Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Lomustine "medac" 40 mg
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lomustine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 "medac" 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 it
e Lomustine "medac"
Do not take Lomustine "medac": • 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 alkylating 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 vaccines at the same time. Warnings and precautions Talk to your doctor or pharmacist before taking Lomustine "medac". Please note that lomustine may have an effect on your bone marrow function and that this effect may occur after a certain amount of time. This may increase the risk of bleeding or getting an infection. pal (UK) Lomustine "medac" 40 mg capsules National version: 01/2026
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 after handling lomustine. You must not receive live vaccines during treatment with lomustine and until at least 3 months after the end of treatment. Other medicines and Lomustine "medac" 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 cell growth) and radiation therapy due to an increased risk 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 vaccination with yellow fever vaccines may increase the risk of fatal complications. You should therefore 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 offered advice regarding the risk of harmful effects on the child through treatment. You should consult 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. pal (UK) Lomustine "medac" 40 mg capsules National version: 01/2026
Fertility Lomustine can have 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 "medac" 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 as 'glutenfree' 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 it
Lomustine "medac"
Care must be taken whenever handling anticancer products. Caution! Do not break open the Lomustine "medac" 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 "medac" 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 "medac" 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 "medac" capsules may be used in children with certain types of tumours. You must only use Lomustine "medac" for children as prescribed by the doctor. Lomustine "medac" 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 "medac" than you should If you have taken more 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.
pal (UK) Lomustine "medac" 40 mg capsules National version: 01/2026
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 immediately 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, appropriate supportive measures) should therefore be started. If you forget to take Lomustine "medac" 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 "medac". 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. • 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, injury 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. pal (UK) Lomustine "medac" 40 mg capsules National version: 01/2026
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-nonproductive 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 it
Lomustine "medac"
Keep this medicine out of the sight and reach of children. pal (UK) Lomustine "medac" 40 mg capsules National version: 01/2026
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 "medac" 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 "medac" looks like and contents of the pack Lomustine "medac" are blue hard capsules, with "medac" in white ink on the cap and with "LOM 40" in white ink on the body. Lomustine "medac" 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.
pal (UK) Lomustine "medac" 40 mg capsules National version: 01/2026
Frequently asked questions about Lomustine "medac" 40 mg
What is the active substance in Lomustine "medac" 40 mg?
The active substance in Lomustine "medac" 40 mg is lomustine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lomustine "medac" 40 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Lomustine "medac" 40 mg without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: lomustine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
As palliative or supplementary treatment, usually in combination with radiotherapy and/or surgery as part of multiple drug regimens in:
- brain tumours (primary or metastatic)
- lung tumours (especially oat-cell carcinoma)
Hodgkin's disease (resistant to conventional combination chemotherapy)
- malignant melanoma (metastatic)
Lomustine "medac" may also be of value as second-line treatment in Non-Hodgkin's lymphoma, myelomatosis, gastrointestinal tumours, carcinoma of the kidney, the testis, the ovary, the cervix uteri and the breast.
4.2. Posology and method of administration
Posology
Adults
Lomustine "medac" is given by mouth. The recommended dose in patients with normally functioning bone marrow receiving Lomustine "medac" as their only chemotherapy is 120 – 130 mg/m2 as a single dose every six to eight weeks (or as a divided dose over 3 days, e.g. 40 mg/m2/day).
Dosage is reduced
- if Lomustine "medac" is given as part of a drug regimen which includes other marrow-depressant medicinal products.
- in the presence of leucopenia below 3,000/mm3 or thrombocytopenia below 75,000/mm3.
Marrow depression after Lomustine "medac" is sustained longer than after nitrogen mustards and recovery of white cell and platelet counts may not occur for six weeks or more. Blood elements depressed below the above levels should be allowed to recover to 4,000/mm3 (WBC) and 100,000/mm3 (platelets) before repeating Lomustine "medac" dosage.
Paediatric population
Until further data is available, administration of Lomustine "medac" to children with malignancies other than brain tumours should be restricted to specialised centres and exceptional situations. Dosage in children, like that in adults, is based on body surface area (120 - 130 mg/m2 every six to eight weeks, with the same qualifications as apply to adults).
Method of administration
Lomustine "medac" is given by mouth. The capsules should not be opened and should be swallowed whole.
4.3. Contraindications
- Hypersensitivity to the active substance, to other nitrosoureas or to any of the excipients listed in section 6.1,
- Previous failure of the tumour to respond to other nitrosoureas,
- Severe bone marrow depression,
- Severe renal impairment,
- Pregnancy, breast-feeding,
- Wheat allergy,
- Concomitant use of yellow fever vaccine or other live vaccines in immunosuppressed patients (see section 4.5).
