Bosentan Cipla 125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bosentan Cipla 125 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Bosentan Cipla is used to treat:

• Pulmonary arterial hypertension (PAH): PAH is a disease characterized by severe narrowing of the blood vessels in the lungs, leading to increased 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 enter 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 relieves symptoms.

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

• idiopathic (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 supporting the skin and other organs),
• caused by congenital heart defects (present at birth) with shunts

(abnormal communications) causing abnormal blood flow between the heart and lungs.

• Digital ulcers (ulcers on the fingers and toes) in adult patients who

have a disease called scleroderma. Bosentan Cipla reduces the number of new digital ulcers (in hands and feet) that develop.

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

Do not take Bosentan Cipla:

• if you are allergic to bosentan or 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 pregnant due to not using reliable contraceptive methods. Please read the information in the sections “Contraception” and “Other medicines and Bosentan Cipla”
• if you are taking cyclosporine A (a medicine used after organ transplant 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 your doctor will perform before prescribing treatment

• a blood test to assess liver function
• a blood test to check for anemia (low hemoglobin)
• a pregnancy test if you are a woman of childbearing potential

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

Blood tests 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 (included inside the Bosentan Cipla tablet pack). It is important that you undergo regular blood tests while taking Bosentan Cipla. We recommend that you write the date of your most recent test and your next scheduled test (ask your doctor for the date) on the Patient Alert Card to help you remember when your next visit is due.

Liver function blood tests

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

Blood tests for anemia

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

If these tests show abnormal results, your doctor may decide to reduce the dose or discontinue 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 and active digital ulceration. Bosentan Cipla should not be used in children with a body weight below 31 kg with pulmonary arterial hypertension. See also section 3. How to take Bosentan Cipla.

Taking Bosentan Cipla with other medicines

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

• cyclosporine A (a medicine used after organ transplantation and to treat psoriasis), which must not be administered together with bosentan.
• sirolimus or tacrolimus, medicines used after transplantation, which are not recommended to be administered together with bosentan.

•?glibenclamide (a medicine for diabetes), rifampicin (a medicine for tuberculosis), fluconazole (a medicine for fungal infections), ketoconazole (a medicine to treat Cushing's syndrome), or nevirapine (a medicine for HIV), as administration of these medicines together with bosentan is not recommended.

• other medicines for the treatment of HIV infection, which when administered together with Bosentan Cipla may require special monitoring.
• oral hormonal contraceptives, which are not effective as the sole contraceptive method when taking bosentan. Inside the bosentan packaging, 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 hypercholesterolemia).

Taking Bosentan with food

Bosentan Cipla can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Women of childbearing potential

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

Pregnancy tests

Bosentan may harm unborn children conceived before or during treatment. If you are a woman of childbearing potential, your doctor will require you to take a pregnancy test before starting treatment with bosentan and regularly while taking Bosentan Cipla.

Contraception

If there is any possibility you could become pregnant, use a reliable method of contraception (birth control) while taking bosentan. Your doctor or gynecologist will advise you on reliable contraceptive methods during treatment with bosentan. Since bosentan may reduce the effectiveness of hormonal contraception (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 should also use a condom). Inside the bosentan tablet pack, you will find the 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 whether you need an alternative or additional reliable contraceptive method. A monthly pregnancy test is recommended while taking bosentan if you are of childbearing potential.

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

Breastfeeding

Bosentan passes into breast milk. You are advised to discontinue breastfeeding if you are prescribed Bosentan Cipla, as it is unknown whether the presence of bosentan in breast milk may harm your baby. Discuss this with your doctor.

Fertility

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

Driving and using machines

Bosentan has no influence or only a negligible influence on the ability to drive and use machines. However, bosentan may cause hypotension (lowering of blood pressure), which can lead to dizziness, blurred vision, and may affect your ability to drive or operate tools and machinery. Therefore, if you feel dizzy or experience blurred vision while being treated with bosentan, do not drive or operate tools or machinery.

Bosentan Cipla contains sodium

This medicine contains at least 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 monitored by a physician experienced in the treatment of pulmonary arterial hypertension (PAH) or systemic sclerosis.

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults:

Treatment in adults usually starts with 62.5 mg twice daily (morning and evening) for the first 4 weeks. After this, your doctor will usually advise you to take 125 mg twice daily, depending on your response to Bosentan Cipla.

