Volibris
ambrisentan
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Volibris is and what it is used for
What you need to know before you take Volibris
How to take Volibris
Possible side effects
How to store Volibris
Contents of the pack and other information
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.
if you are allergic to ambrisentan, soya, or any of the other ingredients of this medicine (listed in section 6)
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).
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).
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.
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:
Do not give this medicine to children aged under 8 years as the safety and effectiveness is not known in this age group.
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.
Volibris may harm unborn babies conceived before, during or soon after treatment.
It is not known if the active substance of Volibris can pass into breast milk.
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.
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.
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:
If you are allergic to soya, do not use this medicine (see section 2 ‘Don’t take Volibris’).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
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.
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.
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.
These tablets come in special packaging to prevent children removing them.
Volibris 2.5 mg tablets are provided in a bottle, not a blister pack.
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:
If you forget a dose of Volibris, just take the tablet as soon as you remember, then carry on as before.
Volibris is a treatment that you will need to keep on taking to control your PAH.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
This is a very common side effect that may affect more than 1 in 10 people.
This is due to the heart not pumping out enough blood. This is a common side effect that may affect
shortness of breath
extreme tiredness
swelling in the ankles and legs.
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.
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.
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 addition to the above:
flushing (redness of the skin)
being sick (vomiting)
chest pain/discomfort.
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 addition to the above, (except abnormal blood test results for liver function):
ringing in the ears (tinnitus).
liver injury
inflammation of the liver caused by the body’s own defences (autoimmune hepatitis).
sudden hearing loss.
These are expected to be similar to those listed above for adults.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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).
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 × 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.
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Ireland
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Citywest Business Campus Dublin 24
Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline (Ireland) Limited Tel: + 370 80000334
GlaxoSmithKline (Ireland) Limited
Teл.: + 359 80018205
Tél/Tel: + 32 (0) 10 85 52 00
GlaxoSmithKline (Ireland) Limited Tel.: + 36 80088309
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline (Ireland) Limited Tel: + 356 80065004
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701
GlaxoSmithKline (Ireland) Limited Tel: + 372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44
GlaxoSmithKline – Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00
GlaxoSmithKline (Ireland) Limited Tel: + 385 800787089
GlaxoSmithKline (Ireland) Limited Tel: + 40 800672524
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
GlaxoSmithKline (Ireland) Limited Tel: + 386 80688869
Vistor hf.
Sími: + 354 535 7000
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 111
GlaxoSmithKline (Ireland) Limited
Τηλ: + 357 80070017
GlaxoSmithKline (Ireland) Limited Tel: + 371 80205045
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