Hycamtin

Package leaflet: Information for the user

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

topotecan
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of 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 treat tumors. A doctor or nurse will administer the medicine to you in a
hospital by intravenous infusion (slow injection into a vein).
Hycamtin is used to treat:

• relapsed ovarian cancer or relapsed small cell lung cancer after chemotherapy.
• advanced cervical cancer when surgery or radiotherapy is not possible. In the treatment of cervical cancer, Hycamtin is used in combination with another medicine called cisplatin.

Your doctor will decide with you whether Hycamtin therapy is preferable to further treatment with the
initial chemotherapy.

2. What you should know before being given Hycamtin

Do not take Hycamtin

• if you are allergic to topotecan or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.
• if your blood cell count is too low. Your doctor will advise you if this applies, based on your most recent blood test results. Tell your doctor if any of these situations apply to you.

Warnings and precautions
Before you are given this medicine, your doctor must know:

• if you have any kidney or liver problems. Your Hycamtin dose may need to be adjusted.
• if you are pregnant or think you may become pregnant. See the section below “Pregnancy and breastfeeding”.
• if you intend to father a child. See the section below “Pregnancy and breastfeeding”.
  Tell your doctor if any of these situations apply to you.

Other medicines and Hycamtin
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including herbal products or medicines obtained without a prescription.
Remember to inform your doctor if you start taking any other medicines while undergoing treatment with Hycamtin.

Pregnancy and breastfeeding
Hycamtin is not recommended for use in pregnant women. It may harm a child conceived before, during, or shortly after treatment. You must always use effective contraception during treatment with Hycamtin and for 6 months after completion of treatment. Ask your doctor for advice. Do not attempt to become pregnant until your doctor tells you it is safe to do so.

Men are advised to use effective contraception and to avoid fathering a child during treatment with Hycamtin and for 3 months after completion of treatment. Male patients who wish to father children should seek advice or treatment regarding fertility planning from their doctor. If your partner becomes pregnant during your treatment, inform your doctor immediately.

Do not breastfeed during treatment with Hycamtin. Do not resume breastfeeding until your doctor tells you it is safe to do so.

Driving and using machines
Hycamtin may cause tiredness. If you feel tired or weak, do not drive or operate machinery.

Hycamtin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’. However, if a common salt solution (0.9% w/v sodium chloride solution) is used to dilute Hycamtin before administration, the amount of sodium received may be higher.

3. How Hycamtin is used

The dose of Hycamtin you will be given is calculated by your doctor based on:

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

The usual dose

• Ovarian cancer and small cell lung cancer: 1.5 mg per square meter of body surface area per day. You will receive treatment once daily for 5 days. This treatment schedule is usually repeated every 3 weeks.
• Cervical cancer: 0.75 mg per square meter of body surface area per day. You will receive treatment once daily for 3 days. This treatment schedule is usually repeated every 3 weeks. In the treatment of cervical cancer, Hycamtin is given in combination with another medicine called cisplatin. Your doctor will advise you on the correct dose of cisplatin. Treatment may vary depending on the results of regular blood tests.

How Hycamtin is administered
Hycamtin will be administered by a doctor or nurse as an intravenous infusion into your arm over approximately 30 minutes.

4. Possible side effects

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

Serious side effects: tell your doctor

These side effects are very common and may occur in more than 1 in 10 people treated with Hycamtin:

• Signs of infection: Hycamtin can reduce the number of white blood cells and reduce resistance to infections. This can be life-threatening. Such signs include:
  • fever
  • severe worsening of general condition
  • local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be caused by a urinary tract infection).
• Occasionally, severe stomach pain, fever and possibly diarrhoea (rarely with blood) may be signs of intestinal inflammation ( colitis ).

This side effect is rare and may occur in up to 1 in 1000 people treated with Hycamtin:

• Inflammation of the lungs ( interstitial lung disease ): your risk is higher if you already have lung disease, have had radiation treatment to the lungs, or have previously taken medicines that have caused lung damage. Symptoms include:
  • difficulty breathing
  • cough
  • fever

If you experience any symptoms related to these conditions, speak to your doctor immediately, as hospitalisation may be necessary.

