Patient leaflet - Lomustine Medac 40 mg
1. What Lomustine is and what it is used for
This medicine contains an active ingredient called lomustine.
Lomustine belongs to a group of medicines called antineoplastic or cytotoxic agents. These medicines affect growth and proliferation of cancer cells.
Lomustine capsules are used to treat tumours and other malignant growths or diseases, for example, cancer of the lung or skin.
2. What you need to know before you take Lomustine
Do not take Lomustine:
- if you are allergic to lomustine, to other nitrosourea alkylating agents or any of the other ingredients of this medicine (listed in section 6).
- if the tumour previously failed to respond to other nitrosourea alkyla ting agents.
- if your blood-cell count is too low (certain blood samples are always taken before the treatment in order to check your blood-cell count).
- if you have impaired kidney function.
- if you are pregnant.
- if you are breast-feeding.
- if you are allergic to wheat.
if you receive vaccinations against yellow fever or other live va ccines at the same time.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lomustine.
Please note that lomustine may have an effect on your bone marrow function and that thi s effect may occur after a certain amount of time. This may increase the risk of bleeding or getting an infection. The toxic effects of lomustine on your blood formation system will increase over the time you are taking this medicine. Therefore, your doctor will monitor your blood counts, probably once a week during treatment, and up to 6 weeks after the treatment has been stopped.
You should take lomustine exactly as prescribed by your physician and not repeat the prescribed dose at least for 6 weeks.
Due to the cumulative effect on bone marrow, your doctor may decide to reduce the dose of lomustine based on your blood values.
Before you start taking lomustine, your doctor will check that your lungs, liver and kidney are working properly. These tests will be performed throughout the whole treatment.
Long-term use of lomustine may possibly increase the risk of developing another cancer in the future.
Please note that you are handling a cancer medicine. Take care not to come into contact with the contents
of the capsule and wash your hands with soap and water af ter handli ng lomustine.
You must not receive live vaccines during treat ment with lomustine and until at least 3 months after the end of treatment.
Other medicines and Lomustine
No special studies regarding interactions between lomustine and other medicines have been performed. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Treatment may be affected if you use certain other medicines such as medicines that contain:
- Theophylline (medicine against bronchial asthma, lung disease),
- Cimetidine (used in the treatment of e.g. stomach ulcers),
- Medicines that are used to treat epilepsy (convulsions) e.g. phenobarbital,
- Other cytostatic medicines (medicines that inhibit cel l growth) and radiation therapy due to an increased ris k of adverse effects on the bone marrow. You may be more prone to infections.
- Other alkylating agents due to cross-resistance, e.g. carmustine.
You should also inform your doctor if you have been vaccinated recently. Parallel vaccinat ion with yellow fever vaccines ma y increase the risk of fatal complications. You should theref ore not receive
vaccination with live vaccines (e.g. yellow fever vaccine) until at least 3 months after the end of treatment with lomustine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Contraception
Women must use effective contraceptives before the start of, during treatment and for 7 months after treatment is concluded.
Men must use effective contraception before the start of, during and for 4 months after treatment is concluded.
Pregnancy
You must not take lomustine during pregnancy or if you are trying to become pregnant. If you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible. You should be off ered advice regarding the risk of harmful effects on the child through treatment . You should consul t your doctor first if you are planning to become pregnant.
Breast-feeding
Do not take lomustine when you are breast-feeding, because lomustine might be excreted in your breast
milk. If treatment with lomustine is necessary, you must stop breast-feeding.
Fertility
Lomustine can hav e a genetically harmful effect. Men who are treated with lomustine should not father a child during their therapy and for 4 months afterwards. As lomustine may affect your fertility, ask your doctor to inform you about possible precautions like sperm conservation before the start of treatment. Genetic counselling is recommended for patients intending to have children after therapy.
Driving and using machines
This medicine can cause e.g. nausea and vomiting, which may reduce your ability to drive or use machines.
Lomustine contains lactose and wheat starch
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains only very low levels of gluten (from wheat starch). It is regarded a s ‘gluten-free’ and is very unlikely to cause problems if you have coeliac disease. One capsule contains no more than 4 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine.
3. How to take Lomustine
Care must be taken whenever handling anticancer products. Caution! Do not break open the Lomustine capsules. If you accidentally get the powder on your skin or in your mouth, wash it off with plenty of water. Wash your hands with soap and water after handling this product.
Always take this medicine exactly as your doctor has told you, and in an interval of no less than 6 weeks. Check with your doctor or pharmacist if you are not sure.
Lomustine capsules are taken by mouth. Swallow the capsules whole, do not chew or break them.
Use in adults
Your doctor will decide the exact dose to give you and how often to give it. Usually the dose depends on your height and weight. You may expect to receive 200 – 240 mg lomustine. Lomustine capsules are usually taken once every 6 to 8 weeks either as a single dose or as a divided dose over 3 days, e.g. 80 mg/day.
The dose you take may be reduced if you are taking other medicines to treat your condition or if you have a blood disorder.
Use in children
Lomustine capsules may be used in children with certain types of tumours. You must only use Lomustine for children as prescribed by the doctor. Lomustine capsules are usually taken once every 6 to 8 weeks either as a single dose or as a divided dose over 3 days, e.g. 40 mg/day.
