Package Leaflet: Information for the User

Clorambucilo Aspen 2 mg Coated Tablets

Read this leaflet carefully before you start taking 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 or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Clorambucilo Aspen

3. How to take Clorambucilo Aspen

4. Possible side effects

5. Storage of Clorambucilo Aspen

6. Contents of the pack and additional information

This medicationcontains an active ingredient called chlorambucil that belongs to a group of medications called cytotoxics (also known as chemotherapy). This medication is used to treat certain types of cancer that affect the blood and lymphatic system.Your doctor may explain how this medication could help you in your particular situation.

This medicationis used for the treatment of:

• Hodgkin's disease and non-Hodgkin lymphoma. This is a group of diseases called lymphomas. They are cancers of the lymphatic system.
• Chronic lymphocytic leukemia. A type of blood cancer in which the bone marrow produces a large number of abnormal white blood cells.
• Waldenström macroglobulinemia. This is a rare lymphoma characterized by an uncontrolled proliferation of B lymphocytes, a type of white blood cell, resulting in the release of an abnormal protein into the blood.

Do not take Clorambucilo Aspen:

• if you are allergic to clorambucilo or any of the other ingredients of this medication (listed in section 6).
• This medication should not be used for the treatment of non-malignant cancers.

If you are unsure, consult your doctor before taking this medication.

Warnings and precautions

Consult your doctor or nurse before starting to take this medication:

• If you have recently been vaccinated or are planning to be vaccinated with a live attenuated vaccine (see Other medications and Clorambucilo Aspen), as this medication may reduce the ability to fight infections.
• If you are a potential candidate for bone marrow transplantation (autotransplantation of stem cells), as long-term use of this medication may reduce the number of stem cells.
• If you are currently receiving or have recently received radiation therapy or chemotherapy.
• If you have liver disease.
• If you have kidney disease (nephritic syndrome), if you have been on a high-dose pulse regimen or if you have ever had a seizure or convulsion. If you have ever had seizures or convulsions, you may be at a higher risk of having them again during treatment with this medication.

It is possible that the use of this medication, especially long-term, may increase the risk of developing a secondary acute hematological malignancy. In many cases, patients who develop this type of cancer have also received other types of chemotherapy or some form of radiation therapy. Symptoms of a secondary acute hematological malignancy include fatigue, fever, infection, and the appearance of bruises.Inform your doctor as soon as possible if you have any of these symptoms (see section 4).

Other medications and Clorambucilo Aspen

Inform your doctor if you are taking or have recently taken:

• Live vaccines that contain organisms (such as the oral poliovirus vaccine, measles, mumps, and rubella).
• Phenylbutazone (a medication used to treat fever, pain, and body inflammation): you may need a lower dose of this medication.
• Fludarabine, pentostatin, or cladribine, which are other chemotherapy medications that may be used to treat certain blood cancers.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. This also includes herbal medications.

Administration of Clorambucilo Aspen with food

This medication should be taken on an empty stomach. See section 3.

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Do not take this medication if you are planning to have a child. This applies to both men and women.

It is not recommended to use this medication during pregnancy, as it may harm the fetus.

It is not recommended to breastfeed during treatment with clorambucilo.

Fertility

This medication may affect the functioning of the ovaries or sperm production, causing infertility (inability to conceive a baby). In women, menstruation may stop (amenorrhea), and in men, there may be a lack of sperm production (azoospermia). Use effective contraceptive measures to avoid pregnancy when one of the partners is receiving treatment with this medication. Ask your doctor for advice.

Driving and operating machinery

There is no information available about the effects of Clorambucilo on the ability to drive and operate machinery.

Clorambucilo Aspen contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

This medicationwill only be prescribed by a specialist doctor with experience in cancer treatment.

Your doctor will indicate the amount of medication you need, the frequency of administration, and the duration of treatment. The dose will be calculated based on your body weight and disease.

• This medicationtablets are administered orally. It is known that food affects the absorption ofthis medication, therefore, it should be taken on an empty stomach (at least one hour before or three hours after meals).
• Swallow the tablets whole with a glass of water.
• Do not break, crush, or chew the tablets.

The dose ofthis medicationwill depend on the type of disease (see section 1).

• Your doctor may modify the doseduring treatment, depending on your response to treatment.In some cases, the dose may be reduced in elderly people or those with liver problems. In elderly people, liver and kidney function will be monitored during treatment.
• During treatment withthis medication,your doctor may perform blood tests to check the number of blood cells and adjust the medication dose based on the test results.