Very common side effects
These may occur in more than 1 in 10 people treated with Hycamtin:

• General feeling of weakness and tiredness (due to temporary anaemia). In some cases, you may need a blood transfusion.
• Unusual bruising and bleeding, caused by a decrease in the number of platelets, the blood cells responsible for blood clotting. This may lead to serious bleeding following relatively minor injuries, such as small cuts. Rarely, it may result in more severe bleeding ( haemorrhage ). Speak to your doctor for advice on how to minimise the risk of bleeding.
• Weight loss and loss of appetite ( anorexia ); tiredness; weakness.
• Nausea, vomiting; diarrhoea; stomach pain; constipation.
• Inflammation and sores on the lining of the mouth, tongue or gums.
• High body temperature (fever).
• Hair loss.

Common side effects
These may occur in up to 1 in 10 people treated with Hycamtin:

• Allergic reactions or hypersensitivity (including skin rash).
• Yellowing of the skin.
• Feeling unwell.
• Itching.

Rare side effects
These may occur in up to 1 in 1000 people treated with Hycamtin:

• Severe allergic or anaphylactic reactions.
• Swelling caused by fluid accumulation ( angioedema ).
• Mild pain and inflammation at the injection site.
• Itching with skin rash ( urticaria ).

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

• Severe stomach pain, nausea, blood in vomit, dark 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 intestine [mucositis]).

If you are being treated for cervical cancer, you may experience side effects due to the other medicine (cisplatin) you are receiving together with Hycamtin. These side effects are described in the patient leaflet for cisplatin therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hycamtin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
Keep the vial in the outer packaging to protect the medicine from light.
This medicine is for single use only. After opening, the product must be used immediately.
If not used immediately, the storage times during use and the conditions prior to use are the responsibility of the user.
If reconstitution and dilution are carried out under strict aseptic conditions (e.g. in a laminar flow hood), the product must be used (i.e. the infusion completed) within 24 hours if stored at 2°C - 8°C after the first puncture of the vial stopper.
Any unused medicine or waste material must be disposed of in accordance with local requirements for cytotoxic materials.

6. Package contents and other information

What Hycamtin contains

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

Description of the appearance of Hycamtin and contents of the pack
Hycamtin is a powder for concentrate for solution for intravenous infusion. It is available in cartons containing 1 or 5 glass vials; each vial contains 1 mg or 4 mg of topotecan. The powder must be reconstituted and diluted before infusion. The powder in the vial provides 1 mg of active substance per ml when reconstituted as indicated.

Marketing Authorisation Holder
Sandoz Pharmaceuticals d.d.
Verovškova ulica 57
1000 Ljubljana
Slovenia

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

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

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

België/Belgique/Belgien Lietuva
Sandoz N.V. Sandoz Pharmaceuticals d.d
Telecom Gardens Branch Office Lithuania
Medialaan 40 Seimyniskiu 3A
B-1800 Vilvoorde LT – 09312 Vilnius
Tél/Tel: +32 (0)2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
КЧТ Сандоз България Sandoz N.V.
Teл.: +359 2 970 47 47 Telecom Gardens
Medialaan 40
B-1800 Vilvoorde
Tél/Tel: +32 (0)2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Na Pankráci 1724/129 Bartók Béla út 43-47
CZ-140 00, Praha 4 H-1114 Budapest
Tel: +420 225 775 111 Tel: +36 1 430 2890
[email protected] [email protected]

Danmark Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Edvard Thomsens Vej 14 Verovskova 57
DK-2300 København S SI-1000 Ljubljana
Tlf: +45 6395 1000 Slovenia
Tel: +356 21222872

