HYCAMTIN 4 mg CONCENTRATED POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Hycamtin 1mg powder for concentrate for solution for infusion

Hycamtin 4mgpowder for concentrate for solution for infusion

topotecan

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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.

Contents of the pack

1. What is Hycamtin and what is it used for
2. What you need to know before you are given Hycamtin
3. How to use Hycamtin
4. Possible side effects
5. Storage of Hycamtin
6. Contents of the pack and other information

1. What is Hycamtin and what is it used for

Hycamtin helps to get rid of tumors. A doctor or nurse will give you your medicine as an infusion into a vein in the hospital.

Hycamtin is used to treat:

• ovarian cancer or small cell lung cancerthat has come back after you have had chemotherapy
• advanced cancer of the cervix, if surgery or radiotherapy is not possible. When used to treat cancer of the cervix, Hycamtin is given with another medicine called cisplatin.

Your doctor will decide with you whether treatment with Hycamtin is better than treatment with your initial chemotherapy.

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

You should not be given Hycamtin

• 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 count is very low. Your doctor will tell you if this is the case based on your latest blood test results.

Tell your doctorif you are in any of these situations.

Warnings and precautions

Before you are given this medicine, your doctor needs to know:

• if you have liver or kidney problems. Your dose of Hycamtin may need to be adjusted.
• if you are pregnant or think you may be pregnant. See the section “Pregnancy and breast-feeding” below
• if you are planning to become a father. See the section “Pregnancy and breast-feeding” below.

Tell your doctorif you are in any of these situations.

Other medicines and Hycamtin

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription or any herbal medicines.

Remember to tell your doctor if you start taking any new medicine while being treated with Hycamtin.

Pregnancy and breast-feeding

Hycamtin should not be used in pregnant women. It may harm the baby before, during or after birth. You must use an effective method of contraception. Do not try to become pregnant or father a child until your doctor tells you it is safe to do so.

Men who wish to become fathers should ask their doctor for advice on family planning. If your partner becomes pregnant during your treatment, tell your doctor immediately.

Avoid breast-feeding while being treated with Hycamtin.Do not start breast-feeding again until your doctor tells you it is safe to do so.

Driving and using machines

Hycamtin can make you feel tired. If you feel tired or weak, do not drive or use machines.

Hycamtin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”. If your doctor uses a saline solution to dilute Hycamtin, the amount of sodium you receive will be higher.

3. How to use Hycamtin

The dose of Hycamtin you receive will be calculated by your doctor based on:

• your body size (body surface area measured in square meters)
• the results of your blood tests before treatment
• the type of disease being treated.

The usual dose is

• Ovarian cancer and small cell lung cancer:1.5 mg per square meter of body surface area per day. You will receive treatment once a day for 5 days. This treatment schedule will normally be repeated every 3 weeks.
• Cancer of the cervix:0.75 mg per square meter of body surface area per day. You will receive treatment once a day for 3 days. This treatment schedule will normally be repeated every 3 weeks.

When treating cancer of the cervix, Hycamtin is given with another medicine called cisplatin. Your doctor will tell you what dose of cisplatinis right for you.

This treatment may vary depending on the results of your regular blood tests.

How Hycamtin is given

A doctor or nurse will give you Hycamtin as an infusion into your arm that lasts about 30 minutes.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects: tell your doctor

These very commonside effects may affect more than 1 in 10peopletreated with Hycamtin.

• Signs of infection: Hycamtin can reduce the number of white blood cells and decrease your resistance to infections. This can be life-threatening. Some signs of infection are:
• • fever
  • severe deterioration of your general condition
  • local symptoms such as sore throat or urinary problems (e.g. burning sensation when urinating, which may be due to a urinary tract infection)
• Ocasionalmente, severe stomach pain, fever, and possible diarrhea (rarely with blood) can be signs of intestinal inflammation (colitis).

This rareside effect may affect up to 1 in 1,000peopletreated with Hycamtin:

• Lung inflammation(interstitial lung disease): you are more at risk if you already have a lung disease, have had radiation treatment to your lungs, or have taken medicines that have caused lung damage in the past. The signs include:
• • difficulty breathing
  • cough
  • fever.

Tell your doctor immediatelyif you notice any of these symptoms, as you may need to be hospitalized.

