Ambrisentan accord

Package leaflet: Information for the patient

Ambrisentan Accord, 5 mg, film-coated tablets
Ambrisentan Accord, 10 mg, film-coated tablets
Ambrisentanum
Please read all of this leaflet carefully before 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 a specific individual. 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, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Ambrisentan Accord is and what it is used for
2. What you need to know 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 Ambrisentan Accord is and what it is used for

Ambrisentan Accord contains the active substance ambrisentan. It belongs to a group of medicines
used to treat high blood pressure (antihypertensives).
It is used to treat pulmonary arterial hypertension (PAH) in adults, adolescents, and children aged 8 years and older. PAH means elevated 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, causing the heart to work harder to pump blood through them. This leads to symptoms such as fatigue, dizziness, and shortness of breath.
Ambrisentan Accord works by relaxing and widening the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and helps relieve symptoms.
Ambrisentan Accord may also be used in combination with other medicines used to treat PAH.

2. Important information before taking Ambrisentan Accord

When not to use Ambrisentan Accord:

• if the patient is allergic to ambrisentan, soya, or any other ingredient of the medicine (listed in section 6);
• if the patient is pregnant, intends to become pregnant, or could become pregnant and is not using an effective method of contraception (birth control). Please read the information provided in the section "Pregnancy";
• if the patient is breast-feeding. Please read the information provided in the section "Breast-feeding";
• in case of liver disease. In such a case, consult the treating physician, who will decide whether this medicine is suitable for the patient;
• if the patient has lung damage (fibrosis) of unknown cause

(idiopathic pulmonary fibrosis).
Warnings and precautions:
Before starting treatment with this medicine, consult a doctor:

• if the patient has impaired liver function
• if the patient has anaemia (low number of red blood cells)
• if the patient has swelling of the hands, ankles or feet due to fluid retention (peripheral oedema)
• if the patient has a lung disease causing blockage of blood vessels in the lungs (pulmonary veno-occlusive disease).
  → The doctor will decide whether Ambrisentan Accord is suitable for the patient.

Regular blood tests are required
Before starting treatment with Ambrisentan Accord, and at regular intervals during treatment,
the doctor will order blood tests to check whether:

• the patient has anaemia
• liver function is normal.

→ It is important to have the above-mentioned blood tests performed regularly while taking
Ambrisentan Accord.
The following symptoms may indicate impaired liver function:

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

If any of these symptoms occur:
→ contact the treating doctor immediately.
Children
This medicine should not be given to children under 8 years of age, as efficacy and safety have not been established in this age group.
Other medicines and Ambrisentan Accord
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
If the patient has started taking cyclosporine A (a medicine used after organ transplantation or in the treatment of psoriasis), the doctor will adjust the dose of Ambrisentan Accord.
If the patient is taking rifampicin (an antibiotic used in severe infections), the doctor will monitor the patient after the first dose of Ambrisentan Accord.
If the patient is taking other medicines used in the treatment of PAH (e.g. iloprost, epoprostenol, sildenafil), the doctor may need to monitor the patient.
→ Inform the doctor or pharmacist if taking any of these medicines.
Pregnancy
Ambrisentan Accord may harm an unborn child if conception occurs before, during, or shortly after treatment.
→ If pregnancy is possible, effective contraception methods (birth control) must be used during treatment with Ambrisentan Accord. Discuss this with the treating doctor.
→ Do not take Ambrisentan Accord if the patient is pregnant or intends to become pregnant.
→ If pregnancy occurs or is suspected while taking Ambrisentan Accord, contact the treating doctor immediately.
For women who could become pregnant, the treating doctor will recommend a pregnancy test before starting Ambrisentan Accord and regular testing during treatment.
Breast-feeding
There is no data on whether the active substance in Ambrisentan Accord passes into human milk.
→ Breast-feeding should not be used during treatment with Ambrisentan Accord. Discuss this with the treating doctor.
Effect on fertility
In men taking Ambrisentan Accord, a reduction in sperm count may occur. Discuss any questions or concerns with the treating doctor.
Driving and using machines
Ambrisentan Accord may cause adverse effects such as low blood pressure, dizziness, and fatigue (see section 4), which may affect the ability to drive and operate machinery. The symptoms of the disease being treated may also negatively affect the ability to drive and operate machinery.
→ If the patient feels unwell, driving and operating machinery should be avoided.
Ambrisentan Accord contains lactose, soya lecithin, Allura Red AC colour, aluminium lake (E 129), and sodium.
Ambrisentan Accord tablets contain a small amount of a sugar called lactose. In case of intolerance to certain sugars:
→ contact the treating doctor before starting this medicine.
Ambrisentan Accord tablets contain lecithin derived from soya. In case of allergy to soya, this medicine should not be used (see section 2 "When not to use Ambrisentan Accord").
Ambrisentan Accord tablets contain the colour Allura Red AC, aluminium lake (E 129), which may cause allergic reactions (see section 4).
This medicine contains less than 1 mmol of sodium (23 mg) per tablet and is therefore essentially "sodium-free".

