Ambiensentan Aurovitas 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ambrisentan Aurovitas 5 mg film-coated tablets EFG

Ambrisentan Aurovitas 10 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ambrisentan Aurovitas is and what it is used for
2. What you need to know before taking Ambrisentan Aurovitas
3. How to take Ambrisentan Aurovitas
4. Possible side effects
5. How to store 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 is characterized by 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, causing the heart to work harder to pump blood through to the lungs. This leads to fatigue, dizziness, and shortness of breath.

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

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

2. What you need to know before taking Ambrisentan Aurovitas

Do not take Ambrisentan Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

• if you have liver problems.
• if you have anaemia (reduced number of red blood cells).
• if you have swelling of the hands, ankles or feet due to fluid retention (peripheral oedema).
• if you have a lung disease in which the veins in the lungs are blocked (pulmonary veno-occlusive disease).

→ Your doctor will decide whether ambrisentan is suitable for you.

You will need regular blood tests

Before starting ambrisentan and periodically during treatment, your doctor will perform blood tests to check:

• whether you have anaemia.
• whether your liver is functioning properly.

→ It is important that you have these blood tests regularly while taking ambrisentan.

Signs that your liver may not be working properly include:

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

If you notice any of these symptoms:

→ Contact your doctor immediately.

Children

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

Other medicines and Ambrisentan Aurovitas

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

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

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

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

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

Pregnancy

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

→ If you could become pregnant, use a reliable method of contraception while taking ambrisentan. Discuss this with your doctor.

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

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

If you are a woman of childbearing potential, your doctor will require you to take a pregnancy test before starting ambrisentan and periodically during treatment.

Breast-feeding

It is not known whether the active ingredient of this medicine passes 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 reduce your sperm count. Speak with your doctor if you have any questions or concerns about this.

Driving and using machines

This medicine may cause side effects such as hypotension, dizziness, and fatigue (see section 4), which may affect your ability to drive or operate machinery. Symptoms of your underlying disease may also impair your ability to drive or use machines.

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

Ambrisentan Aurovitas contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Ambrisentan Aurovitas contains lecithin (from soya)

This medicine contains lecithin derived from soya. Do not use this medicine if you are allergic to soya (see section 2 “Do not take Ambrisentan Aurovitas”).

Ambrisentan Aurovitas contains Allura Red AC aluminium lake (E129)

This medicine contains a colouring agent called Allura Red AC aluminium lake (E129), which may cause allergic-type reactions (see section 4).

Ambrisentan Aurovitas contains sodium

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

3. How to take Ambrisentan Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much Ambrisentan Aurovitas to take

Adults

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

If you are taking cyclosporine A, do not take more than one 5 mg tablet of ambrisentan once daily.

Adolescents and children from 8 to under 18 years of age

Usual starting dose of ambrisentan
Weight of 35 kg or more	One tablet of 5 mg, once daily
Weight of at least 20 kg and less than 35 kg	One tablet of 2.5 mg, once daily

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 cyclosporine A, the dose of ambrisentan should be limited to 2.5 mg once daily in adolescents and children weighing less than 50 kg, or to 5 mg once daily if they weigh 50 kg or more.

How to take Ambrisentan Aurovitas

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

How to remove the tablet from the blister pack

These tablets come in special packaging designed to prevent children from removing them.

1. Separate one tablet: tear along the perforated lines to separate one "pocket" from the strip.

2. Open the outer foil: starting at the corner indicated by the arrow, open and separate the foil along the pocket.

3. Remove the tablet: gently push the tablet out through one side of the foil.

If you take more Ambrisentan Aurovitas than you should

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

→ Seek advice from your doctor or pharmacist if you take more tablets than prescribed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication 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 missed doses.

If you stop taking Ambrisentan Aurovitas

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Tell your doctor if you experience any of the following:

Allergic reactions

This is a common adverse effect which may affect up to 1 in 10 people. You may notice:

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

Swelling (edema ), especially in the ankles and feet

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

Heart failure

This occurs because the heart does not pump enough blood. This is a common adverse effect which may affect up to 1 in 10 people. Symptoms include:

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

Reduced number of red blood cells (anemia)

This is a very common adverse effect which may affect more than 1 in 10 people. Sometimes this requires a blood transfusion. Symptoms include:

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

Low blood pressure (hypotension )

This is a common adverse effect which may affect up to 1 in 10 people. Symptoms include:

• dizziness.

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

Regular blood tests are important to monitor whether you have anemia and to ensure your liver is functioning properly. Make sure you have also read the information in section 2 about “the need for regular blood tests” and “the signs that your liver may not be working properly.”

Other adverse effects:

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

• headache.
• dizziness.
• palpitations (fast or irregular heartbeat).
• difficulty breathing that worsens shortly after starting ambrisentan.
• runny or stuffy nose, nasal congestion or sinus pain.
• nausea.
• diarrhea.
• feeling of fatigue.

In combination with tadalafil (another medicine for PAH)

In addition to the above:

• flushing (skin redness).
• vomiting.
• chest pain/discomfort.

Common (may affect up to 1 in 10 people)

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

In combination with tadalafil

In addition to the above, except for abnormalities in blood test results for liver function:

• ringing in the ears (tinnitus).

Uncommon (may affect up to 1 in 100 people)

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

In combination with tadalafil

• sudden hearing loss.

Adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambrisentan Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ambrisentan Aurovitas

• The active substance 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.

• Other components are:

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

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

Description of the product and contents of the pack

Ambrisentan Aurovitas 5 mg film-coated tablets EFG

Pale pink, square, approximately 6.9 mm, biconvex, film-coated tablets with the imprint “AS” on one side and “5” on the other.

Ambrisentan Aurovitas 10 mg film-coated tablets EFG

Dark pink, oval, approximately 9.8 × 4.9 mm, biconvex, film-coated tablets with the imprint “AS” on one side and “10” on the other.

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

Only certain 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 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 most recent review of this leaflet: September 2022

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