AMBRISENTAN ALEMBIC 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

AmbrisentanAlembic 5 mg film-coated tablets EFG

AmbrisentanAlembic 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Ambrisentan Alembic 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 Alembic

Do not take Ambrisentan Alembic

• if you are allergic to ambrisentan, soy, or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, planning to become pregnant, or may become pregnant because you are not using a reliable method of birth control (contraceptive). Please read the information under the heading "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 if this medicine is suitable for you.
• if you have pulmonary fibrosis of unknown cause (idiopathic pulmonary fibrosis).

Warnings and precautions

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

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

→Your doctor will decide if ambrisentan is suitable for you.

You will need to have blood tests on a regular basis

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

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

→It is important that you have these blood tests on a regular basis while taking ambrisentan

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

• loss of appetite
• nausea (feeling sick)
• 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 Alembic with other medicines

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

If you start taking ciclosporin 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 used 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 may harm the fetus conceived before, during, or shortly after treatment.

→

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

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

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

Breast-feeding

It is not known if ambrisentan can pass 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.

Ambrisentan Alembic contains lactose

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

Ambrisentan Alembic contains soy lecithin

This medicine contains soy oil. It must not be used in case of peanut or soy allergy (see section 2 “do not take Ambrisentan Alembic”).

Ambrisentan Alembic contains the azoic colouring red Allura AC aluminium lake (E129)

This medicine may cause allergic reactions because it contains red Allura AC aluminium lake (E129) (see section 4).

Ambrisentan Alembic contains sodium

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

3. How to take Ambrisentan Alembic

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

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

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

Your doctor may decide to increase your dose. It is important 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 ciclosporin 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.

Ambrisentan tablets should not be split to try to provide a fraction of the dose. If treatment requires different doses of 5 mg and 10 mg, an alternative medicine containing ambrisentan should be used.

How to take Ambrisentan Alembic

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.

How to remove the tablet

For Ambrisentan Alembic, different packaging materials can be used: normal pressure blisters, single-dose pressure blisters without a removable foil or single-dose pressure blisters with a removable foil (to prevent children from removing the tablets). For single-dose pressure blisters with a removable foil, follow these instructions:

1. Separate a tablet: tear along the cutting lines to separate a "cell" from the strip.

1. Open the outer foil: open and separate the foil along the cell.

1. Remove the tablet: gently push the tablet through the foil from one side.

If you take more Ambrisentan Alembic 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 the Toxicology Information Service. Telephone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take Ambrisentan Alembic

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 Alembic

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

→

If you have any other 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 everybody gets them.

Serious side effects:

Tell your doctor if you get any of these:

Allergic reactions

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

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

Swelling (oedema), especially of the ankles and feet

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

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 10 people treated. The symptoms include:

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

Low red blood cell count (

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

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

Low blood pressure ()

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

The symptoms include:

• dizziness

→ Tell your doctor immediately if you experience these effects or if they occur suddenly after taking ambrisentan

It is important to have regular blood tests to check if you have anaemia and that your liver is working properly.

Make sure you have also read the information in section 2 about "the need for 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 (rapid or irregular heartbeats)
• worsening of breathing difficulties shortly after starting to take Ambrisentan
• runny nose or stuffy nose, congestion or pain in the nasal passages
• nausea
• diarrhoea
• 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 side effects (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/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 (

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

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

In combination with tadalafil

• sudden loss of hearing.

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 effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambrisentan Alembic

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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. 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 Alembic

The active substance is ambrisentan.

Each film-coated tablet contains 5 or 10 mg.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, poloxamer, sodium croscarmellose, magnesium stearate, polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553b), titanium dioxide (E171), macrogol, soy lecithin (E322), and red Allura AC aluminium lake (E129).

Appearance of the product and pack contents

Ambrisentan Alembic 5 mg is a film-coated tablet, pale pink in colour, square in shape, convex, with "L" engraved on one side and "20" on the other side. It is approximately 4.70 mm in length and approximately 4.70 mm in width.

Ambrisentan Alembic 10 mg is a film-coated tablet, dark pink in colour, oval in shape, convex, with "L" engraved on one side and "722" on the other side. It is approximately 9.90 mm in length and approximately 4.90 mm in width.

Ambrisentan Alembic is supplied in the form of 5 mg and 10 mg film-coated tablets in blisters of 10 or 30 tablets.

Only certain pack sizes may be marketed.

Marketing authorisation holder

Alembic Pharmaceuticals Europe Ltd

Palazzo Pietro Stiges, 103, Strait Street, Valletta

VLT 1436, Malta

Manufacturer

Pharmadox Healthcare Ltd

KW20A, Corradino Industrial Estate, Paola

PLA 3000, Malta

Date of last revision of this leaflet: August 2025

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