Ambrisentan Aop

Leaflet accompanying the packaging: information for the user

Ambrisentan AOP, 5 mg, film-coated tablets

Ambrisentan AOP, 10 mg, film-coated tablets

Ambrisentan

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Ambrisentan AOP contains the active substance ambrisentan. It belongs to a group of medicines called antihypertensives (used to treat high blood pressure). This medicine is used to treat pulmonary arterial hypertension (PAH) in adults, adolescents, and children aged 8 years and older. PAH means high blood pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries become narrowed, making it harder for the heart to pump blood through them. This causes symptoms such as fatigue, dizziness, and shortness of breath. Ambrisentan AOP widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and alleviates symptoms. Ambrisentan AOP can also be used in combination with other medicines used to treat PAH.

2. Important information before taking Ambrisentan AOP

When not to take Ambrisentan AOP

• if you are allergic to ambrisentan, soy, or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant, plan to become pregnant, or may become pregnant, as you are not using effective birth control methods. You should read the information in the "Pregnancy" section,
• if you are breastfeeding. You should read the information in the "Breastfeeding" section,
• in case of liver disease. In this case, you should discuss it with your doctor, who will decide if this medicine is suitable for you,
• if you have idiopathic pulmonary fibrosis (scarring of the lungs of unknown cause).

Warnings and precautions

Before taking Ambrisentan AOP, you should discuss it with your doctor:

• if you have liver function disorders,
• if you have anemia (reduced red blood cell count),
• if you have swelling of the hands, feet, or ankles due to fluid retention (peripheral edema),
• if you have a lung disease that blocks the blood vessels in the lungs (pulmonary veno-occlusive disease).

→ Your doctor will decideif Ambrisentan AOP is suitable for you. Regular blood tests are necessary Before starting treatment with Ambrisentan AOP and at regular intervals during its use, your doctor will order blood tests to check if:

• you have anemia,
• your liver function is normal.

→ It is essential to regularly perform the above blood tests while taking Ambrisentan AOP. The following symptoms indicate liver function disorders:

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

If you notice any of these symptoms:
→ You should contact your doctor immediately.

Children

This medicine should not be given to children under 8 years of age, as its safety and efficacy have not been evaluated in this age group.

Ambrisentan AOP and other medicines

You should tell your doctor or pharmacistabout all medicines you are taking or have recently taken, as well as any medicines you plan to take. It may be necessary to adjust the dose of Ambrisentan AOP if you start taking cyclosporin A (a medicine used after transplants or to treat psoriasis). If you are taking rifampicin (an antibiotic used to treat severe infections), your doctor will monitor you after the first use of Ambrisentan AOP. If you are taking other medicines used to treat PAH (e.g., iloprost, epoprostenol, sildenafil), it may be necessary to monitor your condition. → You should inform your doctor or pharmacistif you are taking these medicines.

Pregnancy

Ambrisentan AOP may harm the unborn baby if conceived before, during, or shortly after treatment.
→ In case of potential pregnancy, you should use effective birth control methodswhile taking Ambrisentan AOP. You should discuss this with your doctor. → Do not take Ambrisentan AOP if you are pregnant or plan to become pregnant.
→ In case of pregnancy or suspected pregnancy while taking Ambrisentan AOP, you should contact your doctor immediately.

Ambrisentan AOP and pregnancy testing

Your doctor will ask you to perform a pregnancy test before starting Ambrisentan AOP and will recommend regular testing during treatment.

Breastfeeding

There is no data on the passage of Ambrisentan AOP into human milk.
→ You should not breastfeed while taking Ambrisentan AOP. You should discuss this with your doctor.

Effects on fertility

In men taking Ambrisentan AOP, it is possible that this medicine may cause a decrease in sperm count. You should discuss this with your doctor if you have any questions or concerns.

Driving and using machines

Ambrisentan AOP may cause side effects such as low blood pressure, dizziness, fatigue (see section 4), which may affect your ability to drive and use machines. The symptoms of your disease may also negatively affect your ability to drive and use machines.
→ If you feel unwell, you should not drive or use machines.

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

The film-coated tablets of Ambrisentan AOP contain small amounts of sugar called lactose. If you have been diagnosed with intolerance to some sugars:
→ You should contact your doctor before taking Ambrisentan AOP.

The film-coated tablets of Ambrisentan AOP contain soy lecithin.

In case of soy allergy, you should not take this medicine (see section 2 "When not to take Ambrisentan AOP").
The film-coated tablets of Ambrisentan AOP contain aluminum lake red Allura AC (E129), which may cause allergic reactions (see section 4). This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Ambrisentan AOP

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.If you are unsure, you should ask 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 cyclosporin A, you should not take more than one 5 mg tablet of Ambrisentan AOP per day.

Adolescents and children aged 8 years and older

Your doctor may decide to increase the dose. It is essential that children attend regular check-ups with their doctor, as their dose may need to be adjusted based on age or weight gain. If Ambrisentan AOP is used in combination with cyclosporin A, the dose of Ambrisentan AOP in adolescents and children with a body weight below 50 kg will be limited to 2.5 mg once a day or 5 mg once a day if the patient's body weight is 50 kg or more.

How to take Ambrisentan AOP

You should try to take the tablet at the same time every day. The tablet should be swallowed whole, with a glass of water, without dividing, crushing, or chewing the tablet. Ambrisentan AOP can be taken with or without food.

Taking a higher dose of Ambrisentan AOP than recommended

If you take more than the recommended dose of the medicine, you are more likely to experience side effects, such as headache, flushing, dizziness, nausea, or low blood pressure, which may cause a feeling of emptiness in the head:
→ You should consult your doctor or pharmacistif you have taken more tablets than recommended.

Missing a dose of Ambrisentan AOP

If you miss a dose of Ambrisentan AOP, you should take it as soon as possible, and then continue treatment as before.
→ You should not take a double dose to make up for a missed dose.

Do not stop taking Ambrisentan AOP without consulting your doctor.

Ambrisentan AOP should be taken regularly, as it helps control your pulmonary arterial hypertension.
→ Do not stop taking Ambrisentan AOP without discussing it with your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ambrisentan AOP can cause side effects, although not everybody gets them.

Symptoms that you and your doctor should pay special attention to:

Allergic reactions

This symptom is common, may occur in less than 1 in 10patients. It may cause rash or itching and swelling (usually on the face, lips, tongue, or throat), which may cause difficulty breathing or swallowing.

Swelling (edema), particularly of the ankles and feet

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

Heart failure

This symptom is due to the heart not pumping enough blood, causing shortness of breath, severe fatigue, and swelling of the ankles and feet. This is a common side effect, which may occur in less than 1 in 10patients.

Anemia (reduced red blood cell count)

This is a blood disorder that may cause fatigue, weakness, shortness of breath, and malaise. Sometimes it may require blood transfusion. This is a very common side effect, which may occur in more than 1 in 10patients.

Low blood pressure (hypotension)

This symptom may cause dizziness. This is a common side effect, which may occur in less than 1 in 10patients.
→ You should contact your doctor immediatelyif you experience these symptoms or if they occur suddenly after taking Ambrisentan AOP.
It is essential to regularly perform blood teststo detect potential anemia or liver function disorders. You should also read the information in section 2"Regular blood tests" and "The following symptoms indicate liver function disorders".

Other side effects include

Very common side effects (may occur in more than 1 in 10 patients):

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• worsening of shortness of breath shortly after starting treatment with Ambrisentan AOP
• nasal congestion or stuffy nose, 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 occur in less than 1 in 10 patients):

• blurred vision or other vision disturbances
• fainting
• abnormal liver function test results
• nasal congestion
• constipation
• abdominal pain
• chest pain or discomfort
• flushing
• vomiting
• weakness
• nasal bleeding
• rash.

In combination with tadalafil

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

• ringing in the ears (tinnitus) only during combination therapy.

Uncommon side effects (may occur in less than 1 in 100 patients):

• liver damage
• autoimmune hepatitis (liver inflammation 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 the side effects listed above for adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ambrisentan AOP

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date (EXP). The expiry date refers to the last day of the month. White PVC/PVDC/Aluminum blister: There are no special storage instructions for the medicinal product. Store in the original blister to protect from light. Transparent PVC/PE/PVDC/Aluminum blister: There are no special storage instructions for the medicinal product. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ambrisentan AOP contains

The active substance of Ambrisentan AOP 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, soy lecithin, Allura red AC aluminum lake (E 129).

What Ambrisentan AOP looks like and contents of the pack

Ambrisentan AOP, 5 mg are pink, square, biconvex film-coated tablets with "5" embossed on one side and smooth on the other, with a nominal length and width of about 5.9 mm. Ambrisentan AOP, 10 mg are pink, oval, biconvex film-coated tablets with "10" embossed on one side and smooth on the other, with a nominal length of about 11.1 mm and a nominal width of about 5.6 mm. Ambrisentan AOP is available in 5 mg and 10 mg strengths, film-coated tablets are packaged in unit dose blisters containing 30 x 1 tablet.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized 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