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) which 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, please 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 daily. The dose of Actelsar HCT to use depends on the dose of telmisartan that the patient was previously taking: patients taking 40 mg telmisartan should take the 40 / 12.5 mg tablets and patients taking 80 mg telmisartan should take the tablets from 80 / 12.5 mg. The 80/25 mg tablets should be administered to patients whose blood pressure is not controlled using the 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' which means that it inhibits the action of a hormone in the body called angiotensin II. Angiotensin II is a potent vasoconstrictor (a substance that constricts blood vessels). By blocking the receptors that angiotensin II normally attaches to, telmisartan prevents the hormone from working and allows blood vessels to widen.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering blood pressure.
The combination of the two active substances has an additional effect and reduces blood pressure to a greater extent than the two medicines taken alone. By lowering blood pressure, the risks associated with hypertension, including stroke, decrease.
How has Actelsar HCT been studied?
As 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 the active substance in the body.
What are the benefits and risks of Actelsar HCT?
Because Actelsar HCT is a generic medicine that is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
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 that Actelsar HCT be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Actelsar HCT?
Safety information has been added to the summary of product characteristics and package leaflet for Actelsar HCT, including the appropriate precautions to be followed by healthcare professionals and patients.
More information about Actelsar HCT
On 13 March 2013, the European Commission issued a "Marketing Authorization" for Actelsar HCT, valid throughout the European Union.
For the complete version of the Actelsar HCT EPAR, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Actelsar HCT therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website. Last update of this summary: 03-2013.
The information on Actelsar HCT published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
