TREOSULFAN CAPSULES 250 MG - patient leaflet, side effects, dosage

Treosulfan Capsules 250 mg

if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

• 1. What Treosulfan Capsules are and what they are used for

• 2. What you need to know before you take Treosulfan Capsules

• 3. How to take Treosulfan Capsules

• 4. Possible side effects

• 5. How to store Treosulfan Capsules

• 6. Contents of the pack and other information

• 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 ovarian cancer.

2. what you need to know before you take treosulfan capsules

Do not take Treosulfan Capsules

• if you are allergic to treosulfan or any of the other ingredients of this medicine (listed in section 6).
• if you 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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.
• if you 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 of the following:

• the risk of getting different types of infections is increased.
• different types of blood cancer may occur after longterm treatment.
• as treosulfan is excreted via your kidney your blood counts should be carefully monitored and your dosage adjusted accordingly if you suffer from impaired kidney function.
• treatment with anticancer medicines 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.

Other medicines and Treosulfan Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effect of ibuprofen/chlo­roquine treatment may be reduced when given in combination with treosulfan.

It is not advisable to use any medicines 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 or breast-feeding unless your doctor considers it as absolutely necessary. You must use effective contraception during therapy, e.g. birth control pill.

If you are planning to become pregnant or thinking of breast-feeding discuss it with your doctor first.

Driving and using machines

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

3. how to take treosulfan capsules

Always take this medicine exactly as your doctor has told you. 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.

The dose of treosulfan you should get depends on your height and weight, blood tests, general condition, how you respond to treatment and whether you also receive other medicines against cancer or radiotherapy. In general, 400–600 mg/m2 treosulfan (corresponds mostly to 3–4 capsules) are taken per day orally on days 1–28 and break on days 29–56. Courses can be repeated every 8 weeks, depending on the tolerability and efficacy of treatment.

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.

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

If you forget to take Treosulfan Capsules

Do not take a double dose to make up for a forgotten dose. 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 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 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 (may affect more than 1 in 10 people):

• 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.

Common (may affect up to 1 in 10 people):

• Infections caused by fungi, viruses or bacteria.

Uncommon (may affect up to1 in 100 people):

• Different types of blood cancer (after long-term treatment).
• Inflammation of the mouth (stomatitis) if you chew the capsules.

Rare (may affect up to 1 in 1,000 people):

• 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 red blood cells, white blood cells and platelets at the same time which can cause weakness, bruising or make infections more likely (pancytopenia).

Very rare (may affect up to 1 in 10,000 people):

• Severe generalised infection (sepsis)
• 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).
• 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:. 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 sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What Treosulfan Capsules contain

• The active substance is treosulfan.
• The other ingredients are maize starch, hydroxypropyl methylcellulose and magnesium stearate.