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Lomustine 40 mg capsules • 80695-VPGB • BA • 05.15 • Pharma-Code: 295 | Format: 444 x 112 mm • HKS 44 • Corrective action: KV01_jem_13.02.15 / KV02_osc_23.04.15

medac GmbH

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lomustine 40 mg capsules

Lomustine

Read all of this leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Lomustine is and what it is used for

2.    Before you take use Lomustine

3.    How to take Lomustine

4.    Possible side effects

5.    How to store Lomustine

6.    Further information

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.    BEFORE YOU TAKE LOMUSTINE

Do not take Lomustine if you

•    are allergic (hypersensitive) to lomustine or any of the other ingredients of Lomustine.

•    have had a similar medicine before which you had to stop taking because of side effects or because it was ineffective.

•    have any blood disorder.

•    have severe kidney problems.

•    have coeliac disease (your body cannot digest gluten) or wheat allergy.

•    have had a vaccination against yellow fever or another live vaccine vaccination and suffer from immunosuppression.

•    are pregnant or breastfeeding.

You and your partner should avoid contraception (becoming pregnant or fathering children) during treatment and for at least 6 months after your treatment with lomustine has stopped.

Take special care with Lomustine

•    Do not take a higher dose of lomustine as prescribed by your doctor and do not repeat treatment before the end of 6 weeks.

•    Your doctor will check your blood weekly during your therapy and up to 6 weeks afterwards.

•    Lomustine might impair the function of your bloodbuilding system, and increase the risk of bleeding and infections. This effect might occur after a certain time of therapy.

•    As the toxic effects of lomustine to your bloodbuilding system are cumulative your doctor might decide to adjust the dosage of your therapy.

•    Tell your doctor if you have any liver problems. Before you start with lomustine, your doctor will check the function of your liver and additionally of your lung and kidney. These tests will be repeated during the time of your therapy.

•    Long term use of nitrosoureas has been reported to be possibly associated with the development of secondary malignancies.

Taking other medicines

No special studies regarding interactions between lomustine and other drugs have been performed, but tell your doctor if you are taking any of the following medicines:

•    theophylline - medicine used in the treatment of respiratory tract diseases, e.g. asthma

•    cimetidine - medicine largely used in the treatment of heartburn and peptic ulcers

•    other chemotherapeutic drugs, because co-administration can lead to complications secondary to pharmacokinetic interactions between the drugs.

Tell your doctor if you have ever taken phenobarbital - an anticonvulsant or another antiepileptic drug.

You should also inform your doctor if you recently have been vaccinated.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Fertility, pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Pregnant women should not receive this medicine.

It is important to tell your doctor if you are pregnant or think you might be pregnant, because safe use in pregnancy has not been established. If you become pregnant while you are treated with lomustine tell your doctor immediately, as taking lomustine might affect your unborn baby detrimentally. If you are in the childbearing age you should avoid becoming pregnant.

Breast-feeding

You should not breast-feed your baby while being treated with this medicine, because lomustine might be excreted in your breast 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

Men who are treated with lomustine should not father a child during their therapy and up to 6 month afterwards. As lomustine may affect your fertility, ask your doctor to inform you about possible precautions like sperm conservation before you start with the treatment.

Driving and using machines

No special studies have been performed, but Lomustine capsules can impair your ability to drive and use machines, e.g. because of nausea and vomiting.

Important information about some of the ingredients of Lomustine

This medicinal product contains lactose. 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 medicinal product also contains wheat starch. Patients with wheat allergy or coeliac disease should not take this medicine (see above “Do not take Lomustine”).

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 Lomustine exactly as your doctor has told you, and in an interval not less than 6 weeks.

You should 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.

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 drugs to treat your condition or if you have a blood disorder.

Children

Lomustine capsules may be used in children with certain types of tumour. 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

Accidental overdose with lomustine has been reported, including fatal cases.

If you have taken too much medication please consult your doctor or local casualty department immediately.

An overdose might express in abdominal pain, diarrhea, regurgitation, lack of appetite, lethargy, a feeling of dizziness, cough or shortness of breath.

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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lomustine can cause side effects,

although not everybody gets them.

The unwanted effects could include:

Gastrointestinal disorders

•    Nausea and vomiting usually occur about

3 - 6 hours after taking a full single dose and lasts for 24 - 48 hours. This is followed by 2 - 3 days loss of appetite. Your doctor may prescribe another type of medicine (antiemetics) for you to take at the same time to help with these side effects.

Nausea, vomiting and loss of appetite may be less troublesome if you take Lomustine capsules as a divided dose over 3 days. It might also help to take lomustine on an empty stomach.

•    Stomatitis (inflammation inside the mouth) and diarrhoea have occurred rarely.

Blood and liver disorders

•    If you are affected by blood and liver disorders you may, for example, find you bruise more easily, or you may repeatedly get infections such as sore throat or cough. If this occurs report immediately to your doctor. Your doctor will probably carry out regular blood tests while you are on Lomustine capsules therapy to monitor these side effects.

•    Lomustine may produce cumulative myelosuppression, manifested by more depressed indices or longer duration of suppression after repeated doses.

•    Acute leukaemia (blood cancer), and myelodysplastic syndrome (blood-related medical conditions that involve ineffective production

of the myeloid class of blood cells) have been reported in patients following long term nitrosurea therapy, but frequency can not be estimated from the available data.

•    A reversible type of liver toxicity, manifested by increased liver parameters (transaminases, alkaline phosphatase, and bilirubin levels), has been reported in a small percentage of patients receiving lomustine.

Nervous system disorders

•    Mild neurological symptoms, like lack of interest (apathy), lethargy, disorientation, abnormal coordination, confusion and stuttering or speech defects can occur.

Lung disorders

•    Pneumonia has occurred rarely.

•    Lung fibrosis (formation of binding tissue in the lungs) and lung infiltration (accumulation of substances or fluid in the lung) might occur; frequency not known.

•    Pulmonary toxicity has been described to occur after an interval of 6 months or longer from the start of therapy with high total doses (> than 1,100 mg/m²). There is one report of pulmonary toxicity with a total dose of 600 mg.

•    Delayed onset of pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients with intracranial tumors who received related nitrosoureas during their childhood and early adolescence.

Skin disorders

•    Loss of hair has been reported infrequently.

Kidney disorders

•    Kidney disorders have occurred in single cases.

•    Failure of the kidney, azotaemia (increase of nitrogenous compounds in your blood) and decrease in kidney size after prolonged treatment and large total dose has been reported for lomustine and related nitrosoureas. Kidney damage has also been reported occasionally in patients receiving lower total doses.

Eye disorders

• After combined therapy with radiation an irreversible vision loss has been reported in single cases.

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 By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE LOMUSTINE

Keep out of the reach and sight 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 Lomustine after the expiry date which is stated on the box. The expiry date refers to the last day of that month.

At the end of treatment return any leftover medicine to your hospital or pharmacist.

6. FURTHER 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 gelatin and the colouring agents titanium dioxide (E171) and indigotine (E132).

What Lomustine looks like and contents of the pack

Lomustine are blue hard capsules.

Lomustine capsules are packed in a plastic box.

There are 20 capsules in each pack.

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate 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 May 2015.

80695-VPGB BA

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