Volibris 5 mg film-coated tabletsPatient’s LeafletSummary fo - United Kingdom[英国药品]

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Volibris 5 mg film-coated tabletsPatient’s LeafletSummary fo

2015-02-12 22:06:40 来源: 作者: 【大中小】浏览:411次评论:0条

For doctors

What is it and how is it used?

Volibris is used to treat pulmonary arterial hypertension (PAH). PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy and short of breath.

Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms.

What do you have to consider before using it?

Don't take Volibris:

If any of these apply to you:

→ Tell your doctor and don’t take Volibris.

Take special care with Volibris:

→ Tell your doctor, who will decide whether Volibris is suitable for you.

You will need regular blood tests
Before you start taking Volibris, and at regular intervals while you’re taking it, your doctor will take blood tests to check:

→ It is important that you have these regular blood tests for as long as you are taking Volibris.

Signs that your liver may not be working properly include:

If you notice any of these signs:

→ Tell your doctor immediately.

Taking other medicines
Tell your doctor or pharmacist if you’re taking any other medicines, if you’ve taken any recently, or if you start taking new ones – these include herbal medicines or other medicines you bought without a prescription.

Your doctor may need to adjust your dose of Volibris if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis).

→ Tell your doctor or pharmacist if you are taking this.

Pregnancy
Volibris may harm unborn babies conceived before, during or soon after treatment.

→ If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you’re taking Volibris. Talk to your doctor about this.

→ Don’t take Volibris if you are pregnant or planning to become pregnant.

→ If you become pregnant or think that you may be pregnant while you’re taking Volibris, see your doctor immediately.

If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Volibris and regularly while you are taking Volibris.

If you are a man taking Volibris, it is possible that Volibris may lower your sperm count. Talk to your doctor if you have any questions or concerns about this.

Breast-feeding
It is not known if Volibris is transferred to breast milk.

→ Don’t breast feed while you're taking Volibris. Talk to your doctor about this.

Driving and using machines
It is not known whether Volibris affects your ability to drive or use machines. However, it can cause side effects such as headaches (listed in Section 4), and the symptoms of your condition can also make you less fit to drive.

→ Don’t drive or operate machines if you’re feeling unwell.

Important information about some of the ingredients of Volibris
Volibris tablets contain small amounts of a sugar called lactose. If you have an intolerance to lactose or any other sugars:

→ Contact your doctor before taking Volibris.

Volibris tablets contain a colouring called Allura red AC Aluminium Lake (E129) which can cause allergic reactions (see Section 4).

How is it used?

Always take Volibris exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re not sure.

How much Volibris to take
The usual dose of Volibris is one 5 mg tablet, once a day. Your doctor may decide to increase your dose to 10 mg, once a day.

If you take cyclosporine A, do not take more than one 5 mg tablet of Volibris, once a day.

How to take Volibris
It is best to take your tablet at the same time each day. Swallow the tablet whole, with a glass of water, do not chew or break the tablet. You can take Volibris with or without food.

Taking out a tablet

These tablets come in special packaging to prevent children removing them.

Separate one tablet: tear along the cutting lines to separate one “pocket” from the strip.

Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.

Push out the tablet: gently push one end of the tablet through the foil layer.

If you take more Volibris than you should
If you accidentally take too much Volibris:

→ Ask your doctor or pharmacist for advice.

If you forget to take Volibris
If you forget a dose of Volibris, just take the tablet as soon as you remember, then carry on as before.

Don’t take two doses at the same time to make up for a forgotten dose.

Don't stop taking Volibris without your doctor's advice.
Volibris is a treatment that you will need to keep on taking to control your PAH.

→Don’t stop taking Volibris unless you have agreed this with your doctor.

What are possible side effects?

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

Very common side effects

These may affect more than one in 10 people:

Common side effects

These may affect up to one in 10 people:

Uncommon side effects

These may affect up to one in 100 people:

→ Tell your doctor straight away if you get these effects or if they happen suddenly after taking Volibris.

Some patients may have the following side effects:

It is important to have regular blood tests, to check for anaemia and that your liver is working properly. Make sure that you have also read the information in Section 2 under ‘You will need regular blood tests’ and ‘Signs that your liver may not be working properly’.

