Prospect: information for the user

Busulfan Aspen 2 mg film-coated tablets

Busulfan

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

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

Contents of the package and additional information

Busulfano Aspen contains the active ingredient busulfan, which belongs to a group of medicines called alkylating agents (a type of cytotoxic or chemotherapy medication).

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

Busulfano Aspen may be used in combination with other cytotoxic medications such as cyclophosphamide.

Busulfano Aspen is used for:

• Chronic myeloid leukemia:a type of cancer that affects certain blood cells (white blood cells) causing an abnormal increase in the number of white blood cells in the blood. This can cause infections and bleeding.
• Polycthemia vera:a disease that increases the number of red blood cells in the blood. This disease causes the blood to thicken and form blood clots, resulting in symptoms such as headaches, dizziness, and difficulty breathing, etc.
• Thrombocytopenia:a disease that affects platelets (cells that contribute to blood clotting). It can cause an increase in platelets, leading to blood clots. Or the platelets do not work properly, causing easy bleeding such as nosebleeds, bleeding gums, and bruises.
• Mielofibrosis:a disease in which the bone marrow is replaced by fibrous tissue (scar tissue), causing blood cells to be produced abnormally. This disease can cause symptoms such as fatigue, abdominal swelling, bleeding, and bruises.

Ask your doctor if you would like more information about these diseases.

Do not take Busulfano Aspen

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

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

Warnings and precautions

Busulfano Aspen is a potent cytotoxic medication that causes a significant decrease in blood cells. At the recommended dose, this is the desired effect. For this reason, strict control should be performed.

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

Do not recommend vaccination with live vaccines.

Consult your doctor before starting to take Busulfano Aspen:

• If you have been treated with radiation therapy or chemotherapy, now or recently, or if you have ever undergone a stem cell transplant. This is because patients who took Busulfano Aspen may develop severe liver problems (veno-occlusive liver disease). There is a higher risk of developing veno-occlusive liver disease if you have received radiation therapy, three or more cycles of chemotherapy, or have undergone a stem cell transplant.
• If you have a known excessive amount of uric acid in your blood or have gout that can cause joint pain.
• If you have any liver, kidney, or lung problems.

Busulfano Aspen may cause sterility in both men and women.Before starting treatment, talk to your doctor about preserving semen.

Children and adolescents

No clinical data is available on safety and efficacy in adolescents under 18 years old.

Other medications and Busulfano Aspen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.Busulfano Aspen may interact with other medications and should be used with caution.

• Other cytotoxic drugs (chemotherapy): when administered with Busulfano Aspen, there will be a greater likelihood of experiencing side effects that affect the lungs.
• Phenytoin (used for the treatment and prevention of seizures): your doctor may consider substituting phenytoin with another medication.
• Vaccines that contain live organisms (such as the oral poliovirus vaccine, measles, mumps, and rubella vaccine): Busulfano Aspen may cause the body to have a reduced ability to fight infections.
• Itraconazole (used to treat fungal infections) or metronidazole (used to treat bacterial infections), deferasirox (a medication used to remove excess iron from the body), or ketobemidone (used to treat pain), because these medications may cause severe side effects if administered with Busulfano Aspen.
• Cyclophosphamide (used to treat certain blood disorders): if administered with Busulfano Aspen, it is recommended that your first dose of cyclophosphamide be administered 24 hours after the last dose of Busulfano Aspen to reduce the likelihood of any possible side effect.
• If you need anesthesia for surgery in the hospital or dental clinic, inform your doctor or dentist that you are taking Busulfano Aspen.
• The use of paracetamol during the administration of Busulfano Aspen should be done with caution.
• In pediatric patients, if busulfan-melfalan is administered, if the dose of melfalan is administered before 24 hours after the last dose of busulfan, it may cause the appearance of toxicity.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Pregnancy

Busulfano Aspen 2 mg coated tablets should be avoided whenever possible during pregnancy, especially during the first trimester. The potential risk to the fetus should be evaluated against the expected benefit for the mother in each individual case.

Effective contraceptive methods should be used when one of the partners is being treated with this medication.

Breastfeeding

You should not take Busulfano Aspen if you are breastfeeding.

Fertility

Busulfano Aspen may damage sperm or eggs, causing sterility in both sexes. It may cause severe ovarian failure that even prevents puberty in girls and preadolescents. In men, it may cause testicular atrophy.

Driving and operating machinery

No information is available on the effects of Busulfano Aspen on the ability to drive and operate machinery.

