Package leaflet: Information for the user

Topotecan Teva 1 mg/1 ml 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 nurse.

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

  
  

  What is in this leaflet:

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

  2. What you need to know before you use Toptecan Teva

  3. How to use Topotecan Teva

  4. Possible side effects

  5. How to store Topotecan Teva

  6. Contents of the pack and other information

  
  

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

     Topotecan Teva helps to kill tumour cells. Topotecan Teva 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 Teva is combined with another medicine called cisplatin.

  
  

  1. What you need to know before you use Topotecan Teva Do not use Topotecan Teva:

• 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 cells count is 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 you think any of these could apply to you.

  
  

  Warnings and precautions

  Talk to your doctor or nurse before using Topotecan Teva:

• if you have any kidney problems. Your dose of Topotecan Teva may need to be adjusted. The use of Topotecan Teva is not recommended in patients with severe renal impairment;

• if you have liver problems. Your dose of Topotecan Teva may need to be adjusted. The use of Topotecan Teva is not recommended in patients with severe liver impairment;

• if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 4 ‘Possible side effects’);

• if you suffer from unusual bruising or bleeding (also see section 4 ‘Possible side effects’);

• if you are feeling very ill.

  
  

  Other medicines and Topotecan Teva

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

  
  

  Pregnancy and breast-feeding

  Topotecan Teva should not be used in pregnant women, unless clearly necessary. If you are or think you might be pregnant, tell your doctor immediately.

  
  

  Women of child-bearing potential should use effective contraception to avoid becoming pregnant while on treatment.

  
  

  Male patients who may wish to father a child should ask their doctor for family planning advice or treatment.

  
  

  You must not breast-feed while on treatment with Topotecan Teva.

  
  

  Driving and using machines

  Topotecan Teva can make you feel tired or weak.

  If you experience this, do not drive or use machines.

  
  

  Topotecan Teva contains sodium

  This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-

  free’.

  
  

  1. How to use Topotecan Teva

     
     

     Your dose of Topotecan Teva will depend on:

• the disease being treated

• your body surface area (m2)

• the results of blood tests carried out before and during treatment

• how well you tolerate treatment.

  
  

  Ovarian and small cell lung cancer

  The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days. This treatment cycle will normally be repeated every three weeks.

  
  

  Cervical cancer

  The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days. This treatment cycle will normally be repeated every three weeks.

  
  

  For cervical cancer it will be used together with another anticancer medicine containing cisplatin. For more information about cisplatin, please refer to the corresponding Package Leaflet.

  
  

  The experience in children is limited and treatment is therefore not recommended.

  
  

  How Topotecan Teva is prepared

  Topotecan Teva is supplied as a concentrate for solution for infusion. The concentrate must be diluted

  before administration.

  
  

  How Topotecan Teva is given

  A doctor or nurse will give you the diluted Topotecan Teva solution as an infusion (a drip) usually into

  your arm over about 30 minutes.

  
  

  1. Possible side effects

     
     

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

     
     

     Serious side effects

     You must tell your doctor immediately if you experience any of the following serious side effects. They may require hospitalisation and could even be life threatening.

     • Infections (very common (may affect more than 1 in 10 people)), with signs such as:

       • fever

       • serious decline of your general condition

       • local symptoms such as sore throat or burning sensation when urinating

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

         Topotecan Teva may reduce your ability to fight infections.

         
         

     • Lung inflammation (rare (may affect up to 1 in 1,000 people)), with signs such as:

       • difficulty breathing,

       • cough

       • fever.

     The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 2 ‘What you need to know before you use Topotecan Teva’).

     
     

     Other side effects with Topotecan Teva include: Very common (may affect more than 1 in 10 people)

• Feeling generally weak and tired, which can be symptoms of a decrease in the number of red

  blood cells (anaemia). In some cases you may need a blood transfusion.

• Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).

• Abnormally low white blood cell count (leucopenia, neutropenia) which may be accompanied

  with fever and signs of infections (febrile neutropenia).

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

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

• Inflammation and ulcers of the mouth, throat, tongue or gums (mucositis).

• Fever.

• Hair loss.

  
  

  Common (may affect up to 1 in 10 people)

• Decrease in the number of all blood cells (pancytopenia)

• Allergic or hypersensitivity reactions (including rash).

• Yellow skin (jaundice) caused by abnormal liver function.

• Itching (pruritus).

• Severe infection (sepsis).

• Feeling unwell (malaise).

  
  

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

• Severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to

  severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness).

• Sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up

  (angioedema).

• Itchy rash (or hives).

