Actelsar HCT
telmisartan / hydrochlorothiazide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Actelsar HCT. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Actelsar HCT.
For practical information about using Actelsar HCT, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
| Product details | |
|---|---|
| Name |
Actelsar HCT
|
| Agency product number |
EMEA/H/C/002676
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Essential Hypertension
|
| Anatomical therapeutic chemical (ATC) code |
C09DA07
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Actavis Group hf
|
| Revision |
15
|
| Date of issue of marketing authorisation valid throughout the European Union |
13/03/2013
|
| Contact address |
Dalshraun 1 |
Product information
31/05/2023 Actelsar HCT - EMEA/H/C/002676 - IG1612
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
-
Agents acting on the renin-angiotensin system
-
Angiotensin II antagonists and diuretics
Therapeutic indication
Treatment of essential hypertension.
Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.