Ambrisentan Zentiva

Leaflet attached to the packaging: patient information

Ambrisentan Zentiva, 5 mg, film-coated tablets

Ambrisentan Zentiva, 10 mg, film-coated tablets

Ambrisentan

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Ambrisentan Zentiva and what is it used for
• 2. Important information before taking Ambrisentan Zentiva
• 3. How to take Ambrisentan Zentiva
• 4. Possible side effects
• 5. How to store Ambrisentan Zentiva
• 6. Package contents and other information

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

Ambrisentan Zentiva contains the active substance ambrisentan. It belongs to a group of antihypertensive medicines (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 Zentiva widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and alleviates symptoms. Ambrisentan Zentiva can also be used in combination with other medicines used to treat PAH.

2. Important information before taking Ambrisentan Zentiva When not to take the medicine

When not to take Ambrisentan Zentiva:

• if the patient is allergic to ambrisentan, peanuts, soy, or any other ingredient of the medicine (listed in section 6);
• if the patient is pregnant, plans to become pregnant, or may become pregnant, as they are not using effective birth control methods. See the information in the "Pregnancy" section;
• if the patient is breastfeeding. See the information in the "Breastfeeding" section;
• in case of liver disease. In this case, consult your doctor, who will decide if this medicine is suitable for you;
• if the patient has idiopathic pulmonary fibrosis (scarring of the lungs of unknown cause).

Warnings and precautions:

Before starting to take this medicine, consult your doctor:

• if the patient has liver function disorders
• if the patient has anemia (reduced red blood cell count)
• if the patient has peripheral edema (swelling of the hands, feet, or ankles due to fluid retention)
• if the patient has a lung disease that blocks the blood vessels in the lungs (pulmonary veno-occlusive disease). The doctor will decide if Ambrisentan Zentiva is suitable for the patient.

Regular blood tests are necessary Before starting treatment with Ambrisentan Zentiva 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 regularly perform the above-mentioned blood tests while taking Ambrisentan Zentiva. The following symptoms indicate liver function disorders:

• loss of appetite
• nausea
• vomiting
• fever
• abdominal pain
• jaundice (yellowing of the skin or eyes)
• dark urine
• itching of the skin. If any of these symptoms are noticed: → consult your doctor immediately.

Children

Do not give this medicine to children under 8 years of age, as its efficacy and safety have not been evaluated in this age group.

Other medicines and Ambrisentan Zentiva

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The doctor may need to adjust the dose of Ambrisentan Zentiva if you start taking cyclosporine A (a medicine used after transplants or to treat psoriasis). If you are taking rifampicin (an antibiotic used to treat severe infections), your doctor will monitor you after the first use of Ambrisentan Zentiva. If you are taking other medicines used to treat PAH (e.g., iloprost, epoprostenol, sildenafil), it may be necessary to monitor your condition. → Inform your doctor or pharmacist if you are taking these medicines.

Pregnancy

Ambrisentan Zentiva may harm the unborn baby if conceived before, during, or shortly after treatment. → If pregnancy is possible, use effective birth control methods (to prevent pregnancy) while taking Ambrisentan Zentiva. Consult your doctor. → Do not take Ambrisentan Zentiva if you are pregnant or plan to become pregnant. → If you become pregnant or suspect you are pregnant while taking Ambrisentan Zentiva, consult your doctor immediately.

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

→ before starting Ambrisentan Zentiva and regular tests during treatment.

Breastfeeding

There is no data on the penetration of the active substance in Ambrisentan Zentiva into breast milk. → Do not breastfeed while taking Ambrisentan Zentiva. Consult your doctor.

Effects on fertility

In men taking Ambrisentan Zentiva, it is possible that this medicine may cause a decrease in sperm count. Consult your doctor if you have any questions or concerns.

Driving and using machines

Ambrisentan Zentiva 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 itself may also negatively affect the ability to drive and use machines. → If you feel unwell, do not drive or operate machines.

Ambrisentan Zentiva contains lactose monohydrate, soy lecithin, and the dye Allura Red AC (E 129).

In case of intolerance to some sugars, consult your doctor before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is essentially "sodium-free". This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine. This medicine contains the dye Allura Red AC (E 129), which may cause allergic reactions (see section 4).

3. How to take Ambrisentan Zentiva

→ Always take the medicine as recommended by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

How much Ambrisentan Zentiva to take

Adults

The usual dose of Ambrisentan Zentiva is one 5 mg tablet, once a day. Your doctor may increase the dose to 10 mg (2 x 5 mg tablets or 1 x 10 mg tablet), once a day. If you are taking cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Zentiva per day.

