Leukeran

Package Leaflet: Information for the Patient

Leukeran, 2 mg, coated tablets

Chlorambucil

Read all of this leaflet carefully before 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Leukeran is and what it is used for
• 2. Before you take Leukeran
• 3. How to take Leukeran
• 4. Possible side effects
• 5. How to store Leukeran
• 6. Contents of the pack and other information

1. What Leukeran is and what it is used for

Leukeran contains the active substance chlorambucil, which belongs to a group of medicines called cytotoxics (also known as chemotherapy). This medicine is used to treat certain types of blood and lymphatic system cancers. Your doctor will be able to explain how Leukeran works in your condition.
Leukeran is indicated for the treatment of patients with:

• Hodgkin's disease and non-Hodgkin's lymphoma.Together, these are a group of diseases known as lymphomas. They are cancers that arise from cells of the lymphatic system.
• Chronic lymphatic leukaemia. A type of blood cancer where the bone marrow produces too many abnormal white blood cells.
• Waldenström's macroglobulinaemia. A rare lymphoma associated with the uncontrolled growth of B cells, a type of white blood cell, resulting in the release of abnormal protein into the blood.

2. Before you take Leukeran

Do not take Leukeran:

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

If you are in doubt, consult your doctor before taking Leukeran.

Warnings and precautions

Before taking this medicine, discuss with your doctor, pharmacist, or nurse if:

• you have recently been vaccinated or plan to be vaccinated with a live vaccine (see "Leukeran and other medicines"), as Leukeran may reduce your body's ability to fight infections.
• you are a potential candidate for bone marrow transplantation (autologous stem cell transplantation), as long-term use of Leukeran may reduce the number of stem cells.
• you are currently undergoing or have recently undergone radiation therapy or chemotherapy.
• you have liver function disorders.
• you have kidney function disorders (nephrotic syndrome), have been treated with high-dose pulses, or have ever had a seizure or convulsion. If you have had a seizure or convulsion, you may be more prone to seizures or convulsions while taking Leukeran.

It is possible that taking Leukeran, especially long-term, may increase the risk of developing a secondary blood cancer. In many cases, patients who developed this disease also received another type of chemotherapy or a form of radiation therapy.
Symptoms of secondary blood cancer include fatigue, fever, infection, and bruising. You should inform your doctor as soon as possible if you experience any of these symptoms (see section 4).

Leukeran and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• live vaccines (e.g., oral polio vaccine, measles, mumps, rubella),
• fludarabine, pentostatin, or cladribine, which are other medicines used in chemotherapy and may be used to treat certain blood cancers,
• phenylbutazone (a medicine used to treat fever, pain, and inflammation in the body) - a lower dose of Leukeran may be required.

Tell your doctor if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Taking Leukeran with food

Leukeran should be taken on an empty stomach. See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking chlorambucil.
Do not take Leukeran if you are planning to have a child. This applies to both women and men.
Taking Leukeran during pregnancy is not recommended, as it may be very harmful to the unborn child.
Do not breastfeed while taking Leukeran.
Leukeran may affect the ovaries or sperm, leading to infertility (inability to have children). In women, this may cause a lack of menstrual periods (amenorrhoea),
and in men, a complete lack of sperm (azoospermia).
During the period when either partner is taking Leukeran, effective contraceptive methods should be used to avoid pregnancy. Consult your doctor.

Driving and using machines

There is no information available on the effects of Leukeran on the ability to drive or use machines.

Leukeran contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Leukeran

This medicine should always be taken exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Leukeran should only be prescribed by a specialist doctor experienced in the treatment of cancer.
Your doctor will tell you how much and how often to take this medicine. The dose is calculated based on your body weight and disease.

• Leukeran tablets are taken orally and should be taken daily on an empty stomach (at least one hour before a meal or three hours after a meal).
• Swallow the tablets whole with a glass of water.
• Do not break, crush, or chew the tablets.

The dose of Leukeran depends on the type of disease (see section 1).