4.4. Special warnings and precautions for use
Patients receiving lomustine chemotherapy should be under the care of physicians experienced in cancer treatment. Blood counts should be monitored before starting the treatment and at frequent intervals during treatment (preferably weekly for at least 6 weeks after a dose; see section 4.8). Delayed bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of lomustine. Treatment and dosage are governed principally by the haemoglobin, white cell count and platelet count.
At the recommended dose, courses of lomustine must not be given more frequently than every 6 weeks.
Patients must be strictly instructed not to use higher doses of lomustine than recommended by a physician and should be told that lomustine is taken as a single oral dose (or as a divided dose over three days) and will not be repeated for at least 6 weeks (see section 4.2).
The bone marrow toxicity of lomustine is cumulative and therefore dose adjustment must be considered on the basis of nadir blood counts from prior dose.
Pulmonary toxicity from lomustine appears to be dose related (see section 4.8). Baseline pulmonary function studies should be conducted along with frequent pulmonary function tests during treatment. Patients with a baseline below 70% of the predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DLco) are particularly at risk.
Since lomustine may cause liver dysfunction, it is recommended that liver function should be monitored periodically (see section 4.8).
Renal function tests should also be assessed periodically. The maximum cumulative dose should not exceed 1,000 mg/m2 (see section 4.8).
Long term use of nitrosoureas has been reported to be possibly associated with the development of secondary malignancies.
Care must be taken whenever handling anticancer products. Steps should be taken to avoid exposure. This includes the use of appropriate equipment, such as wearing gloves, and washing hands with soap and water after handling such products.
It is recommended that patients do not receive live vaccines until at least 3 months after the end of treatment with lomustine.
Excipients
Lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Wheat starch
This medicine contains only very low levels of gluten (from wheat starch). It is regarded as 'gluten-free' and is very unlikely to cause problems in patients with coeliac disease. One capsule contains no more than 4 micrograms of gluten. Patients with wheat allergy must not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Lomustine use in combination with theophylline or with the H2-receptor antagonist cimetidine may potentiate bone marrow toxicity.
Co-administration of antiepileptic and chemotherapeutic medicinal products including lomustine can lead to complications secondary to pharmacokinetic interactions between the medicinal products. For example, pre-treatment with phenobarbital can lead to a reduced antitumour effect of lomustine due to an accelerated elimination of lomustine caused by microsomal liver enzyme induction.
Concomitant treatment with other cytostatics or radiation therapy can increase the bone marrow depression of lomustine.
There is increased risk of fatal systemic vaccinal disease with the use of yellow fever vaccine. Live vaccines are contraindicated in immunosuppressed patients (see section 4.3).
Cross-resistance with other nitrosoureas is common while cross-resistance with conventional alkylating substances is uncommon.
4.6. Fertility, pregnancy and lactation
Contraception in men and women
Due to the genotoxic potential of lomustine (see section 5.3), women of childbearing potential should use effective contraceptive measures while being treated with lomustine and for 7 months following completion of treatment.
Men are recommended to use effective contraceptive measures and to not father a child while receiving lomustine and for 4 months following completion of treatment.
Pregnancy
Lomustine is contraindicated during pregnancy (see section 4.3).
Safe use in pregnancy has not been established. Animal studies have shown reproductive toxicity (see section 5.3). If this medicinal product is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to the foetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Breast-feeding
Lomustine is contraindicated during breast-feeding (see section 4.3).
Due to the lipophilic nature of lomustine, it is likely to be excreted in human milk. As a risk to the nursing child potentially exists, a decision should be made whether to discontinue breast-feeding or to discontinue lomustine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Fertility
Lomustine can have a mutagenic effect. Genetic consultation is recommended if a patient intends to have children after therapy with lomustine. Men treated with lomustine are therefore advised not to father children during treatment and for 4 months afterwards, and to seek advice regarding sperm conservation before the start of treatment given the possibility of irreversible infertility caused by lomustine therapy.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Lomustine can impair the ability to drive and use machines, e.g. because of nausea and vomiting.
4.8. Undesirable effects
Summary of the safety profile
Bone marrow toxicity and gastrointestinal symptoms are the most frequent and relevant undesirable effects of lomustine.
Tabulated list of adverse reactions
The list is presented by system organ class and frequency, using the following categories:
• Very common (≥1/10)
• Common (≥1/100 to <1/10)
• Uncommon (≥1/1,000 to <1/100)
• Rare (≥1/10,000 to <1/1,000)
• Very rare (<1/10,000)
• Not known (cannot be estimated from the available data).
