Package Insert: Information for the Patient

Bosentan Teva 62.5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Bosentan Teva is used to treat:

• Pulmonary arterial hypertension(PAH): PAH is a severe narrowing of the blood vessels in the lungs resulting in an increase in the blood pressure in the 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 to treat patients with PAH class III (PAH) to improve exercise capacity (the ability to engage in 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 mild limitation to physical activity.

PAH for which Bosentan Teva is indicated may be:

• primary (without identified or hereditary cause);
• caused by systemic sclerosis (also known as scleroderma, 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 (birth defects) with 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 systemic sclerosis. Bosentan reduces the number of new ulcers appearing on the fingers of the hands and feet.

Do not take Bosentan Teva

• if you are allergic to bosentanor to 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 ciclosporin A(a medicine used after a transplant or to treat psoriasis).

If any of these situations affect you, consult your doctor.

Warnings and precautions

Tests 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 fertile woman

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

Tests your doctor will perform during treatment

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

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

Liver function tests

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

Anemia tests

These should be performed every month for 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 for pediatric patients with systemic sclerosis and active digital ulcer disease. See also section 3. How to take Bosentan Teva.

Taking Bosentan Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including medicines obtained without a prescription. It is especially important to inform your doctor if you are taking:

• ciclosporin A (a medicine used after a transplant and to treat psoriasis), which should not be taken with bosentan
• sirolimus or tacrolimus, medicines used after a transplant, as it is not recommended to use them with bosentan
• glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (an antifungal medicine), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as it is not recommended to use these medicines 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 sole method of contraception when taking bosentan. Inside your Bosentan Teva tablet pack, you will find a Patient Alert Card that you should read carefully. Your doctor and/or gynecologist will establish an appropriate contraceptive method for you.
• other medicines for the treatment of pulmonary hypertension: sildenafil and tadalafil
• warfarin (an anticoagulant)
• simvastatin (used to treat hypercholesterolemia).

Fertile women

Do not take bosentan if you are pregnant or plan to become pregnant.

Pregnancy tests

Bosentan may affect unborn babies conceived before or during treatment. If you are a fertile woman, your doctor will ask you to perform a pregnancy test before starting treatment with bosentan, and regularly while taking bosentan.

Contraceptives

If you may become pregnant, use a reliable method of contraception (contraception) while taking bosentan. Your doctor or gynecologist may advise you on reliable methods of contraception while taking bosentan. Since bosentan may make hormonal contraceptives ineffective (e.g., oral, injection, implant, or patch), this method alone is not reliable. Therefore, if you use hormonal contraceptives, you must also use a barrier method (e.g., female condom, diaphragm, spermicide, or your partner must also use a condom). Inside your Bosentan Teva tablet pack, you will find a Patient Alert Card that you should read carefully. You should complete this card and bring it to your doctor on your next visit, so your doctor or gynecologist can determine if you need an alternative or additional reliable method of contraception. It is recommended to perform a pregnancy test monthly while taking bosentan and are fertile.

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

Breastfeeding

Bosentan Teva passes into breast milk. We recommend that you STOP breastfeeding if you are prescribed Bosentan Teva, as it is not known if Bosentan Teva in breast milk may harm your baby. Talk to your doctor about this.

Fertility

If you are a man taking bosentan, it is possible that this medicine may decrease your sperm count. It cannot be ruled out that this may affect your ability to father a child. Inform your doctor if you have any questions or doubts about this.

Driving and operating machinery

Bosentan Teva has no influence or is insignificant on your ability to drive or operate machinery. However, bosentan may cause hypotension (low blood pressure) that may make you feel dizzy, affect your vision, and affect your ability to drive and operate machinery. 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 coated tablet; this is essentially “sodium-free”.

The treatment with Bosentan Teva should only be initiated and monitored by a doctor with experience in treating PAH or systemic sclerosis treatment. Follow exactly the administration instructions for this medication 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 night) for the first 4 weeks, after which your doctor will normally advise you to take one 125 mg tablet twice a day, depending on how you react to bosentan.

Childrenand adolescents

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

Please remember that bosentan is also available in dispersible tablets of 32 mg, which may facilitate dosing in children and patients with low body weight or difficulties swallowing coated tablets.

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

How to take Bosentan Teva

The tablets should be taken (morning and night) 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Bosentan Teva

If you forgot 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 compensate for the missed dose.

If you interrupt treatment with Bosentan Teva

If you suddenly interrupt treatment with Bosentan Teva, you may experience a worsening of your symptoms. Your doctor may advise you to reduce the dose for a few days before stopping it completely.

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.

The most serious side effects with bosentan are:

• abnormal liver function that can affect more than 1 in 10 people.
• anemia (decreased blood count) that can 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 these analyses are done as prescribed by your doctor.

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

• nausea (need to vomit)
• vomiting
• fever (high temperature)
• abdominal pain
• jaundice (yellowish color of the skin and the white of the eyes)
• dark urine
• itching of the skin
• 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(can affectmore than 1 in 10people):

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

Common(can affectup to 1 in 10people):

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

Uncommon(can affectup to 1 in 100people):

• thrombocytopenia (decreased platelet count in the blood)
• 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 (yellowish color of the skin or the white of the eyes).

Rare(can affectup to 1 in 1,000people):

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

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

• blurred vision

Side effects in children and adolescents

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

Reporting of side effects

Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, http://: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 packaging and on the blister after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bosentan Teva

• The active ingredient is bosentan.
• Each film-coated tablet contains 62.5 mg of bosentan (as monohydrate).
• The other components are
• Tablet core: maize starch, pregelatinized maize starch, sodium carboxymethyl starch (type A), povidone, glycerol dibehenate, and magnesium stearate.
• Tablet coating: 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 contents of the package

Bosentan Teva 62.5 mg film-coated tablets are pink-orange, round (6 mm in diameter), biconvex, and 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 single-dose blister packs of 7x1, 14x1, 28x1, 56x1, 60x1, and 112x1 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible 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 with 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 comprimidos recubiertos con película 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

Last review date of this leaflet:November 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/