Patient leaflet - Volibris
1. What Volibris is and what it is used for
Volibris contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure).
It is used to treat pulmonary arterial hypertension (PAH) in adults, adolescents and children aged 8 years and over. 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.
Volibris may also be used in combination with other medicines used to treat PAH.
2. What you need to know before you take Volibris
Don't take Volibris:
- if you are allergic to ambrisentan, soya, or any of the other ingredients of this medicine (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’
- if you are breast-feeding. Read the information under ‘Breast-feeding’
- if you have liver disease. Talk to your doctor, who will decide whether this medicine is suitable for you
- if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).
Warnings and precautions
Talk to your doctor before taking this medicine:
- if you have liver problems
- if you have anaemia (a reduced number of red blood cells)
- if you have swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
- if you have lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive
disease ).
^ Your doctor 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 are taking it, your doctor will take blood tests to check:
- whether you have anaemia
- 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.
Children
Do not give this medicine to children aged under 8 years as the safety and effectiveness is not known in this age group.
Other medicines and Volibris
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis), your doctor may need to adjust your dose of Volibris.
If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will monitor you when you first start taking Volibris.
If you are taking other medicines to treat PAH (e.g. iloprost, epoprostenol, sildenafil) your doctor may need to monitor you.
^ Tell your doctor or pharmacist if you are taking any of these medicines.
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 are 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 are 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 this medicine.
Breast-feeding
It is not known if the active substance of Volibris can pass into breast milk.
^ Don’t breast-feed while you are taking Volibris. Talk to your doctor about this.
Fertility
If you are a man taking Volibris, it is possible that this medicine may lower your sperm count. Talk to your doctor if you have any questions or concerns about this.
Driving and using machines
Volibris may cause side effects, such as low blood pressure, dizziness, tiredness (see section 4), that may affect your ability to drive or use machines. The symptoms of your condition can also make you less fit to drive or use machines.
^ Don’t drive or use machines if you are feeling unwell.
Volibris contains lactose
Volibris tablets contain small amounts of a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars:
^ Contact your doctor before taking this medicinal product.
Volibris contains lecithin derived from soya
If you are allergic to soya, do not use this medicine (see section 2 ‘Don’t take Volibris’).
Volibris 5 mg and 10 mg tablets contain a colouring called allura red AC aluminium lake (E129 )
This may cause allergic reactions (see section 4).
Volibris contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Volibris
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure.
How much Volibris to take
Adults
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.
Adolescents and children aged 8 years to less than 18 years
| Usual starting dose of Volibris | |
| Weighing 35 kg or more | One 5 mg tablet, once a day |
| Weighing at least 20 kg, and less than 35 kg | One 2.5 mg tablet, once a day |
Your doctor may decide to increase your dose. It’s important that children attend their regular doctor’s appointments, as their dose needs to be adjusted as they get older or gain weight.
If taken in combination with cyclosporin A, the dose of Volibris for adolescents and children weighing less than 50 kg will be limited to 2.5 mg once daily, or 5 mg once daily if they weigh 50 kg or more.
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 split, crush or chew the tablet. You can take Volibris with or without food.
Taking out a tablet from a blister pack (5 mg and 10 mg tablets only)
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.
Volibris 2.5 mg tablets are provided in a bottle, not a blister pack.
If you take more Volibris than you should
If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness:
^ Ask your doctor or pharmacist for advice if you take more tablets than prescribed.
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 a double dose at the same time to make up for a forgotten dose.
If you stop taking Volibris
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor if you get any of these:
Allergic reactions
This is a common side effect that may affect up to 1 in 10 people. 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.
Swelling ( oedema ), especially of the ankles and feet
This is a very common side effect that may affect more than 1 in 10 people.
Heart failure
This is due to the heart not pumping out enough blood. This is a common side effect that may affect up to 1 in 10 people. Symptoms include:
- shortness of breath
- extreme tiredness
- swelling in the ankles and legs.
Reduced number of red blood cells ( anaemia )
This is a very common side effect that may affect more than 1 in 10 people. Sometimes this requires a blood transfusion. Symptoms include:
- tiredness and weakness
- shortness of breath
- generally feeling unwell.
