InfoCons Consumer Protection informs you – Ambrisentan Viatris – Package Leaflet

Before anything else

Read all of this 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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in thi s leaflet. See section 4.

ℹ️ 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 to treat high blood pressu re).

It is used to treat pulmonary art erial hypertension (PAH) in ad ults. PAH is high blood pressure in the blood vessels (the pulm onary arteries) that carry blood from th e heart to the lung s. In people with PAH, these arteries get narrower, so the heart has to work hard er to pump blood through them. This causes people to feel tired, dizzy and short of breath.

Ambrisentan Viatris widens the p ulmonary arteries, making it ea sier for the heart to pump blood through them.

This lowers the blood pressure and relieves the symptoms.

Ambrisentan Viatris may also be used in combination with other medicines used to treat PAH.

⚠️ 2. What you need to know before you take A mbrisentan Viatris

Do not take Ambrisentan Viatris

• if you are allergic to ambrisentan or any of the oth er ingredients of this medicin e (listed in section 6).
• if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraceptio n). Please read the information under ‘Pregnancy’ – if you are breast feeding. Read the information under ‘Breast-feeding’
• if you have liver disease. Talk to your doctor, who will d ecide whether this medicine is suitable for you
• if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).

33 Warnings and precautions Talk to your doctor, pharmacist o r nurse before taking this med icine if you have:  liver problems  anaemia (a reduced number of red blood cells)  swelling in the hands, ankles or feet cause d by fluid (peripheral oedema)  lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease) .

Your doctor will decide whether Ambrisentan Viatr is is suitable for you.

You will need regular blood tests Before you start takin g Ambrisentan Viatris, and at regular int ervals while you ar e taking it, your doctor will take blood tests to check:  whether you have anaemia  whether your liver is working properly. → It is important that you have these regular blood tests for a s long as you are taking Ambrisentan Viatris.

Signs that your liver may not be working properly include:  loss of appetite  feeling sick (nausea)  being sick (vomiting)  high temperature (fever)  pain in your stomach (abdomen)  yellowing of your skin or the whites of your eyes (jaundice)  dark-coloured urine  itching of your skin.

If you notice any of these signs: → Tell your doctor immediately.

Children and adolescents

Ambrisentan Viatris is not recommended for children and adolesc ents aged under 18 years as the safety and effectiveness is not known in this age group.

Other medicines and Ambrisentan Viatris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis), your doctor may need to adjust your dose of Ambrisentan Viatris.

If you are taking rifampicin (an antibiotic used to treat se rious infections), your doctor will monitor you when you first start tak ing Ambrisentan Viatris.

If you are taking other medicines used to treat PAH (e.g. ilopr ost, 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 may harm unborn babies conceived before, du ring or soon after treatment. → If it is possible you could become pregnant, use a reliable for m of birth control (contraception) while you are tak ing Ambrisentan Viatris. Talk to your doctor a bout this. → Don’t take Ambrisentan Viatris i f you are pregnant or planning to become pregnant. → If you become pregnant or think that you may be pregnant while you are tak ing Ambrisentan Viatris, see your docto r immediately .

If you are a woman wh o could become pregna nt, your doctor will ask you to take a pregnancy test before you start taking Ambrise ntan Viatris and regularly whil e you are taking this medicine.

Breast-feeding

It is not known if the active substance of A mbrisentan Viatris can pass into breast milk. → Don’t breast-feed while you are taking Ambrisentan Viatris. Talk t o your doctor about this.

Fertility

If you are a man taking Ambrisen tan Viatris, it is possible tha t this medicine may lower your sperm count. Talk to your doctor if you have any questions or concern s about this.

Driving and using machines Ambrisentan Viatris may cause side effects, such as low blood p ressure, dizziness, tiredness (see section 4), that may affect your ability to drive or use machin es. The symptoms of your condition can also make you less fit to drive or use machines. → Don’t drive or use machine s if you are f eeling unwell.

Ambrisentan Viatris contains lactose

Ambrisentan Viatris tablets contain small amounts of a sugar ca lled lactose. If you have been told by your doctor that you have an intolerance to some sugars: → Contact your doctor before taking this medicinal product.

Ambrisentan Viatris contains a c olouring agent c alled Allura re d AC Aluminium Lake (E129) This may cause allergic r eactions (see section 4).

Ambrisentan Viatris contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tabl et, that is to say essentially ‘sodium- free’.

💊 3. How to take Ambrisentan Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much Ambrisentan Viatris to take The usual dose of Ambrisentan Vi atris 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 cyclosporine A, do not take more than one 5 mg tabl et of Ambrisentan Viatris once a day.

How to take Ambrisentan Viatris It is best to take your tablet at the same time each day. Swall ow the tablet whole, with a glass of water, do not split, crush or chew the t ablet. You can take Ambrisenta n Viatris with or without food.

If you take more Ambrisentan Viatris than you should

If you take too many tablets you may be more likely to have sid e effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that co uld cause light-headedness: → Ask your doctor or pharmacist for advice if you take more tabl ets than prescribed .

If you forget to take Ambrisentan Viatris

If you forget a dose of Ambrisen tan Viatris, just take the tabl et as soon as you remember, then carry on as before. → Don’t take a double dose at the same time to make up for a fo rgotten dose

If you stop taking Ambrisentan Viatris

Ambrisentan Viatris is a treatme nt that you will need to keep o n taking to control your PAH. →Don’t stop taking Ambrisentan Viatris unless you have agreed t his with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. Possible side effects

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

Serious side effects

Tell your doctor if you get any of these:

Allergic reactions This is a common side effect that may affect up to 1 in 10 people. You may notice:

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

Swelling ( oedema ), especially of the ankles and feet This is a very common side effect that may affect more than 1 in 10 people.

