Volibris 5 mg film-coated tablets

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.

Don't take Volibris:

• if you are allergic (hypersensitive) to ambrisentan, soya, or any of the other ingredients of Volibris (listed in Section 6).
• if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). Please read the information under ?Pregnancy and Breast feeding?.
• if you are breast feeding.
• if you have liver disease. Talk to your doctor, who will decide whether Volibris is suitable for you.
• if you are under 18 years old.

If any of these apply to you:

? Tell your doctor and don?t take Volibris.

Take special care with Volibris:

• if you have anaemia (a reduced number of red blood cells).

? 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:

• whether you have anaemia (a reduced number of red blood cells)
• whether your liver is working properly.

? 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:

• loss of appetite
• feeling sick (nausea)
• being sick (vomiting)
• high temperature (fever)
• pain in your stomach (abdomen)
• yellowing of your skin or the whites of your eyes (jaundice)
• dark-coloured urine
• itching of your skin.

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).

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.

1. Separate one tablet: tear along the cutting lines to separate one ?pocket? from the strip.

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

3. 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.

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:

• swelling (oedema), especially of the ankles and feet. If you notice this side effect, tell your doctor.
• headache.

Common side effects

These may affect up to one in 10 people:

• anaemia (a reduced number of red blood cells), which can cause tiredness, weakness, shortness of breath, and generally feeling unwell
• a runny or blocked nose, congestion or pain in the sinuses
• constipation
• pain in your stomach (abdomen)
• chest pain or discomfort
• flushing (redness of the skin)
• palpitations (fast or irregular heart beats)
• abnormal blood test results for liver function.

Uncommon side effects

These may affect up to one in 100 people:

• Allergic reactions. You may notice a rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing.

? 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:

• heart failure (associated with swelling/fluid retention)
• worsening shortness of breath shortly after starting Volibris.
• fainting or dizziness
• low blood pressure
• feeling sick or being sick (nausea or vomiting)
• diarrhoea

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.

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.

What Volibris contains

The active substance is ambrisentan (5 mg or 10 mg).

The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol/polyethylene glycol 3350, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).

What Volibris looks like and contents of the pack

Volibris 5 mg tablet is a pale pink, square, convex tablet engraved with ?GS? on one face and ?K2C? on the other.

Volibris 10 mg tablet is a deep pink, oval, convex tablet engraved with ?GS? on one face and ?KE3? on the other.

Volibris is supplied as 5 mg and 10 mg film-coated tablets in blister packs of 10 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Manufacturer
Glaxo Wellcome GmbH & Co. KG
Bad Oldesloe
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

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Lietuva

GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in .