System Organ Class
Frequency
MedDRA Term
Infections and infestations
Common
Infection
Not known
Herpes zoster
Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
Very rare
Second primary malignancy, acute leukaemia, myelodysplastic syndrome
Blood and lymphatic system disorders
Very common
Myelosuppression, pancytopenia, thrombocytopenia, leukopenia, neutropenia, anaemia
Immune system disorders
Common
Immunosuppression
Nervous system disorders
Common
Coordination abnormal, disorientation, lethargy, dysarthria, ataxia
Uncommon
Apathy, confusional state, dysphemia
Eye disorders
Very rare
After combined therapy with radiation: blindness
Respiratory, thoracic and mediastinal disorders
Rare
Interstitial lung disease, pulmonary fibrosis, dyspnoea, cough
Not known
Lung infiltration
Gastrointestinal disorders
Very common
Nausea, vomiting, decreased appetite
Common
Stomatitis, diarrhoea
Hepatobiliary disorders
Common
Hepatic function abnormal
Rare
Jaundice cholestatic, hepatic failure
Skin and subcutaneous tissue disorders
Rare
Alopecia, rash, pruritus
Renal and urinary disorders
Uncommon
Renal failure, renal injury
Not known
Azotaemia, renal atrophy
Reproductive system and breast disorders
Rare
Spermatogenesis abnormal, ovulation disorder
General disorders and administration site conditions
Common
Pyrexia, chills, swelling (especially feet and lower legs)
Investigations
Common
Hepatic enzymes increased (ASAT, ALAT, LDH and alkaline phosphatase)
Not known
Blood bilirubin increased
Description of selected adverse reactions
Blood and lymphatic system disorders
The most frequent and most serious toxicity of lomustine is delayed or prolonged myelosuppression. It usually occurs 4 to 6 weeks after administration of the medicinal product and is dose related. Thrombocytopenia occurs at about 4 weeks post-administration and lasts 1 or 2 weeks at a level around 80 - 100,000/mm3. Leukopenia occurs 5 to 6 weeks after a dose of lomustine and persists for 1 to 2 weeks. Approximately 65 % of patients receiving 130 mg/m2 develop white blood cell counts below 5,000 WBC/mm3. Thirty-six percent develop white blood cell counts below 3,000/mm3.
Thrombocytopenia is generally more severe than leukopenia. However, both may be dose-limiting toxicities.
Lomustine may produce cumulative myelosuppression, manifested by more depressed indices or longer duration of suppression after repeated doses.
Anaemia also occurs but is less frequent and less severe than thrombocytopenia or leukopenia.
The occurrence of acute leukaemia and bone marrow dysplasia has been reported in patients following long term nitrosourea therapy.
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity characterised by pulmonary infiltrates, interstitial pneumonia and/or fibrosis has been rarely reported with lomustine. Onset of toxicity has occurred after an interval of 6 months or longer from the start of therapy with cumulative doses of lomustine usually greater than 1,100 mg/m2. There is one report of pulmonary toxicity at a cumulative dose of only 600 mg/m2.
Delayed pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients with intracranial tumours who received related nitrosoureas during their childhood and early adolescence.
Gastrointestinal disorders
Nausea and vomiting may occur 3 to 6 hours after an oral dose and usually last for less than 24 hours, followed by anorexia for 2 to 3 days. The effects are less troublesome if the 6-weekly dose is divided into three doses and given on the first 3 days of each 6-week period. The frequency and duration may be reduced by the use of antiemetics prior to dosing and by the administration of lomustine to fasting patients.
Hepatobiliary disorders
A reversible type of hepatic toxicity, manifested by increased transaminase, alkaline phosphatase, and bilirubin levels, has been reported in a small percentage of patients receiving lomustine.
An effect on liver function manifested by transient elevation of liver enzymes (ASAT, ALAT, LDH and alkaline phosphatase) is commonly observed. In the majority of cases, this is mild. Cholestatic jaundice has been reported in rare cases.
Renal and urinary disorders
Renal abnormalities consisting of decrease in kidney size, progressive azotaemia, and renal failure have been reported in patients who receive large cumulative doses after prolonged therapy with lomustine and related nitrosoureas. The cumulative dose in these cases was higher than 1,500 mg/m2. Kidney damage has also been reported occasionally in patients receiving lower total doses.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Overdose with lomustine has been reported, including fatal cases.
Symptoms
Overdose can lead to increases in side effects. It has been associated with bone marrow suppression, abdominal pain, diarrhoea, nausea, vomiting, anorexia, lethargy, dizziness, abnormal hepatic function, cough and shortness of breath. In very severe cases, multiple organ failure may occur.
Emergency procedures
Overdose should be treated immediately by gastric lavage.
Antidote
There is no specific antidote for overdose with lomustine. In case of overdose, appropriate supportive measures should be taken e.g., infection prophylaxis. Appropriate blood product replacement should be given as clinically required.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- CECENU 40 mg prescriptionLOMUSTINUM · taken by mouth
- LOMOOTHER 40 mg prescriptionLOMUSTINUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
💬 Ask about this leaflet
Ask anything about Lomustine “medac” 40 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.