Package Insert: Information for the User

Ambrisentan Sandoz 5 mg Film-Coated Tablets

Ambrisentan Sandoz 10 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before you start taking Ambrisentan Sandoz

3. How to take Ambrisentan Sandoz

4. Possible side effects

5. Storage of Ambrisentan Sandoz

6. Contents of the pack and additional information

This medication contains the active substance ambrisentán. It belongs to a group of medications 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.

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

This medication may also be used in combination with other medications used to treat PAH.

Do not take Ambrisentán Sala

•if you areallergicto ambrisentán, soybean or any of the other components of this medication (listed in section 6). This medication contains soy. Do not use in case of allergy to peanuts or soy.

•if you are pregnant,if you areplanning to become pregnant,or ifyou may become pregnantbecause you are not using a reliable method of birth control (contraceptive). Please read the information under the heading “Pregnancy”.

•if you arebreastfeedingread the information under the heading “Breastfeeding”.

•if you haveliver disease. Consult your doctor, who will decide if this medication is or is not suitable for you.

•if you haveidiopathic pulmonary fibrosis, a cause unknown.

Warnings and precautions

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

• liver problems

• anemia (reduction of red blood cells)

• swelling of the hands, ankles or feet caused by fluid retention (peripheral edema)

• lung disease where the veins in the lungs are blocked (veno-occlusive pulmonary disease).

→ Your doctor will decideif this medication is or is not suitable for you.

You will need to have regular blood testsfrom

Before starting to take Ambrisentán Sala, and periodically while taking it, your doctor 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 Ambrisentán Sala.

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

•loss of appetite

•unpleasant feeling (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 and adolescents

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

Other medications and Ambrisentán Sala

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

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

If you are taking rifampicine (an antibiotic used to treat serious infections), your doctor will monitor you when you start taking this medication.

If you are taking other medications usedto treat pulmonary arterial hypertension (iloprost, epoprostenol, sildenafilo), your doctor may need to monitor you.

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

Pregnancy

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

→ If there is a possibility that you may become pregnant, use a reliable method of birth controlwhile taking ambrisentán. Consult your doctor about this.

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

→ If you become pregnant or think you may be pregnantwhile taking ambrisentán,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 this medication and periodically while taking it.

Breastfeeding

The safety of ambrisentán in breastfeeding women is unknown.

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

Fertility

If you are a man taking Ambrisentán Sala, it is possible that this medication may decrease your sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and operating machinery

Ambrisentán 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.

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

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

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

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

How much Ambrisentán 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 take cyclosporin A, do not take more than one 5 mg tablet of Ambrisentán Sala, once a day.

How to take Ambrisentán 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 Ambrisentán Sala with or without food.

If you take more Ambrisentán Sala 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, which may cause a mild feeling of dizziness:

→ Ask your doctor or pharmacist for advice if 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, phone 915 620 420, indicating the medication 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 compensate for the missed doses.

Do not stop taking Ambrisentán Sala without consulting your doctor

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

→ Do not stop taking Ambrisentán Sala unless your doctor tells you to.

If you have any other doubts 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:

Allergic reactions

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.

Swelling (edema), especially in the ankles and feet

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

Heart failure

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.

Low blood pressure (hypotension)

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 this medicine.

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

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

Other side effects include

Very common side effects:

•headache

•dizziness

•palpitations (rapid or irregular heartbeat)

•exacerbation of difficulty breathing shortly after starting to take this medicine

•runny nose or stuffy nose, congestion, or pain in the nasal passages

•nausea

•diarrhea

•fatigue.

In combination with tadalafil (another medicine for HAP)

In addition to the above:

•flushing (redness of the skin)

•vomiting

•chest pain/discomfort.

Common side effects:

•blurred vision or other changes in vision

•syncope (fainting)

•abnormal results in liver function blood tests

•increased nasal secretion

•constipation

•abdominal pain (stomach)

•chest pain/discomfort

•flushing (redness of the skin)

•vomiting

•weakness

•nasal bleeding

•skin rash.

In combination with tadalafil

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

•tinnitus (ringing in the ears) or ear buzzing only when the combined treatment is taken.

Uncommon side effects:

•liver damage

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

In combination with tadalafil

•sudden loss of hearing.

Reporting of side effects

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

Keep in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Ambrisentán Sala

The active principle is ambrisentán

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, soy lecithin (E322), and red Allura AC aluminum lake (E129).

Appearance of the product and contents of the packaging

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

The Ambrisentán Sala 10 mg film-coated tablets are dark pink, oblong, biconvex, 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.

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

Marketing Authorization Holder

Reig Jofré, S.A.

C/Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing