Ambrisentan Zentiva

Package Leaflet: Information for the Patient

Ambrisentan Zentiva, 5 mg, film-coated tablets

Ambrisentan Zentiva, 10 mg, film-coated tablets

Ambrisentan

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should 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 and other information

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

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

Ambrisentan Zentiva 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 Zentiva 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 pressure in the vessels that carry blood from the heart to the lungs is too high. In patients with PAH, these vessels become narrowed, making it difficult for the heart to pump blood through them. This can lead to symptoms such as fatigue, dizziness, and shortness of breath.

Ambrisentan Zentiva widens the blood vessels in the lungs, making it easier for the heart to pump blood through them. This can help to reduce the blood pressure and alleviate symptoms.

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

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

When not to take Ambrisentan Zentiva

Do not take Ambrisentan Zentiva:

• if you are allergic to ambrisentan, peanuts, soya, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, or if you are planning to become pregnant, or if you could become pregnant unless you are using a reliable method of contraception. See the information in the section "Pregnancy";
• if you are breast-feeding. See the information in the section "Breast-feeding";
• if you have liver disease. In this case, you should discuss this with your doctor, who will decide whether this medicine is suitable for you;
• if you have idiopathic pulmonary fibrosis (scarring of the lungs with unknown cause).

Warnings and precautions:

Before taking this medicine, tell your doctor:

• if you have liver problems
• if you have anaemia (reduced red blood cell count)
• if you have swelling of the hands, feet, or ankles due to fluid retention (peripheral oedema)
• if you have a disease of the lungs that blocks the blood vessels in the lungs (pulmonary veno-occlusive disease). Your doctor will decide whether Ambrisentan Zentiva is suitable for you.

Regular blood tests are necessary

Before starting treatment with Ambrisentan Zentiva, and at regular intervals while taking it, your doctor will order blood tests to check for:

• anaemia
• liver function.

It is essential to have these blood tests while taking Ambrisentan Zentiva.

The following symptoms may indicate liver problems:

• loss of appetite
• nausea (feeling sick)
• vomiting
• high temperature (fever)
• stomach pain (abdominal pain)
• yellowing of the skin or eyes (jaundice)
• dark urine
• itching of the skin. If you notice any of these symptoms, you should contact your doctor immediately.

Children

Do not give this medicine to children under 8 years old, as the safety and efficacy of Ambrisentan Zentiva in this age group have not been established.

Other medicines and Ambrisentan Zentiva

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

Your doctor may need to adjust the dose of Ambrisentan Zentiva 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 dose of Ambrisentan Zentiva.

If you are taking other medicines for PAH (such as iloprost, epoprostenol, sildenafil), you may need to be monitored.

Tell your doctor or pharmacistif you are taking these medicines.

Pregnancy

Ambrisentan Zentiva may harm the unborn baby if taken during pregnancy.

If you can become pregnant, you must use reliable contraceptionwhile taking Ambrisentan Zentiva. Talk to your doctor about this.

Do not take Ambrisentan Zentiva if you are pregnant or planning to become pregnant.

If you become pregnant or think you may be pregnant while taking Ambrisentan Zentiva, you must contact your doctor immediately.

In women who can become pregnant, your doctor will advise you to have a pregnancy test

before starting Ambrisentan Zentiva and regularly while taking it.

Breast-feeding

There is no information on the passage of ambrisentan into breast milk.

Do not breast-feed while taking Ambrisentan Zentiva.Talk to your doctor about this.

Fertility

In men taking Ambrisentan Zentiva, it is possible that the medicine may reduce sperm count.

Talk to your doctor if you have any questions or concerns.

Driving and using machines

Ambrisentan Zentiva 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.

Your condition may also affect your ability to drive or use machines.

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

Ambrisentan Zentiva contains lactose monohydrate, soya lecithin, and the colouring Allura Red AC (E 129)

If you have an intolerance to some sugars, talk to your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, so it is essentially "sodium-free".

This medicine contains soya lecithin. If you are allergic to peanuts or soya, do not take this medicine.

This medicine contains the colouring Allura Red AC (E 129), which may cause allergic reactions (see section 4).

3. How to take Ambrisentan Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, ask your doctor or pharmacist.

How much Ambrisentan Zentiva to take

Adults

The usual dose of Ambrisentan Zentiva is one 5 mg tablet per day.

Your doctor may increase the dose to 10 mg (2 x 5 mg tablets or 1 x 10 mg tablet) per day.

If you are taking cyclosporin A, do not take more than one 5 mg tablet of Ambrisentan Zentiva per day.

Children and adolescents from 8 years to less than 18 years

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 as they grow or gain weight.

