Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - hycamtin

Document Subject

Generated Narrative: MedicinalProductDefinition mpd9561f20b6898b3c62b048e0c8b52401

identifier: http://ema.europa.eu/identifier/EU/1/96/027/004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: HYCAMTIN 1 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d9561f20b6898b3c62b048e0c8b52401

identifier: http://ema.europa.eu/identifier/EU/1/96/027/004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - hycamtin

Attesters

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

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.

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.

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.

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.

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 2 C 8 C 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.

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 Sandoz Pharmaceuticals d.d. Verov kova ulica 1000 Ljubljana Slovenia

Manufacturer Novartis Farmac utica S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

GlaxoSmithKline Manufacturing S.p.A. Strada Provinciale Asolana 43056 San Polo di Torrile Parma Italy

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

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

Belgi /Belgique/Belgien Sandoz N.V. Telecom Gardens Medialaan B-1800 Vilvoorde T l/Tel: +32 (0)2 722 97 Lietuva Sandoz Pharmaceuticals d.d Branch Office Lithuania Seimyniskiu 3A LT 09312 Vilnius Tel: +370 5 2636

Te .: +359 2 970 47 Luxembourg/Luxemburg Sandoz N.V. Telecom Gardens Medialaan B-1800 Vilvoorde T l/Tel: +32 (0)2 722 97 esk republika Sandoz s.r.o. Na Pankr ci 1724/CZ-140 00, Praha 4 Tel: +420 225 775 office.cz@ sandoz.com

Magyarorsz g Sandoz Hung ria Kft. Bart k B la t 43-H-1114 Budapest Tel: +36 1 430 2Info.hungary@sandoz.com Danmark Sandoz A/S Edvard Thomsens Vej DK-2300 K benhavn S Tlf: +45 6395 1info.danmark@sandoz.com

Malta Sandoz Pharmaceuticals d.d. Verovskova SI-1000 Ljubljana Slovenia Tel: +356 21222Deutschland Hexal AG Industriestr. D-83607 Holzkirchen Tel: +49 8024 908-0 service@hexal.com

Nederland Sandoz B.V. Veluwezoom NL-1327 AH Almere Tel: +31 (0)36 5241info.sandoz-nl@sandoz.com Eesti Sandoz d.d. Eesti filiaal P rnu mnt EE 11312 Tallinn Tel: +372 6652Norge Sandoz A/S Edvard Thomsens Vej DK-2300 K benhavn S Danmark Tlf: +45 6395 1info.norge@sandoz.com

SANDOZ HELLAS . . : +30 216 600 5 sterreich Sandoz GmbH Biochemiestr. A-6250 Kundl Tel: +43(0)1 86659-0

Espa a Bexal Farmac utica, S.A Centro Empresarial Parque Norte Edificio Roble C/ Serrano Galvache, 28033 Madrid Tel: +34 900 456 Polska Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02 672 Warszawa Tel.: +48 22 209 7France Sandoz SAS 49, avenue Georges Pompidou F-92300 Levallois-Perret T l: +33 1 49 64 48 Portugal Sandoz Farmac utica Lda. Avenida Professor Doutor Cavaco Silva, n. 10E Taguspark P-2740 255 Porto Salvo Tel: +351 21 196 40 regaff.portugal@sandoz.com

Hrvatska Sandoz d.o.o. Maksimirska 10 000 Zagreb Tel : +385 1 235 3upit.croatia@sandoz.com

Rom nia Sandoz S.R.L. Strada Livezeni Nr. 7a 540472 T rgu Mure
Tel: +40 21 407 51 Ireland Sandoz Pharmaceuticals d.d. Verov kova ulica 1000 Ljubljana Slovenia

Slovenija Lek farmacevtska dru ba d.d. Verov kova SI-1526 Ljubljana Tel: +386 1 580 21 Info.lek@sandoz.com sland Sandoz A/S Edvard Thomsens Vej DK-2300 Kaupmaannah fn S Danm rk Tlf: +45 6395 1info.danmark@sandoz.com

Slovensk republika Sandoz d.d. - organiza n zlo ka i kova 22B 811 02 Bratislava Tel: +421 2 48 200 sk.regulatory@sandoz.com

Italia Sandoz S.p.A. Largo Umberto Boccioni, 1 I-21040 Origgio / VA Tel: +39 02 96 54 1 regaff.italy@sandoz.com Suomi/Finland Sandoz A/S Edvard Thomsens Vej DK-2300 K penhamina S Tanska Puh: + 358 010 6133 info.suomi@sandoz.com

Sandoz Pharmaceuticals d.d. Verovskova SI-1000 Ljubljana

: +357 22 69 0Sverige Sandoz A/S Edvard Thomsens Vej DK-2300 K penhamn S Danmark Tel: +45 6395 1info.sverige@sandoz.com

Latvija Sandoz d.d. Latvia fili le K.Valdem ra 33 LV-1010 R ga Tel: +371 67892United Kingdom (Northern Ireland) Sandoz Pharmaceuticals d.d. Verovskova SI-1000 Ljubljana Slovenia Tel: +43 5338 2This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: