BOSENTAN TEVA 62.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Bosentan Teva 62.5 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Bosentan Teva and what is it used for

Bosentan Teva contains bosentan, which blocks a natural hormone called endothelin-1 (ET-1) that causes narrowing of blood vessels. Bosentan Teva, therefore, causes widening of blood vessels and belongs to a class of medicines called “endothelin receptor antagonists”.

Bosentan Teva is used to treat:

• Pulmonary Arterial Hypertension (PAH): PAH is a disease of severe narrowing of the blood vessels in the lungs leading to an increase in blood pressure in the vessels (pulmonary arteries) that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that can reach the blood in the lungs, making physical activity more difficult. Bosentan Teva widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and alleviates symptoms.

Bosentan Teva is used for the treatment of patients with pulmonary arterial hypertension class III (PAH) to improve exercise capacity (the ability to perform physical activity) and symptoms. The “class” reflects the severity of the disease: “class III” implies marked limitation to physical activity. Some improvements have been observed in patients with PAH class II. “Class II” implies slight limitation to physical activity.

The PAH for which Bosentan Teva is indicated may be:

• primary (without identified cause or hereditary);
• caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of connective tissue that forms the support of the skin and other organs);
• caused by congenital heart defects (at birth) with shunts (abnormal communications) causing abnormal blood flow through the heart and lungs.

Digital Ulcers:(pain in the fingers of the hands and feet) in adult patients with a disease called scleroderma. Bosentan reduces the number of new ulcers in the fingers of the hands and feet.

2. What you need to know before you take Bosentan Teva

Do not take Bosentan Teva

• if you are allergic to bosentanor any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems(ask your doctor)
• if you are pregnant, or could be pregnantbecause you are not using reliable contraceptive methods. Please read the information “Contraceptives” and “Bosentan Teva with other medicines”
• if you are taking cyclosporin A(a medicine used after a transplant or to treat psoriasis).

If any of these situations apply to you, consult your doctor.

Warnings and precautions

Tests that your doctor will perform before treatment

• a blood test to check your liver function
• a blood test to check if you have anemia (low hemoglobin)
• a pregnancy test if you are a woman of childbearing age

Abnormalities in liver function tests and anemia have been found in some patients taking bosentan.

Blood tests that your doctor will perform during treatment

During treatment with bosentan, your doctor may perform regular blood tests to check changes in your liver function and hemoglobin levels.

For all these tests, please see the Patient Alert Card (inside your Bosentan Teva tablet pack). It is essential that you have these regular blood tests while taking bosentan. We suggest that you write the date of your last blood test and also the date of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next test is due.

Liver function blood tests

These tests must be performed monthly throughout the duration of treatment with bosentan. After a dose increase, an additional test must be performed after 2 weeks.

Anemia blood tests

These will be performed every month during the first 4 months of treatment, and then every 3 months, as patients taking bosentan may develop anemia.

If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with bosentan and perform further tests to investigate the cause.

Children and adolescents

Bosentan Teva is NOT recommended in pediatric patients with systemic sclerosis and active digital ulcers. See also section 3. How to take Bosentan Teva.

Taking Bosentan Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. It is especially important that you tell your doctor if you are taking:

• cyclosporin A (a medicine used after a transplant and to treat psoriasis), which must not be taken with bosentan
• sirolimus or tacrolimus, medicines used after a transplant, which are not recommended to be used with bosentan
• glibenclamide (a medicine for diabetes), rifampicin (a medicine for tuberculosis), fluconazole (an antifungal medicine), ketoconazole (a medicine used to treat Cushing's syndrome) or nevirapine (a medicine for HIV), which are not recommended to be used with bosentan
• other medicines for the treatment of HIV infection, which may require special monitoring if used with bosentan
• hormonal contraceptives, which are not effective as the only contraceptive method when taking bosentan. Inside your Bosentan Teva tablet pack, you will find a Patient Alert Card that you must read carefully. Your doctor and/or gynecologist will determine the appropriate contraceptive method for you.
• other medicines for the treatment of pulmonary hypertension: sildenafil and tadalafil
• warfarin (an anticoagulant)
• simvastatin (used to treat high cholesterol).

Women of childbearing age

DO NOT take bosentan if you are pregnant or plan to become pregnant.

Pregnancy tests

Bosentan may affect unborn children conceived before or during treatment. If you are a woman of childbearing age, your doctor will ask you to have a pregnancy test before starting treatment with bosentan, and regularly while taking bosentan.

Contraceptives

If you could become pregnant, use a reliable contraceptive method (contraception) while taking bosentan. Your doctor or gynecologist may advise you on reliable contraceptive methods while taking bosentan. Because bosentan may make hormonal contraception less effective (e.g., oral, injection, implant, or patches), this method alone is not reliable. Therefore, if you use hormonal contraceptives, you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom). Inside your Bosentan Teva tablet pack, you will find a Patient Alert Card. You must complete this card and take it to your doctor at your next visit, so your doctor or gynecologist can determine if you need an alternative or additional reliable contraceptive method. It is recommended to have a monthly pregnancy test while taking bosentan and being of childbearing age.

Tell your doctor immediately if you become pregnant while taking Bosentan Teva, or plan to become pregnant in the near future.

Breast-feeding

Bosentan Teva passes into breast milk. You are advised to STOP breast-feeding if you are prescribed Bosentan Teva, as it is not known if Bosentan Teva in breast milk can harm your baby. Talk to your doctor about this.

Fertility

If you are a man taking bosentan, this medicine may decrease your sperm count. It cannot be excluded that this may affect your ability to father a child. Tell your doctor if you have any questions or concerns about this.

