Twinsta

What is Twinsta?

Twynsta is a medicine that contains two active substances, telmisartan and amlodipine. It is available as blue and white oval shaped two-layer 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).

What is Twinsta used for?

Twynsta is indicated in adults (aged 18 years or over) for the treatment of essential hypertension (high blood pressure). The term "essential" means that hypertension has no obvious cause.

Twynsta is used in patients whose blood pressure is not adequately controlled on amlodipine alone. Twynsta can also be used instead of being treated with telmisartan and amlodipine in patients taking both medicines as separate tablets.

The medicine can only be obtained with a prescription.

How is Twinsta used?

Twynsta is administered orally at the rate of 1 tablet per day and is used for long-term treatment. The maximum dose is 1 tablet per day in its highest dose (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 Twynsta. If appropriate, direct transfer to Twynsta may be considered.

In patients taking telmisartan and amlodipine as separate tablets, the dose of Twynsta depends on the doses of telmisartan and amlodipine that the patient previously took.

How does Twinsta work?

Twynsta contains two active substances, 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, that is producing a relaxation of the blood vessels. With reduced blood pressure, the risks associated with high blood pressure, such as having a stroke, decrease.

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 carried out on Twinsta?

Since telmisartan and amlodipine have been in use for several years, the company presented information from the scientific literature and results from new studies conducted by the company.

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 Twynsta 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 Twynsta tablets are absorbed into the body in the same way as amlodipine and telmisartan tablets taken alone.

What benefits has Twinsta 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, Twynsta was more effective in reducing diastolic blood pressure than continuous treatment with amlodipine monotherapy: depending on the dosages of Twynsta and amlodipine, the reduction in diastolic blood pressure was greater in patients taking Twynsta in 1, 4 mmHg and 4.9 mmHg.

What are the risks associated with Twinsta?

The most common side effects associated with Twynsta (seen in more than 1 patient in 10) are dizziness and peripheral edema (swelling, especially of ankles and feet). For the full list of all side effects reported with Twynsta, see the Package Leaflet.

Twynsta 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. Furthermore, Twynsta 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 Twinsta 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 the use of Twynsta is prescribed. Studies have also shown that the medicine is effective in patients whose blood pressure is not adequately controlled with amlodipine alone. The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorization.

More information on Twinsta

On 7 October 2010, the European Commission issued a marketing authorization for Twynsta to Boehringer Ingelheim International GmbH, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed. For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 08-2010.

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