ZEJULA 100 mg Kapsułka Twarda

Treść ulotki

1. Zejula 100 mg hard capsules
   1. What is Zejula and what is it used for
   2. What you need to know before you take Zejula
   3. How to take Zejula
   4. Possible side effects
   5. How to store Zejula
   6. Contents of the pack and other information
2. Zejula 100 mg film-coated tablets
   1. What is Zejula and what is it used for
   2. What you need to know before taking Zejula
   3. How to take Zejula
   4. Possible side effects
   5. How to store Zejula
   6. Contents of the pack and other information

Zejula 100 mg hard capsules

niraparib

Read this leaflet carefully before you start to take 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, pharmacist or nurse.
• 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Zejula and what is it used for

What is Zejula and how does it work
Zejula contains the active substance niraparib. Niraparib is a type of anticancer medicine called a
PARP inhibitor, an enzyme called [adenosine diphosphate-ribose] polymerase. PARP helps cells
repair damaged DNA, so its inhibition by Zejula prevents the repair of
tumor cell DNA. This leads to the death of tumor cells and helps to keep the tumor
under control.

What is Zejula used for
Zejula is used in adult women for the treatment of ovarian cancer, fallopian tube cancer (part of the female reproductive system that connects the ovaries to the uterus) or peritoneal cancer (the
membrane that lines the abdomen).
Zejula is used for cancer that:

• has responded to first-line platinum-based chemotherapy, or
• has recurred (relapsed) after the cancer has responded to a previous treatment with standard platinum-based chemotherapy.

2. What you need to know before you take Zejula

Do not take Zejula

• if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking or while taking this
medicine in the following cases:
Low blood cell levels
Zejula reduces the levels of blood cells, such as red blood cells (anemia), white blood
cells (neutropenia) or platelets (thrombocytopenia). The signs and symptoms to watch out for are fever
or infection and an unusual tendency to bruise or bleed (for more
information see section 4). Your doctor will regularly perform blood tests during
the entire treatment.
Myelodysplastic syndrome/acute myeloid leukemia
In rare cases, low blood cell levels may be a sign of more serious problems affecting the bone marrow, such as ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid
leukemia’ (AML). Your doctor may request a bone marrow examination to detect the possible
presence of these problems.
High blood pressure
Zejula may cause an increase in blood pressure, which in some cases may be severe. Your
doctor will regularly check your blood pressure during the entire treatment. They may also
give you medicine to treat high blood pressure and correct the dose of Zejula, if
necessary. Your doctor may recommend that you check your blood pressure at home and give you
instructions on when to contact them if your blood pressure increases.
Reversible posterior encephalopathy syndrome (PRES)
A rare neurological side effect, called PRES, has been associated with treatment with Zejula.
Talk to your doctor if you experience headache, vision changes, confusion or seizures, with or
without high blood pressure.

Children and adolescents
Zejula should not be given to children under 18 years of age. This medicine has not been studied in
this age group.

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

Pregnancy
Do not take Zejula during pregnancy as it may harm the baby. If you are
pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before starting to take this medicine.
If you are a woman who could become pregnant, you must use a highly
effective method of contraception while taking Zejula and must continue to use it for 6 months after having taken the last dose.
Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting
treatment. If you become pregnant during treatment with Zejula, contact your
doctor immediately.

Breastfeeding
Do not take Zejula if you are breastfeeding as it is not known whether Zejula passes into breast milk. If you are
breastfeeding, you must stop before starting to take Zejula and must not restart breastfeeding
until 1 month after having taken the last dose. Ask your doctor for advice before taking this
medicine.

Driving and using machines
When you take Zejula you may experience weakness, difficulty concentrating, fatigue or
dizziness and this may affect your ability to drive and use machines. Be careful
when driving or using machines.

Zejula contains lactose
If your doctor has told you that you have an intolerance to some types of sugars, contact them before
taking this medicine.

Zejula contains tartrazine (E 102)
May cause allergic reactions.

