Volibris

PACKAGE LEAFLET: INFORMATION FOR THE USER

Volibris 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets

ambrisentan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Volibris is and what it is used for
2. What you need to know before taking Volibris
3. How to take Volibris
4. Possible side effects
5. How to store Volibris
6. Contents of the pack and other information

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 for the treatment of high blood pressure).
It is used for the treatment of Pulmonary Arterial Hypertension (PAH) in adults, adolescents, and children aged 8 years and older. Pulmonary Arterial Hypertension (PAH) is high blood pressure in the blood vessels of the lung (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries become narrowed, causing the heart to work harder to pump blood through them. This leads to symptoms such as fatigue, dizziness, and shortness of breath.
Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.
Volibris may also be used in combination with other medicines used to treat PAH.

2. What you should know before taking Volibris

Do not take Volibris:
if you are allergic to ambrisentan, soy, or any of the other excipients of this
medicinal product (listed in section 6)
if you are pregnant, if you are planning a pregnancy, or if there is a possibility
of becoming pregnant because you are not using an effective method of birth control (contraception). Please read the section titled “Pregnancy”
if you are breastfeeding. Read the information titled “Breast-feeding”
if you have liver disease. Talk to your doctor, who will decide whether you can take this
medicinal product.
if you have idiopathic pulmonary fibrosis (lung scarring of unknown origin).

Warnings and precautions
Talk to your doctor before taking this medicinal product:

• if you have liver problems
• if you have anaemia (reduced number of red blood cells)
• if you have swelling in your hands, ankles or feet due to fluid retention (peripheral oedema)
• if you have a lung disease in which the veins in the lungs are blocked (pulmonary veno-occlusive disease)

→ Your doctor will decide whether Volibris is suitable for you.
You need to have regular blood tests
Before starting treatment with Volibris, and at regular intervals during treatment, your doctor will arrange for you to have
blood tests to check:

• whether you have anaemia
• whether your liver is functioning properly.
  → It is important that you have all these blood tests regularly throughout your entire treatment with Volibris.
  Signs that your liver may not be working properly include:
  loss of appetite
  feeling unwell (nausea)
  stomach problems (vomiting)
  elevated body temperature (fever)
  abdominal pain
  yellowing of the skin or eyes (jaundice)
  dark-coloured urine
  itching of the skin.
  If you notice any of these signs:
  → contact your doctor immediately.
  Children
  Do not give this medicinal product to children under 8 years of age, as its safety and efficacy have not been established 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 medicinal products.
  If you start treatment with cyclosporine A (a medicine used after organ transplantation or for the treatment of psoriasis), your doctor may need to adjust the dose of Volibris.
  If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will need to monitor you when starting treatment with Volibris.
  If you are taking other medicines for the treatment of PAH (e.g. iloprost, epoprostenol, sildenafil), your doctor may need to monitor you.
  → Inform your doctor or pharmacist if you are taking any of these medicines.
  Pregnancy
  Volibris may cause harm to the unborn child if conception occurs before, during, or shortly after treatment.
  → If there is a possibility of becoming pregnant, use an effective method of birth control (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 are pregnant while taking Volibris, contact your doctor immediately.
  If you are a woman of childbearing potential (able to become pregnant), your doctor will require you to undergo
  a pregnancy test before starting Volibris and regularly during treatment with this medicinal product.
  Breast-feeding
  It is not known whether the active ingredient of Volibris passes into breast milk.
  → Do not breast-feed while taking Volibris. Discuss this with your doctor.
  Fertility
  If you are a man taking Volibris, it is possible that Volibris may reduce the number of spermatozoa in semen. For any questions or concerns, talk to your doctor.
  Driving and use of machines
  Volibris may cause adverse reactions such as low blood pressure, dizziness, and fatigue (see section 4), which may affect your ability to drive or operate machinery. The symptoms of your underlying illness may also impair your ability to drive or use machinery.
  → Do not drive or operate machinery if you do not feel well.
  Volibris contains lactose.
  Volibris tablets contain small amounts of a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars:
  → Inform your doctor before taking this medicinal product.
  Volibris contains soya-derived lecithin.
  If you are allergic to soya, do not take this medicinal product (see section 2 ‘Do not take Volibris’).
  Volibris 5 mg and 10 mg tablets contain a colouring agent called aluminium lake of red allura AC (E129)
  This may cause allergic reactions (see section 4).
  Volibris contains sodium
  This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Volibris

Take this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, consult your doctor or pharmacist.
How much Volibris to take
Adults
The usual dose of Volibris is one 5 mg tablet once daily. Your doctor may decide to increase the dose to 10 mg once daily.
If you are taking cyclosporine A, do not take more than one 5 mg tablet of Volibris once daily.
Adolescents and children aged 8 to 18 years

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

If taken in combination with ciclosporin 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 the 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 may take Volibris with or without food.

