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Tekturna (aliskiren) - C09XA02

Updated on site: 10-Oct-2017

Medication nameTekturna
ATC CodeC09XA02
Substancealiskiren
ManufacturerNovartis Europharm Ltd.
European Medicines Agency
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

TEKTURNA

EPAR summary for the public

Tekturna is a medicine that contains the active substance aliskiren. It is available as tablets (pink and round: 150 mg; red and oval: 300 mg).

Tekturna is used to treat essential hypertension (high bl od pressure). ‘Essential’ means that the

hypertension has no obvious cause.

How is Tekturna used?

The medicine can only beproductobtained with a prescription.

The recommended dose of Tekturna is 150 mg once a day, either taken alone or in combination with other medicines for hypertensi n. It should be taken with a light meal preferably at the same time each day, but grapefruit juice should n t be taken together with Tekturna. The dose of Tekturna may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.

Tekturna is not recommended for use in patients below 18 years of age, because of a lack of Medicinalinformation on s fety nd effectiveness in this age group.

How does Tektur a work?

The act ve substance in Tekturna, aliskiren, is a renin inhibitor. It blocks the activity of a human enzyme alled renin, which is involved in the production of a substance called angiotensin I in the body. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the production of angiotensin I, levels of both angiot nsin I and angiotensin II fall. This causes vasodilation (widening of the blood vessels), so that the blood pressure drops. This may reduce the risks associated with high blood pressure, such as having a stroke.

How has Tekturna been studied?

The effects of Tekturna were first tested in experimental models before being studied in humans. Tekturna was studied in 14 main studies involving over 10,000 patients with essential hypertension. Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension. In five of the studies, the effects of Tekturna taken alone were

compared with those of placebo (a dummy treatment). Tekturna, taken alone or in combination with other medicines, was also compared with other medicines for hypertension. Combination studies looked at Tekturna used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide). The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic). The blood pressure was measured in ‘millimetres of mercury’ (mmHg).

What benefit has Tekturna shown during the studies?

pressure of 9.0 mmHg after eight weeks of taking 150 mg Tekturna, from an average of 99.4 mmHg at the start of the study. This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the pat ents taking placebo.

Tekturna on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure. When the results of the five studies comparing Tekturnaauthorisedtaken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood

Larger falls were seen in patients aged 65 years or over and those taking higher doses f Tekturna.

Tekturna also reduced blood pressure in patients with diabetes and patients who were overweight. The

medicine’s effects were maintained for up to a year in two of the studies.

The studies also showed that Tekturna, when taken in combination with other medicines (especially

What is the risk associated with Tekturna?

hydrochlorothiazide), can produce additional decreases in blood pressure comp red with the decreases produced by these medicines when they are taken withoutlongerTekturna.

The most common side effect with Tekturna (seen in between 1 a d 10 patients in 100) is diarrhoea. For the full list of all side effects reported with Tekturna, see the Package Leaflet.

Tekturna should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the

other ingredients. It must not be in patients who have had angioedema (swelling under the skin) with aliskiren or in women who are more than three nom nths pregnant. Its use during the first three months

of pregnancy and in women planning to become pregnant is not recommended. Tekturna must also not be taken with ciclosporinproduct(a medicine that reduces the activity of the immune system), quinidine (used to correct irregular heartbeat) or verapamil (used to treat heart problems).

Why has Tekturna been approve ?

The Committee for Medicinal Pr ucts for Human Use (CHMP) decided that the benefits of Tekturna are greater than its risks for the t eatment of essential hypertension. The Committee recommended that Tekturna be given marketing authorisation.

MedicinalOther information about Tekturna:

The European Commission granted a marketing authorisation valid throughout the European Union for Tekturna to Novartis Europharm Limited on 22 August 2007.

The full EPAR for Tekturna can be found here.

This summary was last updated in 04-2009.

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