Ambri sentan Vivanta 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ambrisentán Vivanta 5 mg film-coated tablets EFG

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

Contents of the leaflet

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

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

This medicine 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 elevated blood pressure in the vessels (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 difficulty breathing.

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 Ambrisentán Vivanta

Do not take this medicine

• if you are allergic to ambrisentán, to soy, or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using a reliable method of birth control (contraception). Please read the information in the section "Pregnancy".
• if you are breastfeeding, read the information under the heading “Breastfeeding”.
• 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 before starting to take 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 lung disease in which the blood vessels in the lungs are blocked (pulmonary veno-occlusive disease).

→ Your doctor will decide whether this medicine is suitable for you.

You will need regular blood tests

Before starting this medicine, and periodically while taking it, 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 ambrisentán.

Signs that your liver may not be working properly include:

• loss of appetite
• feeling unwell (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:

→ Inform 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 Ambrisentán Vivanta

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 this medicine.

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

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

→ Tell your doctor or pharmacist if you are taking this medicine.

Pregnancy

This medicine may harm a fetus conceived before, during, or shortly after treatment.

→ If there is any possibility you could become pregnant, use a reliable method of contraception while taking this medicine. Discuss this with your doctor.

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

→ If you become pregnant or think you might be pregnant while taking this medicine, contact your doctor immediately.

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

Breastfeeding

It is not known whether the active ingredient of this medicine passes into breast milk.

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

Fertility

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

Driving and use of machines

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

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

Ambrisentán Vivanta contains lactose

The tablets contain small amounts of a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars:

→ Consult your doctor before taking this medicine.

Ambrisentán Vivanta contains sodium

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

3. How to take Ambrisentán Vivanta

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

How much Ambrisentán Vivanta to take

Adults

The usual dose of this medicine 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 once daily.

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

Usual starting dose of Ambrisentan Vivanta
Weight of 35 kg or more	One tablet of 5 mg, once daily
Weight at least 20 kg and less than 35 kg	2.5 mg (half a 5 mg tablet), 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 in those weighing 50 kg or more.

How to take Ambrisentán Vivanta

It is best to take the tablet at the same time each day. Swallow the Ambrisentán Vivanta 10 mg tablet whole, with a glass of water. Do not divide, crush, or chew the tablets. You may take this medicine with or without food.

The Ambrisentán Vivanta 5 mg tablet may be split into equal doses.

If you take more Ambrisentán Vivanta than you should

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

If you forget to take Ambrisentán Vivanta

If you forget to take a dose, 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 Ambrisentán Vivanta

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

→ Do not stop taking Ambrisentán Vivanta 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 that may affect up to 1 in 10 people. You may notice:

• rash or itching and 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 that 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 that 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 (anaemia )

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

• dizziness

→Contact your doctor immediately if you (or your child) experience these effects or if they occur suddenly after taking Ambrisentan Vivanta.

Regular blood tests are important to monitor whether you have anaemia and to ensure your liver is functioning properly. Make sure you have also read the information in section 2 on "the need for regular blood tests" and "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 (rapid or irregular heartbeat)
• difficulty breathing that worsens shortly after starting Ambrisentan Vivanta
• runny or stuffy nose, nasal congestion or sinus pain
• nausea
• diarrhoea
• feeling of tiredness.

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 10 people)

• liver damage
• inflammation of the liver caused by the body's own immune defences (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, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambrisentan Vivanta

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

Do not use this medicine after the expiry date stated on the packaging 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 unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ambrisentan Vivanta

The active substance is ambrisentan.

Each film-coated tablet contains 5 or 10 mg of ambrisentan.

The other components are: monohydrate lactose, microcrystalline cellulose (PH102), sodium croscarmellose, magnesium stearate.

Tablet coating: partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 4000 / PEG 3350 (E1521), red iron oxide (E172), yellow iron oxide (E172) (only for 5 mg).

Appearance of the product and contents of the pack

Ambrisentan Vivanta 5 mg film-coated tablets EFG are yellow, capsule-shaped, biconvex, film-coated tablets, approximately 6.9 mm long and 3.5 mm wide, scored on both sides, engraved with "A" and "5" on one side and smooth on the other.

The tablet can be divided into equal doses.

Ambrisentan Vivanta 10 mg film-coated tablets EFG are pink, oval-shaped, biconvex, film-coated tablets, approximately 10 mm long and 5 mm wide, engraved with "A" on one side and "10" on the other.

Ambrisentan Vivanta is supplied as 5 mg and 10 mg film-coated tablets in blister packs, in unit dose packaging of 10×1, 30×1, or 60×1 tablets, and in 30-tablet packs.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

Manufacturer responsible for manufacturing

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park, Paola, PLA3000, Malta

Or

MSN Labs Europe Limited,

KW20A Corradino Park, Paola, PLA3000, Malta

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Local Representative:

Vivanta Generics s.r.o. Spanish branch

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Ambrisentan Vivanta 5 mg/ 10 mg Filmtabletten

Cyprus: Ambrisentan MSN 5 mg/10 mg film-coated tablets

Spain: Ambrisentán Vivanta 5 mg/ 10 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date 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/