3. How to take Zejula

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

For ovarian cancer that has responded to first-line platinum-based chemotherapy
The recommended initial dose is 200 mg (two 100 mg capsules), to be taken together once a
day, with or without food. If you have a weight ≥ 77 kg and a platelet count ≥ 150,000/μL before starting
treatment, the recommended initial dose is 300 mg (three 100 mg capsules), to be taken together
once a day, with or without food.

For recurrent ovarian cancer
The recommended initial dose is 300 mg (three 100 mg capsules) to be taken together once a
day, with or without food.
Take Zejula at approximately the same time each day. Taking Zejula at bedtime may
help manage nausea.
Your doctor may adjust the initial dose if you have liver problems.
Swallow the capsules whole with a little water. Do not chew or crush them. This will ensure that the
medicine works in the best possible way.
Your doctor may recommend a lower dose if you experience side effects (such as nausea,
fatigue, unusual bleeding/bruising, anemia).
Your doctor will check you periodically and you will usually continue to take Zejula as long as you
benefit from it and do not experience unacceptable side effects.

If you take more Zejula than you should
If you take more than the normal dose, contact your doctor immediately.

If you forget to take Zejula
Do not take an extra dose if you forget a dose or if you vomit after taking Zejula. Take the
next dose at the scheduled time. Do not take a double dose to make up for a missed
dose.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek immediate medical attention if you notice any of the following GRAVE side effects; you may urgently need medical treatment:
Very common(may affect more than 1 in 10 people)

• Bruising or bleeding that lasts longer than usual after an injury; these may be signs of a

low number of platelets (thrombocytopenia).

• Shortness of breath, profound fatigue, pale skin, or a rapid heartbeat; these may be signs of a low number of red blood cells (anemia).
• Fever or infection; a low number of white blood cells (neutropenia) can increase the risk of infection. Symptoms may include fever, chills, feeling weak or confused, coughing, pain or burning when urinating. Some infections can be serious and life-threatening.
• Reduction in the number of white blood cells in the blood (leukopenia)

Common(may affect up to 1 in 10 people)

• Allergic reaction (including a severe allergic reaction that can be life-threatening). Symptoms include a raised, itchy rash (urticaria) and swelling - sometimes of the face or mouth (angioedema), which causes difficulty breathing and collapse or loss of consciousness
• Low number of blood cells due to a problem in the bone marrow or a blood cancer starting in the bone marrow “myelodysplastic syndrome” (MDS) or “acute myeloid leukemia” (AML).

Uncommon(may affect up to 1 in 100 people)

• fever with a low number of white blood cells (febrile neutropenia)
• reduction in the number of white blood cells, red blood cells, and platelets (pancytopenia)

Rare(may affect up to 1 in 1000 people)

• a sudden increase in blood pressure, which can be a medical emergency that could damage organs or be life-threatening
• a neurological condition with symptoms including seizures, headache, confusion, and changes in vision (reversible posterior encephalopathy syndrome or PRES), which is a medical emergency that could damage organs or be life-threatening.

If any other side effects occur, tell your doctor. Among others:

Very common(may affect more than 1 in 10 people)

• nausea
• decrease in the number of white blood cells in the blood
• decrease in the number of platelets in the blood
• decrease in the number of red blood cells in the blood (anemia)
• feeling tired
• feeling weak
• constipation
• vomiting
• stomach pain
• inability to sleep
• headache
• decreased appetite
• runny or blocked nose
• diarrhea
• shortness of breath
• back pain
• joint pain
• high blood pressure
• indigestion (dyspepsia)
• dizziness
• cough
• urinary tract infection
• palpitations (feeling that the heart is beating irregularly or faster than usual)

Common(may affect up to 1 in 10 people)

• sunburn-like reactions after exposure to light
• swelling of the feet, ankles, legs and/or hands
• low levels of potassium in the blood
• inflammation or swelling of the airways between the mouth and nose and the lungs, bronchitis
• abdominal bloating
• worry, nervousness or restlessness
• feeling sad, depression
• nosebleeds
• weight loss
• muscle pain
• problems with concentration, understanding, memory and thinking (cognitive impairment)
• red eyes
• fast heartbeat that can cause dizziness, chest pain or shortness of breath
• dry mouth
• inflammation of the mouth and/or digestive tract
• rash
• blood tests with elevated values
• altered blood tests
• altered sense of taste