Deutschland Nederland
Hexal AG Sandoz B.V.
Industriestr. 25 Veluwezoom 22
D-83607 Holzkirchen NL-1327 AH Almere
Tel: +49 8024 908-0 Tel: +31 (0)36 5241600
[email protected] [email protected]

Eesti Norge
Sandoz d.d. Eesti filiaal Sandoz A/S
Pärnu mnt 105 Edvard Thomsens Vej 14
EE – 11312 Tallinn DK-2300 København S
Tel: +372 6652405 Denmark
Tlf: +45 6395 1000
[email protected]

Ελλάδα
SANDOZ HELLAS
ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Österreich
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Tel: +43(0)1 86659-0

España Polska
Bexal Farmacéutica, S.A. Sandoz Polska Sp. z o.o.
Centro Empresarial Parque Norte ul. Domaniewska 50 C
Edificio Roble 02 672 Warszawa
C/ Serrano Galvache, 56 Tel.: +48 22 209 7000
28033 Madrid [email protected]
Tel: +34 900 456 856

France Portugal
Sandoz SAS Sandoz Farmacêutica Lda.
49, avenue Georges Pompidou Avenida Professor Doutor Cavaco Silva, n.º10E
F-92300 Levallois-Perret Taguspark
Tél: +33 1 49 64 48 00 P-2740 − 255 Porto Salvo
Tel: +351 21 196 40 42
[email protected]

Hrvatska România
Sandoz d.o.o. Sandoz S.R.L.
Maksimirska 120 Strada Livezeni Nr. 7a
10 000 Zagreb 540472 Târgu Mureș
Tel: +385 1 235 3111 Tel: +40 21 407 51 60
[email protected]

Ireland Slovenija
Sandoz Pharmaceuticals d.d. Lek farmacevtska družba d.d.
Verovškova ulica 57 Verovškova 57
1000 Ljubljana SI-1526 Ljubljana
Slovenia Tel: +386 1 580 21 11

Ísland Slovenská republika
Sandoz A/S Sandoz d.d. - organizačná zložka
Edvard Thomsens Vej 14 Žižkova 22B
DK-2300 Kaupmannahöfn S 811 02 Bratislava
Iceland Tel: +421 2 48 200 600
Tlf: +45 6395 1000 [email protected]
[email protected]

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Largo Umberto Boccioni, 1 Edvard Thomsens Vej 14
I-21040 Origgio / VA DK-2300 Copenhagen S
Tel: +39 02 96 54 1 Denmark
[email protected] Puh: +358 010 6133 400
[email protected]

Κύπρος Sverige
Sandoz Pharmaceuticals d.d. Sandoz A/S
Verovskova 57 Edvard Thomsens Vej 14
SI-1000 Ljubljana DK-2300 Copenhagen S
Slovenia Denmark
Tel: +357 22 69 0690 Tel: +45 6395 1000
[email protected]

Latvija United Kingdom (Northern Ireland)
Sandoz d.d. Latvia filiāle Sandoz Pharmaceuticals d.d.
K.Valdemāra 33 – 29 Verovskova 57
LV-1010 Rīga SI-1000 Ljubljana
Tel: +371 67892006 Slovenia
Tel: +43 5338 2000

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

Instructions for reconstitution, storage, and disposal of Hycamtin
Reconstitution
Hycamtin 1 mg powder for concentrate for solution for infusion must be reconstituted with
1.1 mL of water for injections to yield a solution containing 1 mg/mL of topotecan.
Hycamtin 4 mg powder for concentrate for solution for infusion must be reconstituted with 4 mL
of water for injections to yield a solution containing 1 mg/mL of topotecan.
A further dilution is required . To achieve a final concentration between 25 and
50 micrograms/mL, the appropriate volume of reconstituted solution must be diluted either with 0.9% w/v sodium chloride for intravenous infusion or with 5% w/v glucose for intravenous infusion.

Storage of the prepared solution
The product should be used immediately after preparation for infusion. If reconstitution is carried out under strict aseptic conditions, the Hycamtin infusion may be completed within 12 hours at room temperature (or within 24 hours if stored at 2–8°C).