Use in children and adolescents

The recommended dose for children applies only to PAH. For children aged 1 year and older, treatment with bosentan usually starts at 2 mg per kg of body weight twice daily (morning and evening). Your doctor will advise you on the appropriate dose; however, certain dose strengths are not suitable for children weighing less than 31 kg. For such patients, the lower-dose bosentan tablet is required. Your doctor will advise you on the correct dosing.

Please remember that bosentan is also available as 32 mg dispersible tablets, which may facilitate dosing in children, low-weight patients, or patients who have difficulty swallowing coated tablets.

If you feel that the effect of bosentan is too strong or too weak, consult your doctor to determine whether a dose adjustment is needed.

How to take Bosentan Cipla

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

If you take more Bosentan Cipla than you should

If you take more tablets than prescribed, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 915620420, indicating the medication and the amount ingested.

If you forget to take Bosentan Cipla

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

If you stop taking Bosentan Cipla

If you stop bosentan treatment suddenly, your symptoms may worsen. Do not stop taking Bosentan Cipla unless instructed by your doctor. Your doctor may advise you to gradually reduce the dose over several days before stopping completely.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most serious adverse effects with Bosentan Cipla are:

• Abnormal liver function, which may affect more than 1 in 10 people
• Anaemia (reduced blood count), which may affect more than 1 in 10 people. Anaemia may occasionally require blood transfusion.

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

Signs that your liver may not be functioning properly include:

• Nausea (feeling the need to vomit)
• Vomiting
• Fever (high temperature)
• Stomach (abdominal) pain
• Jaundice (yellowing of the skin or whites of the eyes)
• Dark-coloured urine
• Itching of the skin
• Lethargy or fatigue (unusual tiredness or exhaustion)
• Pseudo-flu syndrome (joint and muscle pain with fever)

If you experience any of these symptoms**, consult your doctor immediately**

Other adverse effects:

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

• Headache
• Oedema (swelling of the legs and ankles or other signs of fluid retention)

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

• Flushing (redness of the skin)
• Hypersensitivity reactions (including skin inflammation, itching, and skin rash)
• Gastro-oesophageal reflux (acid reflux)
• Diarrhoea
• Syncope (fainting)
• Palpitations (rapid or irregular heartbeats)
• Low blood pressure
• Nasal congestion

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

• Thrombocytopenia (decreased number of platelets in the blood)
• Neutropenia/leucopenia (decreased number of white blood cells in the blood)
• Elevated liver function tests with hepatitis (liver inflammation), including possible worsening of hepatitis and/or jaundice (yellowing of the skin or whites of the eyes)

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

• Anaphylaxis (generalised allergic reaction), angioedema (swelling, most frequently around the eyes, lips, tongue or throat)
• Liver cirrhosis (fibrosis), liver failure (severe impairment of liver function), autoimmune hepatitis (liver inflammation caused by the body's own immune system attacking liver cells), which may occur several months or even years after starting treatment

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

• Blurred vision

Other adverse effects in children and adolescents

The adverse effects observed in children treated with Bosentan Cipla are the same as those in adults.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 on the blister after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy or any other medicine take-back system. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Bosentan Cipla

The active substance is bosentan.

Bosentan Cipla 125 mg film-coated tablets:

Each tablet contains 125 mg of bosentan (as monohydrate).

The other components are:

• tablet core: maize starch, sodium starch glycolate (type B), povidone K-30, pregelatinized maize starch, glyceryl 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.

Appearance of the product and contents of the container

Bosentan Cipla 125 mg film-coated tablets are oblong, biconvex, film-coated tablets of cream to light yellow colour, marked with "125" on one side and plain on the other. Dimensions: length: 11.10 ± 0.20 mm and thickness: 5.10 ± 0.20 mm.

PVC/PE/PVDC/aluminum blisters containing 14, 56, 112 and 120 film-coated tablets.

Single-dose precut 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 60C, Bus-1301
2018 Antwerp, Belgium

Manufacturer

Cipla Europe NV
De Keyserlei 60C, Bus-1301
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, Spanish branch
C/Guzmán el Bueno 133, Edificio Britannia
28003 Madrid, Spain

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

Date of the most recent review of this leaflet: November 2025

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