Topotecan Teva 4 mg/4 ml concentrate for solution forinfusion

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.

Do not use Topotecan Teva

• if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Topotecan Teva (listed in section 6 under ?What Topotecan Teva contains?);
• if you are breast feeding. You should stop breast-feeding before starting treatment with Topotecan Teva;
• if your blood cells count is too low. ? Tell your doctor if you think any of these could apply to you.

Take special care with Topotecan Teva

Tell your doctor:

• 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 liver problems;
• 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.

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

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.

Your dose of Topotecan Teva will depend on:

• the disease being treated - your body surface area (m 2)
• 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 is1.5 mg per m 2 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 m 2 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.

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

These side effects may occur with certain frequencies, which are defined as follows:

• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data.

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), 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), with signs such as:
• difficulty in 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 ?Before you use Topotecan Teva?).

Other side effects with Topotecan Teva include:
Very common side effects

• 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 (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.
• Infections.
• Hair loss.

Common side effects

• Allergic or hypersensitivity reactions (including rash).
• Yellow skin (jaundice) caused by abnormal liver function.
• Itching (pruritus).
• Severe infection (sepsis).
• Feeling unwell (malaise).

Rare side effects

• 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 side effects

• Discharge of blood into tissues (extravasation).

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.

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

Keep out of the reach and sight of children.

Do not use Topotecan Teva 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.

Medicines should not be disposed of via wastewater or household waste. Your doctor should dispose of medicines that are no longer required. These measures will help to protect the environment.

What Topotecan Teva contains

• The active substance is topotecan hydrochloride. One vial of 4 ml of concentrate contains 4 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 4 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

Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
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 Gödöll-
Hungary

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. Tél 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Genéricos Española, S.L.U. Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 212 08 90

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911

Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in

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

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

General precautions

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.
• All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
• Liquid waste may be flushed with large amounts of water.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.

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.

Disposal

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