Patient Information Leaflet: Package Insert

Ambrisentan Accord 5 mg Film-Coated Tablets

Ambrisentan Accord 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Ambrisentan Accordcontains the active ingredient ambrisentan. 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 through them. 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 can also be used in combination with other medicines used to treat PAH.

Do not take Ambrisentan Accord

• 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 ifyou may become pregnantbecause you are not using a reliable method of birth control (contraceptive). Please read the information in the section "Pregnancy".
• 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 (pulmonary fibrosis).

Warnings and precautions

Consult your doctor before starting to take this medication:

→ Your doctor will decideif Ambrisentan Accord is or is not suitable for you.

You will need to have regular blood tests

Before starting to take Ambrisentan Accord, 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 that you have these blood tests regularly while taking Ambrisentan Accord.

The signs thatyour 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.

Ambrisentan Accord with other medications

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

If you start taking ciclosporin A (a medication used after a transplant or to treat psoriasis), your doctor may need to adjust your dose of Ambrisentan Accord

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

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

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

Pregnancy

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

→If there is a possibility that you may become pregnant, use a reliable method of birth controlwhile taking Ambrisentan Accord. Consult your doctor about this.

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

→ If you become pregnant or think you may be pregnantwhile taking Ambrisentan Accord,consult your doctor immediately..

Women of childbearing age

Your doctor will ask you to have a pregnancy testbefore starting to take Ambrisentan Accord and periodically while taking this medication.

Breastfeeding

It is unknown whether ambrisentan can pass into human breast milk.

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

Fertility

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

Driving and operating machinery

Ambrisentan Accord 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 do not feel well.

Ambrisentan Accord contains lactose, lecithin (soy), Red Allura AC aluminium lake (E129) and sodium

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

→ Consult your doctorbefore taking this medication.

The Ambrisentan Accord tablets contain soy-derived lecithin. If you are allergic to soy, do not use this medication (see section 2 “do not take Ambrisentan Accord”).

The Ambrisentan Accord tablets contain a synthetic food dye called Red Allura AC aluminium lake (E129), which may cause allergic reactions (see section 4).

This medication contains less than 1 mmol of sodium (23 mg) per 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 much Ambrisentan Accord to 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.

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 cyclosporin 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.

* It is recommended to use other 2.5 mg tablets of ambrisentan available on the market for the 2.5 mg dose, as this dose is not feasible with Ambrisentan Accord.

How to take Ambrisentan Accord

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 take ambrisentan with or without food.

How to remove the tablet from the blister

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

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

1. Open the outer sheet: starting from the colored corner, open and separate the sheet along the cell.

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

If you take more Ambrisentan Accord than you should

If you take too many tablets, you may be more prone to side effects, such as headaches, flushing, dizziness, nausea (discomfort), or a drop in blood pressure that 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 forgot to take Ambrisentan Accord

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

→Do not take a double dose to compensate for the missed dose.

→Do not stop taking ambrisentan without consulting your doctor.

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

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

If you have any other doubts aboutthe 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 doctor if you experience any of the following:

Allergic reactions

This is a common side effect that can affectup to 1 in 10people treated. You may notice that a rash or itching and swelling (usually on the face, lips, tongue, or throat) appears, which can cause difficulty breathing or swallowing.

Swelling (edema), especially of the ankles and feet

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

Heart failure

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

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

Reduced number of red blood cells (anemia)

This is a very common side effect that can affectmore than1 in 10people.Occasionally, 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 treated. Symptoms include:

• dizziness

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

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 2about "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 to takeAmbrisentan Accord
• runny nose or stuffy nose, congestion, or pain in the nasal passages
• nausea
• diarrhea
• feeling tired.

In combination with tadalafil (another medication for PAH)

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 (stomach)
• chest pain/discomfort
• flushing (redness of the skin)
• vomiting
• feeling weak
• nosebleeds
• skin rash.

In combination with tadalafil

Additionally, except for the abnormalities in liver function blood test results:

Rare (can affectup to 1 in 100people):

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

In combination with tadalafil

Side effects in children and adolescents

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

Reporting of 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 Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 box and blister after CAD or EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ambrisentan Accord

Ambrisentan Accord 5 mg film-coated tablets:

The active ingredient is ambrisentan

Each film-coated tablet contains 5 mg.

The other components are:

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

Tablet coating: partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, soy lecithin (E322), and Red Allura AC aluminum lake (E129).

Ambrisentan Accord 10 mg film-coated tablets:

• The active ingredient is ambrisentan.

Each film-coated tablet contains 10 mg.

• The other components are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, and magnesium stearate. Tablet coating: partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, soy lecithin (E322), and Red Allura AC aluminum lake (E129).

Appearance of the product and contents of the package

Ambrisentan Accord 5 mg film-coated tablets:

Pinkish film-coated, oval, biconvex tablets, engraved with "5" on one side and approximately 7.0 mm in dimension.

Ambrisentan Accord 10 mg film-coated tablets:

Pink film-coated, oval, biconvex tablets, engraved with "10" on one side and approximately 9.9 mm x 5.0 mm in dimension.

Ambrisentan Accord is supplied in blister packs of 5 mg and 10 mg film-coated tablets, in packs of 10x1 or 30x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Responsible for manufacturing

Delorbis Pharmaceuticals Ltd

17 Athinon Street, Ergates Industrial Area 2643 Ergates,

Cyprus

or

Laboratori Fundació DAU (BS 1)

C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last revision date of this leaflet: May 2023

Other sources of information

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