AMBRISENTAN BLUEFISH 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ambrisentan Bluefish 5 mg film-coated tablets EFG

Ambrisentan Bluefish 10 mg film-coated tablets EFG

ambrisentan

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

1. What is Ambrisentan Bluefish and what is it 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.

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 Bluefish

Do not take Ambrisentan Bluefish

• if you are allergicto ambrisentan, soy, or any of the other ingredients of this medicine (listed in section 6).
• 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 (contraception). 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 pulmonary fibrosisof unknown cause (idiopathic pulmonary fibrosis).

Warnings and precautions

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

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

→ Your doctor will decideif this medicine 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 anemia
• 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:

→ Tell 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 Bluefish

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 cyclosporin 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 ambrisentan.

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

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

Pregnancy

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

→ If you may become pregnant, use a reliable contraceptive methodwhile taking this medicine. Consult your doctor about this.

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

→ If you become pregnant or think you may be pregnant while taking this medicine, 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 ambrisentan 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, this medicine may decrease your sperm count. Consult 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), which 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 Bluefish contains lactose, soy lecithin (E322), Allura Red AC (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 contains soy lecithin. Do not use if you are allergic to peanuts or soy (see section 2 "Do not take Ambrisentan Bluefish").

This medicine may cause allergic reactions because it contains Allura Red AC (E129). It may cause asthma, especially in patients allergic to acetylsalicylic acid (see section 4).

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

3. How to take Ambrisentan Bluefish

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

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

How to take Ambrisentan Bluefish

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.

If you take more Ambrisentan Bluefish 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ambrisentan Bluefish

If you forget to take a dose, 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 Bluefish without your doctor's advice

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

→ Do not stop taking Ambrisentan Bluefish unless your doctor tells you to.

If you have any further 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.

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 (edema), 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 due to the heart not pumping 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.

Anemia (reduced number of red blood cells)

This is a blood disorder 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 experience these side effects or if they occur suddenly after taking ambrisentan.

It is important to have regular blood teststo check if you have anemia and that your liver is working properly. Make sure you 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

? diarrhea

? feeling of tiredness.

In combination with tadalafil (another medicine for PAH)

In addition to the above:

? flushing

? vomiting

? skin rash

? 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
• 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 (tinnitus) only when taking the combination treatment.

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

5. Storage of Ambrisentan Bluefish

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Ambrisentan Bluefish

The active substance is ambrisentan.

Each film-coated tablet contains 5 or 10 mg of ambrisentan.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, polyvinyl alcohol (E 1203), talc (E 553b), titanium dioxide (E171), macrogol (E 1521), soy lecithin (E322), and Allura Red AC (E129).

Appearance of the product and pack contents

Ambrisentan Bluefish 5 mg film-coated tablets EFG are convex, square tablets, pale pink in color, engraved with "5" on one side and smooth on the other, with a length/width of approximately 5.9 mm.

Ambrisentan Bluefish 10 mg film-coated tablets EFG are oblong, biconvex tablets, pink in color, engraved with "10" on one side and smooth on the other, with a length of 11.1 mm and a width of 5.6 mm approximately.

Ambrisentan Bluefish 5 mg/10 mg film-coated tablets EFG are packed in white PVC/PVDC/aluminum blisters and/or transparent PVC/PE/PVDC/aluminum blisters.

Package size: 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer:

Genepharm S.A.

18 km Marathonos Avenue

153 51 Pallini Attiki

Greece

or

Delorbis Pharmaceuticals Ltd

17 Athinon str.,

Ergates Industrial Area,

2643 Ergates, Lefkosia,

Cyprus

You can obtain further information on this medicine from the representative of the marketing authorization holder in your country:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Sucursal 36

Date of last revision of this leaflet:September 2021

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