Package Leaflet: Information for the User

Volibris 2.5mg Film-Coated Tablets

Volibris 5mg Film-Coated Tablets

Volibris 10mg Film-Coated Tablets

ambrisentan

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you onlyand you should not give it to others, even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceany side effects, talk to your doctor, pharmacist or nurse,even if they are not listed in this leaflet. See section4.

1.What is Volibris and what it is used for

2.What you need to knowbeforestarting totake Volibris

3.How to take Volibris

4.Possible side effects

5.Storage of Volibris

6.Contents of the pack and additional information

Volibris contains the active substance ambrisentán. It belongs to a group of medications called other antihypertensives (used to treat high blood pressure).

It is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults, adolescents, and children 8 years of age and older. PAH consists of elevated blood pressure in the blood vessels (pulmonary arteries) that carry 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 to the lungs. This makes people feel tired, dizzy, and have difficulty breathing.

Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and alleviates symptoms.

Volibris may also be used in combination with other medications used to treat PAH.

Do not take Volibris

• if you areallergicto ambrisentan, soybean, or any of the other components of this medication (listed in section6).
• if you are pregnant,if you areplanning to become pregnant,or if you may become pregnant because you are not using a reliable method of birth control (contraceptive). Please read the information in the "Pregnancy" section.
• if you arebreastfeedingread the information under the heading “Breastfeeding”.
• if you haveliver disease. Consult your doctor, who will decide if this medication is or is not suitable for you.
• if you haveidiopathic pulmonary fibrosis, a cause unknown.

Warnings and precautions

Consult your doctor before starting to take this medication:

• if you have liver problems
• if you have anemia (reduction of red blood cells)
• if you have swelling of the hands, ankles, or feet caused by fluid retention (peripheral edema)
• if you have a lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease).

→ Your doctor will decideif Volibris is or is not suitable for you.

You will need to have regular blood tests
Before starting to take Volibris, and periodically while taking it, your doctor will perform blood tests to check:

• if you have anemia
• if your liver is functioning correctly.

→ It is important that you have these blood tests regularly while taking Volibris.

The signs that your liver may not be functioning properly include:

• loss of appetite
• nausea (nausea)
• vomiting
• high temperature (fever)
• abdominal pain (abdomen)
• yellowing of the skin or eyes (jaundice)
• darkening of the urine
• itching of the skin.

If you notice any of these circumstances:

→ Inform your doctor immediately.

Children

Do not administer this medication to children under 8 years of age, as its safety and efficacy in this age group are unknown.

Volibris with other medications

Inform your doctor or pharmacistif you are taking, have taken recentlyor may need to take any other medication.

If you start takingciclosporin A(a medication used after a transplant or to treat psoriasis), your doctor may need to adjust your Volibris dose.

If you are takingrifampicin(an antibiotic used to treat severe infections), your doctor will monitor you when you start taking Volibris.

If you are taking other medications to treat PAH (iloprost, epoprostenol, sildenafilo), your doctor may need to monitor you.

→ Inform your doctor or pharmacistif you are taking this medication.

Pregnancy

Volibris may harm the conceived fetus before, during, or shortly after treatment.

→ If there is a possibility of becoming pregnant, use a reliable contraceptive methodwhile taking Volibris. Consult your doctor about this.

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

→If you become pregnant or think you may be pregnantwhile taking Volibris,consult your doctor immediately.

→ Your doctor will ask you to have a pregnancy testbefore starting to take Volibris and periodically while taking this medication.

Breastfeeding

The active ingredient in Volibris may pass into breast milk.

→ Do not breastfeed while taking Volibris.Consult your doctor about this.

Fertility

If you are a man taking Volibris, it is possible that this medication may reduce 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, and fatigue (see section 4) that may affect your ability to drive and use machines. Your own symptoms of the disease may also reduce your ability to drive or use machines

→ Do not drive or use machines if you do not feel well.

Volibris contains lactose

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

→ Consult your doctorbefore taking this medication.

Volibris contains soy-derived lecithin

Do not use this medication in case of soy allergy (see section 2 “do not take Volibris”).

The 5 mg and 10 mg tablets of Volibris contain a synthetic food dye calledaluminum lake red allura AC (E129)

This may cause allergic reactions (see section 4).

Volibris contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctoror pharmacist.In case of doubt, consult your doctor or pharmacist again.

How much Volibris to take

Adults
The usual dose 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 ciclosporina A, do not take more than one 5 mg tablet of Volibris, once a day.

Adolescents and children from 8 years to under 18 years of age

Your doctor may decide to increase your dose. It is important that children attend their regular medical appointments, as their dose needs to be adjusted as they grow or gain weight.

If taken in combination with ciclosporina A, the dose of Volibris should be limited to 2.5 mg once a day in adolescents and children weighing less than 50 kg or to 5 mg once a day if they weigh 50 kg or more.

How to take Volibris
It is best to take the tablet at the same time every day. Swallow the tablet whole, with a glass of water; do not divide, crush or chew the tablet. You can take Volibris with or without food.

How to remove the tabletfrom the blister pack (only for 5 mg and 10 mg tablets)

These tablets come in a special packaging to prevent children from getting them out.

1. Separate a tablet: tear along the cutting lines to separate a "cell" from the strip.

2. Open the outer sheet: starting from the colored corner, open and separate the sheet along the cell.

3.Remove the tablet:gently push the tablet through the sheet from one side.

The 2.5 mg tablets of Volibris are supplied in a bottle, not in a blister pack.

If you take more Volibris than you should

If you take too many tablets, you may be more prone to side effects, such as headache, hot flushes, dizziness, nausea (discomfort), or a slight drop in blood pressure that may cause a feeling of dizziness:

→ Consult your doctor or pharmacistif 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 you remember and then continue as before.

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

If you interrupt treatment with Volibris

Volibris is a treatment that you will need to continue taking to control your HAP.

→Do not stop taking Volibris unless your doctor tells you to.

If you have any other doubts about the use of thismedication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctorif you experience any of the following:

Allergic reactions

This is a common side effect that can affectup to 1 in 10people.You may notice:

• a rash or itching and swelling (usually on the face, lips, tongue, or throat), which can cause difficulty breathing or swallowing.

Swelling (edema), especially in the ankles and feet

This is a very common side effect that can affectmore than 1 in 10people.

Heart failure

This is due to the heart not pumping enough blood. This is a common side effect that can affectup to 1 in 10people.The symptoms include:

• difficulty breathing
• extreme fatigue
• swelling in the ankles and legs.

Reduced number of red blood cells (anemia)

This is a very common side effect that can affectamore than 1 in 10people.In some cases, this may require a blood transfusion.The symptoms include:

• fatigue and weakness
• difficulty breathing
• general feeling of illness.

Low blood pressure (hypotension)

This is a common side effect that can affectup to 1 in 10people. The symptoms include:

• dizziness

→Inform your doctor immediatelyif you (or your child) experience these side effects or if they occur suddenly after taking Volibris.

It is essential to have regular blood tests, to monitor if you have anemia and if your liver is functioning correctly.Alsorefer to section 2on "the need to have regular blood tests" and "the signs that your liver may not be functioning properly".

Other side effects

Very common(may affectmore than 1 in 10people)

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• difficulty breathing that worsens shortly after starting to take Volibris
• runny nose or stuffy nose, congestion, or pain in the nasal passages
• nausea
• diarrhea
• feeling of fatigue

In combination with tadalafil (another medication for HAP)

In addition to the above:

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

Common(may affectup to 1 in 10people)

• blurred vision or other changes in vision
• syncope (fainting)
• abnormal results in liver function blood tests
• increased nasal discharge
• constipation
• stomach pain (abdomen)
• chest pain/discomfort
• flushing (redness of the skin)
• vomiting
• feeling of weakness
• nosebleeds
• skin rash.

In combination with tadalafil

In addition to the above, except for abnormal results in liver function blood tests:

• tinnitus (ringing in the ears).

Rare(may affectup to 1 in 10people)

• liver damage
• inflammation of the liver caused by the body's own defenses (autoimmune hepatitis).

In combination with tadalafil

• sudden loss of hearing.

Side effects in children and adolescents

It is expected to be similar to those listed above for adults.

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect not listed in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of sightand out of reachof children.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD.

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Volibris

The active ingredient is ambrisentan.

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

For the 2.5mg tablets:

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

For the 5mg and 10mg tablets:

The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soy) (E322) andaluminium lake red allura AC (E129).

Appearance of the product and contents of the pack

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

Volibris 5mg film-coated tablets (tablet) is a pale pink, square 6.6mm, convex tablet, engraved with "GS" on one side and with "K2C" on the other side.

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

Volibris is supplied as 2.5mg film-coated tablets in a bottle. Each bottle contains 30 tablets.

Volibris is supplied as 5mg and 10mg film-coated tablets in a blister pack, in 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

Responsible for manufacturing

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. It also provides links to other websites on rare diseases and orphan medicinal products.