Twynsta

telmisartan / amlodipine

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 Twynsta. 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 Twynsta.

: Twynsta is a medicine that contains two active substances, telmisartan and amlodipine. It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).

: Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over). ‘Essential’ means that the hypertension has no obvious cause.
Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone. Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
The medicine can only be obtained with a prescription.

: Twynsta is taken by mouth as one tablet once a day and is used for long-term treatment. The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Twynsta. When appropriate, direct switch to Twynsta may be considered.
For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Twynsta to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.

: Twynsta contains two active substances, telmisartan and amlodipine. Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
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.
Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.

: Because telmisartan and amlodipine have been used for many years, the company presented information from scientific literature as well as results from new studies that the company had carried out.
In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment). In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Twynsta or continued to take amlodipine at the same or a higher dose. The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.
Studies were also carried to show that Twynsta tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.

: In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.
In the two other studies, Twynsta was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the fall in diastolic blood pressure was greater in patients taking Twynsta by between 1.4 mmHg and 4.9 mmHg.

: The most common side effects with Twynsta (seen in up to 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet). For the full list of all side effects reported with Twynsta, see the package leaflet.
Twynsta must not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives’ class or to any of the other ingredients. It must not be used in women who are more than three months pregnant. Twynsta must not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack). Twynsta must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.

: The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Twynsta. In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone. The Committee decided that Twynsta’s benefits are greater than its risks and recommended that it be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the EU for Twynsta on 7 October 2010.
For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Twynsta : EPAR - Summary for the public (PDF/83.49 KB)

First published: 19/10/2010
Last updated: 08/10/2015
- Bulgarian
  (PDF/113.16 KB)
- Croatian
  (PDF/105.6 KB)
- Czech
  (PDF/109.7 KB)
- Danish
  (PDF/87.15 KB)
- Dutch
  (PDF/87.41 KB)
- Estonian
  (PDF/86.18 KB)
- Finnish
  (PDF/86.69 KB)
- French
  (PDF/88.82 KB)
- German
  (PDF/88.47 KB)
- Greek
  (PDF/113.46 KB)
- Hungarian
  (PDF/105.47 KB)
- Italian
  (PDF/87.01 KB)
- Latvian
  (PDF/106.88 KB)
- Lithuanian
  (PDF/105.31 KB)
- Maltese
  (PDF/110.08 KB)
- Polish
  (PDF/108.83 KB)
- Portuguese
  (PDF/87.98 KB)
- Romanian
  (PDF/104.94 KB)
- Slovak
  (PDF/107.78 KB)
- Slovenian
  (PDF/95.31 KB)
- Spanish
  (PDF/87.96 KB)
- Swedish
  (PDF/87.1 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 13/06/2018

Authorisation details

Product details
Name	Twynsta
Agency product number	EMEA/H/C/001224
Active substance	telmisartan amlodipine
International non-proprietary name (INN) or common name	telmisartan / amlodipine
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DB04

Publication details
Marketing-authorisation holder	Boehringer Ingelheim International GmbH
Revision	9
Date of issue of marketing authorisation valid throughout the European Union	07/10/2010
Contact address	Binger Strasse 173 D-55216 Ingelheim am Rhein Germany

Product information

22/05/2018 Twynsta - EMEA/H/C/001224 - IB/0035

List item

Twynsta : EPAR - Product Information (PDF/571.08 KB)

First published: 19/10/2010
Last updated: 13/06/2018
- Bulgarian
  (PDF/671.23 KB)
- Croatian
  (PDF/592.62 KB)
- Czech
  (PDF/623 KB)
- Danish
  (PDF/637.99 KB)
- Dutch
  (PDF/587.43 KB)
- Estonian
  (PDF/575.33 KB)
- Finnish
  (PDF/597.67 KB)
- French
  (PDF/612.43 KB)
- German
  (PDF/644.48 KB)
- Greek
  (PDF/632.19 KB)
- Hungarian
  (PDF/628.86 KB)
- Icelandic
  (PDF/590.05 KB)
- Italian
  (PDF/593.81 KB)
- Latvian
  (PDF/593.61 KB)
- Lithuanian
  (PDF/591.21 KB)
- Maltese
  (PDF/730.85 KB)
- Norwegian
  (PDF/591.04 KB)
- Polish
  (PDF/636.5 KB)
- Portuguese
  (PDF/599.26 KB)
- Romanian
  (PDF/729.3 KB)
- Slovak
  (PDF/578.27 KB)
- Slovenian
  (PDF/580.02 KB)
- Spanish
  (PDF/602.21 KB)
- Swedish
  (PDF/573.1 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.

List item

Twynsta : EPAR - All Authorised presentations (PDF/40.61 KB)

First published: 19/10/2010
Last updated: 19/10/2010
- Bulgarian
  (PDF/74.62 KB)
- Croatian
  (PDF/30.05 KB)
- Czech
  (PDF/54.29 KB)
- Danish
  (PDF/40.74 KB)
- Dutch
  (PDF/41.93 KB)
- Estonian
  (PDF/41.35 KB)
- Finnish
  (PDF/40.94 KB)
- French
  (PDF/42.51 KB)
- German
  (PDF/41.57 KB)
- Greek
  (PDF/73.51 KB)
- Hungarian
  (PDF/72.73 KB)
- Italian
  (PDF/40.81 KB)
- Latvian
  (PDF/71.22 KB)
- Lithuanian
  (PDF/74.47 KB)
- Maltese
  (PDF/70.13 KB)
- Polish
  (PDF/55.89 KB)
- Portuguese
  (PDF/41.16 KB)
- Romanian
  (PDF/70.39 KB)
- Slovak
  (PDF/53.59 KB)
- Slovenian
  (PDF/40.96 KB)
- Spanish
  (PDF/41.58 KB)
- Swedish
  (PDF/42.57 KB)

Pharmacotherapeutic group

Agents acting on the renin angiotensin system

Therapeutic indication

Treatment of essential hypertension in adults:

Add-on therapy

Twynsta is indicated in adults whose blood pressure is not adequately controlled on amlodipine.

Replacement therapy

Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.

Assessment history

Changes since initial authorisation of medicine

List item

Twynsta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/151.68 KB)

First published: 12/09/2011
Last updated: 13/06/2018
List item

Twynsta-H-C-1224-A31-0017 : 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 recommend... (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

Twynsta-H-C-1224-PSU-0007: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/114.38 KB)

First published: 30/07/2014
Last updated: 30/07/2014
EMA/CHMP/256061/2013
List item

CHMP post-authorisation summary of positive opinion for Twynsta (PDF/67.43 KB)

Adopted

First published: 26/04/2013
Last updated: 26/04/2013
EMA/CHMP/261191/2013

Twynsta

Table of contents

Overview

Twynsta : EPAR - Summary for the public (PDF/83.49 KB)

Authorisation details

Product information

Twynsta : EPAR - Product Information (PDF/571.08 KB)

Contents

Twynsta : EPAR - All Authorised presentations (PDF/40.61 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Twynsta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/151.68 KB)

Twynsta-H-C-1224-A31-0017 : 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 recommend... (PDF/48.81 KB)

Twynsta-H-C-1224-PSU-0007: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/114.38 KB)

CHMP post-authorisation summary of positive opinion for Twynsta (PDF/67.43 KB)

Initial marketing-authorisation documents

Twynsta-H-C-1224-A31-0017 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Twynsta : EPAR - Public assessment report (PDF/668.16 KB)

CHMP positive summary of opinion for Twynsta (PDF/52 KB)

News

More information on Twynsta

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

How useful was this page?