AMBRISENTAN SALA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ambrisentan Sala 5 mg film-coated tablets EFG

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

1. What Ambrisentan Sala 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. 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.

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

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

2. What you need to know before you take 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 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 pregnant because 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 idiopathic pulmonary fibrosis (a condition in which the lungs become scarred).

Warnings and precautions

Consult 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 caused by fluid retention (peripheral oedema)
• pulmonary veno-occlusive disease (a condition in which the veins in the lungs are blocked).

→ Your doctor will decideif this medicine is suitable for you.

You will need to have regular blood tests

Before you start taking Ambrisentan Sala, and periodically while you are 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 regularly while taking Ambrisentan Sala.

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 and adolescents

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

Other medicines and Ambrisentan Sala

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

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 severe 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.

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

Pregnancy

Ambrisentan may harm the unborn baby 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 this medicine 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 this medicine and periodically while taking this medicine.

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 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 Sala contains lactose, lecithin (soy), red Allura AC aluminium Lake (E129), 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.

This medicine may cause allergic reactions because it contains red Allura 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 Ambrisentan Sala

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

How much Ambrisentan Sala 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 are taking ciclosporin A, do not take more than one 5 mg tablet of Ambrisentan Sala, once a day.

How to take Ambrisentan Sala

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 Sala with or without food.

If you take more Ambrisentan Sala 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:

→ Ask your doctor or pharmacist for adviceif you take more tablets than prescribed.

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

If you forget to take Ambrisentan Sala

If you forget to take a dose of Ambrisentan 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 Ambrisentan Sala without your doctor's advice

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

→Do not stop taking Ambrisentan Sala 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.

Conditions that you and your doctor need to be aware of:

Allergic reactions

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

Heart failure

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

Anaemia (reduced number of red blood cells)

This is a disorder of the blood that can cause tiredness, weakness, difficulty breathing, and general feeling of being unwell. Sometimes this requires a blood transfusion. This is a very frequent side effect that may affect more than 1 in 10people treated.

Low blood pressure (hypotension)

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

→Tell your doctor immediatelyif you suffer from these effects or if they occur suddenly after taking this medicine.

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

Make sureyou 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 include

Very frequent side effects:

• headache
• dizziness
• palpitations (rapid or irregular heartbeats)
• worsening of breathing difficulties shortly after starting to take this medicine
• runny nose or stuffy nose, congestion or pain in the nasal sinuses
• 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.

Frequent side effects:

• 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
• nasal bleeding
• 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) only when taking the combination treatment.

Uncommon side effects:

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

In combination with tadalafil

• sudden loss of hearing.

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: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP.

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

This medicine does not require any special storage temperature.

Keep in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to the pharmacy. Ask your pharmacist how to dispose of containers and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ambrisentan Sala

The active substance is ambrisentan

Each film-coated tablet contains 5 or 10 mg.

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

Appearance of the product and contents of the pack

The Ambrisentan Sala 5 mg film-coated tablet EFG is a pale pink, square, convex tablet, engraved with "5" on one side, flat on the other side, with a nominal length and width of approximately 5.9 mm.

The Ambrisentan Sala 10 mg film-coated tablet EFG is a dark pink, oblong, biconvex tablet, engraved with "10" on one side, flat on the other side, with a nominal length of approximately 11.1 mm and a nominal width of approximately 5.6 mm.

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

Marketing authorisation holder

Laboratorio Reig Jofré, S.A.

C/Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer