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 white tablets (round: 20 mg; oblong: 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?
Kinzalmono is taken by mouth, with or without food. The usual recommended dose is 40 mg once a day, but some patients may benefit from using a 20-mg dose. 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.
- 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: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia (difficulty sleeping), vertigo (a spinning sensation), hypotension (low blood pressure), dyspnoea (difficulty breathing), abdominal (tummy) pain, diarrhoea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), pruritus (itching), myalgia (muscle pain), renal impairment (kidney problems) including renal failure (kidney failure), and chest pain. For the full list of all side effects reported with Kinzalmono, see the package leaflet.
Kinzalmono should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients. It 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.
- 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.
- 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.
This EPAR was last updated on 19/12/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
25/08/2011 Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) -EMEA/H/C/000211 -IG/0094/G
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.
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:
i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
ii) 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 | (English only) | 25/06/2009 | 19/12/2011 |
| Kinzalmono-H-C-211-II-72 : EPAR - Assessment Report - Variation | (English only) | 08/02/2010 | |
| Kinzalmono : EPAR - Steps taken after authorisation when a cutoff date has been used | (English only) | 10/07/2006 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Kinzalmono : EPAR - Scientific Discussion | (English only) | 10/07/2006 | |
| Kinzalmono : EPAR - Procedural steps taken before authorisation | (English only) | 10/07/2006 |
Authorised
This medicine is approved for use in the European Union
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) RSS feedPatient safety
More information on Kinzalmono
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011 (21/10/2011)
- European Medicines Agency concludes that benefit-risk balance of angiotensin II receptor antagonists remains positive (20/10/2011)
- European Medicines Agency recommendation on use of angiotensin II receptor antagonists during pregnancy (24/04/2008)