AMBRISENTAN AUROVITAS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ambrisentan Aurovitas 5 mg film-coated tablets EFG

Ambrisentan Aurovitas 10 mg film-coated tablets EFG

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Ambrisentan Aurovitas contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure).

It is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults, adolescents, and children aged 8 years and older. PAH consists of high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries become narrower, so the heart has to work harder to pump blood to the lungs. This makes people feel tired, dizzy, and have difficulty breathing.

Ambrisentan widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and alleviates symptoms.

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

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

Do not take Ambrisentan Aurovitas

• if you are allergic to ambrisentan, soy, or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, planning to become pregnant, or may become pregnant because you are not using a reliable method of birth control (contraceptive). Read the information in the "Pregnancy" section.
• if you are breast-feeding, read the information under the heading "Breast-feeding".
• if you have liver disease. Consult your doctor, who will decide if this medicine is suitable for you.
• if you have idiopathic pulmonary fibrosis (lung fibrosis of unknown cause).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• if you have liver problems.
• if you have anemia (reduced number of red blood cells).
• if you have swelling of the hands, ankles, or feet caused by fluid retention (peripheral edema).
• if you have a lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease).

→ Your doctor will decideif ambrisentan is suitable for you.

You will need to have blood tests on a regular basis

Before starting to take ambrisentan, and periodically while taking it, your doctor will perform blood tests to check:

• if you have anemia.
• if your liver is working correctly.

→ It is essential to have these blood tests regularly while taking ambrisentan.

The signs that your liver may not be working properly include:

• loss of appetite.
• nausea.
• vomiting.
• high temperature (fever).
• stomach pain (abdomen).
• yellowing of the skin or eyes (jaundice).
• darkening of the urine.
• itching of the skin.

If you notice any of these circumstances:

→ Tell your doctor immediately.

Children

Do not give this medicine to children under 8 years of age, as the safety and efficacy in this age group are unknown.

Other medicines and Ambrisentan Aurovitas

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

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

If you are taking rifampicin(an antibiotic used to treat severe infections), your doctor will monitor you when you start taking ambrisentan.

If you are taking other medicines for PAH (e.g., iloprost, epoprostenol, sildenafil), your doctor may need to monitor you.

→ Tell your doctor or pharmacistif you are taking any of these medicines.

Pregnancy

Ambrisentan may harm the fetus conceived before, during, or shortly after treatment.

→ If there is a possibility that you may become pregnant, use a reliable contraceptive methodwhile taking ambrisentan. Consult your doctor about this.

→ Do not take ambrisentan if you are pregnant or planning to become pregnant.

→ If you become pregnant or think you may be pregnantwhile taking ambrisentan, consult your doctor immediately.

If you are a woman of childbearing age, your doctor will ask you to have a pregnancy testbefore starting to take ambrisentan and periodically while taking this medicine.

Breast-feeding

It is unknown whether the active substance of this medicine can pass into breast milk.

→ Do not breast-feed while taking ambrisentan.Consult your doctor about this.

Fertility

If you are a man taking ambrisentan, this medicine may decrease your sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and using machines

This medicine may cause side effects such as low blood pressure, dizziness, fatigue (see section 4) that may affect your ability to drive and use machines. The symptoms of your disease may also reduce your ability to drive or use machines

→ Do not drive or use machines if you do not feel well.

Ambrisentan Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ambrisentan Aurovitas contains soy lecithin

This medicine contains soy lecithin. Do not use this medicine if you are allergic to soy (see section 2 "Do not take Ambrisentan Aurovitas").

Ambrisentan Aurovitas contains red allura AC aluminum lake (E129)

This medicine contains a colorant called red allura AC aluminum lake (E129), which may cause allergic reactions (see section 4).

Ambrisentan Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Ambrisentan Aurovitas

Follow exactly the instructions for administration of this medicine indicated by your doctor or pharmacist.If you are in doubt, consult your doctor or pharmacist again.

How much Ambrisentan Aurovitas to take

Adults

The usual dose is one 5 mg tablet, once a day. Your doctor may decide to increase your dose to 10 mg, once a day.

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

Adolescents and children from 8 years to less than 18 years of age

Your doctor may decide to increase your dose. It is essential that children attend their regular medical appointments, as their dose needs to be adjusted as they grow or gain weight.

If taken in combination with cyclosporin A, the dose of ambrisentan should be limited to 2.5 mg once a day in adolescents and children who weigh less than 50 kg or to 5 mg once a day if they weigh 50 kg or more.

How to take Ambrisentan Aurovitas

It is best to take the tablet at the same time every day. Swallow the tablet whole, with a glass of water; do not divide, crush, or chew the tablet. You can take ambrisentan with or without food.

How to remove the tablet from the blister pack

These tablets come in a special packaging to prevent children from accessing them.

