific information after authorisation (PDF/240.86 KB)

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 recomme... (PDF/48.81 KB)

CHMP post-authorisation summary of positive opinion for Kinzalkomb (PDF/66.65 KB)

Kinzalkomb-H-C-415-X-0039 : EPAR - Scientific Discussion - Extension (PDF/383.69 KB)

Kinzalkomb : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/84.13 KB)

Initial marketing-authorisation documents

Kinzalkomb-H-C-415-A31-0084 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Kinzalkomb : EPAR - Scientific Discussion (PDF/264.71 KB)

Kinzalkomb : EPAR - Procedural steps taken before authorisation (PDF/85.51 KB)

News

More information on Kinzalkomb

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

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