Uncommon(may affect up to 1 in 100 people)

• confused state
• inflammation of the lungs that can cause shortness of breath and difficulty breathing (non-infectious pneumonia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Zejula

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 package and on the blister after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zejula contains

• The active ingredient is niraparib. Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib.
• The other ingredients (excipients) are: capsule content: magnesium stearate, lactose monohydrate capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102)

ink for printing: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), sodium hydroxide (E 524), povidone (E 1201) and titanium dioxide (E 171).
This medicine contains lactose and tartrazine; for more information, see section 2.

Description of the appearance of Zejula and contents of the pack
The hard capsules of Zejula consist of an opaque white body and an opaque purple cap.
‘100 mg’ is imprinted on the opaque white body of the capsule with black ink and ‘Niraparib’ is imprinted on the purple
cap of the capsule with white ink. The capsules contain a white or off-white powder.
The hard capsules are packaged in blister packs of

• 84 × 1 hard capsules
• 56 × 1 hard capsules
• 28 × 1 hard capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer
GlaxoSmithKline Trading Services Ltd.
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

Lietuva
GlaxoSmithKline (Ireland) Limited
Tel: + 370 80000334

България
GlaxoSmithKline (Ireland) Limited
Тел.: + 359 80018205

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
GlaxoSmithKline (Ireland) Limited
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline (Malta) (Ireland) Limited
Tel: + 356 80065004

DeutschlandNederland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
[email protected]
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
GlaxoSmithKline (Ireland) Limited
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44
[email protected]

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

Hrvatska
GlaxoSmithKline (Ireland) Limited
Tel: +385 800787089

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

România
GlaxoSmithKline (Ireland) Limited
Tel: + 40 800672524

Slovenija
GlaxoSmithKline (Ireland) Limited
Tel: + 386 80688869

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
GlaxoSmithKline (Ireland) Limited
Tel: + 421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline (Ireland) Limited
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline (Ireland) Limited
Tel: + 371 80205045

United Kingdom (Northern Ireland)
GlaxoSmithKline (Ireland) Limited
Tel: + 44 (0)800 221441
[email protected]

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 .

Zejula 100 mg film-coated tablets

niraparib

Read this leaflet carefully before you start to take 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Zejula and what is it used for

What is Zejula and how does it work
Zejula contains the active substance niraparib. Niraparib is a type of anticancer medicine called a
PARP inhibitor, an enzyme called [adenosine diphosphate-ribose] polymerase. PARP helps cells
repair damaged DNA, so inhibiting it by Zejula prevents the repair of
tumor cell DNA. This leads to the death of tumor cells and helps to keep the tumor
under control.

What is Zejula used for
Zejula is used in adult women for the treatment of ovarian cancer, fallopian tube cancer (part of the female reproductive system that connects the ovaries to the uterus) or peritoneal cancer (the
membrane that lines the abdomen).
Zejula is used for cancer that:

• responded to the first treatment with platinum-based chemotherapy, or
• has come back (recurred) after the cancer responded to a previous treatment with standard platinum-based chemotherapy.

2. What you need to know before taking Zejula

Do not take Zejula

• if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking or while taking this
medicine in the following cases:
Low blood cell levels
Zejula reduces the levels of blood cells, such as red blood cells (anemia), white blood cells
(neutropenia) or platelets (thrombocytopenia). The signs and symptoms to watch out for are fever
or infection and an abnormal tendency to bruise or bleed (for more
information see section 4). Your doctor will regularly perform blood tests during
the entire treatment.
Myelodysplastic syndrome/acute myeloid leukemia
In rare cases, low blood cell levels may be a sign of more serious problems affecting the bone marrow, such as ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukemia’ (AML). Your doctor may request a bone marrow examination to detect the possible
presence of these problems.
High blood pressure
Zejula can cause an increase in blood pressure, which in some cases may be severe. Your
doctor will regularly check your blood pressure during the entire treatment. They may also
give you a medicine to treat high blood pressure and correct the dose of Zejula, if
necessary. Your doctor may recommend that you check your blood pressure at home and give you
instructions on when to contact them if your blood pressure increases.
Reversible posterior encephalopathy syndrome (PRES)
A rare neurological side effect, called PRES, has been associated with treatment with Zejula.
Talk to your doctor if you experience headache, changes in vision, confusion or seizures, with or
without high blood pressure.

