Ambisentan Kern Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ambrisentan Kern Pharma 5 mg film-coated tablets EFG

Ambrisentan Kern Pharma 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ambrisentan Kern Pharma is and what it is used for

This medicine contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure).

It is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults, adolescents, and children aged 8 years and older. PAH is characterized by elevated blood pressure in the vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries become narrower, causing the heart to work harder to pump blood through to the lungs. This leads to fatigue, dizziness, and difficulty breathing.

Ambrisentan widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and relieves symptoms.

Ambrisentan may also be used in combination with other medicines used to treat PAH.

2. What you need to know before starting Ambrisentan Kern Pharma

Do not take Ambrisentan Kern Pharma

• if you are allergic to ambrisentan, to soy, or to any of the other components of this medicine (listed in section 6). This medicine contains soy. It should not be used if you are allergic to peanuts or soy.
• if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using a reliable method of birth control (contraception). Please read the information in the section "Pregnancy".
• if you are breast-feeding, read the information under the heading “Breast-feeding”.
• if you have liver disease. Consult your doctor, who will decide whether this medicine is suitable for you or not.
• if you have lung fibrosis of unknown cause (idiopathic pulmonary fibrosis).

Warnings and precautions

Talk to your doctor before starting to take this medicine if you have:

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

→ Your doctor will decide whether Ambrisentan Kern Pharma is suitable for you or not.

You will need regular blood tests

Before starting this medicine, and periodically during treatment, your doctor will perform blood tests to check:

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

→ It is important that you have these blood tests regularly while taking ambrisentan.

Signs that your liver may not be working properly include:

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

If you notice any of these symptoms:

→ inform your doctor immediately.

Children

Do not administer this medication to children under 8 years of age, as safety and efficacy are unknown in this age group.

Taking Ambrisentan Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you start taking cyclosporine A (a medicine used after transplantation or to treat psoriasis), your doctor may need to adjust your dose of ambrisentan.

If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will monitor you when you start taking ambrisentan.

If you are taking other medicines to treat PAH (iloprost, epoprostenol, sildenafil), your doctor may need to monitor you.

→ Inform your doctor or pharmacist if you are taking this medicine.

Pregnancy

Ambrisentan can harm the unborn child conceived before, during, or shortly after treatment.

→ If there is any possibility you could become pregnant, use a reliable method of contraception while taking ambrisentan. Discuss this with your doctor.

→ Do not take ambrisentan if you are pregnant or plan to become pregnant.

→ If you become pregnant or think you might be pregnant while taking ambrisentan, contact your doctor immediately.

If you are a woman of childbearing age, your doctor will require you to have a pregnancy test before starting ambrisentan and periodically during treatment with this medicine.

Breastfeeding

It is unknown whether ambrisentan passes into breast milk.

→ Do not breastfeed while taking ambrisentan. Consult your doctor about this.

Fertility

If you are a man taking ambrisentan, this medicine may reduce your sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and using machines

Ambrisentan may cause adverse effects such as hypotension, dizziness, fatigue (see section 4), which may affect your ability to drive and operate machinery. Symptoms of your underlying illness may also impair your ability to drive or operate machinery.

→ Do not drive or operate machinery if you do not feel well.

→ Consult your doctor before taking this medicine.

Ambrisentan Kern Pharma contains lactose, lecithin (soy), and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Ambrisentan tablets contain soy lecithin. It should not be used if you are allergic to peanuts or soy (see section 2 “Do not take Ambrisentan Kern Pharma”).

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Ambrisentan Kern Pharma

Follow exactly the instructions for use given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

How much Ambrisentan Kern Pharma to take

Adults

The usual dose is one 5 mg tablet once daily. Your doctor may decide to increase your dose to 10 mg once daily.

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

Adolescents and children from 8 to under 18 years of age

Your doctor may decide to increase your dose. It is important that children attend their regular medical appointments, as their dose needs to be adjusted as they grow or gain weight.

