What is Actelsar HCT and what is it used for?
Actelsar HCT is a medicine that contains the two active substances telmisartan and hydrochlorothiazide. It is used in adults with essential hypertension (high blood pressure) that is not adequately controlled with telmisartan alone. The term "essential" indicates that hypertension has no obvious cause.
Actelsar HCT is a "generic medicine". This means that Actelsar HCT is similar to a "reference medicine" already authorized in the European Union (EU) called MicardisPlus. For more information on generic medicines, see the questions and answers by clicking here.
How is Actelsar HCT used?
Actelsar HCT is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken orally with liquid once a day. The dose of Actelsar HCT to be used depends on the dose of telmisartan the patient previously took: patients taking 40 mg telmisartan should take 40 / 12.5 mg tablets and patients taking 80 mg telmisartan should take the tablets from 80 / 12.5 mg. 80/25 mg tablets should be administered to patients whose blood pressure is not controlled using 80 / 12.5 mg tablets or to patients who have been stabilized using the two active substances separately before switching to Actelsar HCT.
The medicine can only be obtained with a prescription.
How does Actelsar HCT work?
Actelsar HCT contains two active substances, telmisartan and hydrochlorothiazide.
Telmisartan is an "angiotensin II receptor antagonist", ie it inhibits 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 prevents the hormone effect and allows the blood vessels to dilate.
Hydrochlorothiazide is a diuretic, which is another type of treatment against hypertension. It works by increasing urine excretion, reducing the amount of fluid in the blood and lowering blood pressure.
The combination of the two active ingredients has an additional effect and reduces blood pressure to a greater extent than the two medicines taken individually. Reducing blood pressure reduces the risks associated with hypertension, including stroke.
How has Actelsar HCT been studied?
Because Actelsar HCT is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, MicardisPlus. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Actelsar HCT?
Because Actelsar HCT is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Actelsar HCT been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus. Therefore, the CHMP considered that, as in the case of MicardisPlus, the benefits outweigh the identified risks and recommended to approve the use of Actelsar HCT in the EU.
What measures are being taken to ensure the safe and effective use of Actelsar HCT?
Safety information has been included in the summary of product characteristics and the package leaflet for Actelsar HCT, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Actelsar HCT
On 13 March 2013, the European Commission issued a marketing authorization for Actelsar HCT, valid throughout the European Union.
For the full EPAR version of Actelsar HCT consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Actelsar HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 03-2013.