Children and adolescents
Zejula should not be given to children under 18 years of age. This medicine has not been studied in
this age group.

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

Pregnancy
Do not take Zejula during pregnancy as it may harm the baby. If you are
pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before starting to take this medicine.
If you are a woman who could become pregnant, you must use a highly
effective method of contraception while taking Zejula and must continue to use it for 6 months after having taken the last dose.
Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting
treatment. If you become pregnant during treatment with Zejula, contact your
doctor immediately.

Breastfeeding
Do not take Zejula if you are breastfeeding as it is not known whether Zejula passes into breast milk. If you are
breastfeeding, you must stop before starting to take Zejula and must not restart breastfeeding
until 1 month after having taken the last dose. Ask your doctor for advice before taking this
medicine.

Driving and using machines
When taking Zejula you may experience weakness, difficulty concentrating, fatigue or
dizziness, and this may affect your ability to drive and use machines. Be careful
when driving or using machines.

Zejula contains lactose
If your doctor has told you that you have an intolerance to some types of sugar, contact them before
taking this medicine.

3. How to take Zejula

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

For ovarian cancer that has responded to first-line platinum-based chemotherapy
The recommended initial dose is 200 mg, which is two 100 mg tablets taken together once
daily, away from meals (at least 1 hour before or 2 hours after a meal) or with a light meal. If you have a weight ≥ 77 kg and a platelet count ≥ 150,000/μL before starting treatment, the
recommended initial dose is 300 mg, which is three 100 mg tablets taken together once
daily, away from meals (at least 1 hour before or 2 hours after a meal) or with a light meal.

For recurrent ovarian cancer
The recommended initial dose is 300 mg, which is three 100 mg tablets taken together once
daily, away from meals (at least 1 hour before or 2 hours after a meal) or with a light meal.
Take Zejula at approximately the same time each day. Taking Zejula at bedtime may
help manage nausea.
Your doctor may adjust the initial dose if you have liver problems.
Your doctor may recommend a lower dose if side effects occur (such as nausea,
fatigue, abnormal bleeding/bruising, anemia).
Your doctor will check you periodically and you will usually continue to take Zejula as long as
you benefit from it and do not experience unacceptable side effects.

If you take more Zejula than you should
If you take more than the normal dose, contact your doctor immediately.

If you forget to take Zejula
Do not take an extra dose if you forget a dose or if you vomit after taking Zejula. Take the
next dose at the scheduled time. Do not take a double dose to make up for a missed
dose.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Seek immediate medical attention if you notice any of the following serious side effects; you may urgently need medical treatment:
Very common(may affect more than 1 in 10 people)

• Bruising or bleeding that lasts longer than usual after an injury; these may be signs of a low number of platelets (thrombocytopenia).
• Shortness of breath, feeling very tired, pale skin, or a fast heartbeat; these may be signs of a low number of red blood cells (anemia).
• Fever or infection; a low number of white blood cells (neutropenia) can increase the risk of infection. Symptoms may include fever, chills, feeling weak or confused,

cough, pain or burning when urinating. Some infections can be serious and life-threatening.

• Reduction in the number of white blood cells in the blood (leukopenia)

Common(may affect up to 1 in 10 people)

• Allergic reaction (including severe allergic reaction that can be life-threatening). Symptoms include a raised, itchy rash (urticaria) and swelling - sometimes of the face or mouth (angioedema), causing difficulty breathing and collapse or loss of consciousness
• Low number of blood cells due to a problem in the bone marrow or a blood cancer starting in the bone marrow “myelodysplastic syndrome” (MDS) or “acute myeloid leukemia” (AML).

