AMBRISENTAN VIVANTA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ambrisentan Vivanta 5 mg film-coated tablets EFG

Ambrisentan 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 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 symptoms 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

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

1. What is Ambrisentan Vivanta and what is it 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 from 8 years of age 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 Vivanta

Do not take this medicine

• if you are allergicto ambrisentan, soy, or 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 may become pregnantbecause you are not using a reliable method of birth control (contraceptive). Please 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 pulmonary fibrosisof unknown cause (idiopathic pulmonary fibrosis).

Warnings and precautions

Consult your doctor 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 pulmonary veno-occlusive disease (a disease where the veins in the lungs are blocked).

→ Your doctor will decideif this medicine is suitable for you.

You will need to have regular blood tests

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

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

→It is essential 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 pain (abdomen)
• 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 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 Vivanta

Tell your doctor or pharmacistif 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 this medicine.

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

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

→ Inform your doctor or pharmacistif you are taking this medicine.

Pregnancy

This medicine 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 this medicine. Consult your doctor about this.

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

→ If you become pregnant or think you may be pregnantwhile taking this medicine, 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 this medicine 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 this medicine.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

Ambrisentan 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 Vivanta contains lactose

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

→ Consult your doctorbefore taking this medicine.

Ambrisentan Vivanta contains sodium

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

3. How to take Ambrisentan Vivanta

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

How much Ambrisentan Vivanta to take

Adults

The usual dose of this medicine 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, 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 Vivanta

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

The Ambrisentan Vivanta 5 mg tablet can be divided into equal doses.

If you take more Ambrisentan Vivanta than you should

If you take too many tablets, you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), 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.

If you forget to take Ambrisentan 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 forgotten doses.

If you stop taking Ambrisentan Vivanta

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

→Do not stop taking Ambrisentan Vivanta 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 get any of these:

Allergic reactions

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

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

Low number of red blood cells (anemia)

This is a very common 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 feeling of being unwell.

Low blood pressure (hypotension)

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

• dizziness

→Tell your doctor immediatelyif you (or your child) suffer from these effects or if they occur suddenly after taking Ambrisentan Vivanta.

It is essential to have regular blood tests, to check if you have anemia and that your liver is working properly. Make sure you have also read the information in section 2on "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 Vivanta
• runny nose or stuffy nose, congestion or pain in the nasal passages
• nausea
• diarrhea
• feeling of tiredness.

In combination with tadalafil (another medicine for PAH)

In addition to the above:

• flushing
• vomiting
• chest pain/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/discomfort
• flushing
• vomiting
• feeling of weakness
• nasal bleeding
• 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 immune system (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, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side 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 that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 ingredients are: lactose monohydrate, microcrystalline cellulose (PH102), sodium croscarmellose, magnesium stearate.

Tablet coating: partially hydrolyzed 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 and packaging

Ambrisentan Vivanta 5 mg film-coated tablets EFG are yellow, capsule-shaped, biconvex, 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, 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 packs of 10x1 or 30x1 or 60x1 tablets and packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park, Paola, PLA3000, Malta

Or

MSN Labs Europe Limited,

KW20A Corradino Park, Paola, PLA3000, Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local representative:

Vivanta Generics s.r.o., branch in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

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

Germany: Ambrisentan Vivanta 5 mg/10 mg film-coated tablets

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

Spain: Ambrisentan Vivanta 5 mg/10 mg film-coated tablets EFG

Date of the last revision of this leaflet: September 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/