Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)

telmisartan

  • Email
  • Help

About

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

What is Kinzalmono?

Kinzalmono is a medicine that contains the active substance telmisartan. It is available as tablets (20, 40 and 80 mg).

What is Kinzalmono used for?

Kinzalmono is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is Kinzalmono used?

For the treatment of essential hypertension, the usual recommended dose of Kinzalmono is 40 mg once a day, but some patients may benefit from using 20 mg once a day. If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.

For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. The doctor should monitor the patient’s blood pressure closely when starting Kinzalmono, and may decide to adjust the patient’s blood-pressure-lowering medication. Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day. Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.

How does Kinzalmono work?

The active substance in Kinzalmono, 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. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.

How has Kinzalmono been studied?

Kinzalmono has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide. Kinzalmono was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

What benefit has Kinzalmono shown during the studies?

Kinzalmono was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.

What is the risk associated with Kinzalmono?

Side effects with Kinzalmono are not common. However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown). Hypotension may be more common in patients receiving Kinzalmono to prevent cardiovascular problems. For the full list of all side effects reported with Kinzalmono, see the package leaflet.

Kinzalmono 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. Kinzalmono must not be used in people who have severe liver problems or bile problems. In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Kinzalmono 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.

Why has Kinzalmono been approved?

The CHMP decided that Kinzalmono’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

A risk management plan has been developed to ensure that Kinzalmono 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 Kinzalmono, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Kinzalmono

The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalmono on 16 December 1998.

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

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

This EPAR was last updated on 27/04/2018 .

Authorisation details

Product details

Product details for Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
NameKinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
Agency product numberEMEA/H/C/000211
Active substance

telmisartan

International non-proprietary name (INN) or common name

telmisartan

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09CA07

Publication details

Publication details for Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
Marketing-authorisation holder

Bayer AG

Revision29
Date of issue of marketing authorisation valid throughout the European Union16/12/1998

Contact address:

Bayer AG
51368 Leverkusen
Germany

Product information

Product information

04/04/2018  Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) -EMEA/H/C/000211 -T/0111

Name Language First published Last updated
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27
Kinzalmono : EPAR - Product Information HR = Hrvatski 2009-06-16 2018-04-27

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
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  
Kinzalmono : EPAR - All Authorised presentations HR = Hrvatski 2007-01-23  

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Hypertension

Treatment of essential hypertension in adults.

Cardiovascular prevention

Reduction of cardiovascular morbidity in patients with:

  • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;
  • type-2 diabetes mellitus with documented target-organ damage.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Kinzalmono : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-06-25 2018-04-27
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : EPAR - Assessment Report - Article 31 HR = Hrvatski 2014-10-03  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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  
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : 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 Kinzalmono HR = Hrvatski 2013-04-26  
Kinzalmono-H-C-211-WS-0254 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-02-28  
Kinzalmono-H-C-211-II-0072 : EPAR - Assessment Report - Variation HR = Hrvatski 2010-02-08  
CHMP post-authorisation summary of positive opinion for Kinzalmono on 22 October 2009 HR = Hrvatski 2009-10-22  
Kinzalmono : EPAR - Steps taken after authorisation when a cutoff date has been used HR = Hrvatski 2006-07-10  

Initial marketing-authorisation documents

Name Language First published Last updated
Kinzalmono : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-07-10  
Kinzalmono : EPAR - Scientific Discussion HR = Hrvatski 2006-07-10