Volibris - Ambrisentan uses, dose and side effects

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 and over. PAH is high blood pressure in the blood vessels (pulmonary arteries) that transport blood from the heart to the lungs. In people with PAH, these arteries become narrower so the heart has to work harder to pump blood through them. This makes you feel tired, dizzy, and short of breath.

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

Volibris can also be used in combination with other medicines used to treat PAH.

What you need to know before you take Volibris

Do not take Volibris

if you are allergic to ambrisentan, soy, 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 may become pregnant because you are not using a reliable method of contraception. Read the information under “Pregnancy”
if you are breastfeeding. Read the information under “Breastfeeding”
if you have liver disease. Talk to your doctor who will decide if 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 anemia (reduced number of red blood cells )
if you have swollen hands, ankles, or feet caused by fluid retention ( peripheral edema)
if you have lung disease which means that the veins in the lungs are blocked ( pulmonary venous-occlusive disease).

→ Your doctor will decide if Volibris is suitable for you.

You need to take blood tests regularly

Before you start taking Volibris and regularly while you are taking it, your doctor will take blood tests to check:

if you have anemia
and if your liver is working properly.

→ you must submit these regular blood tests as long as you are taking Volibris.

Signs that your liver may not be working as it should include:

loss of appetite
nausea
vomiting
fever
stomach ache
yellowing of the skin or the whites of the eyes (jaundice)
dark colored urine
itching of the skin.

If you notice any of these signs:

→ Tell your doctor immediately.

Children

Do not give this medicine to children under 8 years of age as safety and efficacy are 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 ciclosporin A (a medicine used after transplantation 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 more frequently when you start taking Volibris.

If you are taking other medicines used to treat PAH (eg iloprost, epoprostenol, sildenafil) your doctor may need to monitor you more often.

→ Tell your doctor or pharmacist if you are taking any of these medicines.

Pregnancy

Volibris can harm the unborn baby if you become pregnant before, during, or shortly after treatment.

→ If it is possible that you could become pregnant, you should use reliable contraception while taking Volibris. Discuss this with your doctor.

→ Do not take Volibris if you are pregnant or planning to become pregnant.

→ If you become pregnant or suspect you may be pregnant while taking Volibris, contact your doctor immediately.

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

Breast-feeding

It is not known whether the active substance in Volibris can pass into breast milk.

→ Do not breastfeed while taking Volibris. Discuss this with your doctor.

Fertility

If you are a man and take Volibris, there may be a risk that Volibris reduces the number of sperm. Talk to your doctor if you have any questions about this.

Driving ability and use of machinery

Volibris can cause side effects, such as low blood pressure, dizziness, and fatigue (see section 4) which can affect your ability to drive or use machines. The symptoms of your illness may also make you less fit to drive or use machinery.

→ Do not drive a vehicle or use machinery if you do not feel well.

Volibris contains lactose

Volibris tablets contain small amounts of sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars:

→ Consult your doctor before taking this medicine.

Volibris contains lecithin that comes from soy

If you are allergic to soya, do not take this medicine (see section 2 “Do not take Volibris”).

Volibris 5 mg and 10 mg tablets contain a dye called Allura red AC aluminum lake (E129)

This can cause allergic reactions (see section 4).

Volibris contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.

How to take Volibris

Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

How much Volibris you should take

Adults

The usual dose of Volibris is one 5 mg tablet once a day. The doctor may decide to increase the dose by one to 10 mg once a day.

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

Young people and children aged 8 to younger than 18 years

The usual starting dose of Volibris
Weighs 35 kg or more	One 5 mg tablet once daily
Weighs at least 20 kg and less than 35 kg	One 2.5 mg tablet once daily

The doctor may decide to increase the dose. Children must come to their regular doctor’s appointments because the dose may need to be adjusted as they get older or gain weight.

When taking ciclosporin A at the same time, 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 the tablet at the same time each day. Swallow the tablet whole with a glass of water. The tablet should not be split, crushed, or chewed. You can take Volibris with or without food.

Removing a tablet from a blister card (5 mg and 10 mg tablets only)

The tablets are supplied in special packaging to prevent children from taking them out.

