Treosulfan Capsules 250 mg • 80300-VPGB • BA • 01.15 • Pharma-Code: 528 Format: 296 x 150 mm • HKS 44 • Corrective action: KV01_osc_22.12.14

PACKAGE LEAFLET: INFORMATION FOR THE USER

Treosulfan Capsules 250 mg

Treosulfan

1. WHAT TREOSULFAN CAPSULES ARE AND WHAT THEY ARE USED FOR

Treosulfan belongs to the group of anticancer medicines called bifunctional alkylating agents. These agents inhibit tumour growth.

Treosulfan Capsules have been prescribed by your doctor for the treatment of all types of ovarian cancer or certain types of cancer which do not respond to usually given kind of therapy.

2. BEFORE YOU TAKE TREOSULFAN CAPSULES

Do not take Treosulfan Capsules, if you

•    are allergic (hypersensitive) to treosulfan or any of the other ingredients of Treosulfan Capsules.

•    do not have enough blood cells (severe bone marrow depression).

You will have regular blood tests to check that you have enough blood cells to take Treosulfan Capsules.

Take special care with Treosulfan Capsules,

if you

•    experience reduction in blood cells as this may become worse with ongoing treatment. Blood tests will be performed at shorter intervals starting with the third course of treatment. This is especially important if combined with other forms of therapy that suppress the bone marrow function such as radiotherapy.

•    develop inflammation of the lungs which causes shortness of breath (allergic alveolitis or pulmonary fibrosis); treatment with treosulfan should then be stopped.

Be also aware that:

•    the risk of getting different types of infections is increased.

•    treatment with cytostatics may increase the risk of generalised infection after some vaccinations. Therefore you should not receive vaccination with live vaccines.

•    because of the possible development of bladder inflammation with pain, more frequent or urgent urination with or without bloody urine (haemorrhagic cystitis) you are advised to drink more fluids than usual while taking Treosulfan Capsules.

•    inflammation of the mouth (stomatitis) may occur if you chew the capsules. For this reason swallow the capsules whole.

Taking other medicines

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

It is not advisable to use any medical treatment, without telling your doctor as there may be interactions between treosulfan and other medicines.

Pregnancy and breast-feeding

Do not take treosulfan if you are pregnant or planning to become pregnant. You must use effective contraception during therapy, e.g. birth control pill.

Do not breast-feed while taking treosulfan.

If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first.

Driving and using machines

Your ability to drive or operate machines may be influenced because of nausea and vomiting. If you are affected in this way do not drive or operate machinery.

3. HOW TO TAKE TREOSULFAN CAPSULES

Always take Treosulfan Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor decides on the exact dose for you and how often you should take this medicine.

Your doctor will calculate your treosulfan dose on the basis of your blood counts measured, concurrent chemotherapy and your weight.

Your doctor reduces the dose if other cytotoxic medicines or radiotherapy have also been given.

The course of treosulfan therapy usually lasts 8 weeks. The following regimen may be indicated for your treatment:

Regimen A: 4 capsules daily, given in four divided doses for four weeks, followed by four weeks without treosulfan.

Regimen B: 4 capsules daily, given in four divided doses for two weeks, followed by two weeks without treosulfan.

Regimen C: 6 capsules daily, given in three divided doses for one week only, followed by three weeks without treosulfan.

Swallow the capsules whole. Do not let them dissolve in your mouth.

It is important to complete the treatment course exactly as prescribed by your doctor.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition, further therapies and your response to treosulfan. If you have any questions about your treatment, ask your doctor, nurse or pharmacist.

Children

This medicine is not recommended for use in children.

If you take more Treosulfan Capsules than you should

If you have taken too many capsules tell your doctor or contact the nearest hospital accident and emergency department immediately. Your

Treosulfan Capsules 250 mg • 80300-VPGB • BA • 01.15 • Pharma-Code: 528 Format: 296 x 150 mm • HKS 44 • Corrective action: KV01_osc_22.12.14

doctor may give you a blood transfusion and will undertake other measures if necessary.

If you forget to take Treosulfan Capsules

If you have missed one or several doses please ask your doctor or pharmacist immediately for advice. It is important to complete the treatment course exactly as prescribed by your doctor.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, treosulfan can cause side

effects, although not everybody gets them.

Contact your doctor straight away if you notice

any of the following:

•    Allergic reactions: if you develop itching, rash, swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing or breathing, drop of blood pressure.

•    Fever or infection: if you have a body temperature of 38 °C or higher, sweating or other signs of infection (since you might have fewer white blood cells than normal).

•    Weakness, becoming easily breathless or if you look pale (since you might have fewer red blood cells than normal).

•    Bleedings from gums, mouth or nose, unexpected bruising (since you might have fewer platelets than normal).

•    Difficulty in breathing (since you might have an allergic reaction, inflammation or infection of the lung).

Very common (affect more than 1 in 10 patients):

•    Reduction in white blood cells (which make infections more likely), platelets (which can cause bruising and bleeding from gums, mouth and nose) and red blood cells (which can make the skin pale and cause weakness or breathlessness) - hence the need for regular blood tests.

•    Stomach upsets including nausea (feeling sick) with or without vomiting (being sick).

•    Mild loss of hair. After your treatment, normal hair growth should return.

•    Bronze discolouration of the skin.

Uncommon (affect 1 to 10 in 1,000 patients):

•    Different types of blood cancer (after long-term treatment).

Not known (frequency cannot be estimated

from the available data):

•    Allergic reactions (e.g. itching, rash, swelling of the face, lips, tongue and/or throat with difficulties in swallowing or breathing, drop of blood pressure).

•    Severe reduction of different blood cells at the same time which can cause weakness, bruising or make infections more likely (pancytopenia).

The following side effects have also been

reported:

•    Addison‘s disease, a condition where the adrenal glands do not work properly, leading to bronzed skin, stomach upset, low blood pressure (feeling faint) and a general feeling of weakness.

•    Sweating, trembling and hunger as a result of the decreased amount of glucose in your blood (hypoglycaemia).

•    Pins and needles and a feeling of numbness (paraesthesia).

•    Inflammation of the mouth (stomatitis) if you chew the capsules.

•    Weakening of the heart muscle caused by a structural change (cardiomyopathy).

•    Difficulty in breathing (inflammation and scarring of the lungs and infection of the lungs).

•    Urticaria or hives, an itchy rash; inflammation of the skin with or without scale formation (scleroderma and psoriasis).

•    Inflammation of the bladder with pain, more frequent and urgent urination and with or without bloody urine (haemorrhagic cystitis).

•    Feeling of getting ill (flu-like complaints).

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 TREOSULFAN CAPSULES

Keep out of the reach and sight of children.

Do not use Treosulfan Capsules after the expiry date which is stated on the bottle after EXP.

The expiry date refers to the last day of that month.

Medicines 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.

6. FURTHER INFORMATION

What Treosulfan Capsules contain

•    The active substance is treosulfan.

•    The other ingredients are maize starch, hydroxypropyl methylcellulose and magnesium stearate.

The capsule consists of gelatine and the colour is called titanium dioxide E 171.

What Treosulfan Capsules look like and contents of the pack

Treosulfan Capsules are packed in bottles, each containing 100 capsules.

Each capsule contains 250 mg of treosulfan.

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Full information is available on request from

medac

Gesellschaft fur klinische Spezialpraparate mbH Scion House

Stirling University Innovation Park Stirling FK9 4NF Tel.: 01786/ 458 086 Fax: 01786/ 458 032

80300-VPGB

BA