Ambrisentan Aop

Package Leaflet: Information for the User

Ambrisentan AOP, 5 mg, film-coated tablets

Ambrisentan AOP, 10 mg, film-coated tablets

Ambrisentan

Read all of 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 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 this leaflet. See section 4.

Contents of the pack

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

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

Ambrisentan AOP contains the active substance ambrisentan. It belongs to a group of medicines called endothelin receptor antagonists, which are used to treat high blood pressure.

Ambrisentan AOP is used to treat pulmonary arterial hypertension (PAH) in adults, adolescents, and children aged 8 years and older. PAH is a condition where the blood vessels in the lungs are narrowed, making it difficult for the heart to pump blood through them. This can lead to symptoms such as shortness of breath, fatigue, and swelling of the feet and ankles.

Ambrisentan AOP works by widening the blood vessels in the lungs, making it easier for the heart to pump blood through them. This can help to reduce the symptoms of PAH and improve the ability to exercise.

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

2. What you need to know before you take Ambrisentan AOP

Do not take Ambrisentan AOP

• if you are allergic to ambrisentan or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or think you might be pregnant, or if you are planning to become pregnant, as Ambrisentan AOP may harm the unborn baby
• if you are breast-feeding, as the active substance in Ambrisentan AOP may pass into breast milk
• if you have liver disease, as Ambrisentan AOP may worsen liver function
• if you have idiopathic pulmonary fibrosis (scarring of the lungs), as Ambrisentan AOP may worsen this condition

Warnings and precautions

Before taking Ambrisentan AOP, tell your doctor:

• if you have liver problems
• if you have anemia (low red blood cell count)
• if you have swelling of the feet, ankles, or hands due to fluid retention
• if you have pulmonary veno-occlusive disease (a condition where the small blood vessels in the lungs become blocked)

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

Regular blood tests are necessary

Before starting treatment with Ambrisentan AOP and at regular intervals during treatment, your doctor will perform blood tests to check for:

• anemia
• liver function

It is essential to have these blood tests done regularly while taking Ambrisentan AOP.

The following symptoms may indicate liver problems:

• loss of appetite
• nausea
• vomiting
• fever
• abdominal pain
• jaundice (yellowing of the skin and eyes)
• dark urine
• itching

If you experience any of these symptoms, contact your doctor immediately.

Children

Ambrisentan AOP should not be given to children under 8 years of age, as its safety and efficacy have not been established in this age group.

Ambrisentan AOP with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.

It may be necessary to adjust the dose of Ambrisentan AOP if you start taking cyclosporine A (a medicine used to prevent rejection after organ transplantation or to treat psoriasis).

If you are taking rifampicin (an antibiotic used to treat severe infections), your doctor will monitor you closely after the first dose of Ambrisentan AOP.

If you are taking other medicines for PAH (such as iloprost, epoprostenol, or sildenafil), your doctor may need to monitor you closely.

Pregnancy

Ambrisentan AOP may harm the unborn baby if taken during pregnancy. If you are able to become pregnant, you must use effective birth control methods while taking Ambrisentan AOP. Talk to your doctor about this.

Do not take Ambrisentan AOP if you are pregnant or think you might be pregnant.

If you become pregnant or think you might be pregnant while taking Ambrisentan AOP, contact your doctor immediately.

Breast-feeding

There is no information on the use of Ambrisentan AOP in breast-feeding women. Do not breast-feed while taking Ambrisentan AOP. Talk to your doctor about this.

Fertility

Ambrisentan AOP may reduce sperm count in men. If you have any questions or concerns, talk to your doctor.

Driving and using machines

Ambrisentan AOP may cause side effects 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 condition may also affect your ability to drive or use machines.

If you feel unwell, do not drive or use machines.

Ambrisentan AOP contains lactose, soya lecithin, and aluminum lake Allura red AC (E129) and sodium

Ambrisentan AOP tablets contain a small amount of sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ambrisentan AOP.

Ambrisentan AOP contains soya lecithin

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

3. How to take Ambrisentan AOP

Always take Ambrisentan AOP exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much Ambrisentan AOP to take

Adults

The usual dose of Ambrisentan AOP is one 5 mg tablet once a day. Your doctor may increase the dose to 10 mg once a day.

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

Adolescents and children aged 8 years and older

Your doctor may increase the dose. It is essential for children to attend regular check-ups with their doctor, as their dose may need to be adjusted based on their age or weight gain.

If you are taking cyclosporine A, the dose of Ambrisentan AOP will be limited to 2.5 mg once a day or 5 mg once a day if your weight is 50 kg or more.

How to take Ambrisentan AOP

Try to take your tablet at the same time each day. Swallow the tablet whole with a glass of water, without splitting, crushing, or chewing the tablet.

Ambrisentan AOP can be taken with or without food.

If you take more Ambrisentan AOP than you should

If you take more Ambrisentan AOP than you should, you may be more likely to experience side effects such as headache, flushing, dizziness, nausea, or low blood pressure, which can cause lightheadedness.

Contact your doctor or pharmacist if you take more Ambrisentan AOP than you should.