Very common side effects

May affect more than 1 in 10peopletreated with Hycamtin:

• Feeling of general weakness and tiredness (temporary anemia). In some cases, you may need to have a blood transfusion.
• Bruising or unexplained bleeding, caused by a decrease in the number of cells that help the blood to clot. This can lead to serious bleeding from relatively small wounds, such as small cuts. Rarely, this can lead to more serious bleeding (hemorrhage). Talk to your doctor for advice on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia); tiredness; weakness.
• Nausea, vomiting; diarrhea; stomach pain; constipation.
• Inflammation and ulcers in the mouth, tongue, and gums.
• High temperature (fever).
• Hair loss.

Common side effects

May affect up to 1 in 10peopletreated with Hycamtin:

• Allergic reactions or hypersensitivity reactions (including skin rash).
• Yellowing of the skin.
• Discomfort.
• Feeling of itching.

Rare side effects

May affect up to 1 in 1,000peopletreated with Hycamtin:

• Severe allergic reactions or anaphylactic reactions.
• Swelling caused by fluid retention (angioedema).
• Mild pain and inflammation at the injection site.
• Itchy skin rash (or hives).

Side effects with unknown frequency

The frequency of some side effects is unknown (effects from spontaneous reports and frequency cannot be estimated from available data):

• Severe stomach pain, nausea, vomiting with blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
• Sores in the mouth, difficulty swallowing, stomach pain, nausea, vomiting, diarrhea, bloody stools (possible signs and symptoms of inflammation of the lining of the mouth, stomach and/or gut [mucosal inflammation]).

If you are being treated for cancer of the cervix, you may have side effects related to the other medicine (cisplatin) that will be given to you with Hycamtin. These side effects are described in the package leaflet for cisplatin.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hycamtin

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.

Store the vial in the outer packaging to protect it from light.

This medicine is for single use only. It should be used immediately after opening. If it is not used immediately, the storage time and conditions before use are the responsibility of the user. If reconstitution and dilution are performed under strict aseptic conditions (e.g. a laminar flow cabinet), the product should be used within 24 hours (infusion completed) if stored at 2°C-8°C after first puncture of the vial.

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

6. Container Content and Additional Information

Composition of Hycamtin

• The active ingredient istopotecan. Each vial contains 1 mg or 4 mg of topotecan (as hydrochloride).
• The other components are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), and sodium hydroxide.

Appearance of the Product and Container Content

Hycamtin is presented as a powder for concentrate for solution for infusion.

It is available in containers containing 1 or 5 glass vials; each vial contains 1 mg or 4 mg of topotecan.

The powder needs to be reconstituted and diluted before infusion.

The powder in the vial provides 1 mg per ml of active ingredient when reconstituted as recommended.

Marketing Authorization Holder

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57

1000 Ljubljana

Slovenia

Manufacturer

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana 90

43056 San Polo di Torrile

Parma

Italy

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of the Last Revision of this Prospectus:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

This information is intended solely for healthcare professionals:

Instructions on how to reconstitute, store, and dispose of Hycamtin

Reconstitution

Hycamtin 1 mg powderfor concentrate for solution for infusion must be reconstituted with 1.1 ml of water for injectable preparations to provide 1 mg per ml of topotecan.

Hycamtin 4 mg powderfor concentrate for solution for infusion must be reconstituted with 4 ml of water for injectable preparations to provide 1 mg per ml of topotecan.

These solutions need to be further diluted.The appropriate volume of the reconstituted solution should be diluted, eitherwith sodium chloride 0.9% w/v for intravenous infusion orwith glucose 5% w/v for intravenous infusion, to achieve a final concentration of between 25 and 50 micrograms/ml.

Storage of the Prepared Solution

The product should be used immediately after preparation for infusion. If reconstitution is performed under strict aseptic conditions, the infusion of Hycamtin can be completed within a maximum of 12 hours at room temperature (or 24 hours if stored at 2-8°C).

Handling and Disposal

Usual procedures for handling and disposal of antitumor drugs should be followed:

• Personnel should be trained in the reconstitution of the medicinal product.
• Healthcare personnel should not handle this medicinal product during pregnancy.
• Healthcare personnel handling this medicinal product during reconstitution should wear protective clothing, including a mask, protective glasses, and gloves.
• All items used for administration or cleaning, including gloves, should be placed in high-risk biological waste disposable bags for high-temperature incineration.
• Accidental contact with skin or eyes should be treated immediately with abundant water.