Prospect: information for the user

Ambrisentán Aurovitas 5 mg film-coated tablets

Ambrisentán Aurovitas 10 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Ambrisentán Aurovitas

3.How to take Ambrisentán Aurovitas

4.Possible adverse effects

5.Storage of Ambrisentán Aurovitas

6.Contents of the package and additional information

Ambrisentán Aurovitascontains the active ingredient ambrisentán. It belongs to a group of medications 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 8 years of age and older. PAH consists of elevated blood pressure in the blood vessels (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 causes people to feel tired, dizzy, and short of breath.

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

Ambrisentánmay also be used in combination with other medications used to treat PAH.

Do not take Ambrisentán Aurovitas

•if you areallergicto ambrisentán, soybean, or any of the other ingredients of this medication (listed in section 6).

•if you are pregnant, or if you areplanning to become pregnant, or if you may become pregnant because you are not using a reliable method of birth control (contraceptive). Read the information under the heading “Pregnancy”.

•if you arebreastfeeding, read the information under the heading “Breastfeeding”.

•if you haveliver disease. Consult your doctor, who will decide if this medication is suitable for you.

•if you haveidiopathic pulmonary fibrosis, a type of lung disease.

Warnings and precautions

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

•if you have liver problems.

•if you have anemia (a reduction in the 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 ambrisentán is suitable for you.

You will need to have regular blood tests

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

•if you have anemia.

•if your liver is functioning correctly.

→ It is important to have these blood tests regularly while taking ambrisentán.

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

•loss of appetite.

•nausea.

•vomiting.

•high temperature (fever).

•abdominal pain.

•yellowing of the skin or eyes (jaundice).

•darkening of the urine.

•itching of the skin.

If you notice any of these circumstances:

→Inform your doctor immediately.

Children

Do not administer this medication to children under 8 years of age, as its safety and efficacy in this age group are unknown.

Other medications and Ambrisentán Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you start takingciclosporina A(a medication used after a transplant or to treat psoriasis), your doctor may need to adjust your dose of ambrisentán.

If you are takingrifampicina(an antibiotic used to treat serious infections), your doctor will monitor you when you start takingambrisentán.

If you are taking other medications to treat pulmonary arterial hypertension (PAH) (e.g., iloprost, epoprostenol, sildenafilo), your doctor may need to monitor you.

→ Inform your doctor or pharmacistif you are taking any of these medications.

Pregnancy

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

→If there is a possibility of becoming pregnant, use a reliable method of birth control while taking ambrisentán. Consult your doctor about this.

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

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

→If you are a woman of childbearing age, your doctor will ask you to have a pregnancy test before starting ambrisentán and periodically while taking it.

Breastfeeding

The active ingredient of this medication may pass into breast milk.

→Do not breastfeed while taking ambrisentán..Consult your doctor about this.

Fertility

If you are a man taking ambrisentán, it is possible that this medication may decrease your sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and operating machinery

This medication may cause side effects such as low blood pressure, dizziness, and fatigue (see section 4) that may affect your ability to drive and operate machinery. Your symptoms may also reduce your ability to drive or operate machinery.

→Do not drive or operate machinery if you do not feel well.

Ambrisentán Aurovitas contains lactose

If your doctor has told you that you have intolerance to certain sugars, consult with them before taking this medication.

Ambrisentán Aurovitas contains lecithin (from soy)

This medication contains soy-derived lecithin. Do not use this medication if you are allergic to soy (see section 2 “Do not take Ambrisentán Aurovitas”).

Ambrisentán Aurovitas contains red iron oxide E129

This medication contains a colorant called red iron oxide E129, which may cause allergic reactions (see section 4).

Ambrisentán Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

How muchAmbrisentán Aurovitasto 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 take ciclosporina A, do not take more than one 5 mg tablet ofambrisentán, once a day.

Adolescents and children from 8 years to under 18 years of age

Your doctor may decide to increase your dose. It is important 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 ciclosporina A, the dose ofambrisentánshould be limited to 2.5 mg once a day in adolescents and children weighing less than 50 kg, or 5 mg once a day if they weigh 50 kg or more.

