Busulfan Aspen 2 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Busulfan Aspen 2 mg film-coated tablets

Busulfan

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Busulfan Aspen is and what it is used for
2. What you need to know before taking Busulfan Aspen
3. How to take Busulfan Aspen
4. Possible side effects
5. How to store Busulfan Aspen

Pack contents and other information

1. What Busulfan Aspen is and what it is used for

Busulfan Aspen contains the active substance busulfan, which belongs to a group of medicines called alkylating agents (a type of cytotoxic medicine or chemotherapy).

This medicine is used to treat certain blood disorders, including some types of cancer. It works by reducing the number of new blood cells produced by your bone marrow.

Busulfan Aspen may be used in combination with other cytotoxic medicines such as cyclophosphamide.

Busulfan Aspen is used for:

• Chronic myeloid leukaemia: a type of cancer affecting certain blood cells (white blood cells), causing an abnormal increase in white blood cell count in the blood. This can lead to infections and bleeding.
• Polycythaemia vera: a condition in which the number of red blood cells in the blood increases. This causes the blood to thicken and may lead to blood clots, resulting in symptoms such as headaches, dizziness and shortness of breath, etc.
• Thrombocythaemia: a condition affecting platelets (cells involved in blood clotting). Platelet counts may increase, leading to blood clots. Alternatively, platelets may not function properly, resulting in easy bleeding such as nosebleeds, bleeding gums and bruising.
• Myelofibrosis: a disease in which the bone marrow is replaced by fibrous (scar) tissue, causing abnormal production of white and red blood cells. This condition may cause symptoms such as fatigue, abdominal swelling, bleeding and bruising.

Ask your doctor if you would like further information about these conditions.

2. What you need to know before taking Busulfan Aspen

Do not take Busulfan Aspen

• If you are allergic to busulfan or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure, consult your doctor before taking Busulfan Aspen.

Warnings and precautions

Busulfan Aspen is a potent cytotoxic medicine that causes a significant decrease in blood cells. At the recommended dose, this is the intended effect. For this reason, strict monitoring is required.

There is a possibility that the use of Busulfan Aspen may increase the risk of developing another malignant tumour in the future.

Vaccination with vaccines containing live organisms is not recommended.

Consult your doctor before starting Busulfan Aspen:

• If you have been treated with radiotherapy or chemotherapy, currently or recently, or if you have ever undergone a stem cell transplant. This is because patients who have taken Busulfan Aspen may develop serious liver problems (hepatic veno-occlusive disease). The risk of developing hepatic veno-occlusive disease is higher if you have received radiotherapy, three or more cycles of chemotherapy, or have undergone a stem cell transplant.
• If you are known to have high levels of uric acid in your blood or suffer from gout, which can cause joint pain.
• If you have any liver, kidney, or lung problems.

Busulfan Aspen may cause sterility in both men and women. Before starting treatment, talk to your doctor about sperm preservation.

Children and adolescents

There are no clinical data available on safety and efficacy in adolescents under 18 years of age.

Other medicines and Busulfan Aspen

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Busulfan Aspen may interact with other medicines and should be used with caution.

• Other cytotoxic drugs (chemotherapy): when administered with Busulfan Aspen, there is an increased risk of side effects affecting the lungs.
• Phenytoin (used to treat and prevent seizures): your doctor may consider replacing phenytoin with another medicine.
• Vaccines containing live organisms (such as oral polio vaccine, measles, mumps, and rubella vaccines): Busulfan Aspen may reduce the body's ability to fight infections.
• Itraconazole (used to treat fungal infections), metronidazole (used to treat bacterial infections), deferasirox (a medicine used to remove excess iron from the body), or ketobemidone (used to treat pain), because these medicines may cause serious side effects if administered with Busulfan Aspen.
• Cyclophosphamide (used to treat certain types of blood disorders): if administered with Busulfan Aspen, it is recommended that your first dose of cyclophosphamide be given 24 hours after the last dose of Busulfan Aspen to reduce the risk of potential side effects.
• If anesthesia is needed for surgery in hospital or at the dental clinic, inform your doctor or dentist that you are taking Busulfan Aspen.
• The use of paracetamol during administration of Busulfan Aspen should be done with caution.
• In pediatric patients, when administering busulfan-melphalan, if the dose of melphalan is given less than 24 hours after the last dose of busulfan, it may lead to the occurrence of toxicity.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The use of Busulfan Aspen 2 mg coated tablets should be avoided whenever possible during pregnancy, especially during the first trimester. The potential risk to the fetus versus the expected benefit to the mother should be assessed on a case-by-case basis.

Effective contraceptive methods should be used when either partner is being treated with this medicine.

Breastfeeding

You should not take Busulfan Aspen if you are breastfeeding.

Fertility

Busulfan Aspen may damage sperm or eggs, causing sterility in both sexes. It may cause severe ovarian failure, even preventing puberty in girls and pre-adolescents. In males, it may cause testicular atrophy.

Driving and use of machines

There is no information available on the effects of Busulfan Aspen on the ability to drive or operate machinery.

Busulfan Aspen contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Busulfan Aspen

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

Busulfan Aspen should only be administered by a specialist doctor experienced in the treatment of cancer.

