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Imprida (amlodipine (as besylate) / valsartan) - C09DB01

Updated on site: 07-Oct-2017

Medication nameImprida
ATC CodeC09DB01
Substanceamlodipine (as besylate) / valsartan
ManufacturerNovartis Europharm Ltd

What is Imprida?

EMA/288275/2015
EMEA/H/C/000775

Imprida

amlodipine / valsartan

Committee for Medicinal Products for Human Use (CHMP) assess d the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Imprida.

no Imprida is a medicine thatproductcontains two ac ive substances, amlodipine and valsartan. It is available as

tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).

What is Imprida used f ?

Imprida is used in patients who have essential hypertension (high blood pressure) that is not

The medicine an o ly be obtained with a prescription

adequatelyMedicinalcontrolled on either amlodipine or valsartan taken alone. ‘Essential’ means that the hypertension has no obvious cause.

How is Imprida used?

Imprida is taken by mouth as one tablet once a day with some water. The dose of Imprida to be used depends on the doses of amlodipine or valsartan that the patient was taking before. The patient may need to take separate tablets or capsules before switching to the combination tablet.

How does Imprida work?

Imprida contains two active substances, amlodipine and valsartan. Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s. They

work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with by high blood pressure, such as having a stroke, are reduced.

Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.

Valsartan is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone

in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that

Five main studies involving nearly 5,200 patients, mostly with mild to moderauthorisedte hypertension, were carried out. Two studies (involving almost 3,200 patients) compar d amlodipine, valsartan or a

narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.

How has Imprida been studied?

Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.

combination of both substances with placebo (a dummy treatment). Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan. The fifth, smaller study compared the combination with

What benefit has Imprida shown during the studies?

The combination of amlodi ine and valsartan was more effective at reducing blood pressure than

placebo or either valsartan or amlodipine taken alone. In the studies comparing the combination in patientsMedicinalwho were lre dy taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had f llen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the

patients adding 5 or 10 mg amlodipine, respectively. Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.

What is the risk associated with Imprida?

The most common side effects with Imprida (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes. For the full list of all side effects reported with Imprida, see the package leaflet.

Imprida must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients. It

must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Imprida must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure). Imprida must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment. For the full list of restrictions, see the package leaflet.

Why has Imprida been approved?

The CHMP decided that Imprida’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Imprida

The European Commission granted a marketing authorisation valid throughout t e EU f r Imprida on 17 January 2007.

The full EPAR for Imprida can be found on the Agency’s website: ema.europa.e /Find medicine/Human

medicines/European public assessment reports. For more information bout treatment with Imprida, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

authorised

This summary was last updated in 05-2015.

 

 

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