Package leaflet: Information for the user

Hycamtin 1 mg powder for concentrate for solution for infusion Hycamtin 4 mg powder 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.

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

  
  

  What is in this leaflet

  
  

  1. What Hycamtin is and what it is used for

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

  3. How Hycamtin is used

  4. Possible side effects

  5. How to store Hycamtin

  6. Contents of the pack and other information

  
  

  1. What Hycamtin is and what it is used for

     
     

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

     
     

     Hycamtin 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, Hycamtin is combined with another medicine called cisplatin.

  
  

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

  
  

  1. What you need to know before you are given Hycamtin You should not receive 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 counts are too low. Your doctor will tell you whether this is the case, based on the results of your last blood test.

  Tell your doctor if any of these applies to you.

  
  

  Warnings and precautions

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

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

• if you are pregnant or plan to become pregnant. See section “Pregnancy and breast-feeding” below.

• if you plan to father a child. See section “Pregnancy and breast-feeding” below.

  Tell your doctor if any of these applies to you.

  Other medicines and Hycamtin

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

  
  

  Remember to tell your doctor if you start to take any other medicines while you are on Hycamtin.

  
  

  Pregnancy and breast-feeding

  Hycamtin is not recommended for pregnant women. It may harm a baby conceived before, during or

  soon after treatment. You should use an effective method of contraception. Ask your doctor for advice. Do not try to become pregnant until a doctor advises you it is safe to do so.

  
  

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

  
  

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

  
  

  Driving and using machines

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

  
  

  Hycamtin contains sodium

  This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”. If your doctor uses a solution of common salt to dilute Hycamtin, the dose of sodium received

  would be larger.

  
  

  1. How Hycamtin is used

     
     

     The dose of Hycamtin 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

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

       You will have treatment once a day for 5 days. This pattern of treatment will normally be repeated every 3 weeks.

     • Cervical cancer: 0.75 mg per square metre of body surface area per day. You will have treatment once a day for 3 days. This pattern of treatment will normally be repeated every 3 weeks.

     When treating cervical cancer, Hycamtin is combined with another medicine, called cisplatin. Your doctor will determine the correct dose of cisplatin.

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

     
     

     How Hycamtin is given

     A doctor or nurse will administer Hycamtin as an infusion into your arm lasting about 30 minutes.

  2. 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 common side effects may affect more than 1 in 10 people treated with Hycamtin:

• Signs of infections: Hycamtin 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 Hycamtin:

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

  • difficulty 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 Hycamtin:

• 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 minimise the risk of bleeding.

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

• 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 side effects

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

• Allergic or hypersensitivity reactions (including rash).

• Yellow skin.

• Feeling unwell.

• Itching sensation.

  
  

  Rare side effects

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

• 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).

  Side effects with frequency not known

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

• Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).

• Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or

  gut [mucosal inflammation]).

  
  

  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 Hycamtin. Those effects are described in the cisplatin patient leaflet.

  
  

  Reporting of side effects

  

  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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.

  
  

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

     This medicine is for single use only. After opening, 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. If reconstitution and dilution are performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 24 hours if stored at 2ºC – 8ºC after the first puncture of the vial.

     
     

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

     
     

  2. Contents of the pack and other information What Hycamtin contains

• The active substance is topotecan. Each vial contains 1 mg or 4 mg of topotecan (as hydrochloride).

• The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and sodium hydroxide.

  
  

  What Hycamtin looks like and contents of the pack

  Hycamtin comes as a powder for concentrate for solution for intravenous infusion.

  It is available in packs containing either 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 substance when reconstituted as recommended.

  Marketing Authorisation Holder

  Novartis Europharm Limited Vista Building

  Elm Park, Merrion Road

  Dublin 4 Ireland

  
  

  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

  
  

  

  For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

  
  

  België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

  Lietuva

  SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50

  
  

  България

  Novartis Bulgaria EOOD Тел: +359 2 489 98 28

  Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

  
  

  Česká republika

  Novartis s.r.o.

  Tel: +420 225 775 111

  Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00

  
  

  Danmark

  Sandoz A/S

  Tlf: +45 63 95 10 00

  Malta

  Novartis Pharma Services Inc. Tel: +356 2122 2872

  
  

  Deutschland

  Novartis Pharma GmbH

  Tel: +49 911 273 0

  Nederland

  Novartis Pharma B.V.

  Tel: +31 88 04 52 555

  
  

  Eesti

  SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810

  Norge

  Sandoz A/S

  Tlf: +45 63 95 10 00

  
  

  Ελλάδα

  Novartis (Hellas) A.E.B.E.

  Τηλ: +30 210 281 17 12

  Österreich

  Novartis Pharma GmbH

  Tel: +43 1 86 6570

  España

  BEXAL FARMACÉUTICA, S.A. Tel: +34 900 456 856

  Polska

  Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888

  
  

  France

  Sandoz

  Tél: +33 800 45 57 99

  Portugal

  Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600

  
  

  Hrvatska

  Novartis Hrvatska d.o.o. Tel. +385 1 6274 220

  România

  Sandoz S.R.L.

  Tel: +40 21 40751 60

  
  

  Ireland

  Novartis Ireland Limited Tel: +353 1 260 12 55

  Slovenija

  Novartis Pharma Services Inc. Tel: +386 1 300 75 50

  
  

  Ísland

  Vistor hf.

  Sími: +354 535 7000

  Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439

  
  

  Italia

  Novartis Farma S.p.A. Tel: +39 02 96 54 1

  Suomi/Finland

  Novartis Finland Oy

  Puh/Tel: +358 (0)10 6133 200

  
  

  Κύπρος

  Novartis Pharma Services Inc. Τηλ: +357 22 690 690

  Sverige

  Sandoz A/S

  Tel: +45 63 95 10 00

  
  

  Latvija

  SIA Novartis Baltics

  Tel: +371 67 887 070

  United Kingdom (Northern Ireland)

  Novartis Ireland Limited

  Tel: +44 1276 698370

  
  

  This leaflet was last revised in

  
  

  .

  The following information is intended for healthcare professionals only: Instructions on how to reconstitute, store and dispose of Hycamtin

  Reconstitution

  Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan.

  Hycamtin 4 mg powder for concentrate for solution for infusion should be reconstituted with 4 ml of

  water for injections to provide 1 mg per ml of topotecan.

  
  

  Further dilution is required. The appropriate volume of the reconstituted solution 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.

  
  

  Storage of the prepared solution

  The product should be used immediately after it is prepared for infusion. If reconstitution is performed under strict aseptic conditions Hycamtin infusion may be completed within 12 hours at room temperature (or 24 hours if stored at 2-8oC).

  
  

  Handling and disposal

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

• Staff should be trained to reconstitute the medicinal product.

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

• Staff handling this medicinal product during reconstitution 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.

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