ZYTIGA 250 мг Таблетка

Содержание инструкции

1. ZYTIGA 250 mg tablets
   1. What is ZYTIGA and what is it used for
   2. What you need to know before taking ZYTIGA
   3. How to take ZYTIGA
   4. Possible side effects
   5. How to store ZYTIGA
   6. Package contents and other information
2. ZYTIGA 500 mg film-coated tablets
   1. What is ZYTIGA and what is it used for
   2. What you need to know before taking ZYTIGA
   3. How to take ZYTIGA
   4. Possible side effects
   5. How to store ZYTIGA
   6. Package contents and other information

ZYTIGA 250 mg tablets

abiraterone acetate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet:

• 1. What ZYTIGA is and what it is used for
• 2. What you need to know before you take ZYTIGA
• 3. How to take ZYTIGA
• 4. Possible side effects
• 5. How to store ZYTIGA
• 6. Contents of the pack and other information

1. What is ZYTIGA and what is it used for

ZYTIGA contains a medicine called abiraterone acetate. It is used for the treatment of
prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops the
production of testosterone by the body; this may slow the growth of prostate
cancer.
When ZYTIGA is prescribed in the early stages of the disease, which still responds to hormonal
therapy, it is used with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe you another medicine called
prednisone or prednisolone. This medicine is used to reduce the possibility of having high blood
pressure, too much water in the body (fluid retention), or reduced levels in the blood of
a chemical substance known as potassium.

2. What you need to know before taking ZYTIGA

Do not take ZYTIGA

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if you are pregnant. The use of ZYTIGA is only indicated in men.
• if you have severe liver damage.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of these conditions apply to you. If you have any doubts, ask your doctor
or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels can increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or fast heartbeat
• if you are short of breath
• if you have rapidly gained weight
• if you have swelling of your feet, ankles or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about the possible effects on bones
• if you have high levels of sugar in your blood.

Tell your doctor if you have been told you have any heart or blood vessel disorder, including
heart rhythm problems (arrhythmia) or if you are being treated for these disorders.
Tell your doctor if you have yellowing of the skin or eyes, dark-colored urine, or severe nausea or
vomiting, as these could be signs or symptoms of liver problems. Rarely, a
liver problem (called acute liver failure) may occur, which can lead to
death.
Decreases in red blood cells, decreased sexual desire (libido),
muscle weakness and/or muscle pain may occur.
ZYTIGA must not be administered in combination with Ra-223 due to a possible increased
risk of fractures or death.
If you think you are going to take Ra-223 after treatment with ZYTIGA and prednisone/prednisolone, you must
wait 5 days before starting treatment with Ra-223.
If you have any doubts about whether any of the above points apply to you, ask your doctor
or pharmacist before taking this medicine.

Blood monitoring
ZYTIGA can affect the liver and may not have any symptoms. When you take this
medicine, your doctor will periodically perform blood tests to check for any effects
of ZYTIGA on your liver.

Children and adolescents
The medicine is not indicated in children and adolescents. If ZYTIGA is accidentally swallowed
by a child or adolescent, go to hospital immediately and take the leaflet
with you to show to the emergency room doctor.

Other medicines and ZYTIGA
Ask your doctor or pharmacist before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. This is important because ZYTIGA can increase the effects of some
medicines, including medicines for the heart, sedatives, some medicines for diabetes, herbal medicines (e.g. St John's Wort) and others. Your doctor may decide to change the dose of
these medicines. Also, some medicines can increase or decrease the effects of ZYTIGA.
This can lead to undesirable effects or ZYTIGA may not work as well as it should.
Androgen deprivation therapy can increase the risk of heart rhythm problems.
Tell your doctor if you are taking medicines:

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for the treatment of drug dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Tell your doctor if you are taking any of the medicines listed above.

ZYTIGA with food

• This medicine should not be taken with food (see section “How to take this medicine”).
• Taking ZYTIGA with food can cause undesirable effects.

