Rasilez 300 mg film-coated tablets Aliskiren - United Kingdom[英国药品]

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Rasilez 300 mg film-coated tablets Aliskiren

2014-02-25 19:43:25 来源: 作者: 【大中小】浏览:317次评论:0条

For doctors

What is it and how is it used?

Rasilez belongs to a new class of medicines called renin inhibitors. Rasilez helps to lower high blood pressure. Renin inhibitors reduce the amount of angiotensin II the body can produce. Angiotensin II causes blood vessels to tighten, which increases the blood pressure. Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.

High blood pressure increases the workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk of developing these disorders.

What do you have to consider before using it?

Do not take Rasilez

Take special care with Rasilez

If any of these apply to you, tell your doctor before you take Rasilez.

The use of Rasilez in children and adolescents is not recommended.
There are no special dose recommendations for patients aged 65 years or older.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Your doctor may need to change your dose and/or to take other precautions if you are taking one of the following medicines:

Taking Rasilez with food and drink
You should take Rasilez with a light meal once a day, preferably at the same time each day. You should not take Rasilez together with grapefruit juice.

Pregnancy and breast-feeding
Do not take Rasilez if you are pregnant. It is important to talk to your doctor immediately if you think you may be pregnant or are planning to become pregnant. Do not breast-feed if you are taking Rasilez.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
You may feel dizzy and this can affect your ability to concentrate. Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Rasilez.

How is it used?

Always take Rasilez exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

People who have high blood pressure often do not notice any signs of the problem. Many may feel quite normal. It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep your appointments with the doctor even if you are feeling well.

The usual starting dose is one 150 mg tablet once daily.

Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily. Your doctor may prescribe Rasilez together with other medicines used to treat high blood pressure.

Method of administration
It is recommended that you take the tablets with some water. You should take Rasilez with a light meal once a day, preferably at the same time each day. You should not take Rasilez together with grapefruit juice.

If you take more Rasilez than you should
If you have accidentally taken too many Rasilez tablets, consult a doctor immediately. You may require medical attention.

If you forget to take Rasilez
If you forget to take a dose of Rasilez, take it as soon as you remember and then take the next dose at its usual time. However, if it is almost time for your next dose you should simply take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

What are possible side effects?

Like all medicines, Rasilez can cause side effects, although not everybody gets them.

Common (affecting less than 1 in 10 patients): Diarrhoea.
Uncommon (affecting less than 1 in 100 patients): Skin rash, kidney problems, swelling of hands, ankles or feet (peripheral oedema).
Rare (affecting less than 1 in 1,000 patients): Angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue), increased level of creatinine in the blood.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.
Do not use Rasilez after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.

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For doctors

What is it?

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

What is it used for?

Rasilez is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is it used?

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

How does it work?

The active substance in Rasilez, aliskiren, is a renin inhibitor. It blocks the activity of a human enzyme called 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 angiotensin 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 it been studied?

Rasilez 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 Rasilez taken alone were compared with those of placebo (a dummy treatment). Rasilez, taken alone or in combination with other medicines, was also compared with other medicines for hypertension. Combination studies looked at Rasilez 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 benefits has it shown during the studies?

Rasilez 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 Rasilez taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Rasilez, 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 patients taking placebo.

Larger falls were seen in patients aged 65 years or over and those taking higher doses of Rasilez. Rasilez 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 Rasilez, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with the decreases produced by these medicines when they are taken without Rasilez.

What is the risk associated?

The most common side effect with Rasilez (seen in between 1 and 10 patients in 100) is diarrhoea. For the full list of all side effects reported with Rasilez, see the package leaflet.

Rasilez should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients. It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren or in women who are more than three months pregnant. Its use during the first three months of pregnancy and in women planning to become pregnant is not recommended. Rasilez must also not be taken with ciclosporin (a medicine that reduces the activity of the immune system), itraconazole (used to treat fungal infections) or quinidine (used to correct irregular heartbeat).

Why has it been approved?

The CHMP decided that the benefits of Rasilez are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Rasilez to Novartis Europharm Limited on 22 August 2007. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Rasilez, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011.

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