BOSENTAN CIPLA 62.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Bosentan Cipla contains bosentan, which blocks a natural hormone called endothelin-1 (ET-1), causing narrowing of blood vessels. Bosentan Cipla therefore causes dilation of blood vessels and belongs to a class of medicines called "endothelin receptor antagonists".

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

Bosentan Cipla is used to treat patients with PAH in class III to improve symptoms and exercise capacity (the ability to perform physical activity). The "class" reflects the severity of the disease: 'class III' implies marked limitation of physical activity. Some improvements have been observed in patients with PAH class II. 'Class II' implies mild limitation of physical activity. The PAH for which Bosentan Cipla is indicated may be:

• primary (in which no cause is identified or hereditary),
• caused by scleroderma (also called systemic sclerosis, a disease in which there is abnormal growth of connective tissue that forms the support of the skin and other organs),
• caused by congenital heart defects (present at birth) with shunts (abnormal communications) that cause abnormal blood flow between the heart and lungs.

(comprising abnormal communications that cause abnormal blood flow between the heart and lungs).

• Digital ulcers (ulcers on the fingers of the hands and feet) in adult patients who

suffer from a disease called scleroderma. Bosentan Cipla reduces the number of new digital ulcers (on hands and feet) that appear.

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

Do not take Bosentan Cipla:

• if you are allergic to bosentan or 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 pregnant by not using reliable contraceptive methods. Please read the information in the section "Contraceptives" and "Other medicines and Bosentan Cipla"
• if you are taking cyclosporin A (a medicine used after transplants or to treat psoriasis)

If you have any of these conditions, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Bosentan Cipla

Tests that your doctor will perform before prescribing the treatment

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

Abnormal liver function tests and anemia have been found in some patients taking Bosentan Cipla.

Blood tests that your doctor will perform during treatment

During treatment with Bosentan Cipla, your doctor will schedule regular blood tests to monitor changes in your liver function and hemoglobin levels.

For all these tests, please refer to the Patient Alert Card (inside the box of Bosentan Cipla tablets). It is essential that you have these blood tests as prescribed by your doctor. We suggest that you write the date of the most recent test and also your next test (ask your doctor for the date) on the Patient Alert Card to help you remember when you have your next visit.

Liver function blood tests

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

Anemia blood tests

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

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

Children and adolescents

Bosentan Cipla is not recommended in pediatric patients with systemic sclerosis with active digital ulcers. Bosentan Cipla should not be used in children with a body weight of less than 31 kg with pulmonary arterial hypertension. See also section 3. How to take Bosentan Cipla.

Taking Bosentan Cipla with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, even those bought without a prescription. It is especially important that you tell your doctor if you are taking:

• cyclosporin A (a medicine given after transplants and to treat psoriasis) which must not be given with bosentan.
• sirolimus or tacrolimus, which are medicines given after transplants, and are not recommended to be given 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) as these medicines are not recommended to be given with bosentan.

• other medicines for the treatment of HIV infection, which when given with Bosentan Cipla may require special monitoring.
• hormonal contraceptives, which are not effective as the only contraceptive method when taking bosentan. Inside the pack of bosentan, you will find a Patient Alert Card that you should 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).

Taking Bosentan with food

Bosentan Cipla can be taken with or without food

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women of childbearing age

DO NOT take Bosentan Cipla if you are pregnant or planning to become pregnant.

Pregnancy tests

Bosentan may affect unborn babies 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 you are taking Bosentan Cipla.

Contraceptives

If you can become pregnant, use a reliable method of contraception while taking bosentan. Your doctor or gynecologist will advise you on reliable methods of contraception while taking bosentan. Since bosentan can make hormonal contraception ineffective (e.g., oral, injection, implant, or skin 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 the pack of bosentan, you will find a Patient Alert Card. You must complete this card and bring it to your doctor at your next visit so that 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 or plan to become pregnant in the near future.

Breast-feeding

Bosentan passes into breast milk. You are advised to stop breast-feeding if you are prescribed Bosentan Cipla, because it is not known whether the presence of bosentan in breast milk can harm your baby. Talk to your doctor about this.