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 Volibris after the expiry date which is stated on pack and blister.

The expiry date means the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help to protect the environment.

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For doctors

What is it?

Volibris is a medicine that contains the active substance ambrisentan. It is available as tablets (pale pink, square: 5 mg; deep pink, oval: 10 mg).

What is it used for?

Volibris is used to treat patients with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity). PAH is abnormally high blood pressure in the arteries of the lungs. Volibris is used in patients with class II or III disease. The ‘class’ reflects the seriousness of the disease: ‘class II’ involves slight limitation of physical activity and ‘class III’ involves marked limitation of physical activity. Volibris has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Because the number of patients with PAH is low, the disease is considered ‘rare’, and Volibris was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 11 April 2005. The medicine can only be obtained with a prescription.

How is it used?

Treatment with Volibris must be started by a doctor who has experience in the treatment of PAH. The standard dose of Volibris is 5 mg once a day. The tablets should be swallowed whole. A 10 mg dose may have a greater effect in patients with class III disease but this is associated with an increased risk of fluid retention and swelling. Patients with PAH caused by connective tissue disease may also need to take 10 mg to get the best benefit from Volibris. The dose should only be increased if the 5 mg dose is well tolerated. Patients also taking ciclosporin (a medicine that reduces the activity of the immune system) should not take more than 5 mg Volibris a day and should be closely monitored by their doctor.

How does it work?

PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs. This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. The active substance in Volibris, ambrisentan, blocks the receptors for a hormone called endothelin, which causes blood vessels to constrict. By blocking the effect of endothelin, Volibris allows the vessels to dilate (expand), helping to lower the blood pressure and improving symptoms.

How has it been studied?

Various doses of Volibris (2.5, 5 and 10 mg) have been compared with placebo (a dummy treatment) in two main studies involving a total of 394 patients with PAH, most of whom had class II or III disease that was of unknown cause or caused by connective tissue disease. The main measure of effectiveness was the change in the distance the patients could walk in six minutes after 12 weeks of treatment. This is a way of measuring the change in exercise capacity.

What benefits has it shown during the studies?

Volibris was more effective than placebo at improving exercise capacity in patients with class II or III disease. Overall, in the two studies taken together, the patients could walk an average of around 345 m in six minutes at the start of the study. The patients taking 5 mg Volibris once a day could walk an average of 36 m further after 12 weeks of treatment, and the patients taking placebo showed a reduction of 9 m. Patients with class III disease and those with PAH caused by connective tissue disease gained a greater benefit from the 10-mg dose than from the 5-mg dose.

What is the risk associated?

The most common side effects with Volibris (seen in more than 1 patient in 10) are headache (including sinus headache and migraine), peripheral oedema (swelling, especially of the ankles and feet) and fluid retention. For the full list of all side effects reported with Volibris, see the Package Leaflet.
Volibris should not be used in people who may be hypersensitive (allergic) to soya, ambrisentan or any of the other ingredients. Because it might be able to cause birth defects, Volibris must not be used in pregnant women or in women who could become pregnant unless they are using reliable contraception. It must not be used in patients who are breast-feeding, who have severe liver problems or who have high levels of liver enzymes in the blood.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Volibris’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes Volibris will set up a study in the European Union (EU) looking at how the medicine is used. It will also agree on a system in each Member State to control the distribution of Volibris, and will prepare information packs to make sure that healthcare workers, patients, and the male partners of female patients are provided with information on the medicine’s side effects and the need to avoid pregnancy.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Volibris to Glaxo Group Ltd on 21 April 2008. The marketing authorisation is valid for five years, after which it can be renewed.

The summary of the opinion of the Committee for Orphan Medicinal Products for Volibris is available here.

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Name

Volibris 5 mg film-coated tablets

Composition

Each tablet contains 5 mg of ambrisentan.

Excipients

Each tablet contains lactose monohydrate (approximately 95 mg), Lecithin (Soya) (E322) (approximately 0.25 mg) and Allura red AC Aluminium Lake (E129) (approximately 0.11 mg).

For a full list of excipients, see section 6.1.