Label: information for the user

Hycamtin 1mg powder for concentrate for solution for infusion

Hycamtin 4mgpowder for concentrate for solution for infusion

topotecan

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

Hycamtin helps to eliminate tumors. A doctor or nurse will administer your medication as an infusion through a vein in the hospital.

Hycamtin is used to treat:

• ovarian cancer or small cell lung cancerthat has recurred after receiving chemotherapy
• advanced cervical cancer, if surgery or radiation therapy is not possible. When used to treat cervical cancer, Hycamtin is combined with another medication calledcisplatin.

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

You should not receive Hycamtin

• if you are allergic to topotecan or any of the other components of this medication (listed in section6).
• if you are breastfeeding.
• if your blood cell count is very low. Your doctor will tell you if this is the case, based on the results of your last blood test.

Inform your doctorif you are in any of these situations.

Warnings and precautions

Before this medication is administered to you, your doctor needs to know:

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

Inform your doctorif you are in any of these situations.

Other medications and Hycamtin

Inform your doctor if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription or any herbal medication.

Remember to inform your doctor if you start taking any medication while you are being treated with Hycamtin.

Pregnancy and breastfeeding

Hycamtin is not recommended for use in pregnant women. It may cause harm to the fetus, before, during, or after treatment. You should use an effective contraceptive method. Do not attempt to become pregnant or father a child until your doctor tells you it is safe to do so.

Men who wish to father a child should seek advice from their doctor on family planning.If your partner becomes pregnant during your treatment, inform your doctor immediately.

Avoid breastfeeding if you are being treated withHycamtin.Do not resume breastfeeding until your doctor tells you it is safe to do so.

Driving and operating machines

Hycamtinmay cause fatigue. If you feel fatigued or weak, do not drive and do not operate machines.

Hycamtin contains sodium

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

The dose ofHycamtinyou will receive will be calculated by your doctor based on:

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

The usual dose is

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

When treating cervical cancer,Hycamtinis combined with another medication calledcisplatin. Your doctor will indicate the appropriate dose ofcisplatin.

This treatment may vary depending on the results obtained in your periodic blood tests.

How Hycamtin is administered

A doctor or nurse will administer Hycamtin as an infusion in your arm that lasts about 30minutes.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects: report to your doctor

These side effectsvery frequentmay affectmore than 1 in 10peopletreated with Hycamtin.

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

This side effectraremay affectup to 1 in 1,000peopletreated with Hycamtin:

• Pulmonary inflammation(interstitial lung disease): you have a higher risk if you already have a lung disease, have received radiation treatment in your lungs, or have previously taken medications that caused lung damage. The signs include:
• • difficulty breathing
  • cough
  • fever.

Report to your doctor immediatelyif you notice any of these symptoms, as you may require hospitalization.

Very frequent side effects

May affectmore than 1 in 10peopletreated with Hycamtin:

• General feeling of weakness and fatigue (temporary anemia). In some cases, a blood transfusion may be necessary.
• Unjustified bruises or bleeding, caused by a decrease in the number of cells that participate in blood clotting. This may lead to severe bleeding from relatively small injuries such as small cuts. Rarely, this may lead to more severe bleeding (hemorrhage). Consult with your doctor to advise on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia); fatigue; weakness.
• Nausea, vomiting; diarrhea; stomach pain; constipation.
• Mouth, tongue, and gum inflammation and ulcers.
• Elevation of body temperature (fever).
• Hair loss.

Frequent side effects

May affectup to 1 in 10peopletreated with Hycamtin:

• Allergies or hypersensitivity reactions (including skin rash).
• Skin yellowing.
• Discomfort.
• Itching sensation.

Rare side effects

May affectup 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.
• Skin rash with itching (or hives).

Side effects of unknown frequency

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

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

If you are being treated for cervical cancer, you may experience side effects related to the other medication (cisplatino) that will be administered with Hycamtin. These side effects are described in the cisplatino prospectus.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through the national notification system included in theApéndice V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging.

Storethe vial in theouter packagingtoprotect itfrom light.

This medication is for single use only. It must be used immediately once opened. If not used immediately, 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 24hours (completed infusion) if stored at 2°C-8°C after the first puncture of the vial.

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

Composition of Hycamtin

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

Appearance of the product and contents of the package

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

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

The powder needs to be reconstituted and diluted before infusion.

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

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley, Surrey GU16 7SR

United Kingdom

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana 90

43056 San Polo di Torrile

Parma

Italy

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: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 1mg powderforconcentratefor solution for infusion must be reconstituted with 1.1ml of water for injection to provide 1 mg per ml of topotecan.

Hycamtin 4mg powderforconcentratefor solution for infusion must be reconstituted with 4ml of water for injection to provide 1mg per ml of topotecan.

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

Storage of the prepared solution

The product must be used immediately after preparation for infusion. If reconstitution is carried out in strict aseptic conditions, the infusion of Hycamtin may be completed within a maximum of 12 hours at room temperature (or 24hours if stored at 2‑8°C).

Handling and disposal

Standard procedures for handling and disposal of anticancer drugs should be adopted:

• Staff should be trained in the reconstitution of the medicine.
• Healthcare staff should not handle this medicine during pregnancy.
• Healthcare staff handling this drug 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 bags for incineration at high temperature.

Accidental contact with the skin or eyes should be treated immediately with plenty of water.