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EMA Approval

Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)

C09CA07

telmisartan

Agents acting on the renin-angiotensin system

telmisartan

Hypertension

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeC09CA07
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

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.

Authorisations (1)

EMEA/H/C/000211

Bayer AG,Kaiser-Wilhelm-Allee 1,51373 Leverkusen,Germany

Authorised

December 16, 1998

Active Substances (1)

Telmisartan

Documents (16)

CHMP post-authorisation summary of positive opinion for Kinzalmono

April 26, 2013

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono : EPAR - Scientific Discussion

July 9, 2006

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Kinzalmono : EPAR - Summary for the public

May 27, 2009

OVERVIEW_DOCUMENT

Kinzalmono : EPAR - Procedural steps taken and scientific information after authorisation

April 23, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono : EPAR - Scientific Discussion

July 9, 2006

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono : EPAR - Steps taken after authorisation when a cutoff date has been used

July 9, 2006

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono : EPAR - Procedural steps taken before authorisation

July 9, 2006

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP post-authorisation summary of positive opinion for Kinzalmono on 22 October 2009

October 21, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono-H-C-211-WS-0254 : EPAR - Assessment Report - Variation

February 27, 2013

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono-H-C-211-II-0072 : EPAR - Assessment Report - Variation

February 7, 2010

CHANGES_SINCE_INITIAL_AUTHORISATION

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 scie...

October 2, 2014

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono : EPAR - All Authorised presentations

January 22, 2007

AUTHORISED_PRESENTATIONS

Kinzalmono : EPAR - Procedural steps taken and scientific information after authorisation (archive)

June 24, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono : EPAR - Product Information

June 15, 2009

DRUG_PRODUCT_INFORMATION

Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)-H-C-211-A31-0094 : EPAR - Assessment Report - Article 31

October 2, 2014

CHANGES_SINCE_INITIAL_AUTHORISATION

Kinzalmono : EPAR - Procedural steps taken before authorisation

July 9, 2006

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Overview Q&A (10)

Question

What is Kinzalmono?

Answer

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

Question

What is Kinzalmono used for?

Answer

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.

Question

How is Kinzalmono used?

Answer

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.

Question

How does Kinzalmono work?

Answer

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.

Question

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

Answer

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.

Question

Other information about Kinzalmono

Answer

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.

Question

Why has Kinzalmono been approved?

Answer

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

Question

How has Kinzalmono been studied?

Answer

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).

Question

What benefit has Kinzalmono shown during the studies?

Answer

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

Question

What is the risk associated with Kinzalmono?

Answer

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.

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Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) - EMA Approval | MedPath