Ambisentan Medac

Package leaflet: Information for the patient

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

Ambrisentan
Generic medicine
Please read all of this leaflet carefully before you take 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 other people, 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 medac is and what it is used for
2. What you need to know before taking Ambrisentan medac
3. How to take Ambrisentan medac
4. Possible side effects
5. How to store Ambrisentan medac
6. Contents of the pack and other information

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

Ambrisentan medac 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 to treat Pulmonary Arterial Hypertension (PAH) in adults. Pulmonary Arterial Hypertension (PAH) is
high blood pressure in the blood vessels of the lung (pulmonary arteries) that carry blood from the heart to the lungs. 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 medac widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.
Ambrisentan medac may also be used in combination with other medicines used to treat PAH.

2. What you need to know before taking Ambrisentan medac

Do not take Ambrisentan medac:

• if you are allergic to ambrisentan, peanuts, soy, or any of the other excipients of this medicine (listed in section 6).
• if you are pregnant, if you are planning a pregnancy, or if there is a possibility of becoming pregnant because you are not using an effective 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. Speak with your doctor, who will decide whether you can take this medicine.
• if you have lung scarring of unknown origin (idiopathic pulmonary fibrosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you have:

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

Your doctor will decide whether Ambrisentan medac is suitable for you.
You will need regular blood tests
Before starting treatment with Ambrisentan medac, and at regular intervals during treatment, your doctor will
arrange for you to have blood tests 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 medac.
Signs that your liver may not be working properly include:

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

If you notice any of these signs, contact your doctor immediately.
Children and adolescents
Ambrisentan medac is not recommended for children and adolescents under 18 years of age, as its safety and efficacy have not been established in this age group.
Other medicines and Ambrisentan medac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose of Ambrisentan medac if you start treatment with
ciclosporin A (a medicine used after organ transplantation or for the treatment of psoriasis).
If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will need
to monitor you when starting treatment with Ambrisentan medac.
If you are taking other medicines used to treat PAH (e.g. iloprost, epoprostenol,
sildenafil), your doctor may need to monitor you.
Talk to your doctor or pharmacist if you are taking any of these medicines.
Pregnancy
Ambrisentan may cause harm to unborn babies conceived before, during, or shortly after treatment.
If there is a possibility of becoming pregnant, use an effective method of birth control
(contraception) while taking Ambrisentan medac. Discuss this with your doctor.
Do not take Ambrisentan medac if you are pregnant or planning to become pregnant.
If you become pregnant or suspect you are pregnant while taking Ambrisentan medac, contact your doctor immediately.
If you are a woman of childbearing potential, your doctor will require you to have a pregnancy test before starting Ambrisentan medac and regularly during treatment
with this medicine.
Breastfeeding
It is not known whether ambrisentan passes into breast milk.
Do not breastfeed while taking Ambrisentan medac. Discuss this with your doctor.
Fertility
If you are a man taking ambrisentan, this medicine may reduce the number of sperm in your semen. For any questions or concerns about this, talk to your doctor.
Driving and using machines
Ambrisentan medac may 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 illness may also make you feel unable to drive or use machinery.
Do not drive or operate machinery if you do not feel well.
Ambrisentan medac tablets contain lactose, lecithin (soy), and sodium.
Ambrisentan medac 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 medac tablets contain lecithin derived from soy. If you are allergic to peanuts or soy, do not use this medicine (see section 2 “Do not take Ambrisentan medac”).
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Ambrisentan medac

Always take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How much Ambrisentan medac to take
The usual dose of Ambrisentan medac is one 5 mg tablet once daily. Your doctor may
decide to 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 medac once
daily.
How to take Ambrisentan medac
It is best to take the tablet at the same time each day. Swallow the tablet whole with a
glass of water; do not break, crush, or chew the tablet. You may take Ambrisentan medac
with or without food.
[Applies only to unit-dose blister packs]:
These tablets are supplied in special packaging designed to prevent children from removing them.

1. Do not try to push the tablet directly out of the blister. The tablet cannot be pushed through the foil. Instead, the foil must be peeled away.
2. First, separate one blister from the rest of the strip along the perforations.

3. Then carefully peel back the backing to open the blister.

4. Now you can remove the tablet from the blister.

If you take more Ambrisentan medac than you should
If you take too many tablets, you are more likely to experience adverse reactions such as headache, flushing, dizziness,
nausea (feeling unwell), or a drop in blood pressure that may make you feel like you are about to faint:
Seek advice from your doctor or pharmacist if you have taken more tablets than prescribed.
If you forget to take Ambrisentan medac
If you forget to take a dose of Ambrisentan medac, take the tablet as soon as you remember,
and then continue your treatment as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ambrisentan medac
Do not stop taking Ambrisentan medac unless you have discussed it with your doctor.
Ambrisentan medac is a treatment you need to control Pulmonary Arterial Hypertension.
Ambrisentan medac
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 rash, itching, and swelling (usually of the face, lips, tongue, or throat), which may cause difficulty breathing or swallowing.
Swelling (oedema), 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. It is a common side effect which may affect up to 1 in 10 people. Symptoms include:

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

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

• tiredness and weakness
• shortness of breath
• feeling generally unwell.

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

• feeling faint

Contact your doctor immediately if you experience any of these adverse events, or if they occur shortly after taking Ambrisentan medac.
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 include
Very common side effects (may affect more than 1 in 10 people):

• headache
• dizziness
• palpitations (fast or irregular heartbeat)
• worsening of shortness of breath soon after starting treatment with Ambrisentan medac
• runny or stuffy nose, nasal congestion, or sinus pain
• feeling unwell (nausea)
• diarrhoea
• feeling tired

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

• flushing (skin redness)
• stomach problems (vomiting)
• chest pain or discomfort

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

• blurred vision or other vision disturbances
• fainting
• abnormal liver function blood test results
• runny nose
• constipation
• stomach (abdominal) pain
• chest pain or discomfort
• flushing (skin redness)
• stomach problems (vomiting)
• feeling weak
• nosebleeds
• skin rash

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

• ringing in the ears ( tinnitus ), only when taking combination therapy.

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

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

Combination with tadalafil

• sudden hearing loss

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

5. How to store Ambrisentan medac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 medac contains

• The active substance is ambrisentan.
• Each film-coated tablet contains 5 mg or 10 mg.
• The other excipients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, film coating (containing partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, lecithin (soy) (E322)).

Description of the appearance of Ambrisentan medac and contents of the pack
The film-coated tablet of Ambrisentan medac 5 mg is a white to almost white, oblong tablet, imprinted with "5" on one side and "405" on the other side.
The film-coated tablet of Ambrisentan medac 10 mg is a white to almost white, oblong tablet, imprinted with "10" on one side and "406" on the other side.
Ambrisentan medac is available in blister packs of film-coated tablets of 5 mg and 10 mg containing 30 tablets, and in unit dose blister packs of 30x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
MEDAC PHARMA s.r.l
Via Viggiano, 90
00178 Roma
Italy

Manufacturer
Balkanpharma Dupnitsa AD,
3 Samokovsko Shosse Str.
2600 Dupnitsa,
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:
Ambrisentan medac
Italy: Ambrisentan medac