  
  

  Very rare (may affect up to 1 in 10,000 people)

• Discharge of blood into tissues (extravasation).

  
  

  Not known (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]).

  
  

  Tell a doctor if any of these becomes troublesome.

  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 Teva.

  
  

  Reporting of side effects

  If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Topotecan Teva

     
     

     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 and vial after EXP. The expiry date refers to the last day of that month.

     
     

     Store in a refrigerator (2°C - 8°C). Do not freeze.

     
     

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

     
     

     Diluted solution

     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 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

     
     

     Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.

     
     

     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 Topotecan Teva contains

• The active substance is topotecan hydrochloride. One vial of 1 ml of concentrate contains 1 mg topotecan (as hydrochloride).

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

  (E524) and water for injections.

  
  

  What Topotecan Teva looks like and contents of the pack

  
  

  Topotecan Teva is a clear pale yellow liquid in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and snap-cap.

  Each vial contains 1 ml of the concentrate for solution for infusion. Topotecan Teva is supplied in cartons containing 1 vial or 5 vials. Not all pack sizes may be marketed.

  
  

  Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

  Teva B.V. Swensweg 5 2031GA Haarlem The Netherlands

  Manufacturer

  
  

  Pharmachemie B.V. Swensweg 5

  2031 GA Haarlem

  The Netherlands

  
  

  TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82

  H-2100 Gödöllő

  Hungary

  
  

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

  
  

  België/Belgique/Belgien

  Teva Pharma Belgium N.V./S.A./A.G. Tel/Tél: +32 3 820 73 73

  Lietuva

  UAB “Sicor Biotech” Tel: +370 5 266 02 03

  
  

  България

  Тева Фармасютикълс България ЕООД

  Teл: +359 2 489 95 82

  Luxembourg/Luxemburg

  Teva Pharma Belgium N.V./S.A./A.G. Tél: +32 3 820 73 73

  
  

  Česká republika

  Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111

  Magyarország

  Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00

  
  

  Danmark

  Teva Denmark A/S

  Tlf: +45 44 98 55 11

  Malta

  Teva Pharmaceuticals Ireland L-Irlanda

  Tel: +353 51 321740

  
  

  Deutschland

  Teva GmbH

  Tel: +49 731 402 08

  Nederland

  Teva Nederland B.V.

  Tel: +31 800 0228 400

  
  

  Eesti

  Teva Eesti esindus UAB Sicor Biotech Eesti filiaal

  Tel: +372 661 0801

  Norge

  Teva Norway AS Tlf: +47 6677 55 90

  
  

  Ελλάδα

  Teva Ελλάς Α.Ε.

  Τηλ: +30 210 72 79 099

  Österreich

  ratiopharm Arzneimittel Vertriebs GmbH

  Tel: +43 1 97007 0

  
  

  España

  Teva Pharma S.L.U. Tél: +34 91 387 32 80

  Polska

  Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00

  
  

  
  

  France

  Teva Santé

  Tél: +33 1 55 91 7800

  Portugal

  Teva Pharma - Produtos Farmacêuticos Lda

  Tel: +351 21 476 75 50

  Hrvatska

  Pliva Hrvatska d.o.o

  Tel: + 385 1 37 20 000

  România

  Teva Pharmaceuticals S.R.L Tel: +4021 230 6524

  
  

  Ireland

  Teva Pharmaceuticals Ireland Tel: +353 51 321 740

  Slovenija

  Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390

  
  

  Ísland

  ratiopharm Oy

  Puh/Tel: +358 20 180 5900

  Slovenská republika

  Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911

  
  

  Italia

  Teva Italia S.r.l.

  Tel: +39 028 917 981

  Suomi/Finland

  ratiopharm Oy

  Puh/Tel: +358 20 180 5900

  
  

  Κύπρος

  Teva Ελλάς Α.Ε.

  Τηλ: +30 210 72 79 099

  Sverige

  Teva Sweden AB Tel: +46 42 12 11 00

  
  

  Latvija

  UAB Sicor Biotech filiāle Latvijā

  Tel: +371 67 323 666

  United Kingdom

  Teva UK Limited

  Tel: +44 1977 628 500

  
  

  This leaflet was last revised in MM/YYYY.

  
  

  .

  
  

  The following information is intended for healthcare professionals only: Instructions on how to dilute, store and dispose of Topotecan Teva

  Instructions for dilution

  The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan. Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for

  injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.

  
  

  Storage of the diluted solution

  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 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

  
  

  Handling and disposal

  The normal procedures for proper handling and disposal of anticancer medicinal products should be

  adopted:

• Staff should be trained to dilute the medicinal product.

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

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

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

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