us2 mg film-coated tablets
Chlorambucil
What LEUKERAN is What it is used for
Leukeran contains an active substance called chlorambucil, which belongs to a group of medicines called cytotoxic drugs (also called chemotherapy ). This drug is used to treat certain cancers that affect the human blood and lymphatic system. Your doctor can explain how Leukeran can help you in your specific condition.
Leukeran is used in patients with:
- various forms of severe lymphatic tissue disease (malignant lymphoma )
BEFORE YOU TAKE THE LEUKERAN
Take special care with 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 not sure, talk to your doctor before taking Leukeran.
Warnings and cautions
Talk to your doctor or nurse before taking Leukeran if:
- You have recently been vaccinated or are planning to be vaccinated with a live vaccine (see Other medicines and Leukeran) as Leukeran can make it difficult for your body to fight infection .
- You may be waiting for a bone marrow transplant ( autologous stem cell transplant ), as long-term use of Leukeran may reduce the amount of stem cells .
- You are currently receiving or have recently received radiation therapy or chemotherapy (drug treatment for cancer).
- You have a liver or kidney disease.
- You have a kidney disease ( nephrotic syndrome ), have had a regimen with pulse er of high-dose treatment or have ever had a seizure or convulsions.
It is possible that the use of Leukeran, especially with long-term use, may increase the risk of developing another blood cancer. In many cases, patients who have developed this have also received another type of chemotherapy or some form of radiation therapy. Symptoms of secondary blood cancer include fatigue, fever, infection, and bruising. Talk to your doctor as soon as possible if you have any of these symptoms (see section 4).
Other medicines and LEUKERAN
Tell your doctor if you are taking or have recently taken any of the following:
- Vaccines that contain living organisms (such as polio vaccine, measles, mumps, rubella)
- Fludarabine, pentostatin or cladribine, which are other chemotherapy drugs that can be used to treat certain blood cancers.
- Phenylbutazone (a medicine used to treat rheumatic diseases and gout ) may increase the toxic effect when taken with Leukeran.
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
You should not take Leukeran if you are planning to have children. This applies to both men and women. Leukeran treatment is not recommended during pregnancy as it can be very harmful to your unborn baby.
Breast-feeding
You should not breastfeed while taking Leukeran.
Fertility
Leukaria can affect the ovaries or sperm, which can cause infertility (inability to have children). In women, menstruation may cease ( amenorrhea ) and in men, a total absence of sperm may be noted ( azoospermia ).
Use a reliable contraceptive to avoid pregnancy if you or your partner are taking Leukeran. Consult your doctor.
Driving and using machines
There is no information available on the effects of chlorambucil on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Leukeran tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
HOW TO TAKE THE LEUKERAN
Always take Leukeran exactly as your doctor has told you. Ask your doctor if you are unsure.
Leukeran should only be given to you by a specialist doctor who has experience in treating cancer. Your doctor will advise you on how much and how often you need to take this medicine. Your dose is calculated based on your body weight and your illness.
Leukeran can be taken with or without food but should be taken in the same way and at the same time at each time.
Swallow the tablets whole with a glass of water. Do not break or crush the tablets. Do not chew the tablets either.
The dosage of Leukeran depends on your condition (see Section 1).
- Your doctor may change your dose during treatment depending on your needs. The dose of the medicine can sometimes be changed if you are an elderly person or have liver problems. Your kidney or liver function may be checked during treatment if you are an elderly person.
- While you are being treated with Leukeran, your doctor may take regular blood tests to check the number of cells in your blood and the dose of the medicine may change.
Hodgkin’s disease
- The usual starting dose is 0.2 mg per kilogram of your body weight every day for adults and children.
Non-Hodgkin’s lymphoma
- The usual starting dose is 0.1 to 0.2 mg per kilogram of your body weight every day for adults and children.
Lymphocytic lymphoma with leukemia
- The usual starting dose is 0.15 mg per kilogram of your body weight every day for adults.
If you need to have surgery, tell your anesthetist/doctor that you are taking Leukerant tablets.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Bone marrow can be affected with impaired production of various types of blood cells as a result. Therefore, your doctor will take regular blood tests.
If you experience any of the following, talk to your specialist or go directly to a hospital:
- any signs of fever or infection (sore throat, sore mouth or difficulty urinating),
- any unexpected bruising or bleeding, as this may mean that too few cells of a certain type are formed,
- if you suddenly feel unwell (even with normal body temperature),
- if you start to feel very tired,
- if you notice that your muscles become numb or weak,
- if you get Stevens-Johnson syndrome (an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes such as genitals) or have a high fever.
Talk to your doctor if you get any of the following side effects that may occur with this medicine:
Very common (may affect more than 1 user in 10)
- A decreased number of blood cells and platelets caused by decreased formation of new blood cells in the bone marrow (bone marrow suppression)
Common (may affect up to 1 in 10 people)
- Seizures (convulsions) in children with kidney disease ( nephrotic syndrome ).
- Nausea, vomiting, diarrhea, cold sores.
- A decrease in the number of blood cells or anemia that can make you feel tired or weak or short of breath.
- Severe blood disease such as leukemia .
Uncommon (may affect up to 1 in 100 people)
- Rash.
Rare (may affect up to 1 in 1,000 people)
- Allergic symptoms such as skin lumps, hives ( urticaria ) or swelling of the face, lips, tongue or throat, sometimes with shortness of breath or difficulty swallowing ( angioneurotic edema ).
- Skin rashes have been reported to progress to serious diseases, including Steven-Johnson’s disease (An extremely severe allergic reaction with skin rashes usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes such as the genitals) and toxic epidermal necrolysis . These two forms of the same serious skin disease cause rashes, peeling skin and ulcers in the mucous membranes.
- Fever
- Seizures or convulsions
- Liver damage (hepatoxicity)
- Yellowing of the whites of the eyes or the skin (jaundice).
Very rare (may affect up to 1 in 10,000 people)
- Abnormal and repeated tremors in the body or muscle twitching without seizures or convulsions.
- Inflammation of the bladder, so-called cystitis .
- Irreversible bone marrow failure – your body may stop making blood cells for a while.
- Lung disease. Scarring and thickening of the lungs together with shortness of breath.
- Conditions that affect the nerves and lead to impaired functions in terms of sensation, movement and organs ( peripheral neuropathy )
Has been reported (occurs in an unknown number of users)
- missed period ( amenorrhea )
- lack of sperm in the semen
HOW TO STORE LEUKERAN
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
If your doctor tells you to stop taking the tablets, it is important to return any tablets that may be left to the pharmacy staff, who will dispose of them per the hazardous substances guidelines. Only keep the tablets if your doctor tells you to.
The medicine 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 to protect the environment.
CONTENTS OF THE PACKAGING AND OTHER INFORMATION
Marketing Authorization Holder and Manufacturer
Content declaration
– The active substance is chlorambucil. Each Leukerant tablet contains 2 mg of chlorambucil.
The other ingredients are lactose (anhydrous), microcrystalline cellulose, colloidal silica, stearic acid, hypromellose, macrogol, titanium dioxide (dye E171), iron oxide (dye E172).
What the medicine looks like and the contents of the pack:
Leukeran film-coated tablets are brown, round, biconvex tablets imprinted with “L” on one side and “GX EG3” on the other side.
The tablets are supplied in a brown glass jar with a child-resistant lid containing 25 or 50 tablets.
Marketing Authorization Holder and Manufacturer:
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: +46 856 642 572
Manufacturer:
EXCELLA GmbH & Co. KG
Nurnberger Strasse 12
90537 Moisture
Germany