Volibris (Ambrisentan)

Volibris® 5 mg and 10 mg film coated tablets®

VOLIBRIS is a type of medicine called an endothelin receptor antagonist (ERA). It is used to treat adults with pulmonary arterial hypertension (PAH), which 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 become tired, dizzy and short of breath. VOLIBRIS widens the pulmonary arteries, making it easier for your heart to pump blood through them. This lowers the blood pressure and relieves your symptoms.

VOLIBRIS is not recommended for use in children as there have been no studies of its effects in children.

VOLIBRIS is available as 5 mg and 10 mg tablets.

This medicine is available only with a doctor’s prescription.

Do not take VOLIBRIS if:

• you are pregnant, are planning to become pregnant, or could get pregnant because you are not using reliable birth control (contraception)
  
• you have had an allergic reaction to VOLIBRIS or its ingredients
  
• you have or have had a serious liver problem
  
• you have raised levels of some liver enzymes (detected by blood tests).

Tell your doctor if the above applies to you.

Take special care with VOLIBRIS

Your doctor needs to know before you take VOLIBRIS if you have:

• liver disease
  
• a low number of red blood cells (anaemia)
  
• if you have swelling (oedema)
  
• low blood pressure.

If any of these applies to you, your doctor will decide if VOLIBRIS is suitable for you.

Blood tests

Your doctor will take blood tests to check:

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

These blood tests will be taken before you start taking VOLIBRIS and throughout your treatment with VOLIBRIS.

Signs that your liver may not be working as it normally should include: loss of appetite, feeling sick (nausea), being sick (vomiting), fever, unusual tiredness, pain in the stomach (abdominal pain), yellow colouring of your skin or the whites of your eyes (jaundice), your urine turns dark in colour, or itching of the skin. If you notice any of these signs, tell your doctor immediately.

Taking other medicines

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

Pregnancy and breast-feeding

Don’t take VOLIBRIS if you or your partner are pregnant or planning to become pregnant as it may harm unborn babies conceived before, during or soon after treatment.

You must not become pregnant for at least 3 months after stopping VOLIBRIS.

If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you take VOLIBRIS.

If you are a male you should avoid exposing your partner to your semen by use of appropriate contraception.

If it’s possible you could become pregnant, use at least two reliable forms of birth control (contraception) while you’re taking VOLIBRIS. Talk to your doctor about this.

If you do become pregnant, talk to your doctor immediately.

Don’t breast feed while you are taking VOLIBRIS.

Driving and using machines

It is not known whether VOLIBRIS affects your ability to drive or use machines. However, the symptoms of your condition can make you less fit to drive. Don’t drive or operate machines if you’re feeling unwell.

Ask your doctor or pharmacist for advice before taking any medicine if you are unsure.

If you take too much VOLIBRIS

immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice.

If you forget to take VOLIBRIS

If you forget to take a dose of VOLIBRIS, just take the tablet as soon as you remember, then carry on as before. Don’t take two tablets at the same time to make up for a forgotten dose.

VOLIBRIS is a treatment that you will take long term. Don’t stop taking VOLIBRIS without advice from your doctor.

Like all medicines, VOLIBRIS can cause side effects. Your chances of getting these side effects will depend on many things, including how much VOLIBRIS you take.

Very common side effects (could affect more than one in 10 people) include:

• swelling (oedema), especially in the ankles and feet
  
• headache.

Other common side effects (could affect up to one in 10 people) include:

• low number of red blood cells (anaemia), which can cause tiredness, weakness, shortness of breath and feeling generally unwell
  
• rash or flushing (redness of the skin)
  
• a runny or blocked nose, congestion or pain in the sinuses
  
• constipation
  
• pain in your stomach
  
• nausea
  
• vomiting
  
• palpitations (fast or irregular heart beat).

If you notice any of the above side effects and any other unusual effects not listed in this leaflet while taking VOLIBRIS, please tell your doctor or pharmacist.