Handling and disposal
Standard procedures for the safe handling and disposal of cytotoxic medicinal products should be followed:

• Personnel must be trained in the correct reconstitution procedures for this medicinal product.
• Pregnant personnel must not be involved in activities related to the use of this medicinal product.
• Personnel handling the medicinal product during reconstitution must wear protective clothing, including mask, goggles, and gloves.
• All equipment and materials used for administration and cleaning, including gloves, must be placed in sealed bags designated for high-risk waste, to be incinerated at high temperature.
• In case of accidental contact with skin or eyes, immediately flush thoroughly with large amounts of water.

Patient Information Leaflet: Information for the User

Hycamtin 0.25 mg hard capsules, 1 mg hard capsules

topotecan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hycamtin is and what it is used for
2. What you need to know before taking Hycamtin
3. How to use Hycamtin
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 treat tumors.
Hycamtin is used to treat small cell lung cancer that has relapsed
after chemotherapy.
Your doctor will decide with you whether treatment with Hycamtin is preferable to further treatment with the initial chemotherapy.

2. What you need to know before taking Hycamtin

Do not take Hycamtin:

• if you are allergic to topotecan or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.
• if your blood cell count is too low. Your doctor will advise you if this is the case, based on your most recent blood test results. Inform your doctor if any of these situations apply to you.

Warnings and precautions
Before this medicine is administered, your doctor must know:

• if you have any kidney or liver problems. It may be necessary to adjust the dose of Hycamtin.
• if you are pregnant or think you may become pregnant. See section below "Pregnancy and breastfeeding".
• if you intend to father a child. See section below "Pregnancy and breastfeeding". Inform your doctor if any of these situations apply to you.

Other medicines and Hycamtin
Inform your doctor if you are taking, have recently taken, or might take any other medicine, including herbal products or over-the-counter medicines.
If you are also being treated with cyclosporine A, there may be a higher than usual risk of side effects. You must be under close medical supervision if you are taking both of these medicines.
Remember to inform your doctor if you start taking any other medicine while being treated with Hycamtin.

Pregnancy and breastfeeding
Hycamtin is not recommended for use in pregnant women. It may harm a child conceived before, during, or immediately after treatment. You must always use effective contraception during treatment with Hycamtin and for 6 months after completion of treatment. Ask your doctor for advice. Do not attempt to become pregnant until your doctor tells you it is safe.
Men are advised to use effective contraception and not to father a child during treatment with Hycamtin and for 3 months after completion of treatment. Male patients who wish to father children should seek advice or treatment from their doctor regarding fertility planning. If your partner becomes pregnant during your treatment, inform your doctor immediately.
Do not breastfeed during treatment with Hycamtin. Do not restart breastfeeding until your doctor tells you it is safe to do so.

Driving and using machines
Hycamtin may cause tiredness. If you feel tired or weak, do not drive or operate machinery.

Hycamtin contains ethanol
This medicine contains very small amounts of ethanol (alcohol).

3. How to take Hycamtin

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The capsules must be swallowed whole and must not be chewed, crushed, or divided.
Your doctor will determine the dose (and number of capsules) of Hycamtin based on:

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

The prescribed number of capsules must be swallowed whole once daily for 5 days.

Hycamtin capsules must not be opened or crushed. If the capsules are punctured or cracked, wash your hands immediately with soap and water. If the capsule contents come into contact with the eyes, rinse them immediately under a gentle stream of lukewarm running water for at least 15 minutes. Consult your doctor if there is contact with the eyes or if you experience skin reactions.

How to remove a capsule
These capsules are packaged in a special child-resistant blister pack.

1. Separate one capsule: Tear along the perforated lines to separate one "pocket" containing the capsule from the blister pack.

