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1. Topotecan Medac 1 Mg/Ml Concentrate For Solution For Infusion
2. Topotecan Medac 1 Mg/Ml Concentrate For Solution For Infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Topotecan medac 1 mg/ml

concentrate for solution for infusion

Topotecan

Read all of this leaflet carefully before you are given this medicine.

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

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

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

In this leaflet:

1.    What Topotecan medac is and what it is used for

2.    Before you are given Topotecan medac

3.    How to use Topotecan medac

4.    Possible side effects

5.    How to store Topotecan medac

6.    Further information

1.    WHAT TOPOTECAN MEDAC IS AND WHAT IT IS USED FOR

Topotecan medac 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 medac 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 medac is combined with another medicine called cisplatin.

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

2.    BEFORE YOU ARE GIVEN TOPOTECAN MEDAC

You should not receive Topotecan medac

•    if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Topotecan medac.

•    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.

->Tell your doctor if any of these applies to you.

Take special care with Topotecan medac

Your doctor needs to know before you are given this medicine

•    if you have any kidney or liver problems. Your dose of Topotecan medac may need to be adjusted.

•    if you are pregnant or plan to become pregnant.

•    if you plan to father a child.

->Tell your doctor if any of these applies to you.

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.

Taking other medicines

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

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

Using Topotecan medac with food and drink

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

Pregnancy and breast-feeding

Topotecan medac 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 medac. Do not restart

breast-feeding until the doctor tells you it is safe to do so.

Driving and using machines

Topotecan medac can make people feel tired. If you feel tired or weak, do not drive and do not use machines.

3. HOW TOPOTECAN MEDAC IS USED

The dose of Topotecan medac 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 usual dose

•    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 medac is combined with another medicine, called cisplatin. Your doctor will advise you about the correct dose of cisplatin.

How Topotecan medac is given

A doctor or nurse will give you a suitable dose of Topotecan medac 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.

Stopping treatment

Your doctor will decide when to stop treatment.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Topotecan medac can cause side effects, although not everybody gets them.

Serious side effects - tell your doctor immediately

These very common side effects may affect more than 1 in 10 people treated with Topotecan medac:

•    Signs of infections: Topotecan medac 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).

This rare side effect may affect up to 1 in 1,000 people treated with Topotecan medac:

•    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.

Very common side effects

These may affect more than 1 in 10 people treated with Topotecan medac:

•    Feeling generally weak and tired (temporary anaemia). 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. Rarely, it can lead

to more severe bleeding (haemorrhage). Talk to your doctor for advice on how to minimize the risk of bleeding.

•    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.

•    FHigh body temperature (fever).

•    Flair loss.

Common side effects

These may affect up to 1 in 10 people treated with Topotecan medac:

•    Allergic or hypersensitivity reactions (including rash).

•    Yellow skin.

•    Itching sensation.

•    Muscle pain.

Rare side effects

These may affect up to 1 in 1,000 people treated with Topotecan medac:

•    Severe allergic or anaphylactic reactions.

•    Swelling caused by fluid build up (angioedema).

•    Mild pain and inflammation at the site of injection.

•    Itchy rash (or hives).

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 medac. Those effects are described in the cisplatin patient information.

If you get side effects

->Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

5. HOW TO STORE TOPOTECAN MEDAC

Keep out of the reach and sight of children.

Do not use Topotecan medac after the expiry date which is stated on the carton.

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

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

6. FURTHER INFORMATION

What Topotecan medac 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 medac looks like and contents of the pack

Topotecan medac is a concentrate for solution for infusion.

It is available in packs containing either

1    or 5 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 and Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbFI Theaterstr. 6 22880 Wedel Germany

Tel.:+49 4103 8006-0 Fax: +49 4103 8006-100

This leaflet was last approved in 10/2014.

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

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

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.