PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Onduarp - Telmisartan + Amlodipine?
Onduarp 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).
This medicine is the same as Twynsta, which is already authorized in the European Union (EU). The company that makes Twynsta has agreed that its scientific data can also be used for Onduarp ("informed consent").
What is Onduarp - Telmisartan + Amlodipine used for?
Onduarp is indicated in adults (people aged 18 years and over) for the treatment of essential hypertension (high blood pressure). The term "essential" means that hypertension has no obvious cause.
Onduarp is used in patients whose blood pressure is not adequately controlled with amlodipine alone (alone). Onduarp can also be used instead of telmisartan and amlodipine treatment in patients who are taking both medicines as separate tablets.
The medicine can only be obtained with a prescription.
How is Onduarp - Telmisartan + Amlodipine used?
Onduarp is administered orally (by mouth) at the rate of one tablet per day and is used for long-term treatment. The maximum dose is one tablet per day in its highest strength (80/10 mg).
In patients with blood pressure not adequately controlled with amlodipine, it is recommended to use separate amlodipine and telmisartan tablets to adjust the doses before switching to Onduarp. If appropriate, a direct switch to Onduarp can be considered.
In patients taking telmisartan and amlodipine as separate tablets, the dose of Onduarp depends on the doses of telmisartan and amlodipine that the patient was previously taking.
How does Onduarp - Telmisartan + Amlodipine work?
Onduarp contains two active ingredients, telmisartan and amlodipine. Both are medicines to lower blood pressure and have been available in the European Union (EU) since the 1990s. They work in a similar way in lowering blood pressure, i.e. by causing the blood vessels to relax. By lowering blood pressure, the risks associated with high blood pressure, such as having a stroke, decrease.
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 to which angiotensin II normally attaches, telmisartan prevents the hormone from working, allowing blood vessels to widen.
Amlodipine is a calcium channel blocker, meaning it blocks particular channels on the cell surface, called calcium channels, which normally allow calcium ions to enter cells. When calcium ions penetrate the muscle cells of the vascular walls, they cause a contraction. By reducing the flow of calcium into the cells, amlodipine inhibits cell contraction, thus promoting relaxation of the vessels.
How has Onduarp - Telmisartan + Amlodipine been studied?
The company presented information from the scientific literature and results from studies carried out with the medicine.
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 took Onduarp or continued to take amlodipine at the same or higher dose. In the three studies, the main measure of effectiveness was the reduction in diastolic blood pressure (blood pressure measured in the interval between two heartbeats) after eight weeks.
In addition, studies have been carried out to show that Onduarp tablets are absorbed into the body in the same way as the separate amlodipine and telmisartan tablets.
What benefit has Onduarp - Telmisartan + Amlodipine shown during the studies?
In the first study, the reductions in diastolic blood pressure observed 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 other two studies, Onduarp was more effective in lowering diastolic blood pressure than continuous treatment with amlodipine alone: depending on the dosages of Onduarp and amlodipine, the reduction in diastolic blood pressure was greater in patients taking Onduarp between 1, 4 mmHg and 4.9 mmHg.
What is the risk associated with Onduarp - Telmisartan + Amlodipine?
The most common side effects with Onduarp (seen in 1 to 10 patients in 100) are dizziness and peripheral edema (swelling, particularly of the ankles and feet). For the full list of side effects reported with Onduarp, see the package leaflet.
Onduarp must not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine or other medicines of 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. Furthermore, Onduarp must not be used in patients with severe liver or bile problems, shock (sharp drop in blood pressure), severe hypotension (low blood pressure), left ventricular outflow tract obstruction or in patients with heart failure after myocardial infarction ( heart attack).
Why has Onduarp - Telmisartan + Amlodipine been approved?
The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to follow treatment if Onduarp is prescribed. Furthermore, studies have shown that the medicine is effective in patients whose blood pressure is blood is not adequately controlled with amlodipine monotherapy The Committee decided that Onduarp's benefits are greater than its risks and recommended that it be given a Marketing Authorization.
Other information about Onduarp - Telmisartan + Amlodipine
On 24 November 2011, the European Commission issued a "marketing authorization" for Onduarp, valid throughout the European Union.
For more information about Onduarp therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
The information on Onduarp - Telmisartan + Amlodipina 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.