If you take more Lomustine than you should
If you have taken mo re lomustine than you should, contact your doctor as soon as possible before taking the next dose. Overdose with lomustine has been reported, including fatal cases.
An overdose might express in bone marrow depression (unexplained bruising or bleeding or susceptibility to infections), abdominal pain, diarrhoea, nausea, vomiting, lack of appetite, lethargy, a feeling of dizziness, symptoms of liver damage such as yellowing of the skin and whites of the eyes, cough and shortness of breath. Multiple organ failure is a possibility in very severe cases.
Tell your doctor imm ediately if you experience any of these symptoms. In case of an overdose your doctor will decide on any measures that may be necessary, depending on the severity of the intoxication. No specific remedy (antidote) is available. The usual general measures (gastric lavage, app r opriate supportive measures) should therefore be started.
If you forget to take Lomustine
It is important to complete the course of medication exactly as prescribed by your doctor. If you think you have missed a dose for any reason please tell your doctor or nurse immediately. Your doctor will decide how to proceed with the intake of Lomustine. 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.
Contact your doctor immediately if any of the following side effects occur:
Very common (may affect more than 1 in 10 people)
- Suppression of your bone marrow activity that causes a decrease in the production of blood cells
- Decreased number of platelets (blood cells that help to clot blood). You may suffer from unusual bleedings and bruises.
- Decreased number of certain white blood cells. Your vulnerability for infections may increase.
- Decreased number of red blood cells. You may observe signs of anaemia like weakness, tiredness, laboured breathing with a feeling of apprehension.
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- Nausea and/or vomiting and loss of appetite. Nausea and vomiting usually occur approximately 3 – 6 hours after you have taken your dose and can last for less than 24 hours, possibly followed by reduced appetite for 2 – 3 days. Your doctor may prescribe other medicines (antiemetics) which you can take concurrently to relieve this. It might also help to take lomustine on an empty stomach.
Common (may affect up to 1 in 10 people)
- Infection
- Abnormal coordination
- Difficulties in orientation
- Inflammation of the mucous membranes in the mouth
- Diarrhoea
Effect on the liver function (usually transient) and increased liver enzyme values.
Your doctor will check for this. You should contact your doctor immediately if symptoms of liver damage such as yellowing of the skin and whites of the eyes occur.
- Fever, chills, swelling (especially your feet and your lower legs)
Uncommon (may affect up to 1 in 100 people)
- Apathy
- State of being confused
- Stuttering
Severe reduction of kidney function, i njury of the kidneys (inability of the kidney to perform its
normal functions). You should contact your doctor immediately if symptoms of kidney damage such as swelling of the hands, ankles or feet or changes in frequency of urination or decrease or absence of urine occur.
Rare (may affect up to 1 in 1,000 people)
- Lung disease affecting the connective tissue causing scarring in the lungs, shortness of breath and dry cough. You should contact your doctor immediately if symptoms like dry-non-productive cough or shortness of breath occur.
- Hair loss
Not known (frequency cannot be estimated from the available data)
- Shingles; Viral disease caused by varicella zoster virus with painful skin rash with blisters in a localised area
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Decreased immune function
- Abnormal lack of energy; abnormal drowsiness or sluggishness
- Difficulty in speaking
- Inability to coordinate muscle movements
Rare (may affect up to 1 in 1,000 people)
Lung damage with tissue scarring and thickening
- Cholestatic jaundice, a condition in which the skin, whites of the eyes and mucous membranes turn yellow due to high levels of bilirubin, a yellow-orange bile pigment, caused by blocked bile flow from the liver
- Severe reduction of liver function (inability of the liver to perform its normal functions)
- Skin rash
- Itching
- Abnormal spermatogenesis
- Disturbances in the production of an egg during menstrual cycle
Very rare (may affect up to 1 in 10,000 people)
- Second, unrelated cancer; cancer of the white blood cells (acute leukaemia); disease in which the bone marrow does not make enough healthy blood cells or platelets (myelodysplastic syndrome)
- Lasting visual impairment (in combination with radiation treatment)
Not known (frequency cannot be estimated from the available data)
- Lung infiltration (increase in the density of the lung tissue as a result of inflammation)
- Higher nitrogen and waste product levels in your blood (azotaemia)
- Shrinkage of kidney (renal atrophy)
High levels of bilirubin seen in blood tests (break-down product of the red blood pigment). Your doctor will check for this.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lomustine
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Keep the box in the outer carton in order to protect from light and moisture.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. At the end of treatment return any leftover medicine to your hospital or pharmacist.
6. Contents of the pack and other information
What Lomustine contains
- The active substance is lomustine. Each capsule contains 40 mg lomustine.
- The other ingredients are lactose, wheat starch, talc and magnesium stearate.
The capsule is made of gelatine and the colouring agents titanium dioxide (E171) and indigotine (E132), and the printing ink consists of shellac and titanium dioxide (E171).
What Lomustine looks like and contents of the pack
Lomustine are blue hard capsules, with in white ink on the cap and with “LOM 40” in white ink on the body. Lomustine capsules are packed in a plastic box. There are 20 capsules in each pack.
Marketing Authorisation Holder and Manufacturer medac
Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6
22880 Wedel
Germany
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100
PL 11587/0003
This leaflet was last revised in January 2026.
80695-VPGB
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