Hodgkin's Disease

• The recommended dose for adults and children is 0.2mg per kilogram of body weight per day.

Non-Hodgkin Lymphoma

• The recommended dose for adults and children is between 0.1and 0.2mg per kilogram of body weight per day.

Chronic Lymphocytic Leukemia

• The recommended initial dose is 0.15mg per kilogram of body weight per day.

Waldenström Macroglobulinemia

• The recommended initial dose is between 6and 12mg per day. Some people may need to takethis medicationfor a long time.Follow the instructions indicated by your doctor.

If you take more Clorambucilo Aspen than you should

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 or go to the hospital immediately.

Carry the medication packaging with you, even if there are no tablets left.

If you forgot to takeClorambucilo Aspen

Inform your doctor.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Clorambucilo Aspen

Do not interrupt treatment with this medication without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Consult your doctor immediately or go to the hospital if you notice any of the following side effects:

• fever or signs of infection (sore throat, mouth, or urinary problems),

• El treatment withthis medicinemay cause a decrease in the number of white blood cells.White blood cells fight infections, and when there are very few white blood cells, infections may occur.

• Bleeding or unexpected bruising,which could indicate insufficient production of a specific type of blood cell.
• Ifyou suddenlydo not feel well (even with a normal temperature),
• If you start to feel exhausted,
• If you notice numbness or muscle weakness,
• If you experience skin eruptions, blisters on the skin, ulcers, and pain in the mouth or eyes, and high fever.

Consult your doctor if you experience any of the following side effects while taking this medicine:

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

• A decrease in the number of blood cells or suppression of the bone marrow.

Common (may affect up to 1 in 10 people)

• Unpleasant feeling (nausea), vomiting, diarrheaor mouth ulcers (sores),
• Secondary blood cancers (acute secondary hematological neoplasias) especially after long-term treatments,
• Seizures (convulsions) in children with a known kidney condition called nephritic syndrome
• A decrease in the number of red blood cells or anemia that may cause fatigue, weakness, or difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Rash.

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

• The skin or white of the eyes turn yellow (jaundice),
• Allergic symptoms such as skin bumps, itching (urticaria) or swelling of the face, eyelids, lips, or throat (edema),
• Cases of skin eruptions that progress to severe conditions, including Stevens‑Johnson syndrome and toxic epidermal necrolysis. These two forms of severe skin disease cause rashes, skin peeling, and ulcers on mucous membranes,
• Fever,
• Seizures or convulsions,
• Liver damage (hepatotoxicity).

Very rare (may affect up to 1 in 10,000 people)

• Repetitive and abnormal body tremors or spasms, without seizures or convulsions, a disorder that affects nerves, causing altered sensations, movement, and organ function (peripheral neuropathy),
• Urinary tract inflammation called cystitis,
• Irreversible bone marrow depression: your body may temporarily stop producing blood cells,
• Pulmonary fibrosis with difficulty breathing,
• A type of pneumonia that can cause lung scarring
• Pulmonary disease,

Frequency not known (the frequency cannot be estimated from available data)

• Menstrual period interruption (amenorrhea),
• Absence of sperm in semen (azoospermia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse 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 bottle label after EXP.The expiration date is the last day of the month indicated.

Store in the original packaging.

Store in the refrigerator (between 2°Cand 8°C).

If your doctor tells you to stop taking the tablets, it is essential that you return any remaining tablets to the pharmacist, who will dispose of them according to hazardous substance disposal guidelines. Only store the tablets if your doctor instructs you to do so.

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

Composition of Clorambucilo Aspen

• The active ingredient is clorambucilo. Each tablet of this medication contains 2mg of clorambucilo.

The other excipients are:microcrystalline cellulose, anhydrous lactose, anhydrous colloidal silica, stearic acid, hypromellose, titanium dioxide(E171),synthetic yellow iron oxide(E172),synthetic red iron oxide(E172)andmacrogol.

Appearance of the product and content of the container

Clorambucilo Aspen are oral tablets, coated with a film, round, biconvex and brown in color, with“GX EG3” engraved on one face and “L” on the other. They are presented in bottles of 25 and 50 tablets.

Only some sizes of packaging may be commercially marketed.

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

Local representative

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

Ground floor, Office 4

08006 Barcelona

Spain

Last review date of this leaflet:June 2020

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