Ambrisentan Accord

Leaflet accompanying the packaging: patient information

Ambrisentan Accord, 5 mg, film-coated tablets

Ambrisentan Accord, 10 mg, film-coated tablets

Ambrisentan

Read the leaflet carefully before taking the medicine because it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Ambrisentan Accord and what is it used for
• 2. Important information before taking Ambrisentan Accord
• 3. How to take Ambrisentan Accord
• 4. Possible side effects
• 5. How to store Ambrisentan Accord
• 6. Contents of the pack and other information

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

Ambrisentan Accord contains the active substance ambrisentan. It belongs to a group of medicines called antihypertensives (used to treat high blood pressure). It is used to treat pulmonary arterial hypertension (PAH) in adults, adolescents, and children aged 8 years and older. PAH means high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arteries). In people with PAH, these arteries become narrowed, which means the heart has to work harder to pump blood through them. This causes patients to feel tired, dizzy, and short of breath. Ambrisentan Accord widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and alleviates symptoms. Ambrisentan Accord can also be used in combination with other medicines used to treat PAH.

2. Important information before taking Ambrisentan Accord

When not to take Ambrisentan Accord:

hypersensitivityto ambrisentan, soy, or any other component of the medicine (listed in section 6);
• if they plan to become pregnant,or may become pregnant, unless they are using effective birth control methods. See the information in the "Pregnancy" section;
breastfeeding. See the information in the "Breastfeeding" section;liver disease. In such cases, the patient should consult their doctor, who will decide whether this medicine is suitable for them;lung damage (pulmonary fibrosis) of unknown cause

(idiopathic pulmonary fibrosis).

Warnings and precautions:

Before starting to take this medicine, the patient should consult their doctor:

peripheral edema)pulmonary veno-occlusive disease). The doctor will decidewhether Ambrisentan Accord is suitable for the patient.

Regular blood tests are necessary Before starting treatment with Ambrisentan Accord and at regular intervals during its use, the doctor will order blood tests to check if:

• the patient has anemia
• liver function is normal.

→It is essential to perform the above blood tests regularly while taking Ambrisentan Accord.
The following symptoms indicate liver function disorders:

• loss of appetite
• nausea (nausea)
• vomiting
• increased body temperature (fever)
• stomach pain (abdominal pain)
• yellowing of the skin or whites of the eyes (jaundice)
• dark urine
• itching of the skin.

In case of noticing any of these symptoms:
→ the patient should contact their doctor immediately.

Children

This medicine should not be given to children under 8 years of age, as its efficacy and safety have not been evaluated in this age group.

Other medicines and Ambrisentan Accord

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient starts taking cyclosporine A (a medicine used after transplants or to treat psoriasis), the doctor will adjust the dose of Ambrisentan Accord.
If the patient is taking rifampicin (an antibiotic used to treat severe infections), the doctor will monitor the patient after the first use of Ambrisentan Accord.
If the patient is taking other medicines used to treat PAH (e.g., iloprost, epoprostenol, sildenafil), the doctor may need to monitor the patient.
→ The patient should inform their doctor or pharmacistif they are taking these medicines.

Pregnancy

Ambrisentan Accord may harm the unborn baby if conceived before, during, or shortly after treatment.
→ If pregnancy is possible, the patient should use effective birth control methods
(contraception)while taking Ambrisentan Accord. They should discuss this with their doctor.
→ The patient should not take Ambrisentan Accord if they are pregnant or plan to become pregnant.
→ If the patient becomes pregnant or suspects they are pregnantwhile taking Ambrisentan Accord, they should contact their doctor immediately.

In the case of women who may become pregnant, the doctor will recommend a pregnancy test

before starting Ambrisentan Accordand regular tests during treatment.

Breastfeeding

There is no data on the penetration of the active substance in Ambrisentan Accord into breast milk.
→ The patient should not breastfeed while taking Ambrisentan Accord.They should discuss this with their doctor.

Effects on fertility

In men taking Ambrisentan Accord, it is possible that Ambrisentan Accord may cause a decrease in sperm count. The patient should discuss this with their doctor if they have any questions or concerns.

Driving and using machines

Ambrisentan Accord may cause side effects such as low blood pressure, dizziness, fatigue (see section 4), which may affect the ability to drive and use machines. The symptoms of the disease may also negatively affect the ability to drive and use machines.
→ If the patient feels unwell, they should not drive or operate machines.

Ambrisentan Accord contains lactose, soy lecithin, Allura Red AC, aluminum lake (E 129), and sodium.

The tablets of Ambrisentan Accord contain small amounts of sugar called lactose. In case of intolerance to some sugars:
→ the patient should consult their doctorbefore starting to take this medicine.
The tablets of Ambrisentan Accord contain soy lecithin. In case of soy allergy, the patient should not take this medicine (see section 2 "When not to take Ambrisentan Accord").
The tablets of Ambrisentan Accord contain the dye Allura Red AC, aluminum lake (E 129), which may cause allergic reactions (see section 4).
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is essentially "sodium-free".

3. How to take Ambrisentan Accord

Adults

The medicine should always be taken as directed by the doctor or pharmacist.The patient should consult their doctor or pharmacist if they have any doubts.

How much Ambrisentan Accord to take

The usual dose of Ambrisentan Accord is one 5 mg tablet, once a day. The doctor may increase the dose to 10 mg, once a day.
If the patient is taking cyclosporine A, they should not take more than one 5 mg tablet of Ambrisentan Accord per day.

Children and adolescents from 8 to less than 18 years of age

The doctor may decide to increase the dose. It is essential for children to attend regular check-ups with their doctor, as their dose may need to be adjusted as they grow or gain weight.
If Ambrisentan Accord is used in combination with cyclosporine A, the dose of Ambrisentan Accord will be limited to 2.5 mg once a day for adolescents and children weighing less than 50 kg or 5 mg once a day for patients weighing 50 kg or more.
*It is recommended to use another ambrisentan medicine available on the market with a strength of 2.5 mg, as Ambrisentan Accord 2.5 mg is not available.

How to take Ambrisentan Accord

The patient should try to take the tablet at the same time every day. The tablet should be swallowed whole, with a glass of water, without dividing, crushing, or chewing. Ambrisentan Accord can be taken with or without food.

Removing the tablet from the blister pack

The tablets are placed in a special package to prevent children from removing them.

• 1. Tear off along the perforation line to separate one pocket from the blister pack.

• 2. Remove the outer foil and take out the tablet.

Taking more than the recommended dose of Ambrisentan Accord

In case of taking a higher dose of the medicine than recommended, it is more likely that side effects such as headache, flushing, dizziness, nausea, or low blood pressure will occur, which may cause dizziness:
→ The patient should consult their doctor or pharmacistif they have taken more tablets than recommended.

Missing a dose of Ambrisentan Accord

In case of missing a dose of Ambrisentan Accord, the patient should take it as soon as possible and then continue treatment as before.
→ The patient should not take a double dose to make up for the missed dose.

The patient should not stop taking Ambrisentan Accord without consulting their doctor.

Ambrisentan Accord should be taken regularly, as it helps control the patient's pulmonary hypertension.
→ The patient should not stop taking Ambrisentan Accord without consulting their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

The patient should tell their doctor if they experience any of the following symptoms:

Allergic reactions

These are common side effects that may occur in less than 1 in 10patients. A rash or itching and swelling (usually on the face, lips, tongue, or throat) may appear, which can cause difficulty breathing and swallowing.

Swelling, particularly of the ankles and feet

This is a very common side effect that may occur in more than 1 in 10patients.

Heart failure

This symptom is due to the heart not pumping enough blood. This is a common side effect that may occur in less than 1 in 10patients. Symptoms include:

• shortness of breath,
• severe fatigue, swelling of the ankles and feet.

Decreased red blood cell count (anemia)

This is a very common side effect that may occur in more than 1 in 10patients. Sometimes it may require a blood transfusion. Symptoms include:

• fatigue, weakness,
• shortness of breath,
• feeling unwell.

Low blood pressure

This is a common side effect that may occur in less than 1 in 10patients. Symptoms include:

• dizziness.

→ The patient should contact their doctor immediatelyif they experience these symptoms or if they occur suddenly after taking Ambrisentan Accord.
It is essential to perform regular blood teststo detect possible anemia or liver function disorders. The patient should also read the information
in section 2"Regular blood tests" and "The following symptoms indicate liver function disorders".

Other side effects:

Very common side effects (may affect more than 1 in 10 patients)

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• worsening of shortness of breath shortly after starting treatment with Ambrisentan Accord
• runny nose or feeling of nasal congestion, sinusitis, or sinus pain
• nausea
• diarrhea
• fatigue.

In combination therapy with tadalafil (another medicine used to treat PAH)

In addition to the above:

• flushing
• vomiting
• chest pain or discomfort.

Common side effects (may affect less than 1 in 10 patients)

• blurred vision or other vision disturbances
• fainting
• abnormal liver function test results
• runny nose
• constipation
• stomach pain (abdominal pain)
• chest pain or discomfort
• flushing of the skin (especially the face)
• vomiting
• weakness
• nasal bleeding
• rash.

In combination therapy with tadalafil

In addition to the above, except for unusual blood test results indicating liver function disorders:

• ringing in the ears (tinnitus)

Uncommon side effects (may affect less than 1 in 100 patients)

• liver damage
• liver inflammation caused by the body's immune system (autoimmune hepatitis).

In combination therapy with tadalafil

• sudden hearing loss.

Side effects in children and adolescents

It is expected that the side effects are similar to those listed above for adults.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ambrisentan Accord

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister pack after the expiry date (EXP). The expiry date refers to the last day of the month stated.
The medicine does not require special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ambrisentan Accord contains

Ambrisentan Accord, 5 mg, film-coated tablets

• The active substance of the medicine is ambrisentan. Each film-coated tablet contains 5 mg of ambrisentan.
• Other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate; coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soy lecithin (E 322), Allura Red AC, aluminum lake (E 129).

Ambrisentan Accord, 10 mg, film-coated tablets

• The active substance of the medicine is ambrisentan. Each film-coated tablet contains 10 mg of ambrisentan.
• Other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate; coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soy lecithin (E 322), Allura Red AC, aluminum lake (E 129).

What Ambrisentan Accord looks like and contents of the pack

Ambrisentan Accord, 5 mg, film-coated tablets (tablet) is a light pink, round, biconvex tablet with the imprint "5" on one side, with a diameter of about 7 mm.
Ambrisentan Accord, 10 mg, film-coated tablets (tablet) is a dark pink, oval, biconvex tablet with the imprint "10" on one side, with dimensions of about 9.9 mm x 5 mm.
Ambrisentan Accord is available in 5 mg and 10 mg film-coated tablets in packs containing 10x1 or 30x1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer

Delorbis Pharmaceuticals Ltd.
Athinon 17, Ergates Industrial Area,
2643 Ergates, Nicosia, Cyprus
Laboratori Fundació Dau
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 and the United Kingdom (Northern Ireland) under the following names:

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Date of last revision of the leaflet: January 2024