AMBRISENTAN KERN PHARMA 5 mg FILM-COATED TABLETS

1. What is Ambrisentan Kern Pharma and what is it 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 from 8 years of age and older. PAH consists of high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries become narrower, so the heart has to work harder to pump blood to the lungs. This makes people feel tired, dizzy, and have difficulty breathing.

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

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

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

Do not take Ambrisentan Kern Pharma

• if you are allergicto ambrisentan, soy, or any of the other ingredients of this medicine (listed in section 6). This medicine contains soy. It must not be used in case of peanut or soy allergy.
• if you are pregnant, if you are planning to become pregnant, or if you may become pregnantbecause you are not using a reliable method of birth control (contraceptive). Please read the information in the "Pregnancy" section.
• if you are breast-feeding, read the information under the heading "Breast-feeding".
• if you have liver disease. Consult your doctor, who will decide if this medicine is suitable for you.
• if you have pulmonary fibrosisof unknown cause (idiopathic pulmonary fibrosis).

Warnings and precautions

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

• liver problems
• anemia (reduction in the number of red blood cells)
• swelling of the hands, ankles, or feet caused by fluid retention (peripheral edema)
• pulmonary veno-occlusive disease (a disease where the veins in the lungs are blocked).

→ Your doctor will decideif Ambrisentan Kern Pharma is suitable for you.

You will need to have regular blood tests

Before starting to take this medicine, and periodically while taking it, your doctor will perform blood tests to check:

• if you have anemia
• if your liver is working properly.

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

The signs that your liver may not be working properly include:

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

If you notice any of these circumstances:

→ inform your doctor immediately.

Children

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

Taking Ambrisentan Kern Pharma with other medicines

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines.

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

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

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

→ Tell your doctor or pharmacistif you are taking this medicine.

Pregnancy

Ambrisentan may harm the fetus conceived before, during, or shortly after treatment.

→ If there is a possibility that you may become pregnant, use a reliable contraceptive methodwhile taking ambrisentan. Consult your doctor about this.

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

→ If you become pregnant or think you may be pregnantwhile taking ambrisentan, consult your doctor immediately.

If you are a woman of childbearing age, your doctor will ask you to have a pregnancy testbefore starting to take ambrisentan and periodically while taking this medicine.

Breast-feeding

It is unknown if ambrisentan passes into breast milk.

→ Do not breast-feed while taking ambrisentan.Consult your doctor about this.

Fertility

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

Driving and using machines

Ambrisentan may cause side effects such as low blood pressure, dizziness, fatigue (see section 4) that may affect your ability to drive and use machines. The symptoms of your disease may also reduce your ability to drive or use machines.

→ Do not drive or use machines if you do not feel well.

→ Consult your doctorbefore taking this medicine.

Ambrisentan Kern Pharma contains lactose, soy lecithin, and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

The ambrisentan tablets contain soy lecithin. It must not be used in case of peanut or soy allergy (see section 2 "Do not take Ambrisentan Kern Pharma").

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

3. How to take Ambrisentan Kern Pharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.

How much Ambrisentan Kern Pharma to take

Adults

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

If you are taking cyclosporin A, do not take more than one 5 mg tablet of ambrisentan, once a day.

Adolescents and children from 8 to less than 18 years of age

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

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

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

How to take Ambrisentan Kern Pharma

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

If you take more Ambrisentan Kern Pharma than you should

If you take too many tablets, you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure, which can cause a mild feeling of dizziness:

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ambrisentan 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 Ambrisentan Kern Pharma

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

→ Do not stop taking Ambrisentan Kern Pharma unless your doctor tells you to.

If you have any further questions on 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 everybody gets them.

Serious side effects

Tell your doctorif you get any of these:

Allergic reactions

This is a frequent side effect that may affect up to 1 in 10people. You may notice:

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

Swelling (edema), especially of the ankles and feet

This is a very frequent side effect that may affect more than 1 in 10people.

Heart failure

This is because the heart does not pump enough blood. This is a frequent side effect that may affect up to 1 in 10people. The symptoms include:

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

Reduced number of red blood cells (anemia)

This is a very frequent side effect that may affect more than 1 in 10people treated. Sometimes this requires a blood transfusion. The symptoms include:

• tiredness and weakness
• difficulty breathing
• general feeling of being unwell

Low blood pressure (hypotension)

This is a frequent side effect that may affect up to 1 in 10people. The symptoms include:

• dizziness

→Tell your doctor immediatelyif you (or your child) suffer from these effects or if they occur suddenly after taking ambrisentan.

It is essential to have regular blood tests, to check if you have anemia and that your liver is working properly.

Make sure you have also read the information in section 2about "the need for regular blood tests" and "the 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 (rapid or irregular heartbeats)
• worsening of breathing difficulties shortly after starting to take ambrisentan
• runny nose or blocked nose, congestion or pain in the nasal sinuses
• nausea
• diarrhea
• feeling of tiredness.

In combination with tadalafil (another medicine for PAH)

In addition to the above:

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

Common (may affect up to 1 in 10 people)

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

In combination with tadalafil

In addition to the above, except for abnormal results in blood tests 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 defenses (autoimmune hepatitis).

In combination with tadalafil

• sudden loss of hearing.

Side effects in children and adolescents

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 ingredients are: Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate. Coating: partially hydrolyzed polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol/macrogol, soy lecithin (E322), and red iron oxide (E172).

Appearance of the product and contents of the pack

Ambrisentan 5 mg film-coated tablets are round, pale pink tablets with a score line on one side. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

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

Ambrisentan Kern Pharma is supplied in single-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 last 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/