Ambriptan Viatris

Package leaflet: Information for the user

Ambrisentan Viatris 5 mg film-coated tablets, 10 mg film-coated tablets

ambrisentan
Read this entire leaflet carefully before you start 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 side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Ambrisentan Viatris is and what it is used for

Ambrisentan Viatris 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.
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
narrow, causing the heart to work harder to pump blood through them. This leads to symptoms such as
tiredness, dizziness, and shortness of breath.
Ambrisentan Viatris widens the pulmonary arteries, making it easier for the heart to pump blood
through them.
This lowers blood pressure and relieves symptoms.
Ambrisentan Viatris may also be used in combination with other medicines used to treat PAH.

2. What you should know before taking Ambrisentan Viatris

Do not take Ambrisentan Viatris:

• if you are allergic to ambrisentan or to any of the other excipients of this medicine (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). It is recommended that you read the information entitled “Pregnancy”.
• if you are breastfeeding. Read the information entitled “Breast-feeding”.
• if you have liver disease. Talk to your doctor, who will decide whether you can take this medicine.
• if you have lung scarring of unknown origin (idiopathic pulmonary fibrosis).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine if you have:

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

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

• whether you have anaemia
• whether your liver is functioning properly.

→ It is important that you have all these blood tests regularly throughout the entire duration of
treatment with Ambrisentan Viatris.
Signs that your liver may not be working properly include:

• loss of appetite
• feeling unwell (nausea)
• stomach problems (vomiting)
• high body temperature (fever)
• stomach (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 and adolescents
Ambrisentan Viatris is not recommended for children and adolescents under 18 years of age, as its
safety and efficacy have not been established in this age group.
Other medicines and Ambrisentan Viatris
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
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 Ambrisentan Viatris.
If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will need to
monitor you when starting treatment with Ambrisentan Viatris.
If you are taking other medicines used to treat PAH (e.g. iloprost, epoprostenol, sildenafil), your doctor
may need to monitor you.
→ Tell your doctor or pharmacist if you are taking any of these medicines.
Pregnancy
Ambrisentan Viatris can cause harm to unborn babies conceived before, during or shortly after the end
of treatment.
→ If there is a possibility of becoming pregnant, use an effective method of birth control
(contraception) while taking Ambrisentan Viatris. Discuss this with your doctor.
→ Do not take Ambrisentan Viatris if you are pregnant or planning to become pregnant.
→ If you become pregnant or suspect you are pregnant while taking Ambrisentan Viatris, contact your
doctor immediately.
If you are a woman of childbearing potential (able to become pregnant), your doctor will ask you to
have a pregnancy test before starting Ambrisentan Viatris and then regularly during treatment with
this medicine.
Breast-feeding
It is not known whether the active substance of Ambrisentan Viatris passes into breast milk.
→ Do not breast-feed during treatment with Ambrisentan Viatris. Discuss this with your doctor.
Fertility
If you are a man taking Ambrisentan Viatris, this medicine may reduce the number of sperm in your
semen. For any questions or concerns about this, talk to your doctor.
Driving and using machines
Ambrisentan Viatris may cause adverse reactions such as low blood pressure, dizziness and fatigue
(see section 4), which may affect your ability to drive or use machines. The symptoms of your illness may
also make you feel unable to drive or use machines.
→ Do not drive or use machines if you do not feel well.
Ambrisentan Viatris contains lactose
Ambrisentan Viatris tablets contain a small amount of a sugar called lactose. If your doctor has told you
that you have an intolerance to certain sugars:
→ Inform your doctor before taking this medicine.
Ambrisentan Viatris contains the colouring agent called Allura Red AC aluminium lake
(E129)
It may cause allergic reactions (see section 4).
Ambrisentan Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

3. How to take Ambrisentan Viatris

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
How much Ambrisentan Viatris to take
The usual dose of Ambrisentan Viatris is one 5 mg tablet once daily. Your doctor may decide to increase the dose up to 10 mg once daily.
If you are taking cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Viatris once daily.
How to take Ambrisentan Viatris
It is best to take the tablet at the same time every day. Swallow the tablet whole with a glass of water. Do not split, break, or chew the tablet. You may take Ambrisentan Viatris with or without food.
If you take more Ambrisentan Viatris than you should
If you accidentally take too many tablets, you may 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 Ambrisentan Viatris
If you forget to take a dose of Ambrisentan Viatris, take the tablet as soon as you remember, and then continue your treatment as usual.
→ Do not take a double dose to make up for the forgotten dose.
If you stop taking Ambrisentan Viatris
Ambrisentan Viatris is a medicine you need to control Pulmonary Arterial Hypertension.
→ Do not stop taking Ambrisentan Viatris unless you have discussed it with your doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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:

• skin rash, itching, and swelling (usually of the face, lips, tongue or throat), which may cause difficulty 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 in the blood ( anaemia )

This is a very common side effect which may affect more than 1 in 10 people. It may sometimes require blood transfusion. Symptoms include:

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

Low blood pressure ( hypotension )

This is a common side effect which may affect up to 1 in 10 people. Symptoms include:

• feeling faint.

→ Tell your doctor immediately if any of these side effects occur in you (or your child) shortly after taking ambrisentan.

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 which worsens soon after starting ambrisentan treatment
• runny or stuffy nose, nasal congestion or sinus pain
• nausea
• diarrhoea
• feeling tired.

In combination with tadalafil (another medicine for PAH)

In addition to the above:

• flushing (skin redness)
• 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 ( rhinorrhoea )
• constipation
• stomach ( abdominal ) pain
• chest pain or discomfort
• flushing (skin redness)
• vomiting
• feeling weak
• nosebleeds
• skin 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
• inflammation of the liver caused by the body's own immune defences ( autoimmune hepatitis ).

Combination with tadalafil

• sudden hearing loss.

Reporting of side effects

If you get any side effects, including ones 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 Ambrisentan Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 any medicine 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 Ambrisentan Viatris contains
The active substance is ambrisentan.
Each film-coated tablet contains 5 mg or 10 mg of ambrisentan.
The other excipients are: lactose, microcrystalline cellulose (E460i), croscarmellose sodium, magnesium stearate (E570), polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol, talc (E553b), Allura Red AC aluminium lake (E129) and Indigo Carmine aluminium lake (E132).

Description of the appearance of Ambrisentan Viatris and contents of the pack
The Ambrisentan Viatris 5 mg film-coated tablet is pink, round, biconvex and marked with “M” on one side and “AN” on the other.
The Ambrisentan Viatris 10 mg film-coated tablet is pink, capsule-shaped and marked with “M” on one side and “AN1” on the other.
Ambrisentan Viatris is available in 5 mg and 10 mg film-coated tablets in packs of 30 tablets and in unit-dose blister packs of 30x1 or 60x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d., Hoeh, Benzstrasse 1, 61352 Bad
Homburg v. d. Hoehe, Germany
Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Hungary

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28116932 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél : +33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: + 386 1 236 31 80

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.