Ambriptan Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ambrisentan Zentiva 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 or pharmacist.
• 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ambrisentan Zentiva 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, adolescents, and children aged 8 years and older. PAH is high blood pressure in the blood vessels of the lung (the
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 Zentiva widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.
Ambrisentan Zentiva may also be used in combination with other medicines used to treat PAH.

2. What you need to know before taking Ambrisentan Zentiva

Do not take Ambrisentan Zentiva:

• If you are allergic to ambrisentan, peanuts, soy, or any of the other ingredients 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 “Breast-feeding”.
• If you have liver disease. Talk to 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 Ambrisentan Zentiva if you have:

• liver problems,
• anaemia (reduced 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 Zentiva is suitable for you.
You need to have regular blood tests
Before starting treatment with Ambrisentan Zentiva, 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 the duration of treatment
with Ambrisentan Zentiva.
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 eyes (jaundice),
• dark-coloured urine,
• itching of the skin.

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 Zentiva
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 Zentiva if you start treatment with cyclosporine 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 Zentiva.
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 Zentiva may cause harm to unborn babies conceived before, during, or shortly after the end of treatment.
→ If there is any possibility of becoming pregnant, use an effective method of birth control (contraception) while taking Ambrisentan Zentiva. Discuss this with your doctor.
→ Do not take Ambrisentan Zentiva if you are pregnant or planning to become pregnant.
→ If you become pregnant or suspect you are pregnant while taking Ambrisentan Zentiva, contact your doctor immediately.
If you are a woman who could become pregnant, your doctor will require you to have a pregnancy test before starting Ambrisentan Zentiva and regularly during treatment with this medicine.
Breast-feeding
It is not known whether the active ingredient of Ambrisentan Zentiva passes into breast milk.
→ Do not breast-feed while taking Ambrisentan Zentiva. Discuss this with your doctor.
Fertility
If you are a man taking Ambrisentan Zentiva, this medicine may reduce the number of sperm in semen. For any questions or concerns about this, talk to your doctor.
Driving and using machines
Ambrisentan Zentiva 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 underlying disease may also impair your ability to drive or use machines.
→ Do not drive or operate machinery if you do not feel well.
Ambrisentan Zentiva contains lactose monohydrate, soy lecithin, and Allura Red AC (E129).
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.
This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.
This medicine contains a colouring agent called Allura Red AC (E129), which may cause allergic reactions.

3. How to take Ambrisentan Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
How much Ambrisentan Zentiva to take
Adults
The usual dose of Ambrisentan Zentiva is one 5 mg tablet once daily. Your doctor may decide to increase
your dose up to 10 mg (two 5 mg tablets or one 10 mg tablet) once daily.
If you are taking cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Zentiva once daily.
Adolescents and children aged 8 to 18 years

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

If taken in combination with ciclosporin A, the dose of Ambrisentan Zentiva 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.

* For doses requiring a 2.5 mg strength, another medicine available on the market must be used.

How to take Ambrisentan Zentiva

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, crush, or chew the tablet. You may take Ambrisentan Zentiva with or without food.

If you take more Ambrisentan Zentiva than you should

If you take too many tablets, you may easily experience adverse reactions such as headache, flushing, dizziness, nausea (feeling unwell), or low blood pressure that could cause a sensation of fainting:

→ Ask your doctor or pharmacist for advice if you have taken more tablets than prescribed.

If you forget to take Ambrisentan Zentiva

If you forget to take a dose of Ambrisentan Zentiva, 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 Zentiva

Ambrisentan Zentiva is a medicine you need to control PAH.

→ Do not stop taking Ambrisentan Zentiva unless you have discussed it with your doctor.

If you have any further questions about 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 everyone experiences them.
Serious side effects
Tell your doctor if you experience any of the following side effects:
Allergic reactions
This is a common side effect that may affect up to 1 in 10 people. You may notice a rash or itching, and swelling (usually of the face, lips, tongue or throat), which may cause difficulty breathing or swallowing.
Swelling (oedema), especially of the ankles and feet
This is a very common side effect that may affect more than 1 in 10 people.
Heart failure
This occurs because the heart does not pump enough blood, causing shortness of breath, extreme tiredness, and swelling of the ankles and legs. This is a common side effect that may affect up to 1 in 10 people.
Anaemia (reduced number of red blood cells)
This is a blood disorder that may cause tiredness, weakness, shortness of breath, and a general feeling of being unwell. Sometimes it requires a blood transfusion. This is a very common side effect that may affect more than 1 in 10 people.
Hypotension (low blood pressure)
This may cause a feeling of fainting. It is a common side effect that may affect up to 1 in 10 people.
→ Contact your doctor immediately if you (or your child) experience any of these adverse events, or if they occur suddenly after taking Ambrisentan Zentiva.
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),
• worsening of shortness of breath soon after starting ambrisentan therapy,
• runny or stuffy nose, nasal sinus congestion or pain,
• feeling sick (nausea),
• diarrhoea,
• feeling tired.

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 test results,
• rhinorrhoea,
• constipation,
• stomach (abdominal) pain,
• chest pain or discomfort,
• flushing (redness of the skin),
• feeling unwell (vomiting),
• feeling weak,
• nosebleeds,
• skin rash.

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

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

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

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

In 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Zentiva

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.
White PVC/PVDC/aluminium blisters:
This medicine does not require any special storage temperature. Store in the
original blister packaging to protect the medicine from light.
Transparent PVC/PE/PVDC/aluminium blisters:
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ambrisentan Zentiva contains
The active substance is ambrisentan.
Ambrisentan Zentiva 5 mg film-coated tablets:
Each tablet contains 5 mg of ambrisentan.
Ambrisentan Zentiva 10 mg film-coated tablets:
Each tablet contains 10 mg of ambrisentan.
The other components are:
Tablet core: microcrystalline cellulose (E460); lactose monohydrate; sodium croscarmellose (E468); magnesium stearate (E572).
Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171); macrogol MW 3350 / polyethylene glycol (E1521); talc (E553b); Allura Red AC (E129); lecithin (soy) (E322).

Description of the appearance of Ambrisentan Zentiva and the contents of the pack
Ambrisentan Zentiva 5 mg film-coated tablets:
Pale pink, film-coated, square-shaped, convex tablets, embossed with "5" on one side and smooth on the other, with a nominal length/width of approximately 5.9 mm.
Ambrisentan Zentiva 10 mg film-coated tablets:
Pink, film-coated, oblong, biconvex tablets, embossed with “10” on one side and smooth on the other, with a nominal length of approximately 11.1 mm and a nominal width of approximately 5.6 mm.
Ambrisentan Zentiva is packaged in white PVC/PVDC/aluminium blisters and/or in transparent PVC/PE/PVDC/aluminium blisters.
Pack sizes: cardboard boxes containing 10, 30 film-coated tablets in blisters or 10x1, 30x1 film-coated tablets in unit-of-use blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturers
Genepharm S.A.
18 km Marathonos Ave
153 51 Pallini Attiki
Greece
Delorbis Pharmaceuticals Ltd
17 Athinon str.,
Ergates Industrial Area,
2643 Ergates,
Lefkosia, Cyprus

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands, Czech Republic, Bulgaria, Romania, Slovakia, Germany, France, Italy, Latvia, Lithuania, Estonia, Poland, United Kingdom: Ambrisentan Zentiva