2. Peel back the outer layer: Starting from the colored corner, lift and peel away the outer layer from the pocket.

3. Push the capsule out: Gently push one end of the capsule through the inner foil.

If you take more Hycamtin than you should
If you have taken too many capsules or if a child has accidentally ingested the medicine, contact a doctor or pharmacist immediately for advice.

If you forget to take Hycamtin
Do not take a double dose to make up for a forgotten dose. Take only the next dose at the scheduled time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects: tell your doctor
These side effects are very common and may occur in more than 1 in 10 people treated with Hycamtin:

• Signs of infection: Hycamtin can reduce the number of white blood cells in the blood and reduce resistance to infections. This can be life-threatening. Such signs include:
  • fever
  • severe worsening of general condition
  • local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be caused by a urinary tract infection).
• Diarrhoea. It may be severe. If you have more than 3 episodes of diarrhoea per day, you must contact your doctor immediately.
• Occasionally, severe stomach pain, fever and possibly diarrhoea (rarely with blood) may be signs of intestinal inflammation ( colitis ).

This side effect is rare and may occur in up to 1 in 1000 people treated with Hycamtin:

• Inflammation of the lungs ( interstitial lung disease ): your risk is higher if you already have lung disease, have previously received radiation therapy to the lungs, or have previously taken medicines that caused lung damage. Symptoms include:
  • difficulty breathing
  • cough
  • fever

If you experience any symptom related to these conditions, speak to your doctor immediately, as hospitalization may be necessary.
Very common side effects
These may occur in more than 1 in 10 people treated with Hycamtin:

• General feeling of weakness and fatigue (due to temporary anaemia). In some cases, you may require a blood transfusion.
• Unusual bruising and bleeding, caused by a decrease in the number of platelets, the blood cells responsible for blood clotting. This may lead to severe bleeding following relatively minor injuries, such as small cuts. Rarely, it may result in more serious bleeding ( haemorrhage ). Talk to your doctor for advice on how to minimize the risk of bleeding.
• Weight loss and loss of appetite ( anorexia ); fatigue; weakness.
• Nausea, vomiting; diarrhoea.
• Hair loss.

Common side effects
These may occur in up to 1 in 10 people treated with Hycamtin:

• Allergic reactions or hypersensitivity (including skin rash).
• Inflammation and sores on the lining of the mouth, tongue or gums.
• High body temperature (fever).
• Stomach pain; constipation; digestive difficulties.
• Feeling unwell.
• Itching.

Uncommon side effects
These may occur in up to 1 in 100 people treated with Hycamtin:

• Yellowing of the skin.

Rare side effects
These may occur in up to 1 in 1000 people treated with Hycamtin:

• Severe allergic or anaphylactic reactions.
• Swelling due to fluid accumulation ( angioedema ).
• Itching with skin rash ( urticaria ).

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

• Severe stomach pain, nausea, blood in vomit, dark 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 intestines [mucositis]).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hycamtin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep the blister pack in the outer packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Hycamtin contains

• The active substance is topotecan. Each capsule contains 0.25 mg or 1 mg of topotecan (as hydrochloride).
• The excipients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and, for the 1 mg capsules only, red iron oxide (E172). The imprint on the capsules is printed with black ink containing black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution, and potassium hydroxide.

Description of the appearance of Hycamtin and contents of the pack
Hycamtin 0.25 mg capsules are white to off-white in colour, imprinted with “Hycamtin” and “0.25 mg”.

Hycamtin 1 mg capsules are pink in colour, imprinted with “Hycamtin” and “1 mg”.
Hycamtin 0.25 mg and 1 mg capsules are available in packs containing 10 capsules.