If you forget to take Ambrisentan AOP

If you forget to take a dose of Ambrisentan AOP, take it as soon as you remember, and then continue with your regular schedule.

Do not take a double dose to make up for a forgotten dose.

Do not stop taking Ambrisentan AOP without talking to your doctor

Ambrisentan AOP helps to control your PAH. Do not stop taking Ambrisentan AOP without talking to 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, Ambrisentan AOP can cause side effects, although not everybody gets them.

Symptoms to look out for:

Allergic reactions

This is a common side effect, which may affect up to 1 in 10 people. It may cause a rash or itching and swelling (usually on the face, lips, tongue, or throat), which can cause difficulty breathing or swallowing.

Swelling (edema), particularly of the feet and ankles

This is a very common side effect, which may affect more than 1 in 10 people.

Heart failure

This is a common side effect, which may affect up to 1 in 10 people. It may cause shortness of breath, severe fatigue, and swelling of the feet and ankles.

Anemia (low red blood cell count)

This is a very common side effect, which may affect more than 1 in 10 people. It may cause fatigue, weakness, shortness of breath, and pale skin.

Low blood pressure (hypotension)

This is a common side effect, which may affect up to 1 in 10 people. It may cause dizziness.

If you experience any of these symptoms, contact your doctor immediately.

It is essential to have regular blood tests done while taking Ambrisentan AOP to check for anemia or liver problems. Also, read the information in section 2 about regular blood tests and symptoms of liver problems.

Other side effects

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

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• worsening of shortness of breath soon after starting Ambrisentan AOP
• nasal congestion or stuffiness, sinusitis, or sinus pain
• nausea
• diarrhea
• fatigue

In combination with tadalafil (another medicine used to treat PAH)

In addition to the above:

• flushing
• vomiting
• chest pain or discomfort

Common side effects (may affect up to 1 in 10 people):

• blurred vision or other vision problems
• fainting
• abnormal liver function tests
• nasal congestion
• constipation
• abdominal pain
• chest pain or discomfort
• flushing
• vomiting
• weakness
• nosebleeds
• rash

In combination with tadalafil

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

• ringing in the ears (tinnitus) during combination therapy

Uncommon side effects (may affect up to 1 in 100 people):

• liver damage
• autoimmune hepatitis (inflammation of the liver caused by the body's immune system)

In combination with tadalafil

• sudden hearing loss

Side effects in children and adolescents

These are expected to be similar to those seen in adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the "Further information" section.

5. How to store Ambrisentan AOP

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 carton and blister after EXP.

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

White PVC/PVDC/Aluminium blister: There are no special storage precautions for this medicinal product.

Store in the original blister to protect from light.

Transparent PVC/PE/PVDC/Aluminium blister: There are no special storage precautions for this medicinal product.

Store in the original packaging to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ambrisentan AOP contains

The active substance is ambrisentan. Each film-coated tablet contains 5 mg or 10 mg of ambrisentan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, soya lecithin, Allura red AC, aluminum lake (E 129).

What Ambrisentan AOP looks like and contents of the pack

Ambrisentan AOP 5 mg are light pink, square, biconvex film-coated tablets with "5" embossed on one side and plain on the other, approximately 5.9 mm in length and width.

Ambrisentan AOP 10 mg are pink, oval, biconvex film-coated tablets with "10" embossed on one side and plain on the other, approximately 11.1 mm in length and 5.6 mm in width.

Ambrisentan AOP is available in 5 mg and 10 mg film-coated tablets, packaged in single-dose blisters containing 30 x 1 tablet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz 2

1190 Vienna

Austria

Manufacturer

Genepharm S.A.

18th Km. Marathonos Ave.

153 51, Pallini Attiki

Greece

Delorbis Pharmaceuticals Ltd.

17 Athinon str.

Ergates Industrial Area

2643 Ergates

Nicosia

Cyprus

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria

Ambrisentan AOP 5 mg, 10 mg, Filmtabletten

Croatia

Ambrisentan AOP 5 mg, 10 mg, filmom obložene tablete

Czech Republic

Ambrisentan AOP

Denmark

Ambrisentan AOP

Estonia

Ambrisentan AOP

Finland

Ambrisentan AOP 5 mg, 10 mg, tabletti, kalvopäällysteinen

Netherlands

Ambrisentan AOP 5 mg, 10 mg, filmomhulde tabletten

Lithuania

Ambrisentan AOP 5 mg, 10 mg, plėvele dengtos tabletės

Latvia

Ambrisentan AOP 5 mg, 10 mg, apvalkotās tabletes

Germany

Ambrisentan AOP 5 mg, 10 mg, Filmtabletten

Norway

Ambrisentan AOP

Poland

Ambrisentan AOP

Romania

Ambrisentan AOP 5 mg, 10 mg, comprimate filmate

Slovakia

Ambrisentan AOP 5 mg, 10 mg, filmom obalené tablety

Slovenia

Ambrisentan AOP Orphan 5 mg, 10 mg, filmsko obložene tablete

Sweden

Ambrisentan AOP 5 mg, 10 mg, filmdragerade tabletter

Hungary

Ambrisentan AOP 5 mg, 10 mg, filmtabletta

Date of last revision of the leaflet:11.2023