Pregnancy and breastfeeding
The use of ZYTIGA is not indicated in women.

• This medicine can cause harm to the unborn child if taken by pregnant women.
• Pregnant women or those who may become pregnant must wear glovesif they need to touch or handle ZYTIGA.
• If you have sexual intercourse with a woman of childbearing potential, you must use a condom andanother effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom toprotect the fetus.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and operate tools or
machinery.

ZYTIGA contains lactose and sodium

• ZYTIGA contains lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 27.2 mg of sodium (the main component of table salt) per daily dose of four tablets. This is equivalent to 1.36% of the recommended maximum daily intake of salt with the diet of an adult.

3. How to take ZYTIGA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much to take
The recommended dose is 1 000 mg (four tablets) once a day.

Taking this medicine

• Take this medicine by mouth.
• Do not take ZYTIGA with food.Taking ZYTIGA with food may cause greater absorption of the medicine by the body than necessary, and this may cause undesirable effects.
• Take the ZYTIGA tablets as a single dose once a day on an empty stomach. ZYTIGA must be taken at least two hours after a meal and no food should be ingested for at least one hour after taking ZYTIGA. (see paragraph 2 “ZYTIGA with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• ZYTIGA is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone following exactly the instructions of your doctor.
• You must take prednisone or prednisolone every day while taking ZYTIGA.
• It may be necessary to change the amount of prednisone or prednisolone, in emergency cases. Your doctor will inform you if you need to change the amount of prednisone or of

prednisolone you are taking. Do not stop taking prednisone or prednisolone unless your
doctor tells you to.
Your doctor may also prescribe other medicines while you are taking ZYTIGA and prednisone or
prednisolone.

If you take more ZYTIGA than you should
If you take more ZYTIGA than you should, contact your doctor or go to hospital immediately.

If you forget to take ZYTIGA

• If you forget to take ZYTIGA or prednisone or prednisolone, take the usual dose the next day.
• If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, talk to your doctor without waiting too long.

If you stop taking ZYTIGA
Do not stop taking ZYTIGA or prednisone or prednisolone unless your
doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following side effects, stop taking ZYTIGA and contact your doctor immediately:

• muscle weakness, muscle spasms or a feeling of a pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
Very common(may affect more than 1 in 10 people)
Fluid in the legs or feet, low potassium levels in the blood, increased values in liver function tests, high blood pressure, urinary tract infection, diarrhoea.

Common(may affect up to 1 in 10 people)
High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, fast heartbeat, serious infection called sepsis, bone fractures, indigestion, blood in urine, rash.

Uncommon(may affect up to 1 in 100 people)
Problems with the adrenal glands (related to problems with salt and water), abnormal heartbeat (arrhythmia), muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000)
Lung irritation (also called allergic alveolitis).
Liver function problems (also called acute liver failure).

Not known(frequency cannot be estimated from available data)
Heart attack, changes in the ECG – electrocardiogram (prolongation of the QT interval), and serious allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.
Bone loss may occur in men treated for prostate cancer. ZYTIGA in combination with prednisone or prednisolone may increase bone loss.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 ZYTIGA

• 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 packaging carton and bottle label. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine in water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZYTIGA contains

• The active ingredient is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
• The other excipients are microcrystalline cellulose, sodium croscarmellose, lactose monohydrate; magnesium stearate, povidone (K29/K32), anhydrous colloidal silica and sodium lauryl sulfate (see section 2 “ZYTIGA contains lactose and sodium”).