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

Your doctor may decide to increase the dose. It is essential for children to attend regular check-ups with their doctor, as their dose of the medicine needs to be adjusted as they grow or gain weight. If Ambrisentan Zentiva is used in combination with cyclosporine A, the dose of Ambrisentan Zentiva will be limited to 2.5 mg once a day in adolescents and children with a body weight below 50 kg or 5 mg once a day in patients with a body weight of 50 kg or more. For doses requiring 2.5 mg, another product available on the market should be used.

How to take Ambrisentan Zentiva

Try to take the tablet at the same time every day. Swallow the tablet whole, with a glass of water, without dividing, crushing, or chewing. Ambrisentan Zentiva can be taken with or without food.

Taking a higher dose of Ambrisentan Zentiva than recommended

If a higher dose of the medicine is taken than recommended, it is more likely that side effects such as headache, flushing, dizziness, nausea, or low blood pressure will occur, which may cause a feeling of emptiness in the head: → consult your doctor or pharmacist if you have taken more tablets than recommended.

Missing a dose of Ambrisentan Zentiva

If a dose of Ambrisentan Zentiva is missed, take it as soon as possible, and then continue treatment as before. → Do not take a double dose to make up for the missed dose.

Stopping treatment with Ambrisentan Zentiva.

Ambrisentan Zentiva should be taken regularly, as it helps control the patient's pulmonary hypertension. → Do not stop taking Ambrisentan Zentiva without consulting your doctor. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ambrisentan Zentiva can cause side effects, although not everybody gets them.

Severe side effects

Tell your doctor if you experience any of the following symptoms:

Allergic reactions

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

Edema, particularly of the ankles and feet

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

Heart failure

This symptom is due to the heart not pumping enough blood, which causes shortness of breath, severe fatigue, and swelling of the ankles and feet. This is a common side effect that may occur in up to 1 in 10 patients.

Anemia (reduced red blood cell count)

This is a blood disorder that can cause fatigue, weakness, shortness of breath, and malaise. Sometimes, it may require a blood transfusion. This is a very common side effect that may occur in more than 1 in 10 patients.

Low blood pressure

This symptom may cause dizziness. This is a common side effect that may occur in up to 1 in 10 patients. → Consult your doctor immediately if you experience any of these symptoms or if they appear suddenly after taking Ambrisentan Zentiva. → It is essential to regularly perform blood tests to detect possible anemia or liver function disorders. → Also, read the information in section 2 "Regular blood tests" and "The following symptoms indicate liver function disorders".

Other side effects

Very common(may occur in more than 1 in 10 people)

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

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

In addition to the above:

• flushing (redness of the skin)
• nausea, vomiting
• chest pain/discomfort.

Common(may occur in less than 1 in 10 people):

• blurred vision or other vision disturbances
• fainting
• abnormal liver function test results
• runny nose
• constipation
• abdominal pain
• chest pain/discomfort
• flushing (redness of the skin)
• nausea (vomiting)
• weakness
• nosebleeds
• rash.

In combination therapy with tadalafil

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

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

Uncommon(may occur in less than 1 in 100 people):

• 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

These are expected to be similar to those listed above for adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ambrisentan Zentiva

Keep out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month. White blisters of PVC/PVDC/Aluminum: There are no special storage instructions for the medicine. Store in the original blister to protect from light. Transparent blisters of PVC/PE/PVDC/Aluminum: There are no special storage instructions for the medicine. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ambrisentan Zentiva contains

The active substance of the medicine is ambrisentan. Ambrisentan Zentiva, 5 mg, film-coated tablets Each film-coated tablet contains 5 mg of ambrisentan. Ambrisentan Zentiva, 10 mg, film-coated tablets Each film-coated tablet contains 10 mg of ambrisentan. The other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate; coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (polyethylene glycol) (E1521), talc, Allura Red AC (E 129), soy lecithin (E 322).

What Ambrisentan Zentiva looks like and what the pack contains

Ambrisentan Zentiva, 5 mg, film-coated tablets Light pink, square, biconvex film-coated tablets with "5" embossed on one side, smooth on the other, with a nominal length/diameter of about 5.9 mm. Ambrisentan Zentiva, 10 mg, film-coated tablets Pink, oval, biconvex film-coated tablets with "10" embossed on one side, smooth on the other, with a nominal length of about 11.1 mm and a nominal diameter of about 5.6 mm. Pack sizes: cardboard boxes containing blisters of 10 or 30 film-coated tablets or single-dose blisters of 10x1 or 30x1 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Delorbis Pharmaceuticals Ltd. Athinon 17, Ergates Industrial Area, 2643 Ergates, Nicosia, Cyprus Genepharm S.A, 18 km Marathonos Avenue, 153 51 Pallini Attiki, Greece

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o. o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:March 2022