Removing a tablet from the blister pack (only for 5 mg and 10 mg tablets)

These tablets are supplied in special packaging to prevent children from accessing them.

1. Separate one tablet: Tear along the perforation to separate one "pocket" from the strip.

2. Peel back the outer layer: Starting at the coloured corner, lift and pull back over the pocket.

3. Push the tablet through: Gently push one end of the tablet through the laminated layer.

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

If you take more Volibris than you should

If you accidentally take too many tablets, you may easily experience adverse reactions such as headache, flushing, dizziness, nausea (feeling unwell), or low blood pressure which may make you feel like you are about to faint:

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

If you forget to take Volibris

If you forget to take a dose of Volibris, take the tablet as soon as you remember, and then continue your treatment as usual.

→ Do not take a double dose at the same time to make up for a forgotten dose.

If you stop taking Volibris

Volibris is a medicine you need to control Pulmonary Arterial Hypertension.

→ Do not stop taking Volibris unless you have discussed it with your doctor.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
Tell your doctor if you experience any of the following side effects:
Allergic reactions
This is a common side effect which may affect up to 1 in 10 people. You may notice:

• rash, itching, and swelling (usually of the face, lips, tongue, or throat), which may cause difficulty in breathing or swallowing.

Swelling ( edema ), especially in the ankles and feet
This is a very common side effect which may affect more than 1 in 10 people.
Heart failure
This occurs because the heart does not pump enough blood. It is a common side effect which 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 which may affect more than 1 in 10 people. Sometimes it may require blood transfusion. Symptoms include:

• tiredness and weakness
• shortness of breath
• feeling generally unwell.

Low blood pressure ( hypotension )
It is a common side effect which may affect up to 1 in 10 people. Symptoms include:

• feeling faint

→ Contact your doctor immediately if any of these side effects occur in you (or in your child) shortly after taking Volibris.
It is important to have regular blood tests to monitor for anaemia and to check that your liver is functioning properly. Make sure you have read the information in
section 2 under the headings ‘You need to have 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 heartbeat)
shortness of breath that worsens soon after starting treatment with Volibris
runny or stuffy nose, nasal congestion or sinus pain
feeling sick ( nausea )
diarrhoea
feeling tired.
In combination with tadalafil (another medicine for PAH)
In addition to the above:

• flushing (skin redness)
• feeling sick ( vomiting )
• chest pain or discomfort.

Common
(may affect up to 1 in 10 people )
blurred vision or other vision disturbances
fainting
abnormal liver function blood test results
runny nose
constipation
stomach ( abdominal ) pain
chest pain or discomfort
flushing (skin redness)
feeling sick ( vomiting )
feeling weak
nosebleeds
rash
Combination with tadalafil
In addition to the above (except abnormal liver function blood test results):

• ringing in the ears ( tinnitus ).

Uncommon
(may affect up to 1 in 100 people )
liver damage
liver inflammation caused by the body's own defences ( autoimmune hepatitis ).
Combination with tadalafil

• sudden hearing loss

Side effects in children and adolescents
These are expected to be similar to those listed above for adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 packaging after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Volibris contains
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:
The other excipients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, and lecithin (soy) (E322).
For 5 mg and 10 mg tablets:
The other excipients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soy) (E322), and
aluminium lake of Allura red AC (E129).

Description of the appearance of Volibris and the pack contents
Volibris 2.5 mg film-coated tablet is a 7 mm white, round, convex tablet, marked with "GS" on one side and "K11" on the other.
Volibris 5 mg film-coated tablet is a 6.6 mm pale pink, square, convex tablet, marked with "GS" on one side and "K2C" on the other.
Volibris 10 mg film-coated tablet is a 9.8 mm x 4.9 mm dark pink, oval, convex tablet, marked with "GS" on one side and "KE3" on the other.
Volibris 2.5 mg film-coated tablets are available in bottles. Each bottle contains 30 tablets.
Volibris 5 mg and 10 mg film-coated tablets are available in packs with unit dose blisters of 10 x 1 or 30 x 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline (Ireland) Limited
Tél/Tel: + 32 (0) 10 85 52 00 Tel: + 370 80000334
[email protected]

България Luxembourg/Luxemburg
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline (Ireland) Limited.
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline (Ireland) Limited
Tlf: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0) 33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline (Ireland) Limited
Tel: + 385 800787089 Tel: + 40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline (Ireland) Limited.
Tel: + 353 (0)1 4955000 Tel: + 386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline (Ireland) Limited
Sími: + 354 535 7000 Tel: + 421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline (Ireland) Limited
Tel: + 371 80205045 Tel: + 44 (0)800 221441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
In addition, links to other websites on rare diseases and their therapeutic treatments are provided.