Prospect: information for the user

Ambrisentan Kern Pharma 5 mg film-coated tablets

Ambrisentan Kern Pharma 10 mg film-coated tablets

Lead the entire prospect carefully before starting to take this medication, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Content of the prospect

1. What Ambrisentan Kern Pharma is and for what it is used
2. What you need to know before starting to take Ambrisentan Kern Pharma
3. How to take Ambrisentan Kern Pharma
4. Possible adverse effects
5. Storage of Ambrisentan Kern Pharma
6. Contents of the package and additional information

This medication contains the active substance ambrisentan. It belongs to a group of medicines called other anti-hypertensives (used to treat high blood pressure).

It is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults. PAH consists of elevated blood pressure in the blood vessels (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 into 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.

Do not takeAmbrisentan Kern Pharma

• if you areallergicto ambrisentan, soybean or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant,if you areplanning to become pregnant,or if youmay become pregnantbecause you are not using a reliable method of birth control (contraceptive). Please read the information in the section "Pregnancy".
• if you arebreastfeedingread the information under the heading “Breastfeeding”.
• if you haveliver disease. Consult your doctor, who will decide if this medicine is or is not suitable for you.
• if you haveidiopathic pulmonary fibrosis, a condition where the lungs become scarred.

Warnings and precautions

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

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

You will need to have regular blood tests

Before starting to take this medicine, and periodically while you are taking it, yourdoctor will perform blood tests to check:

• if you have anemia
• if your liver is functioning correctly.

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

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

• loss of appetite
• unpleasant feeling (nausea)
• vomiting
• high temperature (fever)
• abdominal pain (stomach)
• 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 and adolescents

Ambrisentan is not recommended for children and adolescents under 18 years of age, as its safety and efficacy in this age group are unknown.

Ambrisentan Kern Pharma with othermedicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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

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 usedto treat PAH (iloprost, epoprostenol, sildenafilo) your doctor may need to monitor you.

→ Inform 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 planning to become pregnant.

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

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

Breastfeeding

It is unknown whether ambrisentan passes into human breast milk.

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

Fertility

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

Driving and operating machinery

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

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

→ Consult your doctorbefore taking Ambrisentan Kern Pharma.

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

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

The ambrisentan tablets contain soy lecithin. Do not use in case of allergy 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; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

ChowAmbrisentanKernPharma to take

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 take ciclosporina A, do not take more than one 5 mg tablet of ambrisentan, once a day.

How to takeAmbrisentanKernPharma

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 Kern Pharma with or without food.

If you take moreAmbrisentanKernPharma than you should

If you take too many tablets, you may be more prone to side effects, such as headaches, hot flushes, dizziness, nausea (discomfort), or a drop in blood pressure that may cause a mild sensation of dizziness:

→ Consult your doctor or pharmacistif you take more tablets than prescribed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested

If you forget to takeAmbrisentanKernPharma

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 compensate for the missed doses.

Do not stop taking Ambrisentan Kern Pharma without consulting your doctorAmbrisentan is a treatment that you will need to continue taking to control your HAP.

→Do not stop takingAmbrisentanKernPharma unless your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Conditions you and your doctor should be aware of:

Reactions to allergens

This is a common side effect that can affectup to 1 in 10people treated. You may notice that a rash or itching and swelling (usually on the face, lips, tongue, or throat) appears, which can cause difficulty breathing or swallowing.

Hinchazón (edema), especially of the ankles and feet

This is a very common side effect that can affectmore than 1 in 10people treated.

Insufficiency of the heart

This is due to the heart not pumping enough blood, causing difficulty breathing, extreme fatigue, and swelling in the ankles and legs. This is a common side effect that can affectup to 1 in 10people treated.

Anemia (reduced number of red blood cells)

This is a blood disorder thatcan cause fatigue, weakness, difficulty breathing, and general discomfort. Sometimes this requires a blood transfusion. This is a very common side effect that can affectmore than 1 in 10people treated.

Hipotension (low blood pressure)

This can cause dizziness. This is a common side effect that can affectup to 1 in 10people treated.

→Inform your doctor immediatelyif you experience these side effects or if they occur suddenly after taking ambrisentan.

It is essential to have regular blood tests, to monitor if you have anemia and if your liver is functioning correctly.

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

Other side effects include

Effects that are very common:

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• worsening of difficulty breathing shortly after starting to take ambrisentan
• runny nose or nasal congestion, congestion, or pain in the nasal passages
• nausea
• diarrhea
• feeling of fatigue.

En combination with tadalafilo (another medicine for HAP)

In addition to the above:

Effects that are common:

En combination with tadalafilo

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

Effects that are rare:

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

En combination with tadalafilo

• sudden loss of hearing.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister pack after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ambrisentan Kern Pharma

The active ingredient 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: partially hydrolyzed polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol/macrogol, soy lecithin (E322), and iron oxide red (E172).

A Aspect of the product and contents of the packaging

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

Ambrisentan 10 mg film-coated tablets are oblong-shaped tablets with a red color and no notch.

Ambrisentan Kern Pharma is supplied in blister packs as film-coated tablets of 5 mg and 10 mg, in packs of 30 tablets per pack.

T Trade name of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

F Revision date of this leaflet: April 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/