Marketing Authorisation Holder
Sandoz Pharmaceuticals d.d.
Verovškova ulica 57
1000 Ljubljana
Slovenia

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

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz N.V. Sandoz Pharmaceuticals d.d
Telecom Gardens Branch Office Lithuania
Medialaan 40 Seimyniskiu 3A
B-1800 Vilvoorde LT – 09312 Vilnius
Tél/Tel: +32 (0)2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
КЧТ Сандоз България Sandoz N.V.
Teл.: +359 2 970 47 47 Telecom Gardens
Medialaan 40
B-1800 Vilvoorde
Tél/Tel: +32 (0)2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Na Pankráci 1724/129 Bartók Béla út 43-47
CZ-140 00, Praha 4 H-1114 Budapest
Tel: +420 225 775 111 Tel: +36 1 430 2890
[email protected] [email protected]

Danmark Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Edvard Thomsens Vej 14 Verovskova 57
DK-2300 København S SI-1000 Ljubljana
Tlf: +45 6395 1000 Slovenia
Tel: +356 21222872

Deutschland Nederland
Hexal AG Sandoz B.V.
Industriestr. 25 Veluwezoom 22
D-83607 Holzkirchen NL-1327 AH Almere
Tel: +49 8024 908-0 Tel: +31 (0)36 5241600
[email protected] [email protected]

Eesti Norge
Sandoz d.d. Eesti filiaal Sandoz A/S
Pärnu mnt 105 Edvard Thomsens Vej 14
EE – 11312 Tallinn DK-2300 København S
Tel: +372 6652405 Denmark
Tlf: +45 6395 1000
[email protected]

Ελλάδα
SANDOZ HELLAS
ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Tel: +30 216 600 5000

Österreich
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Tel: +43(0)1 86659-0

España Polska
Bexal Farmacéutica, S.A. Sandoz Polska Sp. z o.o.
Centro Empresarial Parque Norte ul. Domaniewska 50 C
Edificio Roble 02 672 Warszawa
C/ Serrano Galvache, 56 Tel.: +48 22 209 7000
28033 Madrid [email protected]
Tel: +34 900 456 856

France Portugal
Sandoz SAS Sandoz Farmacêutica Lda.
49, avenue Georges Pompidou Avenida Professor Doutor Cavaco Silva, n.º10E
F-92300 Levallois-Perret Taguspark
Tél: +33 1 49 64 48 00 P-2740 − 255 Porto Salvo
Tel: +351 21 196 40 42
[email protected]

Hrvatska România
Sandoz d.o.o. Sandoz S.R.L.
Maksimirska 120 Strada Livezeni Nr. 7a
10 000 Zagreb 540472 Târgu Mureș
Tel: +385 1 235 3111 Tel: +40 21 407 51 60
[email protected]

Ireland Slovenija
Sandoz Pharmaceuticals d.d. Lek farmacevtska družba d.d.
Verovškova ulica 57 Verovškova 57
1000 Ljubljana SI-1526 Ljubljana
Slovenia Tel: +386 1 580 21 11
[email protected]

Ísland Slovenská republika
Sandoz A/S Sandoz d.d. - organizačná zložka
Edvard Thomsens Vej 14 Žižkova 22B
DK-2300 Copenhagen S 811 02 Bratislava
Denmark Slovakia
Tlf: +45 6395 1000 Tel: +421 2 48 200 600
[email protected] [email protected]

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Largo Umberto Boccioni, 1 Edvard Thomsens Vej 14
I-21040 Origgio / VA DK-2300 Copenhagen S
Italy Denmark
Tel: +39 02 96 54 1 Puh: +358 010 6133 400
[email protected] [email protected]

Κύπρος Sverige
Sandoz Pharmaceuticals d.d. Sandoz A/S
Verovskova 57 Edvard Thomsens Vej 14
SI-1000 Ljubljana DK-2300 Stockholm S
Slovenia Denmark
Tel: +357 22 69 0690 Tel: +45 6395 1000
[email protected]

Latvija United Kingdom (Northern Ireland)
Sandoz d.d. Latvia filiāle Sandoz Pharmaceuticals d.d.
K.Valdemāra 33 – 29 Verovskova 57
LV-1010 Rīga SI-1000 Ljubljana
Latvia Slovenia
Tel: +371 67892006 Tel: +43 5338 2000

More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.