Fertility

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

Driving and using machines

Bosentan has no influence or negligible influence on the ability to drive and use machines. However, bosentan may cause low blood pressure that can cause dizziness, affect your vision, and affect your ability to drive and use machines. Therefore, if you feel dizzy or have blurred vision while taking bosentan, do not drive or operate tools or machinery.

Bosentan Cipla contains sodium

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

3. How to take Bosentan Cipla

Treatment with bosentan should only be initiated and controlled by a doctor who has experience in the treatment of PAH or systemic sclerosis.

Follow exactly the instructions of your doctor for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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 usually advise you to take one 125 mg tablet twice a day, depending on how you react to Bosentan Cipla.

Use in 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; however, some dosages are not possible in children with a body weight of less than 31 kg. For such patients, the Bosentan tablet with the lower dose is needed. Your doctor will advise you on the dosage.

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 think that the effect of bosentan is too strong or too weak, talk to your doctor to check if you need a dose adjustment.

How to take Bosentan Cipla

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

If you take more Bosentan Cipla 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, telephone 915620420, indicating the medicine and the amount ingested.

If you forget to take Bosentan Cipla

If you forget to take bosentan, take the dose as soon as you remember and then continue taking it at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Bosentan Cipla

If you suddenly stop taking bosentan, your symptoms may worsen. Do not stop taking Bosentan Cipla unless your doctor tells you to. Your doctor may advise you to reduce the dose for a few days before stopping it completely.

If you have any further questions on the use of this product, 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 Cipla are:

• Abnormal liver function that can affect more than 1 in 10 people
• Anemia (low blood value) that can affect more than 1 in 10 people. Anemia may occasionally require blood transfusion.

Your liver and blood values will be checked during treatment with Bosentan Cipla (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 (feeling sick)
• vomiting
• fever (high temperature)
• stomach pain (abdomen)
• jaundice (yellowing of the skin or whites of the eyes)
• dark-colored urine
• itching of the skin
• lethargy or fatigue (unusual tiredness or exhaustion)
• Pseudo-flu 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 skin rash)
• gastroesophageal reflux (acid reflux)
• diarrhea
• fainting (fainting)
• palpitations (rapid or irregular heartbeats)
• low blood pressure
• nasal congestion

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

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

Rare(may affect up to 1 in 1000people):

• anaphylaxis (generalized allergic reaction), angioedema (swelling, most often around the eyes, lips, tongue, or throat)
• liver cirrhosis (fibrosis), liver failure (severe impairment of liver function)

Not known(frequency cannot be estimated from the available data)

• blurred vision

Other side effects in children and adolescents

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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 Bosentan Cipla

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 conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist or local recycling center. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bosentan Cipla

The active ingredient is bosentan

-Bosentan Cipla 62.5 mg film-coated tablets:

Each tablet contains 62.5 mg of bosentan (as monohydrate).

The other components are:

• tablet core:corn starch, sodium starch glycolate (type B), povidone K-30, pregelatinized corn starch, glycerol dibehenate, and magnesium stearate.
• film coating:hypromellose, titanium dioxide (E171), triacetin, talc, yellow iron oxide (E172) and red iron oxide (E172), ethylcellulose, cetyl alcohol, and sodium lauryl sulfate.

Product Appearance and Package Contents

Bosentan Cipla 62.5 mg film-coated tablets: film-coated tablets, round, biconvex, cream to light yellow in color, and marked with "62.5" on one side and smooth on the other side. Diameter 6.10±0.20mm.

PVC/PE/PVDC, aluminum blisters containing 14, 56, and 112 film-coated tablets.

Perforated monodose blisters: PVC/PE/PVDC, aluminum blisters containing 14x1, 56x1, and 112x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp, Belgium

Manufacturer

Cipla Europe NV

De Keyserlei 58-60 Box 19

2018 Antwerp, Belgium

S&D Pharma CZ, spol. s.r.o

Theodor 28, 273 08 Pchery, (Pharmos a.s. facility)

Czech Republic

Local Representative

Cipla Europe NV branch in Spain

C/Guzmán el Bueno, 133 Edificio Britannia

28003 Madrid

Tel 91 534 1673

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

Date of the last revision of this leaflet: April 2025

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