Busulfano Aspen contains lactose

This medication contains lactose..If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you are unsure, consult your doctor again.

Busulfan Aspen should only be administered by a specialist doctor with experience in cancer treatment.

Your doctor will inform you of the amount of medication you need and the frequency of administration.

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

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

Your doctor may change the dose during treatment, as needed.

The dose may be adjusted if you have excess weight.

If you take a high dose of Busulfan Aspen, your doctor may also prescribe another medication called benzodiazepine to help prevent seizures.

During treatment with Busulfan Aspen, your doctor may perform periodic blood tests to check your blood cell count and adjust the medication dose as necessary.

If you take more Busulfan Aspen than you should

Inform your doctor immediately or go to the hospital. Bring the medication packaging with you, even if there are no tablets left.

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

If you forget to take Busulfan Aspen

Inform your doctor if you forget to take a dose. Do not take a double dose to make up for the missed dose.

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

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

• Abnormal or labored breathing, chest pain or tightness
• Swelling of the eyelids, face, lips, mouth, or tongue
• Uneven or "hives" skin rash anywhere on the body.

Blood abnormalities may occur. Your doctor will perform regular blood tests to check your blood cell counts, but you must tell your doctor immediately if you notice any signs of fever or infection such as cystitis or if you have bruises or unexpected bleeding.

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

• A decrease in blood cell and platelet counts
• Feeling unwell (nausea), vomiting, diarrhea, and mouth sores: with high doses of Busulfano Aspen
• Jaundice (skin or white of the eyes turns yellow), liver damage: with high doses of Busulfano Aspen and increased bilirubin
• In women, menstruation may stop, fertility may be affected, and premature menopause may occur: with high doses of Busulfano Aspen
• In girls, puberty may be delayed or stopped
• In boys and men, sperm production may be delayed, reduced, or stopped, and testicular size may be reduced
• Pneumonia-like syndrome without signs of infection (pneumonitis) with high doses of Busulfano Aspen

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

• The heart may not beat normally (especially if you have a hereditary blood disorder called thalassemia) with high doses of Busulfano Aspen
• Pneumonitis that causes difficulty breathing, cough, and increased temperature
• Hair loss: with high doses of Busulfano Aspen
• Appearance of dark spots on the skin
• Blood in the urine and painful urination (bladder inflammation) with high doses of Busulfano Aspen at the same time as taking cyclophosphamide as an anticancer or transplant rejection prevention medication.
• Leukemia

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

• In women, menstruation may stop, fertility may be affected, and premature menopause may occur: with standard doses of Busulfano Aspen

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

• A severe decrease in red blood cell count in the blood that may cause fatigue, weakness, bruising, and increased risk of infections (aplastic anemia)
• Seizures or convulsions: with high doses of Busulfano Aspen
• Cataracts or other vision problems: after a bone marrow transplant and with high doses of Busulfano Aspen
• Feeling unwell (nausea), vomiting, diarrhea, and mouth sores: with standard doses of Busulfano Aspen. This may improve by dividing the dose throughout the day.
• Jaundice (skin or white of the eyes turns yellow), liver damage: with high doses of Busulfano Aspen
• Dry mouth and lips or any other skin changes, such as very dark skin color, itching, or skin rash. Hair loss.
• Skin lesions in patients previously treated with radiation therapy
• Alterations in the development of certain tissues (dysplasia) that may make it difficult to interpret certain diagnostic tests.

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

• Weakness in muscles that usually causes eyelid drooping and difficulty speaking or moving arms and legs (myasthenia gravis)
• In men, breast enlargement
• Symptoms that resemble Addison's disease (weakness, feeling unwell, weight loss, feeling unwell, and dark spots on the skin) but with functioning adrenal glands.

Frequency not known (cannot be estimated from available data)

• Incomplete development of teeth

Reporting of side effects

If you experienceanytype ofside effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appearin this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 box, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Busulfano Aspen

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

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

Appearance of the product and contents of the packaging

Busulfano Aspen 2 mg film-coated tablets are white, round, coated tablets, engraved with “GX EF3” on one face and with “M” on the other.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aspen Pharma Trading Limited

3016 Lake Drive

Citywest Business Campus

Dublin 24

Ireland

Tel: +34 952 010 137

Responsible for manufacturing

EXCELLA GmbH & Co. KG

Nürnberger Strasse, 12

90537 Feucht

Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

Ground Floor, Office 4

08006 Barcelona

Spain

Last review date of this leaflet:July 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/