PACKAGE LEAFLET: INFORMATION FOR THE USER

Topotecan 1 mg/ml concentrate for solution for infusion

Topotecan

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

•    Keep this leaflet. Y ou may need to read it again.

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

•    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Topotecan is and what it is used for

2.    What you need to know before you are given Topotecan

3.    How Topotecan is used

4.    Possible side effects

5.    How to store Topotecan

6.    Contents of the pack and other information

1. What Topotecan is and what it is used for

Topotecan helps to destroy tumours. A doctor or a nurse will give you the medicine as an infusion into a vein (a drip) in hospital.

Topotecan is used to treat

•    ovarian cancer or small cell lung cancer that has come back after chemotherapy.

•    advanced cervical cancer if surgery or radiotherapy treatment is not possible. When treating cervical cancer, Topotecan is combined with another medicine called cisplatin.

Your doctor will decide with you whether Topotecan therapy is better than further treatment with your initial chemotherapy.

2. What you need to know before you are given Topotecan You should not be given Topotecan

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

•    if you are breast-feeding.

•    if your blood cell counts are too low. Your doctor will tell you, based on the results of your last blood test.

Warnings and precautions

Talk to your doctor before you are given Topotecan •    if you have any kidney or liver problems.

Your dose of Topotecan may need to be adjusted.

•    a history of lung problems such as lung inflammation (interstitial lung disease), scarring of the lungs (pulmonary fibrosis), lung cancer, had radiation treatment to your lungs or have previously taken medicines that caused lung damage or increase the production of white blood cells (see section 4)

•    if you have bleeding problems or have an increased risk of bleeding

•    if you are pregnant or plan to become pregnant.

•    if you plan to father a child.

Topotecan may harm a baby conceived before, during or soon after treatment. You must use an effective method of contraception.

Ask your doctor for advice.

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

Remember to tell your doctor if you start taking any other medicines while you are on Topotecan.

Using Topotecan with alcohol

There is no known interaction between Topotecan and alcohol. However, you should check with your doctor whether drinking alcohol is advisable for you.

Pregnancy and breast-feeding and fertility

Topotecan is not recommended for pregnant women. It may harm the baby if conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor for advice.

Do not try and become pregnant/father a child until a doctor advises you it is safe to do so.

Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment. If pregnancy occurs during treatment, tell your doctor immediately.

Do not breast-feed if you are being treated with Topotecan. Do not restart breast-feeding until the doctor tells you it is safe to do so.

Driving and using machines Topotecan can make people feel tired.

Topotecan contains sodium.

This medicinal product contains less ‘sodium- free’.

3.    How Topotecan is used

The dose of Topotecan you are given will be worked out by your doctor, based on

•    your body size (surface area measured in square metres).

•    the results of blood tests carried out before treatment.

•    the disease being treated.

The recommended dose is:

•    for ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.

•    for cervical cancer: 0.75 mg per square metre of body surface area per day.

When treating cervical cancer, Topotecan is combined with another medicine, called cisplatin.

Your doctor will advise you about the correct dose of cisplatin.

How Topotecan is given

A doctor or nurse will give you a suitable dose of Topotecan as an infusion (a drip). It is usually dripped into your arm over about 30 minutes.

•    For ovarian and small cell lung cancer, you will have treatment once a day for 5 days.

•    For cervical cancer, you will have treatment once a day for 3 days.

This pattern of treatments will normally be repeated every three weeks, for all cancers. The treatment may vary, depending on the results of your regular blood tests.

If you are given too much Topotecan

If you think you have been given too much Topotecan contact your doctor or nurse. The symptoms of an overdose are similar to the side effects you may have with topotecan therapy (see section 4). You may get a sore throat, fever or infection, feel tired or experience bruising and bleeding (bone marrow suppression), inflammation and ulcers of the mouth tongue or gums and increased liver enzymes (as seen on a blood test).

Stopping treatment

Your doctor will decide when to stop treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects - tell your doctor immediately

Very common (may affect more than 1 in 10 people)

•    Signs of infections: Topotecan may reduce the number of white blood cells and lower your resistance to infection. This can even be life threatening. Signs include

-    fever.

-    serious deterioration of your general condition.