If taken in combination with cyclosporine A, the dose of ambrisentan should be limited to 2.5 mg once daily in adolescents and children weighing less than 50 kg, or 5 mg once daily if they weigh 50 kg or more.

• The use of other 2.5 mg ambrisentan tablets available on the market is recommended for the 2.5 mg dose, as this dose is not feasible with Ambrisentán Kern Pharma.

How to take Ambrisentán Kern Pharma

It is best to take the tablet at the same time each day. Swallow the tablet whole with a glass of water; do not divide, crush, or chew the tablet. You may take ambrisentan with or without food.

If you take more Ambrisentán Kern Pharma than you should

If you take too many tablets, you may be more likely to experience adverse effects such as headache, flushing, dizziness, nausea (feeling unwell), or low blood pressure, which may cause a slight feeling of dizziness.

I n case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ambrisentán Kern Pharma

If you forget to take a dose of ambrisentan, take it as soon as you remember, and then continue as before.

→ Do not take a double dose to make up for forgotten doses.

If you stop taking Ambrisentán Kern Pharma

Ambrisentan is a treatment you will need to continue taking to control your PAH.

→ Do not stop taking Ambrisentán Kern Pharma unless your doctor tells you to do so.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Tell your doctor if you experience any of the following:

Allergic reactions

This is a common adverse effect which may affect up to 1 in 10 people. You may notice:

• rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty breathing or swallowing.

Swelling (edema), especially in the ankles and feet

This is a very common adverse effect 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 effect which may affect up to 1 in 10 people. Symptoms include:

• difficulty breathing
• extreme tiredness
• swelling in the ankles and legs.

Reduced number of red blood cells(anemia)**

This is a very common adverse effect which may affect more than 1 in 10 people treated. Sometimes this requires a blood transfusion. Symptoms include:

• tiredness and weakness
• difficulty breathing
• general malaise

Low blood pressure(hypotension)**

This is a common adverse effect which may affect up to 1 in 10 people. Symptoms include:

• dizziness

→Contact your doctor immediately if you (or your child) experience these effects or if they occur suddenly after taking ambrisentan.

It is important to have periodic blood tests to monitor for anemia and to ensure your liver is functioning properly.

Make sure you have also read the information in section 2 regarding "the need for regular blood tests" and "the signs that your liver may not be working properly."

Other adverse effects

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

• headache
• dizziness
• palpitations (fast or irregular heartbeat)
• worsening of breathing difficulty shortly after starting ambrisentan
• rhinorrhea or nasal congestion, sinus congestion or pain
• nausea
• diarrhea
• feeling of fatigue.

In combination with tadalafil (another medicine for PAH)

In addition to the above:

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

Common (may affect up to 1 in 10 people)

• blurred vision or other changes in vision
• fainting
• abnormal blood test results for liver function
• increased nasal secretion
• constipation
• stomach (abdominal) pain
• chest pain or discomfort
• flushing (skin redness)
• vomiting
• feeling of weakness
• nosebleeds
• skin rash.

In combination with tadalafil

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

• ringing in the ears (tinnitus).

Uncommon (may affect up to 1 in 100 people)

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

In combination with tadalafil

• sudden hearing loss.

Adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambrisentan Kern Pharma

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 the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ambrisentan Kern Pharma

The active substance is ambrisentan. Each film-coated tablet contains 5 mg or 10 mg of ambrisentan.

The other components are:
Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
Coating: polyvinyl alcohol (partially hydrolysed), talc (E553b), titanium dioxide (E171), polyethylene glycol/macrogol, lecithin (soy) (E322), and red iron oxide (E172).

Appearance of the medicine and contents of the pack

Ambrisentan 5 mg film-coated tablets are round, light pink tablets with a score on one side. The score is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Ambrisentan 10 mg film-coated tablets are oblong, red tablets without a score.

Ambrisentan Kern Pharma is supplied in unit dose blisters as 5 mg and 10 mg film-coated tablets, in packs of 30x1 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa – Barcelona
Spain

Date of the most recent revision of this leaflet: June 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/