How to takeAmbrisentán 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 takeambrisentánwith or without food.

How to remove the tablet from the blister

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

1. Separate a tablet:tear along the cutting lines to separate a “cell” from the strip.

2. Open the outer sheet: starting from the corner of the arrow, open and separate the sheet along the cell.

3. Remove the tablet:gently push the tablet through the sheet from one side.

If you take more Ambrisentán Aurovitas than you should

If you take too many tablets, you may be more prone to side effects, such as headaches, hot flushes, dizziness, nausea or low blood pressure, which can cause a mild sensation 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 Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ambrisentán Aurovitas

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

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

If you interrupt treatment with Ambrisentán Aurovitas

Ambrisentán is a treatment that you will need to continue taking to control your HAP.

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

If you have any other doubts about the useof this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctorif you experience any of the following:

Allergic reactions

This is a common side effect that can affectup to 1 in 10people. You may notice:

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

Swelling (edema), especially in the ankles and feet

This is a very common side effect that can affectmore than 1 in 10people.

Heart failure

This is due to the heart not pumping enough blood. This is a common side effect that can affectup to 1 in 10people. Symptoms include:

•difficulty breathing.

•extreme fatigue.

•swelling in the ankles and legs.

Reduced red blood cell count (anemia)

This is a very common side effect that can affectmore than 1 in 10people. Sometimes this requires a blood transfusion. Symptoms include:

•fatigue and weakness.

•difficulty breathing.

•general feeling of illness.

Low blood pressure (hypotension)

This is a common side effect that can affectup to 1 in 10people. Symptoms include:

•dizziness.

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

It is essential to have regular blood tests, to monitor for anemia and ensure your liver is functioning correctly.Make sure you have also read the information in section 2on “the need to have regular blood tests” and “signs that your liver may not be functioning properly”.

Other side effects:

Very common(can affectmore than 1 in 10people)

•headache.

•dizziness.

•palpitations (rapid or irregular heartbeat).

•difficulty breathing that worsens shortly after starting ambrisentan.

•runny nose or stuffy nose, congestion, or pain in the nasal passages.

•nausea.

•diarrhea.

•feeling tired.

In combination with tadalafil (another medication for HAP)

Additionally:

•flushing (redness of the skin).

•vomiting.

•chest pain/discomfort.

Common(can affectup to 1 in 10people)

•blurred vision or other changes in vision.

•syncope (fainting).

•abnormal results in liver function blood tests.

•increased nasal discharge.

•constipation.

•abdominal pain (abdomen).

•chest pain/discomfort.

•flushing (redness of the skin).

•vomiting.

•feeling weak.

•nasal bleeding.

•skin rash.

In combination with tadalafil

Additionally, except for abnormal results in liver function blood tests:

•tinnitus (ringing in the ears).

Uncommon(can affectup to 1 in 100people)

•liver damage.

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

In combination with tadalafil

•sudden loss of hearing.

Side effects in children and adolescents

It is expected to be similar to those listed above for adults.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ambrisentan Aurovitas

-The active ingredient is ambrisentan.

Ambrisentan Aurovitas 5 mg film-coated tablets

Each film-coated tablet contains 5 mg of ambrisentan.

Ambrisentan Aurovitas 10 mg film-coated tablets

Each film-coated tablet contains 10 mg of ambrisentan.

-The other components are:

Core tablet:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

Coating:polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, lecithin (from soy) (E322),red iron oxide (3%-5%)(for the 5 mg dose) andred iron oxide (15%-17%)(for the 10 mg dose).

Appearance of the product and contents of the package

Ambrisentan Aurovitas 5 mg film-coated tablets

Film-coated tablets of pale pink color, 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

Film-coated tablets of dark pink color, 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 are available in blister packs with 10, 30, 60, 90 and 120 film-coated tablets.

They may only be marketed in some package sizes.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the member states of the European Economic Area with 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 comprimidos recubiertos con película 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 review of this prospectus:September 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).