Chlorambucil Aspen 2 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Chlorambucil Aspen 2 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

This medicine contains an active substance called chlorambucil, which belongs to a group of medicines known as cytotoxic agents (also called chemotherapy). This medicine is used to treat certain types of cancer affecting the blood and the lymphatic system. Your doctor can explain how this medicine may help in your particular condition.

This medicine is used for the treatment of:

• Hodgkin's disease and non-Hodgkin's lymphoma. These are a group of diseases known as 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's macroglobulinaemia. A rare lymphoma characterised by uncontrolled proliferation of B-lymphocytes, a type of white blood cell, leading to the release of an abnormal protein into the blood.

2. What you need to know before taking Clorambucil Aspen

Do not take Clorambucil Aspen:

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

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

Warnings and precautions

Talk to your doctor or nurse before starting this medicine:

• If you have recently been vaccinated or are planning to receive a live attenuated vaccine (see Other medicines and Clorambucil Aspen), as this medicine may reduce your ability to fight infections.
• If you are a potential candidate for bone marrow transplantation (autologous stem cell transplant), as long-term use of this medicine may reduce the number of stem cells.
• If you are currently receiving or have recently received radiotherapy or chemotherapy.
• If you have liver disease.
• If you have kidney disease (nephrotic syndrome), if you have received a high-dose pulse regimen, or if you have ever had a seizure or convulsion. If you have previously experienced seizures or convulsions, you may have an increased risk of having them again during treatment with this medicine.

Use of this medicine, especially long-term, may increase the risk of developing a secondary blood cancer called secondary acute hematologic neoplasia. In many cases, patients who developed this type of cancer had also received other chemotherapy or some form of radiotherapy. Symptoms of secondary blood cancer include fatigue, fever, infection, and bruising. Inform your doctor as soon as possible if you experience any of these symptoms (see section 4).

Other medicines and Clorambucil Aspen

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

• Vaccines containing live organisms (such as oral polio vaccine, measles, mumps, rubella).
• Phenylbutazone (a medicine used to treat fever, pain, and inflammation in the body): you may require a lower dose of this medicine.
• Fludarabine, pentostatin, or cladribine, which are other chemotherapy medicines that may be used to treat certain blood cancers.

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

Taking Clorambucil Aspen with food

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

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding

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

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

Treatment with this medicine is not recommended during pregnancy, as it may harm the fetus.

Breastfeeding is not recommended during treatment with chlorambucil.

Fertility

This medicine may affect ovarian function or sperm production, leading to infertility (inability to conceive a baby). In women, menstruation may stop (amenorrhea), and in men, absence of sperm production (azoospermia) may occur. Effective contraceptive measures should be used to prevent pregnancy when either partner is receiving treatment with this medicine. Seek advice from your doctor.

Driving and using machines

There are no data available regarding the effects of Clorambucil on the ability to drive or operate machinery.

Clorambucil 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 Clorambucil Aspen

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

This medicine will only be prescribed by a specialist doctor experienced in the treatment of cancer.

Your doctor will determine the amount of medicine you need, how often to take it, and the duration of treatment. The dose will be calculated based on your body weight and your condition.

• This tablet medicine is taken orally. It is known that food affects the absorption of this medicine; 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 of this medicine will depend on the type of disease (see section 1).

• Your doctor may adjust the dose during treatment depending on your response. Occasionally, the dose may be reduced in elderly patients or if you have liver problems. In elderly patients, liver and kidney function will be monitored during treatment.
• During treatment with this medicine, your doctor may perform blood tests to check your blood cell counts and may adjust the dose based on the test results.

Hodgkin's disease

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

Non-Hodgkin's lymphoma

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

Chronic lymphocytic leukemia

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

Waldenström's macroglobulinaemia

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

If you take more Clorambucil Aspen than you should

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

Take the medicine packaging with you, even if no tablets remain.

If you forget to take Clorambucil Aspen

Inform your doctor. Do not take a double dose to make up for forgotten doses.

If you stop taking Clorambucil Aspen

Do not stop treatment with this medicine without consulting your doctor.

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

4. Possible adverse effects

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

Contact your doctor immediately or go to the hospital if you notice any of the following:

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

• treatment with this medicine may cause a decrease in the number of white blood cells. White blood cells fight infections, and when their number is too low, infections may occur.

• unexpected bleeding or bruising, which could indicate insufficient production of a specific type of blood cells,

• if you suddenly feel unwell (even with normal temperature),

• if you start to feel exhausted,

• if you experience numbness or muscle weakness,

• if you develop skin rashes, skin blisters, mouth or eye ulcers, and high fever.

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

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

• Decrease in blood cells or bone marrow suppression.

Common (may affect up to 1 in 10 people)

• Feeling unwell (nausea), vomiting, diarrhea, or mouth ulcers (sores),
• secondary blood cancers (secondary acute hematological neoplasms), especially after long-term treatment,
• seizures in children with a known kidney condition called nephrotic syndrome,
• a decrease in red blood cells or anemia, which may cause tiredness, weakness, or difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Rash.

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

• yellowing of the skin or whites of the eyes (jaundice),
• allergy symptoms such as skin lumps, itching (urticaria), or swelling of the face, eyelids, lips, or throat (edema),
• cases of skin rashes progressing to serious conditions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These forms of the same severe skin disease cause rashes, skin peeling, and mucosal membrane ulcers,
• 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 nerve disorder causing disturbances in sensation, movement, and organ function (peripheral neuropathy),
• inflammation of the bladder known as cystitis,
• irreversible bone marrow depression: your body may temporarily stop producing blood cells,
• scarring and thickening of the lungs causing breathing difficulties,
• a type of pneumonia that may cause scarring in the lungs,
• lung disease.

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

• interruption of menstrual periods (amenorrhea),
• absence of sperm in semen (azoospermia).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Chlorambucil Aspen

Keep this medicine out of the sight and reach of children.

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

Store in the original packaging.

Store in a refrigerator (between 2°C and 8°C).

If your doctor tells you to stop taking the tablets, it is important that you return any remaining tablets to the pharmacist, who will dispose of them according to the guidelines for the disposal of hazardous substances. Keep the tablets only if your doctor instructs you to do so.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clorambucil Aspen

• The active substance is chlorambucil. Each tablet of this medicine contains 2 mg of chlorambucil.

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), and macrogol.

Appearance of the product and contents of the pack

Clorambucil Aspen are film-coated tablets for oral administration, round, biconvex, brown in colour, with "GX EG3" engraved on one side and "L" on the other. They are available in bottles containing 25 and 50 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Local Representative

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 2020

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