• Your doctor may change the dose during treatment depending on your needs. The dose may sometimes be changed in elderly people or people with liver function disorders. In elderly people, kidney or liver function may be monitored during treatment.
• While taking Leukeran, your doctor may perform regular blood tests to check your blood cell count, and the dose may be adjusted accordingly.

Hodgkin's disease

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

Non-Hodgkin's lymphoma

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

Chronic lymphatic leukaemia

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

Waldenström's macroglobulinaemia

• The recommended initial dose is 6 to 12 mg per day in adults. Some people may need to take Leukeran long-term. Follow your doctor's instructions carefully.

If you take more Leukeran than you should

Consult your doctor or go to the hospital immediately. Take the medicine pack with you, even if it is empty.

If you forget to take Leukeran

If you miss a dose of Leukeran, contact your doctor. Do not take a double dose to make up for a forgotten dose.

If you stop taking Leukeran

Do not stop taking Leukeran without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, contact your doctor or go to the hospital immediately:

• any signs of fever or infection (sore throat, mouth ulcers, or problems urinating),
• any unusualbruising or bleeding, as this may indicate that you have too few blood cells of a certain type,
• a suddenworsening of your condition (even if your temperature is normal),
• feeling extremely tired,
• numbness or weakness of the muscles,
• skin rash, blisters on the skin, mouth ulcers, or eye problems, and high temperature.

Tell your doctor if you experience any of the following side effects, which may also occur when taking this medicine:

Very common (affects more than 1 in 10 people)

• reduction in the number of blood cells or platelets, or bone marrow suppression.

Common (affects up to 1 in 10 people)

• nausea, vomiting, diarrhea, and mouth ulcers,
• secondary blood cancers (acute secondary hematologic malignancies),
• seizures (convulsions) in children with kidney function disorders (nephrotic syndrome),
• reduction in the number of red blood cells or anemia, which may cause fatigue, weakness, or shortness of breath.

Uncommon (affects up to 1 in 100 people)

• skin rash.

Rare (affects up to 1 in 1,000 people)

• yellowing of the whites of the eyes or skin (jaundice),
• allergic reactions, such as hives, itching, or swelling of the tissues,
• reports of progression of skin rash to severe disease, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These two forms of the same severe skin disease cause rash, peeling of the skin, and ulcers of the mucous membranes,
• fever,
• seizure or convulsion,
• liver damage (hepatotoxicity).

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

• abnormal or repeated shaking of the body or involuntary trembling not caused by seizures or convulsions,
• inflammation of the bladder,
• irreversible bone marrow failure - the body may stop producing blood cells temporarily,
• scarring and thickening in the lungs with difficulty breathing,
• interstitial lung disease
• a disease affecting the nerves leading to disturbances in sensation, movement, and organ function (peripheral neuropathy).

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

• absence of menstrual periods (amenorrhoea),
• absence of sperm in the semen (azoospermia).

If any side effect becomes serious or if you notice any side effects not listed in this leaflet, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Leukeran

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 after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
If your doctor tells you to stop taking these tablets, it is important that you return all remaining tablets to your pharmacist, who will dispose of them in accordance with the guidelines for the disposal of hazardous waste. Keep the tablets only if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Leukeran contains

• The active substance is chlorambucil. Each tablet contains 2 mg of chlorambucil.
• The other ingredients are: lactose anhydrous, microcrystalline cellulose, colloidal anhydrous silica, stearic acid, and coating (Opadry Brown YS-1-16655-A) composed of: hypromellose, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide.

What Leukeran looks like and contents of the pack

Leukeran is a brown, round, biconvex, film-coated tablet with "GX EG3" on one side and "L" on the other.
It is available in a glass bottle with a child-resistant closure in a cardboard box.
Pack size: 25 tablets.

Marketing authorization holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: +48 22 104 2100

Manufacturer

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

Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
Instructions for handling the medicinal product
Before administering Leukeran, it is recommended to consult the current guidelines for the handling of cytotoxic drugs.
Contact with Leukeran tablets does not pose a risk, provided the outer coating is not damaged.
Leukeran tablets should not be divided.
Disposal of unused medicinal product
Unused Leukeran tablets should be disposed of in accordance with the current regulations for the disposal of hazardous substances.
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