If Ambrisentan Zentiva is taken with cyclosporin A, the dose of Ambrisentan Zentiva will be limited to 2.5 mg per day in adolescents and children weighing less than 50 kg or 5 mg per day in patients weighing 50 kg or more.

If a dose of 2.5 mg is required, another product available on the market should be used.

How to take Ambrisentan Zentiva

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.

Ambrisentan Zentiva can be taken with or without food.

If you take more Ambrisentan Zentiva than you should

If you take more Ambrisentan Zentiva 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:

Talk to a doctor or pharmacist if you have taken more Ambrisentan Zentiva than you should.

If you forget to take Ambrisentan Zentiva

If you forget to take a dose of Ambrisentan Zentiva, take it as soon as you remember, and then continue as before.

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

If you stop taking Ambrisentan Zentiva

Ambrisentan Zentiva should be taken regularly to help control your pulmonary arterial hypertension.

Do not stop taking Ambrisentan Zentiva without talking to your doctor first.

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

4. Possible side effects

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

Severe side effects

Tell your doctor if you experience any of the following symptoms:

Allergic reactions

These are common side effects that may occur in up to 1 in 10 people. You may experience a rash or itching and swelling (usually of the face, lips, tongue, or throat), which can cause difficulty breathing and swallowing.

Swelling, particularly of the ankles and feet

This is a very common side effect that may occur in more than 1 in 10 people.

Heart failure

This symptom occurs when the heart does not pump enough blood, leading to shortness of breath, severe fatigue, and swelling of the ankles and feet. This is a common side effect that may occur in up to 1 in 10 people.

Anaemia (reduced red blood cell count)

This is a condition that can cause fatigue, weakness, shortness of breath, and feeling unwell. Sometimes, it can lead to the need for a blood transfusion. This is a very common side effect that may occur in more than 1 in 10 people.

Low blood pressure

This symptom can cause dizziness. This is a common side effect that may occur in up to 1 in 10 people.

Tell your doctor immediatelyif you or your child experience any of these symptoms or if they occur suddenly after taking Ambrisentan Zentiva.

It is essential to have regular blood teststo check for anaemia or liver problems.

Also, read the information in section 2"Regular blood tests" and "The following symptoms may indicate liver problems".

Other side effects

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

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• worsening shortness of breath soon after starting Ambrisentan Zentiva
• nasal congestion or stuffy nose, sinusitis
• nausea
• diarrhoea
• fatigue

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

In addition to the above:

• flushing (redness of the skin)
• nausea, vomiting
• chest pain/discomfort

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

• blurred vision or other vision disturbances
• fainting
• abnormal liver function tests
• nasal congestion
• constipation
• stomach pain (abdominal pain)
• chest pain/discomfort
• flushing (redness of the skin)
• nausea (vomiting)
• weakness
• nosebleeds
• rash

In combination with tadalafil

In addition to the above, apart from unusual blood test results for liver function:

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

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

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

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

Side effects can also be reported to the Marketing Authorisation Holder or its representative in Poland.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ambrisentan Zentiva

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 blisters: PVC/PVDC/Aluminium blisters

No special storage precautions are necessary.

Store in the original blister to protect from light.

Transparent blisters: PVC/PE/PVDC/Aluminium blisters

No special storage precautions are necessary.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Ambrisentan Zentiva contains

The active substance is ambrisentan.

Ambrisentan Zentiva 5 mg film-coated tablets

Each film-coated tablet contains 5 mg of ambrisentan.

Ambrisentan Zentiva 10 mg film-coated tablets

Each film-coated tablet contains 10 mg of ambrisentan.

The other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate; coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (polyethylene glycol) (E1521), talc, Allura Red AC (E 129), soya lecithin (E 322).

What Ambrisentan Zentiva looks like and contents of the pack

Ambrisentan Zentiva 5 mg film-coated tablets

Pale pink, square, biconvex film-coated tablets with "5" engraved on one side, plain on the other, approximately 5.9 mm in length/diameter.

Ambrisentan Zentiva 10 mg film-coated tablets

Pink, oval, biconvex film-coated tablets with "10" engraved on one side, plain on the other, approximately 11.1 mm in length and 5.6 mm in width.

Pack sizes: cardboard boxes containing blisters of 10 or 30 film-coated tablets or single-dose blisters of 10 x 1 or 30 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Delorbis Pharmaceuticals Ltd. Athinon 17, Ergates Industrial Area, 2643 Ergates, Nicosia, Cyprus

Genepharm S.A, 18 km Marathonos Avenue, 153 51 Pallini Attiki, Greece

For more information on this medicine, including its other names, please contact the Marketing Authorisation Holder or its representative in Poland:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

tel.: +48 22 375 92 00

Date of last revision of the leaflet:March 2022