3. How to take Ambrisentan Accord

Adults
Ambrisentan Accord should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
How much Ambrisentan Accord to take
The usual dose of Ambrisentan Accord is one 5 mg tablet once daily. Your doctor may increase the dose to 10 mg once daily.
If you are taking cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Accord once daily.
Children and adolescents aged 8 years to below 18 years

The doctor may decide to increase the dose. It is important that children attend regular
doctor visits, as their dose of medicine must be adjusted as they grow or gain weight.
When used in combination with cyclosporine A, the dose of Ambrisentan Accord will be
limited to 2.5 mg once daily in adolescents and children weighing less than 50 kg, or 5 mg once
daily in patients weighing 50 kg or more.
*Use of another marketed ambrisentan-containing medicine with a strength of 2.5 mg is recommended,
as Ambrisentan Accord 2.5 mg is not available.
How to take Ambrisentan Accord
Try to take the tablet at the same time each day. Swallow the tablet whole with a glass of water,
without dividing, crushing, or chewing it. Ambrisentan Accord may be taken with or without food.
Removing the tablet from the blister
The tablets are packed in special packaging to prevent children from removing them.

1. Tear along the perforated line to separate one pocket from the blister.

2. Peel back the outer foil and remove the tablet.

If you take more Ambrisentan Accord than you should
If you take more than the prescribed dose, side effects such as headache, flushing, dizziness,
nausea, or low blood pressure (which may cause dizziness) are more likely to occur:
→ Seek advice from your doctor or pharmacist if you have taken more tablets than recommended.
If you forget to take Ambrisentan Accord
If you miss a dose of Ambrisentan Accord, take it as soon as possible and then continue your
treatment as before.
→ Do not take a double dose to make up for a forgotten tablet.
Do not stop taking Ambrisentan Accord without consulting your doctor.
Ambrisentan Accord should be taken regularly, as it helps control the pulmonary hypertension
you have.
→ Do not stop taking Ambrisentan Accord without consulting your doctor.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Serious adverse reactions
Tell your doctor if the patient experiences any of the following symptoms:
Allergic reactions
These are common adverse reactions, which may occur in up to 1 in 10 patients.
A rash or itching may appear, along with swelling (usually of the face, mouth, tongue or throat), which may cause difficulty breathing or swallowing.
Swelling, particularly of the ankles and feet
This is a very common adverse reaction, which may occur in more than 1 in 10 patients.
Heart failure
This symptom results from the heart not pumping enough blood. This is a common adverse reaction, which may occur in up to 1 in 10 patients. Symptoms include:

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

Reduced number of red blood cells (anaemia)
This is a very common adverse reaction, which may occur in more than 1 in 10 patients. Sometimes it may require blood transfusion. Symptoms include:

• fatigue, weakness,
• shortness of breath,
• malaise.

Low blood pressure
This is a common adverse reaction, which may occur in up to 1 in 10 patients. Symptoms include:

• dizziness.

→ Contact your doctor immediately if any of these symptoms occur, or if they suddenly appear after taking Ambrisentan Accord.
It is important to have regular blood tests to detect possible anaemia or liver function abnormalities. You should also read the information provided in section 2, "Necessary regular blood tests" and "The following symptoms indicate liver function abnormalities".
Other adverse reactions:
Very common adverse reactions (may affect more than 1 in 10 patients)

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• worsening of breathlessness shortly after starting treatment with Ambrisentan Accord
• cold or stuffy nose, nasal congestion or sinus pain
• nausea
• diarrhoea
• fatigue.

In combination therapy with tadalafil (another medicine used to treat PAH)
In addition to the above:

• skin redness (flushing)
• vomiting
• chest pain/discomfort.

Common adverse reactions (may affect up to 1 in 10 patients)

• blurred vision or other visual disturbances
• fainting
• abnormal liver function test results
• cold
• constipation
• stomach (abdominal) pain
• chest pain/discomfort
• skin redness (especially of the face)
• vomiting
• weakness
• nosebleeds
• rash.

In combination therapy with tadalafil
In addition to the above, apart from abnormal blood test results related to liver function:

• sensation of ringing in the ears (tinnitus)

Uncommon adverse reactions (may affect up to 1 in 100 patients)

• liver damage
• liver inflammation caused by the body's own immune system (autoimmune hepatitis).
  In combination therapy with tadalafil
• sudden hearing loss.

Adverse reactions in children and adolescents
Adverse reactions are expected to be similar to those listed above for adults.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ambrisentan Accord

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and blister after
Expiry date (EXP). The expiry date refers to the last day of the stated month.
This medicine does not require any special storage precautions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures 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 is ambrisentan. Each film-coated tablet contains 5 mg of ambrisentan.
• Other components are: tablet core: microcrystalline cellulose, sodium croscarmellose, monohydrate lactose, magnesium stearate; coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soya lecithin (E 322), Allura red AC, aluminium lake (E 129).

Ambrisentan Accord, 10 mg, film-coated tablets

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

What Ambrisentan Accord looks like and contents of the pack
Ambrisentan Accord, 5 mg, film-coated tablet (tablet) is a light pink, round, biconvex tablet with an embossed mark "5" on one side, approximately 7 mm in diameter.
Ambrisentan Accord, 10 mg, film-coated tablet (tablet) is a dark pink, oval, biconvex tablet with an embossed mark "10" on one side, approximately 9.9 mm x 5 mm in size.
Ambrisentan Accord is supplied as 5 mg and 10 mg film-coated tablets in blister packs divided into single doses of 10x1 or 30x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
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 authorised for marketing in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

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