Ambrisentan Accord

Patient Information Leaflet

Ambrisentan Accord 5 mg film-coated tablets, 10 mg film-coated tablets

Generic Medicine
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 called other antihypertensives (used for the treatment of high blood pressure).
It is used for the treatment of Pulmonary Arterial Hypertension (PAH) in adults, adolescents,
and children aged 8 years and older.
Pulmonary Arterial Hypertension (PAH) is high blood pressure in the blood vessels (pulmonary arteries)
that carry blood from the heart to the lungs. In people with PAH, these arteries become narrowed, so
the heart has to work harder to pump blood through them. This causes people 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 lowers blood pressure and relieves symptoms.
Ambrisentan Accord may also be used in combination with other medicines used for the treatment of PAH.

2. What you need to know before taking Ambrisentan Accord

Do not take Ambrisentan Accord

• if you are allergic to ambrisentan, soy, or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant, are planning a pregnancy, or if there is a possibility of becoming pregnant because you are not using a reliable method of birth control (contraception). Please read the information titled “Pregnancy”
• if you are breastfeeding. Read the information titled “Breastfeeding”
• if you have liver disease
• if you have lung scarring of unknown origin (idiopathic pulmonary fibrosis)

Warnings and precautions
Talk to your doctor before taking this medicine:

• If you have liver problems
• If you have anaemia (reduced number of red blood cells)
• If you have swelling in your hands, ankles or feet due to fluid retention ( peripheral oedema )
• If you have a lung disease in which the blood vessels in the lungs are blocked ( pulmonary veno-occlusive disease )

→ Your doctor will decide whether Ambrisentan Accord is suitable for you.
You need to have regular blood tests
Before starting treatment with Ambrisentan Accord, and at regular intervals during treatment, your doctor
will take blood samples to check:

• whether you have anaemia
• whether your liver is functioning properly

→ It is important that you have all these blood tests regularly throughout your treatment with
Ambrisentan Accord.
Signs that your liver may not be working properly include:

• loss of appetite
• feeling unwell (nausea)
• vomiting
• high body temperature (fever)
• stomach (abdominal) pain
• yellowing of the skin or eyes (jaundice)
• dark-coloured urine
• skin itching

If you notice any of these signs:
→ Contact your doctor immediately.
Children
Do not give this medicine to children under 8 years of age, as its safety and effectiveness have not been established in this age group.
Other medicines and Ambrisentan Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you start treatment with cyclosporine A (a medicine used after organ transplantation or for the treatment of psoriasis), your doctor may need to adjust the dose of Ambrisentan Accord.
If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will need to monitor you when starting treatment with Ambrisentan Accord.
If you are taking other medicines used to treat PAH (e.g. iloprost, epoprostenol, sildenafil), your doctor may need to monitor you.
→ Tell your doctor or pharmacist if you are taking any of these medicines.
Pregnancy
Ambrisentan Accord can cause harm to unborn babies conceived before, during, or shortly after the end of treatment.
→ If there is a possibility of becoming pregnant, use a reliable method of birth control (contraception) while taking Ambrisentan Accord. Discuss this with your doctor.
→ Do not take Ambrisentan Accord if you are pregnant or planning to become pregnant.
→ If you become pregnant or suspect you are pregnant while taking Ambrisentan Accord, contact your doctor immediately.
If you are a woman who could become pregnant, your doctor will ask you to have a pregnancy test before starting Ambrisentan Accord and then regularly during treatment with this medicine.
Breastfeeding
It is not known whether the active ingredient in Ambrisentan Accord passes into breast milk.
→ Do not breastfeed while taking Ambrisentan Accord. Discuss this with your doctor.
Fertility
If you are a man taking Ambrisentan Accord, this medicine may reduce the number of sperm in your semen. For any questions or concerns, talk to your doctor.
Driving and using machines
Ambrisentan Accord can cause side effects such as low blood pressure, dizziness, and fatigue (see section 4), which may affect your ability to drive or operate machinery. The symptoms of your underlying illness may also impair your ability to drive or use machines.
→ Do not drive or operate machinery if you do not feel well.
Ambrisentan Accord contains lactose, lecithin (soy), Allura Red AC aluminium lake (E129), and
sodium.
Ambrisentan Accord tablets contain a small amount of a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars:
→ Inform your doctor before taking this medicine.
Ambrisentan Accord tablets contain lecithin derived from soy. If you are allergic to soy, do not take this medicine (see section 2 ‘Do not take Ambrisentan Accord’).
Ambrisentan Accord tablets contain a colouring agent called Allura Red AC aluminium lake (E129), which may cause allergic reactions (see section 4).
Ambrisentan Accord contains less than 1 mmol of sodium (23 mg) per tablet; this means it is essentially “sodium-free”.

3. How to take Ambrisentan Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts,
ask your doctor or pharmacist.
How much Ambrisentan Accord to take
Adults
The usual dose of Ambrisentan Accord is one 5 mg tablet once daily. Your doctor may decide to increase
the dose to 10 mg once daily.
Adolescents and children aged between 8 and 18 years

The doctor may decide to increase your dose. It is important that children attend their doctor's appointments regularly, as their dose needs to be adjusted as they grow or gain weight.