Description of the appearance of ZYTIGA and package contents

• ZYTIGA tablets have an oval shape (15.9 mm long x 9.5 mm wide), are white to off-white in color, with “AA250” imprinted on one side.
• The tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 120 tablets. Each pack contains one bottle.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen-Cilag SpA
Via C. Janssen
Borgo San Michele
I-04100 Latina, Italy
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel. +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf: +45 45 94 82 82
[email protected]

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137 955 955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.+48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444

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

ZYTIGA 500 mg film-coated tablets

abiraterone acetate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet:

• 1. What ZYTIGA is and what it is used for
• 2. What you need to know before you take ZYTIGA
• 3. How to take ZYTIGA
• 4. Possible side effects
• 5. How to store ZYTIGA
• 6. Contents of the pack and other information

1. What is ZYTIGA and what is it used for

ZYTIGA contains a medicine called abiraterone acetate. It is used for the treatment of
prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops the
production of testosterone by the body; this may slow down the growth of prostate
cancer.
When ZYTIGA is prescribed in the early stages of the disease, which still responds to hormonal
therapy, it is used with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe you another medicine called
prednisone or prednisolone. This medicine is used to reduce the possibility of having high
blood pressure, too much water in the body (fluid retention), or reduced levels in the blood of
a chemical substance known as potassium.

2. What you need to know before taking ZYTIGA

Do not take ZYTIGA

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if you are pregnant. The use of ZYTIGA is only indicated in men.
• if you have severe liver damage.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of these conditions apply to you. If you have any doubts, ask your doctor
or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels can increase the risk of heart rhythm problems)
• if you have had other problems with your heart or blood vessels
• if you have an irregular or fast heartbeat
• if you are short of breath
• if you have rapidly gained weight
• if you have swelling of your feet, ankles or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about the possible effects on bones
• if you have high levels of sugar in your blood.

Tell your doctor if you have been told you have any heart or blood vessel problems, including
problems with your heart rhythm (arrhythmia) or if you are being treated for these problems.
Tell your doctor if you have yellowing of the skin or eyes, dark colored urine or severe nausea or
vomiting, as these could be signs or symptoms of liver problems. Rarely, a
liver problem (called acute liver failure) can occur, which can lead to
death.
Decreases in red blood cells, decreased sexual desire (libido),
muscle weakness and/or muscle pain may occur.
ZYTIGA must not be given in combination with Ra-223 due to a possible increased risk of
fractures or death.
If you think you are going to take Ra-223 after treatment with ZYTIGA and prednisone/prednisolone, you must
wait 5 days before starting treatment with Ra-223.
If you have any doubts about whether any of the above points apply to you, ask your doctor
or pharmacist before taking this medicine.

Blood monitoring
ZYTIGA can affect the liver and may not have any symptoms. When you take this
medicine, your doctor will periodically perform blood tests to check for any effects
of ZYTIGA on your liver.

Children and adolescents
The medicine is not indicated in children and adolescents. If ZYTIGA is accidentally swallowed
by a child or adolescent, go to hospital immediately and take the leaflet
with you to show to the emergency room doctor.

Other medicines and ZYTIGA
Ask your doctor or pharmacist before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. This is important because ZYTIGA can increase the effects of some
medicines including medicines for the heart, tranquillizers, some medicines for diabetes, herbal medicines (e.g. St John's Wort) and others. Your doctor may decide to change the dose of
these medicines. Also, some medicines can increase or decrease the effects of ZYTIGA.
This can lead to unwanted effects or ZYTIGA may not work as well as it should.
Androgen deprivation therapy can increase the risk of heart rhythm problems.
Tell your doctor if you are taking medicines:

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for the treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Tell your doctor if you are taking any of the medicines listed above.

ZYTIGA with food

• This medicine should not be taken with food (see section “How to take this medicine”).
• Taking ZYTIGA with food can cause unwanted effects.

Pregnancy and breastfeeding
The use of ZYTIGA is not indicated in women.

• This medicine can cause harm to the unborn child if taken by a pregnant woman.
• If you have sexual intercourse with a woman of childbearing potential, you must use a condom andanother effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom toprotect the fetus.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and operate tools or
machinery.

ZYTIGA contains lactose and sodium

• ZYTIGA contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 27 mg of sodium (the main component of table salt) in the daily dose of two tablets. This is equivalent to 1.35% of the recommended maximum daily intake of sodium with the diet for an adult.