Driving and using machines

Bosentan Teva has no influence or is insignificant on your ability to drive or use machines. However, bosentan may cause low blood pressure (hypotension) that may make you feel dizzy, affect your vision, and affect your ability to drive and use machines. Therefore, if you feel dizzy or your vision is blurred while taking bosentan, DO NOT drive or operate tools or machinery.

Bosentan Teva contains sodium

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

3. How to take Bosentan Teva

Treatment with Bosentan Teva should only be initiated and controlled by a doctor who has experience in the treatment of PAH or systemic sclerosis. Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Bosentan Teva with food and drink

Bosentan Teva can be taken with or without food.

Recommended dose

Adults

Treatment in adults usually starts with 62.5 mg twice a day (morning and evening) for the first 4 weeks, then your doctor will normally advise you to take a 125 mg tablet twice a day, depending on how you react to bosentan.

Children and adolescents

The recommended dose in children is only for PAH. For children from 1 year of age, treatment with bosentan usually starts with 2 mg per kg of body weight twice a day (morning and evening). Your doctor will advise you on the dose.

Please note that bosentan is also available in 32 mg dispersible tablets, which may facilitate dosing in children and patients with low body weight or difficulty swallowing film-coated tablets.

If you feel that the effect of Bosentan Teva is too strong or too weak, consult your doctor to check if you need a dose adjustment.

How to take Bosentan Teva

The tablets should be taken (morning and evening) with water. The tablets can be taken with or without food.

If you take more Bosentan Teva than you should

If you take more tablets than you should, consult your doctor immediately.

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 Bosentan Teva

If you forget to take Bosentan Teva, take a dose as soon as you remember, and continue taking your tablets at your usual schedule. Do not take a double dose to make up for the forgotten dose.

If you stop taking Bosentan Teva

If you suddenly stop taking Bosentan Teva, it may lead to worsening of your symptoms. Your doctor may advise you to reduce the dose over a few days before stopping it completely.

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.

The most serious side effects with bosentan are:

• abnormal liver function that may affect more than 1 in 10 people.
• anemia (low blood value) that may affect up to 1 in 10 people. Anemia may occasionally require blood transfusion.

Your liver and blood values will be monitored during treatment with bosentan (see section 2). It is essential that you have these tests as prescribed by your doctor.

Signs that your liver may not be working properly include:

• nausea (need to vomit)
• vomiting
• fever (high temperature)
• stomach pain (abdomen)
• jaundice (yellowing of the skin and the whites of the eyes)
• dark-colored urine
• skin itching
• lethargy or fatigue (unusual tiredness or exhaustion)
• flu-like syndrome (joint and muscle pain with fever).

If you have any of these symptoms, consult your doctor immediately.

Other side effects:

Very common(may affect more than 1 in 10people):

• headache
• edema (swelling of the legs and ankles or other signs of fluid retention).

Common(may affect up to 1 in 10people):

• flushing (redness of the skin)
• hypersensitivity reactions (including skin inflammation, itching, and rash)
• gastroesophageal reflux disease (acid reflux)
• diarrhea
• syncope (fainting)
• palpitations (rapid or irregular heartbeats)
• low blood pressure
• nasal congestion.

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

• thrombocytopenia (decrease in platelet count)
• neutropenia/leucopenia (low white blood cell count)
• elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes).

Rare(may affect up to 1 in 1,000people):

• anaphylaxis (general allergic reaction), angioedema (inflammation, most frequently around the eyes, lips, tongue, or throat)
• liver cirrhosis (fibrosis), liver failure (severe liver dysfunction).

Frequency not known(cannot be estimated from the available data):

• blurred vision

Side effects in children and adolescents

The side effects that have been observed in children treated with bosentan are the same as those in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use, http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bosentan Teva

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 pack and on the blister after the abbreviation “EXP”. The expiry date refers to the last day of the month stated.

Do not store above 30°C.

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. Package Contents and Additional Information

Composition of Bosentan Teva

• The active ingredient is bosentan.
• Each film-coated tablet contains 62.5 mg of bosentan (as monohydrate).
• The other ingredients are
• Core of the tablet: corn starch, pregelatinized corn starch, sodium carboxymethyl potato starch (type A), povidone, glycerol dibehenate, and magnesium stearate.
• Coating of the tablet: hypromellose, triacetin, talc, titanium dioxide, yellow iron oxide (E172), red iron oxide (E172), and aqueous dispersion of ethylcellulose (containing ethylcellulose, sodium lauryl sulfate, and cetyl alcohol).

Appearance of the Product and Package Contents

Bosentan Teva 62.5 mg film-coated tablets are pink-orange, round (6 mm in diameter), biconvex, engraved with 62.5 on one side.

Bosentan Teva 62.5 mg film-coated tablets are available in blister packs of 7, 14, 28, 56, 60, and 112 film-coated tablets or in perforated unit-dose blisters of 7x1, 14x1, 28x1, 56x1, 60x1, and 112x1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

PLIVA Hrvatska d.o.o.

Prilaz baruna Filipovica 25, Zagreb, 10000

Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Bosentan-ratiopharm 62,5 mg Filmtabletten

Belgium: Bosentan Teva 62.5 mg filmomhulde tabletten

Denmark: Bosentan Teva

Spain: Bosentan Teva 62,5 mg film-coated tablets EFG

Italy: Bosentan Teva 62,5 mg compresse rivestite con film

Luxembourg: Bosentan Teva 62.5 mg comprimés pelliculés

Netherlands: Bosentan Teva 62.5 mg, filmomhulde tabletten

Date of the last revision of this leaflet:November 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/