Your doctor will determine the amount of medicine you need and how often it should be taken.

• Swallow the tablets whole with a glass of water.
• Do not break, crush, or chew the tablets.

The dose of Busulfan Aspen will depend on your blood disorder or type of blood cancer (see section 1).

Your doctor may adjust the dose during treatment, depending on your needs.

The dose may sometimes be adjusted if you are overweight.

If you are prescribed a high dose of Busulfan Aspen, your doctor may also prescribe another medicine called a benzodiazepine. This will help prevent seizures.

During treatment with Busulfan Aspen, your doctor may perform regular blood tests to monitor your blood cell counts and may adjust the dose of the medicine as necessary.

If you take more Busulfan Aspen than you should

Inform your doctor immediately or go to a hospital. Take the medicine pack with you, even if no tablets remain.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Busulfan Aspen

If you forget to take a dose, inform your doctor. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

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

Some people may be allergic to this medicine. If you experience any of the following symptoms immediately after taking Busulfan Aspen 2 mg film-coated tablets, STOP taking the tablets and tell your doctor immediately:

• Sudden shortness of breath, difficulty breathing, chest pain or tightness
• Swelling of eyelids, face, lips, mouth or tongue
• Uneven rash or "hives" anywhere on the body

Blood abnormalities may occur. Your doctor will carry out regular blood tests to monitor your blood cell levels, but you must tell your doctor immediately if you notice any signs of fever or infection such as cystitis, or if you develop bruising or unexpected bleeding.

Very common adverse effects (may affect more than 1 in 10 patients)

• A drop in blood cell and platelet counts
• Feeling unwell (nausea), vomiting, diarrhoea, and mouth ulcers: with high doses of Busulfan Aspen
• Jaundice (yellowing of the skin or whites of the eyes), hepatobiliary damage: with high doses of Busulfan Aspen and increased bilirubin
• In women, menstruation may stop, fertility may be affected, and early menopause may occur: with high doses of Busulfan Aspen
• In girls, puberty may be delayed or stop
• In children and men, sperm production may be delayed, reduced or stop, and testicle size may decrease
• Inflammation of the lungs without signs of infection (veno-occlusive disease syndrome) with high doses of Busulfan Aspen

Common adverse effects (may affect up to 1 in 10 patients)

• The heart may not beat normally (especially if you have an inherited blood disorder called thalassemia) with high doses of Busulfan Aspen
• Inflammation of the lungs causing difficulty breathing, cough and increased temperature (pneumonitis)
• Hair loss: with high doses of Busulfan Aspen
• Appearance of dark spots on the skin
• Blood in the urine and stinging when urinating (bladder inflammation) with high doses of Busulfan Aspen taken at the same time as cyclophosphamide for cancer treatment or to prevent transplant rejection
• Leukaemia

Uncommon adverse effects (may affect up to 1 in 100 patients)

• In women, menstruation may stop, fertility may be affected, and early menopause may occur: with usual doses of Busulfan Aspen

Rare adverse effects (may affect up to 1 in 1,000 patients)

• A severe drop in red blood cell count which may cause tiredness, weakness, bruising and increased risk of infections (aplastic anaemia)
• Seizures or convulsions: with high doses of Busulfan Aspen
• Cataracts or other vision problems: after bone marrow transplant and with high doses of Busulfan Aspen
• Feeling unwell (nausea), vomiting, diarrhoea and mouth ulcers: with usual doses of Busulfan Aspen. This can be improved by dividing the dose throughout the day.
• Jaundice (yellowing of the skin or whites of the eyes), hepatobiliary damage: with high doses of Busulfan Aspen
• Dry mouth and lips or any other skin changes, for example very dark skin pigmentation, itching or skin rash. Hair loss.
• Skin lesions in patients previously treated with radiotherapy
• Abnormal development of certain tissues (dysplasia), which may complicate the interpretation of certain diagnostic tests

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Muscle weakness that typically causes drooping eyelids and difficulty speaking or moving arms and legs (myasthenia gravis)
• In men, enlargement of the breasts
• Symptoms resembling Addison's disease (weakness, feeling tired, weight loss, feeling unwell, and dark spots on the skin) but with normally functioning adrenal glands

Frequency not known (cannot be estimated from available data)

• Incomplete tooth development
• Increased blood pressure in the blood vessels of the lungs (pulmonary hypertension)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Busulfan Aspen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Busulfan Aspen

• The active substance is busulfan. Each tablet contains 2 mg of busulfan.

• The other components are: anhydrous lactose, pregelatinized corn starch, magnesium stearate, hypromellose, titanium dioxide and triacetin.

Appearance of the product and contents of the pack

Busulfan Aspen 2 mg film-coated tablets are white, film-coated, round tablets, marked with “GX EF3” on one side and “M” on the other.

Busulfan Aspen is available in amber glass bottles with a child-resistant closure, containing 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: +34 952 010 137

Manufacturer

EXCELLA GmbH & Co. KG
Nürnberger Strasse, 12
90537 Feucht
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aspen Pharmacare España S.L.
Avenida Diagonal, 512
Planta Interior 1, Oficina 4
08006 Barcelona
Spain

Date of the most recent revision of this leaflet: June 2025

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