1.	Remove a tablet: tear along the perforated line to remove a blister pocket from the map.

2.	Peel off the outer casing: starting at the colored corner, lift and pull along the blister pocket.

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

Volibris 2.5 mg is packaged in a can, not blister cards.

If you have taken too much Volibris

If you take too many tablets, there is a greater risk of side effects such as headache, flushing, dizziness, nausea, or low blood pressure, which can cause dizziness.

→ Ask your doctor or pharmacist for advice if you take more tablets than prescribed.

If you forget to take Volibris

If you forget to take a dose of Volibris, take it as soon as possible. Then continue taking the medication as prescribed.

→ Do not take a double dose to make up for the missed dose.

If you stop using Volibris

Volibris is a treatment that you must continue to take to control your PAH.

→ Do not stop taking Volibris without your doctor’s agreement.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

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

Serious side effects are

Tell your doctor if you get any of the following :

Allergic reactions

This is a common side effect that may affect up to 1 in 10 users. You may develop a rash or itching and swelling (usually of the face, lips, tongue, or throat), which may cause difficulty in breathing or swallowing.

Swelling ( edema ), especially of the ankles and feet

This is a very common side effect that may affect more than 1 in 10 users.

Heart failure

This is because the heart is not pumping out enough blood. This is a common side effect that may affect up to 1 in 10 users. Symptoms include:

respiratory distress
extreme fatigue
swollen ankles and legs.

Decreased number of red blood cells ( anemia )

This is a very common side effect that may affect more than 1 in 10 users. Sometimes this requires a blood transfusion. Symptoms include:

fatigue and weakness
respiratory distress
general malaise.

Low blood pressure ( hypotension )

It is a common side effect that may occur in up to 1 in 10 users. Symptoms include:

dizziness.

→ Tell your doctor immediately if you (or your child) get these side effects or if they occur suddenly after you (or your child) have used Volibris.

You must have regular blood tests to check if you have anemia and that your liver is working properly. Make sure you have also read the information in section 2 under “You need to have regular blood tests” and “Signs that your liver may not be working as it should”.

Other side effects ar

Very common (may affect more than 1 in 10 users)

headache
dizziness
palpitations (rapid or irregular heartbeats)
shortness of breath that worsens soon after starting treatment with Volibris
runny or stuffy nose, congestion, or pain in the sinuses
nausea
diarrhea
fatigue.

In combination with tadalafil (another drug against PAH)

In addition to the above:

flushing (redness of the skin)
vomiting
chest pain/discomfort.

Common (may affect up to 1 in 10 users)

blurred vision or other vision changes
fainting
abnormal results on blood tests for liver function
Runny nose
constipation
stomach ache
chest pain or discomfort
flushing (redness of the skin)
vomiting
feeling of weakness
nosebleed
rash.

In combination with tadalafil (another drug against PAH)

In addition to the above, (except abnormal liver function values:

tinnitus (ringing in the ears).

Uncommon (may affect up to 1 in 100 users)

liver damage
inflammation of the liver caused by the body’s immune system ( autoimmune hepatitis ).

In combination with tadalafil

sudden hearing loss.

Side effects on children and adolescents

These are expected to be similar to adults.

How Volibris should be stored

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the packaging after EXP.

The expiration date is the last day of the specified month.

No special storage instructions.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substance is ambrisentan

Each film-coated tablet contains 2.5 mg, 5 mg, or 10 mg of ambrisentan.

For 2.5 mg tablets:

Other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, and lecithin (soy) (E322).

For 5 mg and 10 mg tablets:

Appearance and package sizes of the medicine

Volibris 2.5 mg film-coated tablet (tablet) is a white, 7 mm round, convex tablet debossed with “GS” on one side and “K11” on the other side.

Volibris 5 mg film-coated tablet (tablet) is a 6.6 mm light pink, square, convex tablet debossed with “GS” on one side and “K2C” on the other side.

Volibris 10 mg film-coated tablet (tablet) is a 9.8 mm x 4.9 mm dark pink, oval, convex tablet debossed with “GS” on one side and “KE3” on the other side.

Volibris is available as 2.5 mg film-coated tablets in cans. Each jar contains 30 tablets.

Volibris is available as 5 mg and 10 mg film-coated tablets in single-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