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

• shortness of breath
• extreme tiredness • swelling in the a nkles and legs.

Reduced number of red blood cells ( anaemia ) This is a very common side effect that may affect more than 1 in 10 people. Sometimes this requires a blood transfusion. Symptoms include:

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

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

• light-headedness.

→ Tell your doctor straight away if you (or your child) get these effects or if they happen sud denly after taking ambrisentan.

It is important to have regular blood tests , to check for anaemia and that your liver is working properly. Make sure that you have also read the information in section 2 under ‘You will need regular blood tests’ and ‘Signs that your liver may not be work ing properly’.

36 Other side effects

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

• headache
• dizziness
• palpitations (fast or ir regular heart beats)
• shortness of breat h getting worse shortly after starting ambr isentan
• a runny or blocked nose, conge stion or pain in the sinuses
• feeling sick ( nausea )
• diarrhoea
• feeling tired.

In combination with tadala fil (another PAH medicine) In addition to the above: • flushing (redness of the skin) • being sick ( vomiting )

• chest pain/discomfort.

Common (may affect up to 1 in 10 people)

• blurry or other changes to vision • fainting
• abnormal blood test re sults for liver function
• a runny nose
• constipation
• pain in your stomach ( abdomen )
• chest pain or discomfort • flushing (redness of the skin)
• being sick ( vomiting )
• feeling weak
• nose bleed
• rash.

In combination with tadalafil In addition to the above, (excep t abnormal blood test results f or liver function):

• ringing in the ears ( tinnitus ).

Uncommon (may affect up to 1 in 100 people)

• liver injury • inflammation of the liver caused by the body’s own defences ( autoimmune hepatitis ).

In combination with tadalafil

• sudden hearing loss.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This include s any possible side effects not listed in this leafle t. You can also report side ef fects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more informati on 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 t he expiry date which is stated on the carton after EXP.

The expiry date refers to the last day of that month.

37 This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household was te. Ask your pharmacist how to throw away medicines y ou no longer use. The se measures will hel p protect the environment.

📦 6. Contents of the pack and other information

What Ambrisentan Viatris contains

The active substance is ambrisentan.

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

The other ingredients are: lact ose, microcrystalline cellulose (E460i), croscarmellose sodium, magnesium stearate (E570), polyvinyl alcohol (partly hydrolysed ), titanium dioxide (E171), macrogol, talc (E553b), allura r ed AC aluminium lake (E129) and indigo ca rmine aluminium lake (E132).

What Ambrisentan Viatris looks like and contents of the pack

Ambrisentan Viatris 5 mg film-coated tablet is a pink round bic onvex tablet engraved with ‘M’ on one side and ‘AN’ on the other side.

Ambrisentan Viatris 10 mg film-coated tablet is a pink, capsule shaped tablet engraved with ‘M’ on one side of the tablet and ‘AN1’ on the other side. Ambrisentan Viatris is supplied as 5 mg and 10 mg film-coated t ablets in packs of 30 tablets and unit dose blister packs of 30×1 tablets or 60 x1 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 any information about this m edicine, please contact the loc al representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Viatris Tél/Tel: + 32 (0)2 658 61 00 Lietuva Viatris UAB Tel: +370 5 205 1288 38 България Майлан ЕООД Тел: +359 2 44 55 400 Luxembourg/Luxemburg Viatris Tél/Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) Česká republika Viatris CZ s.r.o.

Tel: + 420 222 004 400 Magyarország Viatris Healthcare Kft.

Tel.: + 36 1 465 2100 Danmark Viatris ApS Tlf: + 45 28116932 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Deutschland Viatris Healthcare GmbH Tel: + 49 800 0700 800 Nederland Mylan BV Tel: +31 (0)20 426 3300 Eesti Viatris OÜ Tel: + 372 6363 052 Norge Viatris AS Tlf: + 47 66 75 33 00 Ελλάδα Viatris Hellas Ltd Τηλ: +30 2100 100 002 Österreich Viatris Austria GmbH Tel: +43 1 86390 España Viatris Pharmaceuticals, S.L.

Tel: + 34 900 102 712 Polska Viatris Healthcare Sp. z.o.o.

Tel.: + 48 22 546 64 00 France Viatris Santé Tél : +33 4 37 25 75 00 Portugal Mylan, Lda.

Tel: + 351 214 127 200 Hrvatska Viatris Hrvatska d.o.o.

Tel: +385 1 23 50 599 România BGP Products SRL Tel: +40 372 579 000 Ireland Viatris Limited Tel: +353 1 8711600 Slovenija Viatris d.o.o.

Tel: + 386 1 23 63 180 Ísland Icepharma hf.

Sími: +354 540 8000 Slovenská republika Viatris Slovakia s.r.o.

Tel: +421 2 32 199 100 Italia Viatris Italia S.r.l.

Tel: + 39 (0) 2 612 46921 Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9555 Κύπρος GPA Pharmaceuticals Ltd Τηλ: +357 22863100 Sverige Viatris AB Tel: +46 (0)8 630 19 00 Latvija Viatris SIA Tel: +371 676 055 80 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600 This leaflet was last revised in.

Detailed information on this medicine is available on the Europ ean Medicines Agency web site: http://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Ambrisentan Viatris (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1368).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.