What is Twinsta?
Twynsta is a medicine that contains two active substances, telmisartan and amlodipine. It is available as two-layer, oval-shaped blue and white 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 and 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 with amlodipine alone. Twynsta can also be used instead of telmisartan and amlodipine treatment 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 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 Twynsta. If appropriate, a direct switch to Twynsta can 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 was previously taking.
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 work in a similar way in lowering blood pressure, i.e. by causing the blood vessels to relax. As blood pressure falls, 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 Twinsta been studied?
As telmisartan and amlodipine have been in use for several years, the company presented information from the scientific literature and results from new studies carried out by the company.
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 Twynsta 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 Twynsta tablets are absorbed into the body in the same way as amlodipine and telmisartan tablets taken alone.
What benefit 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 greater than those seen in patients taking only one of the active substances or placebo.
In the other two studies, Twynsta was more effective in lowering diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the reduction in diastolic blood pressure was greater in patients taking Twynsta between 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 in 10 patients) are dizziness and peripheral edema (swelling, particularly of the ankles and feet). For the full list of 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 other ingredients. It must not be used in women who are more than three months pregnant. Twynsta must also 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 Twinsta been approved?
The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to follow treatment if Twynsta is prescribed. Studies have also shown that the medicine is effective in patients in whom Twynsta is prescribed. blood pressure is not adequately controlled with amlodipine monotherapy The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorization.
Learn more about Twinsta
On 7 October 2010, the European Commission granted Boehringer Ingelheim International GmbH a "Marketing Authorization" for Twynsta, valid throughout the European Union. The "Marketing Authorization" is valid for five years, thereafter. For more information about Twynsta therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08-2010.
The information on Twinsta 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.