-    local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).

•    Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis).

Common (may affect up to 1 in 10 people)

•    A severe infection with whole-body inflammatory response which can even be life-threatening (sepsis often called “blood poisoning”). Signs include:

-    fever, chills and shivering

-    a fast heartbeat

-    fast breathing

•    Reduction in blood cells (pancytopenia). Signs include:

-    feeling generally weak and tired, look pale or you notice yellowing of the skin or eyes. In some cases you may need a blood transfusion

-    unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood. This can lead to severe bleeding from relatively small injuries such as a small cut. It can lead to more severe bleeding (haemorrhage). Talk to your doctor for advice on how to minimise the risk of bleeding

-    frequent infections (see signs of infections)

•    Allergic or hypersensitivity reactions (including rash) (common). In rare cases (may affect up to 1 in 1,000 people) this may be severe allergic (anaphylactic) reactions or swelling caused by fluid buildup (angioedema). Symptoms include:

-    red, itchy rash (hives)

-    swelling of the face, lips, tongue or throat

-    difficulty breathing or swallowing.

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

•    Lung inflammation (interstitial lung disease): You are most at risk if you have a lung disease, had radiation treatment to your lungs, or have previously taken medicines that caused lung damage. Signs include

-    difficulty in breathing.

-    cough.

-    fever.

Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.

Other side effects include:

Very common (may affect more than 1 in 10 people)

•    Weight loss and loss of appetite (anorexia); tiredness; weakness; feeling unwell.

•    Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.

•    Inflammation and ulcers of the mouth, tongue, or gums.

•    High body temperature (fever).

•    Hair loss.

Common (may affect up to 1 in 10 people)^    • Yellow skin.

_•

•    Muscle pain.

•    Feeling unwell

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

•    Mild pain and inflammation at the site of injection.

If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Topotecan. Those effects are described in the cisplatin patient information.

Reporting of side effects

If you get any side effects, talk to your doctor. 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 Topotecan

Keep this medicine out of the sight and reach of children.

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

Store in a refrigerator (2 °C - 8 °C).

Keep the vial in the outer carton in order to protect from light.

Please refer to the information for healthcare professionals at the end of this leaflet for the storage conditions after or dilution.

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 protect the environment.

6.    Contents of the pack and other information What Topotecan contains

•    The active substance is topotecan. Each vial contains topotecan hydrochloride equivalent to 1 mg,

2 mg or 4 mg of topotecan.

•    The other ingredients are: water for injections, hydrochloric acid and sodium hydroxide.

What Topotecan looks like and contents of the pack

Topotecan is a concentrate for solution for infusion.

It is available in packs containing either 1, 5 or 10 vials; each vial contains 1 mg, 2 mg or 4 mg of topotecan.

The concentrate needs to be diluted before infusion.

The concentrate in the vial provides 1 mg per ml of active substance.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Medac Gesellschaft fur klinische Spezialpraparate mbH, Fehlandtstr. 3, 20354 Hamburg, Germany. Oncotec Pharma Produktion GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany.

Mylan S.A.S, 117 allee des Parcs - 69800 SAINT-PRIEST, France.

This leaflet was last revised in: June 2016

The following information is intended for medical or healthcare professionals only:

Instructions on how to dilute, store, and dispose of Topotecan

Dilution

Further dilution is required. The appropriate volume of the concentrate should be diluted with either 0.9 % w/v sodium chloride intravenous infusion or 5 % w/v glucose intravenous infusion, to a final concentration of between 25 and 50 microgram per ml.

Shelf life after opening the container

Chemical and physical in-use stability has been demonstrated for 48 hours at 2 °C - 8 °C or at room temperature. From a microbiological point of view, unless the method of opening precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Shelf life after preparing the solution for infusion ready for use

Chemical and physical in-use stability has been demonstrated for 96 hours at 2 °C - 8 °C and for 48 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place under controlled and validated aseptic conditions.

Handling and disposal

The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted:

•    Pregnant staff should be excluded from working with this medicinal product.

•    Staff handling this medicinal product should wear protective clothing including mask, goggles and gloves.

•    All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.

•    Any unused product or waste material should be disposed of in accordance with local requirements.

•    Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.