CHLORAMBUCIL ASPEN 2 mg FILM-COATED TABLETS

2. What you need to know before you take Clorambucil Aspen

Do not take Clorambucil Aspen:

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

If you are not sure, consult your doctor before taking this medicine.

Warnings and precautions

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

• if you have been recently vaccinated or are planning to be vaccinated with 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 transplantation), 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 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 greater risk of having them again during treatment with this medicine.

It is possible that the use of this medicine, especially long-term, may increase the risk of developing a secondary blood cancer called secondary acute haematological malignancy. In many cases, patients who develop this type of cancer have also received other chemotherapy or some form of radiotherapy. The symptoms of a secondary blood cancer include fatigue, fever, infection, and bruising. Tell your doctor as soon as possible if you have any of these symptoms (see section 4).

Other medicines and Clorambucil Aspen

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

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

Tell your doctor if you are taking, have recently taken, or might 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 taking 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 clorambucil.

Fertility

This medicine 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). Effective contraceptive measures should be used to avoid pregnancy when one partner is receiving treatment with this medicine. Ask your doctor for advice.

Driving and using machines

There is no information on the effects of Clorambucil on the ability to drive and use machines.

Clorambucil Aspen contains lactose

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

3. How to take Clorambucil Aspen

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor again.

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

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

• This medicine is taken orally. It is known that food affects the absorption of this medicine, so it should be taken on an empty stomach (at least 1 hour before or 3 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).

• It is possible that your doctor may change the dose during treatment, depending on your response to treatment. Sometimes the dose may be reduced in elderly people or if you have liver problems. In elderly people, liver and kidney function will be monitored during treatment.
• During treatment with this medicine, your doctor may perform blood tests to check the number of blood cells and may adjust the dose of the medicine according to 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 leukaemia

• 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested, or go to the hospital immediately.

Take the medicine package with you, even if there are no tablets left.

If you forget to take Clorambucil Aspen

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

If you stop taking Clorambucil Aspen

Do not stop taking this medicine without consulting your doctor.

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

4. Possible side effects

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

Consult your doctor immediately if you notice any of the following:

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

• Treatment with this medicine can cause a decrease in the number of white blood cells. White blood cells fight infections, and when there are too few white blood cells, infections can occur.

• Unexpected bleeding or bruising, this could indicate insufficient production of a specific type of blood cell
• if you suddenly feel unwell (even with a normal temperature),
• if you start to feel tired,
• if you notice numbness or muscle weakness,
• if you have skin rashes, blisters, ulcers, and pain in the mouth or eyes, and high fever.

Tell your doctor if you experience any of the following side effects when taking this medicine:

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

• A decrease in the number of 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 haematological malignancies) especially after long-term treatment,
• seizures (convulsions) in children with a known kidney condition called nephrotic syndrome
• a decrease in the number of red blood cells or anemia that can 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 the whites of the eyes turn yellow (jaundice),
• allergic reactions such as skin lumps, itching (urticaria), or swelling of the face, eyelids, lips, or throat (edema),
• there have been reports of skin rashes 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 the mucous membranes,
• fever,
• seizures or convulsions,
• liver damage (hepatotoxicity).

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

• repeated and abnormal body tremors, without seizures or convulsions, peripheral neuropathy: a disorder that affects the nerves, causing alterations in sensations, movement, and organ function,
• inflammation of the bladder called cystitis,
• irreversible bone marrow depression: your body may stop producing blood cells temporarily,
• scarring and thickening of the lungs with difficulty breathing,
• a type of pneumonia that can cause scarring in the lungs
• lung disease,

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clorambucil Aspen

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 and blister after EXP. The expiry date is the last day of the month stated.

Store in the original package.

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

If your doctor tells you to stop taking the tablets, it is important that you return the 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 tells you to.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clorambucil Aspen

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

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

Appearance and packaging

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

Not all 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 last 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 Healthcare Products (AEMPS) http://www.aemps.