1. Separate a tablet: tear along the cutting lines to separate a "blister" from the strip.

1. Open the outer layer: starting from the arrow corner, open and separate the layer along the blister.

1. Remove the tablet: gently push the tablet through the layer from one side.

If you take more Ambrisentan Aurovitas than you should

If you take too many tablets, you may be more likely to have side effects, such as headache, flushing, dizziness, nausea, or low blood pressure, which can cause a mild feeling of dizziness:

→ Ask your doctor or pharmacist for adviceif you take more tablets than prescribed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ambrisentan Aurovitas

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

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

If you stop taking Ambrisentan Aurovitas

Ambrisentan is a treatment that you will need to continue taking to control your PAH.

→ Do not stop taking ambrisentan unless your doctor tells you to.

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, although not everybody gets them.

Serious side effects

Tell your doctorif you have any of these:

Allergic reactions

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

• a rash or itching and swelling (usually of the face, lips, tongue, or throat), which can cause difficulty breathing or swallowing.

Swelling (edema), especially of the ankles and feet

This is a very frequent side effect that may affect more than 1 in 10people.

Heart failure

This is because the heart does not pump enough blood. This is a frequent side effect that may affect up to 1 in 10people. The symptoms include:

• difficulty breathing.
• extreme tiredness.
• swelling in the ankles and legs.

Reduced number of red blood cells (anemia)

This is a very frequent side effect that may affect more than 1 in 10people. Sometimes this requires a blood transfusion. The symptoms include:

• tiredness and weakness.
• difficulty breathing.
• general discomfort.

Low blood pressure (hypotension)

This is a frequent side effect that may affect up to 1 in 10people. The symptoms include:

• dizziness.

→ Tell your doctor immediatelyif you (or your child) experience these effects or if they occur suddenly after taking ambrisentan.

It is essential to have regular blood teststo check if you have anemia and that your liver is working correctly. Make sure you have also read the information in section 2about "the need for regular blood tests" and "signs that your liver may not be working properly".

Other side effects:

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

• headache.
• dizziness.
• palpitations (rapid or irregular heartbeats).
• difficulty breathing that worsens shortly after starting to take ambrisentan.
• runny nose or stuffy nose, congestion or pain in the nasal sinuses.
• nausea.
• diarrhea.
• feeling of tiredness.

In combination with tadalafil (another medicine for PAH)

In addition to the above:

• flushing (redness of the skin).
• vomiting.
• chest pain or discomfort.

Common(may affect up to 1 in 10people)

• blurred vision or other changes in vision.
• fainting.
• abnormal results in blood tests for liver function.
• increased nasal secretion.
• constipation.
• stomach pain (abdomen).
• chest pain or discomfort.
• flushing (redness of the skin).
• vomiting.
• feeling of weakness.
• nosebleeds.
• skin rash.

In combination with tadalafil

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

• ringing in the ears (tinnitus).

Uncommon(may affect up to 1 in 100people)

• liver damage.
• inflammation of the liver caused by the body's own defenses (autoimmune hepatitis).

In combination with tadalafil

• sudden loss of hearing.

Side effects in children and adolescents

These are expected to be similar to those listed above for adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ambrisentan Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Ambrisentan Aurovitas

• The active ingredient is ambrisentan.

Ambrisentan Aurovitas 5 mg film-coated tablets EFG

Each film-coated tablet contains 5 mg of ambrisentan.

Ambrisentan Aurovitas 10 mg film-coated tablets EFG

Each film-coated tablet contains 10 mg of ambrisentan.

• The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Coating:polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, soy lecithin (E322), and Allura Red AC (3%-5% for the 5 mg dose and 15%-17% for the 10 mg dose).

Appearance of the Product and Packaging Contents

Ambrisentan Aurovitas 5 mg film-coated tablets EFG

Film-coated tablets are pale pink, square, approximately 6.9 mm, biconvex, with the mark “AS” on one face and “5” on the other.

Ambrisentan Aurovitas 10 mg film-coated tablets EFG

Film-coated tablets are dark pink, oval, approximately 9.8 × 4.9 mm, biconvex, with the mark “AS” on one face and “10” on the other.

Ambrisentan Aurovitas 5 mg and 10 mg film-coated tablets EFG are available in blister packs of 10, 30, 60, 90, and 120 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Germany: AmbriPUREN 5 mg/10 mg Filmtabletten

Belgium: Ambrisentan AB 5 mg/10 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Spain: Ambrisentán Aurovitas 5 mg/10 mg film-coated tablets EFG

France: AMBRISENTAN ARROW 5 mg/10 mg, comprimé pelliculé

Netherlands: Ambrisentan Aurobindo 5 mg/10 mg, filmomhulde tabletten

Portugal: Ambrisentano Generis

Date of the Last Revision of this Leaflet:September 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).