Low blood pressure ( hypotension )
This is a common side effect that may affect up to 1 in 10 people. Symptoms include:
- light-headedness.
^ Tell your doctor straight away if you (or your child) get these effects or if they happen suddenly after taking Volibris.
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’.
Other side effects
Very common (may affect more than 1 in 10 people)
- headache
- dizziness
- palpitations (fast or irregular heart beats)
- shortness of breath getting worse shortly after starting Volibris
- a runny or blocked nose, congestion or pain in the sinuses
- feeling sick (nausea)
- diarrhoea
- feeling tired.
In combination with tadalafil (another PAH medicine)
In addition to the above:
- flushing (redness of the skin)
- being sick (vomiting)
- chest pain/discomfort.
Common (may affect up to 1 in 10 people)
- blurry or other changes to vision
- fainting
- abnormal blood test results for liver function
- a runny nose
- constipation
- pain in your stomach (abdomen)
- chest pain or discomfort
- flushing (redness of the skin)
- being sick (vomiting)
- feeling weak
- nose bleed
- rash.
In combination with tadalafil
In addition to the above, (except abnormal blood test results for liver function):
- ringing in the ears (tinnitus).
Uncommon (may affect up to 1 in 100 people)
- liver injury
- inflammation of the liver caused by the body’s own defences (autoimmune hepatitis).
In combination with tadalafil
- sudden hearing loss.
5. How to store Volibris
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Volibris contains
The active substance is ambrisentan.
Each film-coated tablet contains 2.5 mg, 5 mg or 10 mg ambrisentan.
For the 2.5 mg tablets:
The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol and lecithin (soya) (E322).
For the 5 mg or 10 mg tablets:
The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soya) (E322) and allura red AC aluminium lake (E129).
What Volibris looks like and contents of the pack
Volibris 2.5 mg film-coated tablet (tablet) is a white, 7 mm round, convex tablet engraved with ‘GS’ on one side and ‘K11’ on the other.
Volibris 5 mg film-coated tablet (tablet) is a pale pink, 6.6 mm square, convex tablet engraved with ‘GS’ on one side and ‘K2C’ on the other.
Volibris 10 mg film-coated tablet (tablet) is a deep pink, 9.8 mm x 4.9 mm oval, convex tablet engraved with ‘GS’ on one side and ‘KE3’ on the other.
Volibris is supplied as 2.5 mg film-coated tablets in bottles. Each bottle contains 30 tablets.
Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10×1 or 30×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Belgie/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline (Ireland) Limited
Tel/Tel: + 32 (0) 10 85 52 00 Tel: + 370 80000334
Etnrapua
GlaxoSmithKline (Ireland) Limited
Ten.: + 359 80018205
Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
Eesti
GlaxoSmithKline (Ireland) Limited
Tel: + 372 8002640
EMáSa
GlaxoSmithKline Movonpóoonn A.E.B.E.
Tql: + 30 210 68 82 100
España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44
Hrvatska
GlaxoSmithKline (Ireland) Limited
Tel: + 385 800787089
Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000
Ísland
Vistor hf.
Sími: + 354 535 7000
Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111
Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00
Magyarország
GlaxoSmithKline (Ireland) Limited
Tel.: + 36 80088309
Malta
GlaxoSmithKline (Ireland) Limited
Tel: + 356 80065004
Nederland
GlaxoSmithKline BV Tel: + 31 (0)33 2081100
Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00
Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000
Portugal
GlaxoSmithKline – Produtos Farmacéuticos, Lda.
Tel: + 351 21 412 95 00
Romania
GlaxoSmithKline (Ireland) Limited
Tel: + 40 800672524
Slovenija
GlaxoSmithKline (Ireland) Limited
Tel: + 386 80688869
Slovenská republika
GlaxoSmithKline (Ireland) Limited
Tel: + 421 800500589
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
Kûnpoç
GlaxoSmithKline (Ireland) Limited
Tql: + 357 80070017
Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
Latvija
GlaxoSmithKline (Ireland) Limited
Tel: + 371 80205045
United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221441
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: There are also links to other websites about rare diseases and treatments.
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