Ambisentan Sala 10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Ambrisentán Sala 5 mg film-coated tablets EFG

Ambrisentán Sala 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. 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 side effects, talk to your doctor, pharmacist, or nurse, even if the side effect is not listed in this leaflet. See section 4.

Leaflet Contents

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

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

This medicinal product contains the active substance ambrisentán. 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. PAH is characterized by elevated 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, causing the heart to work harder to pump blood through them. This leads to fatigue, dizziness, and shortness of breath.

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

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

2. What you need to know before taking Ambrisentan Sala

Do not take Ambrisentan Sala

• if you are allergic to ambrisentan, soy or any of the other ingredients 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, 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 breastfeeding, 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 pulmonary 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 (reduced number of red blood cells)
• swelling of the hands, ankles or feet due to fluid retention (peripheral oedema)
• lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease).

→ Your doctor will decide whether this medicine is suitable for you or not.

You will need regular blood tests

Before starting Ambrisentan Sala, and periodically while taking it, 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 Sala.

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 and adolescents

This medicine is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not been established in this age group.

Other medicines and Ambrisentan Sala

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

Your doctor may need to adjust your dose of ambrisentan if you start taking cyclosporine A (a medicine used after transplantation 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 this medicine.

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

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

Pregnancy

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

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

→ Do not take this medicine 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 take a pregnancy test before starting this medicine and periodically while taking it.

Breast-feeding

It is unknown whether ambrisentan passes into human breast milk.

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

Fertility

If you are a man taking Ambrisentan Sala, 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 and fatigue (see section 4), which may affect your ability to drive and use machines. Symptoms related to your illness may also impair your ability to drive or use machines.

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

Ambrisentan Sala contains lactose, lecithin (soy), Allura Red AC aluminium lake (E129) and sodium

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

This medicine may cause allergic reactions as it contains Allura Red AC aluminium lake (E129). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Ambrisentán Sala

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

How much Ambrisentán Sala to take

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 Ambrisentán Sala per day.

How to take Ambrisentán Sala

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. Ambrisentán Sala may be taken with or without food.

If you take more Ambrisentán Sala 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.

→ Seek advice from your doctor or pharmacist if you take more tablets than prescribed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Ambrisentán Sala

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

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

Do not stop taking Ambrisentán Sala without consulting your doctor

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

→ Do not stop taking Ambrisentán Sala 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 will experience them.

Conditions that you and your doctor should watch for:

Allergic reactions

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

Heart failure

This occurs because the heart does not pump enough blood, causing difficulty breathing, extreme tiredness, and swelling in the ankles and legs. This is a common adverse effect which may affect up to 1 in 10 people treated.

Anaemia (reduced number of red blood cells)

This is a blood disorder that may cause tiredness, weakness, difficulty breathing, and general malaise. Sometimes this requires a blood transfusion. This is a very common adverse effect which may affect more than 1 in 10 people treated.

Hypotension (low blood pressure)

This may cause dizziness. This is a common adverse effect which may affect up to 1 in 10 people treated.

→Contact your doctor immediately if you experience any of these effects or if they occur suddenly after taking this medicine.

It is important to have periodic blood tests to monitor whether you have anaemia and to ensure your liver is functioning properly.

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

Other adverse effects include

Very common adverse effects:

• headache
• dizziness
• palpitations (rapid or irregular heartbeat)
• worsening of breathing difficulty shortly after starting this medicine
• runny or blocked nose, nasal congestion or sinus pain
• 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 adverse effects:

• 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 (redness of the skin)
• 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 or acouphene) only when taking the combination treatment.

Uncommon adverse effects:

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

In combination with tadalafil

• sudden loss of hearing.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Sala

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 temperature conditions.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ambrisentán Sala

The active substance is ambrisentan.

Each film-coated tablet contains 5 or 10 mg.

The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol, lecithin (soy) (E322) and Allura Red AC aluminium lake (E129).

Appearance of the product and contents of the pack

Ambrisentán Sala 5 mg film-coated tablets EFG are pale pink, square, convex tablets, marked with "5" on one side and flat on the other side, with a nominal length and width of approximately 5.9 mm.

Ambrisentán Sala 10 mg film-coated tablets EFG are dark pink, oblong, biconvex tablets, marked with "10" on one side and flat on the other side, with a nominal length of approximately 11.1 mm and a nominal width of approximately 5.6 mm.

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

Marketing Authorization Holder

Laboratorio Reig Jofré, S.A.

C/Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer responsible for batch release