Prospect: information for the user

Ambrisentán Vivanta 5 mg film-coated tablets

Ambrisentán Vivanta 10 mg film-coated tablets

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given 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, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Ambrisentán Vivanta

4.Possible adverse effects

5.Storage of Ambrisentán Vivanta

6.Contents of the package and additional information

This medication contains the active substance ambrisentán. It belongs to a group of medicines called other anti-hypertensives (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 into the lungs. This makes people feel tired, dizzy, and have difficulty breathing.

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

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

Do not take this medication

• if you areallergicto ambrisentan, soybean or any of the other components of this medication (listed in section 6).
• If you are pregnant,if you areplanning to become pregnant,or if youmay become pregnantbecause you are not using a reliable method of birth control (contraceptive). Please read the information in the "Pregnancy" section.

• if you arebreastfeedingread the information under the heading “Breastfeeding”.
• if you haveliver disease. Consult your doctor, who will decide if this medication is or is not suitable for you.
• if you haveidiopathic pulmonary fibrosis, a cause unknown.

Warnings and precautions

Consult your doctor before starting to take this medication:

• if you have liver problems
• if you have anemia (reduction 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 this medication is or is not suitable for you.

You will need to have regular blood tests

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

•if you have anemia

•if your liver is functioning correctly.

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

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

•loss of appetite

•nausea (nausea)

•vomiting

•high temperature (fever)

•abdominal pain (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 Ambrisentan Vivanta

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

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

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

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

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

Pregnancy

This medication 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 medication. 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 this medication, 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 medication and periodically while taking it.

Breastfeeding

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

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

Fertility

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

Driving and operating machinery

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

→ Do not drive or operate machinery if you are not feeling well.

Ambrisentan Vivanta contains lactose

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

→ Consult your doctorbefore taking this medication.

Ambrisentan Vivanta contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this 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 much Ambrisentan Vivanta to take

Adults

The usual dose of this medication 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 cyclosporine A, do not take more than one 5 mg tablet, 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 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 cyclosporine A, the dose of ambrisentan should 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 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 medication 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 prone to side effects, such as headaches, hot flushes, dizziness, nausea (discomfort), or a drop in blood pressure, which may cause a mild sensation of dizziness:

→ Consult your doctor or pharmacistif 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, 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 compensate for the missed doses.

If you interrupt treatment with Ambrisentan Vivanta

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

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

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

Like all medicines, this medicine can 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 Ambrisentán Vivanta.

It is essential to have regular blood tests, to monitor if you have anemia and if your liver is functioning correctly.Make sure you have also read the information in section 2on "the need to have regular blood tests" and "the 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 Ambrisentán Vivanta
• runny nose or stuffy nose, congestion, or pain in the nasal passages
• nausea
• diarrhea
• feeling tired.

In combination with tadalafil (another medication for HAP)

In addition to the above:

• 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
• nosebleeds
• skin rash.

In combination with tadalafil

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

• tinnitus (ringing in the ears).

Rare(can affectup to 1 in 10people)

• 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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging 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 in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.

Composition of Ambrisentan Vivanta

The active ingredient is ambrisentan.

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

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

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

Appearance of the product and contents of the package

Ambrisentan Vivanta 5 mg film-coated tablets EFG are yellow film-coated tablets, 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 intoequal doses.

Ambrisentan Vivanta 10 mg film-coated tablets EFG are pink film-coated tablets, 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 film-coated tablets of 5 mg and 10 mg in blisters, in single-dose packs of 10×1 or 30×1 or 60×1 tablets and packs of 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

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 canrequest more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o. subsidiary in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

This medication is authorized in the member states of the European Economic Area with the following names:

Germany:Ambrisentan Vivanta 5 mg/ 10 mg Filmtabletten

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

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

Last review date of this leaflet: September 2023

Detailed and updated information about this medication is available on the website of the

Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/