AMBRISENTAN ACCORD 10 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Ambrisentan Accord 5 mg film-coated tablets EFG

Ambrisentan Accord 10 mg film-coated tablets EFG

Read this entire 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 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 experience 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 Ambrisentan Accord is and what it is used for
2. What you need to know before you take Ambrisentan Accord
3. How to take Ambrisentan Accord
4. Possible side effects
5. Storage of Ambrisentan Accord
6. Pack contents and further information

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

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

2. What you need to know before you take Ambrisentan Accord

Do not take Ambrisentan Accord

• 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 (contraception). Please read the information under the heading "Pregnancy".
• 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 idiopathic pulmonary fibrosis(scarring of the lungs of unknown cause).

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

→ Your doctor will decideif Ambrisentan Accord is 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 working properly.

→It is essential that you have these blood tests regularly while taking Ambrisentan Accord.

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

• loss of appetite
• nausea
• vomiting
• 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.

Taking Ambrisentan Accord with other medicines

Tell your doctor or pharmacist if 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 Ambrisentan Accord

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

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

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

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 contraceptive methodwhile 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.

If you are a woman of childbearing age, your doctor will ask you to have a pregnancy testbefore starting to take Ambrisentan Accord and periodically while taking this medicine.

Breast-feeding

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

→ Do not breast-feed while taking Ambrisentan Accord.Consult your doctor about this.

Fertility

If you are a man taking Ambrisentan Accord, 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 Accord 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 Accord contains lactose, soy lecithin, Allura Red AC aluminum lake (E129), and sodium

The tablets of Ambrisentan Accord 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.

The tablets of Ambrisentan Accord contain soy lecithin. If you are allergic to soy, do not use this medicine (see section 2 "Do not take Ambrisentan Accord").

The tablets of Ambrisentan Accord contain an azo dye called Allura Red AC aluminum lake (E129), which may cause allergic reactions (see section 4).

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

3. How to take Ambrisentan Accord

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist.If you are unsure, 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 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.

• It is recommended to use other 2.5 mg ambrisentan tablets 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 pack

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 foil: starting from the colored corner, open and separate the foil along the cell.

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

If you take more Ambrisentan Accord 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 Accord

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 a forgotten doses.

→ Do not stop taking ambrisentan without your doctor's advice

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 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 doctor if you have any of these:

Allergic reactions

This is a common side effect that may affect up to 1 in 10people treated. 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 treated.

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 red blood cell count (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 treated. The symptoms include:

• dizziness

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

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 2about "the need for regular blood tests" and "the 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 Accord
• 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 or discomfort
• flushing
• vomiting
• feeling of weakness
• nosebleeds
• 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 (tinnitusor ear noise)

Uncommon (may affect up to 1 in 100people):

• liver damage
• inflammation of the liver caused by the body's 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for human medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambrisentan Accord

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

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 ingredients 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 ingredients 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 Container Content

Ambrisentan Accord 5 mg film-coated tablets:

Light pink, oval, biconvex film-coated tablets, engraved with "5" on one side, with an approximate dimension of 7.0 mm.

Ambrisentan Accord 10 mg film-coated tablets:

Dark pink, oval, biconvex film-coated tablets, engraved with "10" on one side, with an approximate dimension of 9.9 mm x 5.0 mm.

Ambrisentan Accord is supplied in unit-dose blisters as 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

Manufacturer

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 under the following names:

Date of the last revision of this leaflet: May 2023

Other sources of information

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