Onduarp - Telmisartan + Amlodipine

PLEASE NOTE: MEDICINAL PRODUCT IS 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, 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 (subjects aged 18 years or 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 may also be used in place of treatment with telmisartan and amlodipine in patients 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) as one tablet a day and is used for long-term treatment. The maximum dose is one tablet per day in its highest dosage (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 doses before switching to Onduarp. If appropriate, the direct transfer to Onduarp may 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 previously took.

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 act similarly in the reduction of blood pressure, or by producing a relaxation of blood vessels. Reducing blood pressure reduces the risks associated with high blood pressure, such as having a stroke.

Telmisartan is an "angiotensin II receptor antagonist", which means 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, allowing the blood vessels to dilate.

Amlodipine is a calcium channel blocker, which means that it blocks particular channels on the cell surface, called calcium channels, which normally allow calcium ions to enter cells. When calcium ions penetrate the cells of the musculature of the vascular walls, they cause a contraction. By reducing the flow of calcium in the cells, amlodipine inhibits the contraction of the cells, thus favoring the relaxation of the vessels.

What studies have been performed on Onduarp - Telmisartan + Amlodipine?

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 as monotherapy, or with placebo (a dummy treatment). In two other main studies, 1 978 adults in whom hypertension did not respond adequately to amlodipine took Onduarp or continued to take amlodipine at the same dose or at a 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.

Furthermore, 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 higher than those seen in patients taking only one of the active ingredients or placebo.

In the other two studies, Onduarp was more effective in reducing diastolic blood pressure than continuous treatment with amlodipine monotherapy: 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 of Onduarp (seen in between 1 and 10 patients in 100) are dizziness and peripheral edema (swelling, especially of ankles and feet). For the full list of all side effects reported with Onduarp, see the package leaflet.

Onduarp should 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 have been pregnant for more than three months. In addition, Onduarp should not be used in patients with severe liver or bile problems, shock (severe reduction in blood pressure), severe hypotension (low blood pressure), obstruction of the left ventricular outflow tract 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 as separate tablets may be more likely to follow the treatment if Onduarp is prescribed. Furthermore, studies have shown that the medicine is effective in patients whose blood pressure is not adequately controlled with amlodipine alone. The Committee decided that Onduarp's benefits are greater than its risks and recommended that it be given marketing authorization.