Uncommon(may affect up to 1 in 100 people)

• fever with a low number of white blood cells (febrile neutropenia)
• reduction in the number of white blood cells, red blood cells and platelets (pancytopenia)

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

• a sudden increase in blood pressure, which can be a medical emergency that could damage organs or be life-threatening
• a neurological condition with symptoms including seizures, headache, confusion and changes in vision (reversible posterior encephalopathy syndrome or PRES), which is a medical emergency that could damage organs or be life-threatening.

If any other side effects occur, tell your doctor. These include:

Very common(may affect more than 1 in 10 people)

• nausea
• decrease in the number of white blood cells in the blood
• decrease in the number of platelets in the blood
• decrease in the number of red blood cells in the blood (anemia)
• feeling tired
• feeling weak
• constipation
• vomiting
• stomach pain
• difficulty sleeping
• headache
• reduced appetite
• runny or blocked nose
• diarrhea
• shortness of breath
• back pain
• joint pain
• high blood pressure
• indigestion (dyspepsia)
• dizziness
• cough
• urinary tract infection
• palpitations (feeling that the heart is beating irregularly or faster than usual)

Common(may affect up to 1 in 10 people)

• sunburn-like reactions after exposure to light
• swelling of the feet, ankles, legs and/or hands
• low levels of potassium in the blood
• inflammation or swelling of the airways between the mouth and nose and the lungs, bronchitis
• abdominal bloating
• worry, nervousness or restlessness
• feeling sad, depressed
• nosebleeds
• weight loss
• muscle pain
• problems with concentration, understanding, memory and thinking (cognitive impairment)
• red eyes
• fast heartbeat that can cause dizziness, chest pain or shortness of breath
• dry mouth
• inflammation of the mouth and/or digestive tract
• rash
• blood tests with high values
• altered blood tests
• altered taste sensation

Uncommon(may affect up to 1 in 100 people)

• confused state
• inflammation of the lungs that can cause shortness of breath and difficulty breathing (non-infectious pneumonia)

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 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 Zejula

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 box and on the blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the tablets from absorbing water in
conditions of high humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zejula contains

• The active ingredient is niraparib. Each film-coated tablet contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib.
• The other ingredients (excipients) are:

Tablet core: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose (E 460), povidone (E1201), hydrated colloidal silica
Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol (E
1521), talc (E 553b), black iron oxide (E 172).
This medicine contains lactose; for further information, see section 2.

Description of Zejula and contents of the pack
The 100 mg film-coated tablets of Zejula are grey in colour, oval in shape, imprinted
with “100” on one side and “Zejula” on the other.
The film-coated tablets are packaged in blisters or child-resistant blisters containing

• 84 film-coated tablets
• 56 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer
GlaxoSmithKline Trading Services Ltd.
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Millmount Healthcare Ltd.
Block 7, City North Business Campus,
Stamullen, Co Meath
Ireland
Glaxo Wellcome, S.A.
Avda. Extremadura, 3
09400 Aranda de Duero
Burgos
Spain
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

Lietuva
GlaxoSmithKline (Ireland) Limited
Tel: + 370 80000334

България
GlaxoSmithKline (Ireland) Limited
Тел.: + 359 80018205

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
GlaxoSmithKline (Ireland) Limited
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline (Malta) (Ireland) Limited
Tel: + 356 80065004

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
GlaxoSmithKline (Ireland) Limited
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44
[email protected]

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

Hrvatska
GlaxoSmithKline (Ireland) Limited
Tel: +385 800787089

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

România
GlaxoSmithKline (Ireland) Limited
Tel: + 40 800672524

Slovenija
GlaxoSmithKline (Ireland) Limited
Tel: + 386 80688869

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
GlaxoSmithKline (Ireland) Limited
Tel: + 421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline (Ireland) Limited
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline (Ireland) Limited
Tel: + 371 80205045

United Kingdom (Northern Ireland)
GlaxoSmithKline (Ireland) Limited
Tel: + 44 (0)800 221441
[email protected]

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 .