If taken in combination with cyclosporine A, the dose of Ambisentran Accord for adolescents and children weighing less than 50 kg will be limited to 2.5 mg * once daily, or 5 mg once daily if they weigh 50 kg or more.
* Use of other 2.5 mg ambrisentan tablets available on the market is recommended, as the 2.5 mg dose of Ambrisentan Accord is not available.

If you are taking cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Accord once daily.

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 split, break, or chew the tablet. You may take Ambrisentan Accord with or without food.

Removing a tablet from the blister pack
These tablets are supplied in special packaging to prevent children from removing them.

1. Separate one "pocket" from the strip by tearing along the perforation.

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

If you take more Ambrisentan Accord than you should
If you take too many tablets, you may experience adverse reactions such as headache, flushing, dizziness, nausea (feeling unwell), or low blood pressure, which could cause mild confusion:
→ Consult your doctor or pharmacist if you have taken more tablets than prescribed.

If you forget to take Ambrisentan Accord
If you forget to take a dose of Ambrisentan Accord, take it as soon as you remember, then continue your treatment as usual.
→ Do not take a double dose to make up for a missed dose.

Do not stop taking Ambrisentan Accord without consulting your doctor
Ambrisentan Accord is a medicine you need to control Pulmonary Arterial Hypertension.
→ Do not stop taking Ambrisentan Accord unless agreed with your doctor.

If you have further questions about the use of this medicine, consult 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 experience any of the following side effects:

Allergic reactions
This is a common adverse event which may affect up to 1 in 10 people. You may notice a skin rash, itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing.

Swelling (edema), especially in the ankles and feet
This is a very common adverse event which may affect more than 1 in 10 people.

Heart failure
This occurs because the heart does not pump enough blood. This is a common adverse event which may affect up to 1 in 10 people. Symptoms include:

• -shortness of breath,
• extreme tiredness,
• swelling in the ankles and legs.

Reduced number of red blood cells (anaemia)
This is a very common adverse event which may affect more than 1 in 10 people. Sometimes this may require a blood transfusion. Symptoms include:

• tiredness and weakness,
• shortness of breath,
• general feeling of being unwell.

Low blood pressure (hypotension)
This is a common adverse event which may affect up to 1 in 10 people. Symptoms include:

• Mild confusion.

→ Tell your doctor immediately if any of these adverse events occur in you (or in your child) shortly after taking Ambrisentan Accord.
It is important to have regular blood tests to monitor for anaemia and to check that your liver is functioning properly. Make sure you have read the information in
section 2 under the headings ‘You need to have regular blood tests’ and ‘Signs that your liver may not be working properly’.

Other side effects:

Very common (may affect more than 1 in 10 people):

• headache
• dizziness
• palpitations (fast or irregular heartbeat)
• shortness of breath which worsens shortly after starting treatment with Ambrisentan Accord
• runny or stuffy nose, nasal congestion or sinus pain
• feeling unwell (nausea)
• diarrhoea
• feeling of tiredness

In combination with tadalafil (another medicine for PAH):
In addition to the above:

• flushing (redness of the skin)
• feeling sick (vomiting)
• chest pain or discomfort

Common (may affect up to 1 in 10 people):

• blurred vision or other vision disturbances
• fainting
• abnormal liver function blood test results
• rhinorrhoea
• constipation
• stomach (abdominal) pain
• chest pain or discomfort
• flushing (redness of the skin)
• feeling sick (vomiting)
• feeling of weakness
• nose bleeds
• skin rash

Combination with tadalafil
In addition to the above (except for abnormal liver function blood test results):

• ringing in the ears (tinnitus)

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

• liver damage
• liver inflammation caused by the body's own defences (autoimmune hepatitis)

Combination with tadalafil

• sudden hearing loss

Side effects in children and adolescents
These are expected to be similar to those listed above for adults.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ambrisentan Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp..
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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.
• The other excipients are: Core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate.
  Film coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol, lecithin (soy) (E322), and Allura Red AC aluminium lake (E129).

Ambrisentan Accord 10 mg film-coated tablets:

• The active substance is ambrisentan. Each film-coated tablet contains 10 mg of ambrisentan.
• The other excipients are: Core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate.
  Film coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol, lecithin (soy) (E322), and Allura Red AC aluminium lake (E129).

Description of the appearance of Ambrisentan Accord and contents of the pack
Ambrisentan Accord 5 mg film-coated tablets
Film-coated tablet, pale pink in colour, round, biconvex, marked with ‘5’ on one side, approximately 7.0 mm in diameter.

Ambrisentan Accord 10 mg film-coated tablets
Film-coated tablet, dark pink in colour, oval, biconvex, marked with ‘10’ on one side, approximately 9.9 mm x 5.0 mm in size.

Ambrisentan Accord is available in 5 mg and 10 mg film-coated tablets in packs containing unit dose blisters of 10x1 or 30x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Delorbis Pharmaceuticals Limited
Ergates Industrial Area
Athinon 17 V
Ergates, Nicosia
Cyprus

Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca
Barcelona
Spain