3. How to take ZYTIGA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much to take
The recommended dose is 1 000 mg (two tablets) once a day.

Taking this medicine

• Take this medicine by mouth.
• Do not take ZYTIGA with food.Taking ZYTIGA with food may cause greater absorption of the medicine by the body than necessary and this may cause undesirable effects.
• Take the ZYTIGA tablets as a single dose once a day on an empty stomach. ZYTIGA must be taken at least two hours after a meal and no food should be ingested for at least one hour after taking ZYTIGA. (see section 2 “ZYTIGA with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• ZYTIGA is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone following exactly the instructions of your doctor.
• You must take prednisone or prednisolone every day while taking ZYTIGA.
• It may be necessary to change the amount of prednisone or prednisolone, in emergency cases. Your doctor will inform you if you need to change the amount of prednisone or prednisolone you are taking. Do not stop taking prednisone or prednisolone, unless your doctor tells you to.

The doctor may also prescribe you other medicines, while you take ZYTIGA and prednisone or
prednisolone.

If you take more ZYTIGA than you should
If you take more ZYTIGA than you should, contact your doctor or go to hospital immediately.

If you forget to take ZYTIGA

• If you forget to take ZYTIGA or prednisone or prednisolone, take the usual dose the next day.
• If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, talk to your doctor without waiting too long.

If you stop taking ZYTIGA
Do not stop taking ZYTIGA or prednisone or prednisolone, unless your doctor
tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following side effects, stop taking ZYTIGA and contact your doctor immediately:

• muscle weakness, muscle spasms or a feeling of a pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
Very common(may affect more than 1 in 10 people)
Fluid in the legs or feet, low potassium levels in the blood, increased values in liver function tests, high blood pressure, urinary tract infection, diarrhoea.

Common(may affect up to 1 in 10 people)
High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation),
heart failure, fast heartbeat, serious infection called sepsis, bone fractures,
indigestion, blood in urine, rash.

Uncommon(may affect up to 1 in 100 people)
Problems with the adrenal glands (related to salt and water problems), abnormal heartbeat
(arrhythmia), muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000)
Lung irritation (also called allergic alveolitis).
Liver function problems (also called acute hepatic failure).

Not known(frequency cannot be estimated from available data)
Heart attack, changes in the ECG – electrocardiogram (prolongation of the QT interval),
and serious allergic reactions with difficulty swallowing or breathing, swelling of the face, lips,
tongue or throat, or hives.
Bone loss may occur in men treated for prostate cancer. ZYTIGA in
combination with prednisone or prednisolone may increase bone loss.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 ZYTIGA

• 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 packaging, on the cardboard box and on the blister. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine in water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZYTIGA contains

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other excipients are microcrystalline cellulose (silicified); sodium croscarmellose; hypromellose 2910 (15 mPa.S); lactose monohydrate; magnesium stearate; anhydrous colloidal silica and sodium lauryl sulfate (see section 2 “ZYTIGA contains lactose and sodium”). The coating contains black iron oxide (E172); red iron oxide (E172); macrogol 3350; polyvinyl alcohol; talc and titanium dioxide.

Description of the appearance of ZYTIGA and package contents

• ZYTIGA tablets are film-coated, have an oval shape (20 mm long x 10 mm wide), are purple in color, with “AA” imprinted on one side and “500” on the other side. Each 28-day pack contains 56 film-coated tablets in 4 cardboard cartons, each of which contains 14 film-coated tablets. Each 30-day pack contains 60 film-coated tablets in 5 cardboard cartons, each of which contains 12 film-coated tablets.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen-Cilag SpA
Via C. Janssen
Borgo San Michele
I-04100 Latina, Italy
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel. +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf: +45 45 94 82 82
[email protected]

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137 955 955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.+48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: +353 1 800 709 122

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444

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.