Zejula

Package leaflet: Information for the patient

Zejula 100 mg hard capsules

niraparib
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 Zejula is and what it is used for

What Zejula is and how it works
Zejula contains the active substance niraparib. Niraparib is a type of anticancer medicine called a PARP inhibitor—an enzyme known as [adenosine diphosphate-ribose] polymerase. PARP helps cells repair damaged DNA, so by inhibiting PARP, Zejula prevents tumor cells from repairing their DNA. This leads to the death of tumor cells and helps control the cancer.

What Zejula is used for
Zejula is used in adult women for the treatment of cancer of the ovary, fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or peritoneum (the membrane lining the abdominal cavity).

Zejula is used for cancers that:

• have responded to initial platinum-based chemotherapy, or
• have recurred after the cancer previously responded to standard platinum-based chemotherapy.

2. What you should know before taking Zejula

Do not take Zejula

• if you are allergic to niraparib or to 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 counts
Zejula reduces levels of blood cells, such as red blood cells (anaemia), white blood cells (neutropenia),
or platelets (thrombocytopenia). Signs and symptoms to monitor include fever or infection and unusual
bruising or bleeding (for more information see section 4). Your doctor will perform regular blood tests
throughout your treatment.
Myelodysplastic syndrome/acute myeloid leukaemia
In rare cases, low blood cell counts may be a sign of more serious bone marrow problems, such as
‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukaemia’ (AML). Your doctor may perform a
bone marrow examination to check for these conditions.
High blood pressure
Zejula may cause increased blood pressure, which in some cases could be severe. Your doctor will
monitor your blood pressure regularly during treatment. They may also prescribe medication to treat high
blood pressure and adjust your Zejula dose if necessary. Your doctor may recommend that you monitor
your blood pressure at home and will advise you when to contact them if your blood pressure rises.
Reversible posterior encephalopathy syndrome (PRES)
A rare neurological side effect called PRES has been reported with Zejula treatment. Contact your doctor
if you experience headache, vision changes, confusion, or seizures, with or without high blood pressure.
Children and adolescents
Zejula must not be given to individuals under 18 years of age. This medicine has not been studied in this
age group.
Other medicines and Zejula
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Zejula can affect how other medicines work. It is particularly important to inform your doctor about any
medicines containing the active substance metformin (used to lower blood sugar levels), as your doctor may
need to adjust the dose of metformin.
Pregnancy
You must not take Zejula during pregnancy as it may harm the unborn baby. If you are pregnant, suspect you
may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before
starting this medicine.
If you are a woman of childbearing potential, you must use a highly effective method of contraception while
taking Zejula and continue using it for 6 months after taking 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
You must 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 Zejula and must not resume breastfeeding until 1
month after taking the last dose. Consult your doctor before taking this medicine.
Driving and using machines
While taking Zejula, you may experience weakness, difficulty concentrating, fatigue, or dizziness, which
could affect your ability to drive or operate machinery. Exercise caution when driving or using machines.
Zejula contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking
this medicine.
Zejula contains tartrazine (E 102)
It may cause allergic reactions.

3. How to take Zejula

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
For ovarian cancer that has responded to first-line platinum-based chemotherapy
The recommended starting dose is 200 mg (two 100 mg capsules) taken together once daily, with or without food. If you weigh ≥ 77 kg and have a platelet count ≥ 150,000/μL before starting treatment, the recommended starting dose is 300 mg (three 100 mg capsules) taken together once daily, with or without food.
For recurrent ovarian cancer
The recommended starting dose is 300 mg (three 100 mg capsules) taken together once daily, 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 starting dose if you have liver problems.
Swallow the capsules whole with some water. Do not chew or crush them. This will ensure the medicine works as effectively as possible.
Your doctor may recommend a lower dose if you experience side effects (such as nausea, fatigue, unusual bleeding/bruising, anaemia).
Your doctor will monitor you regularly, and you will usually continue taking Zejula for 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 prescribed dose, contact your doctor immediately.
If you forget to take Zejula
Do not take an extra dose if you miss a dose or if you vomit after taking Zejula. Take the next dose at your usual scheduled time. Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of 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.
Contact your doctor immediately 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 injury; may be signs of low platelet count (thrombocytopenia).
• Shortness of breath, feeling extremely tired, pale skin, or rapid heartbeat; may be signs of low red blood cell count (anemia).
• Fever or infection; low white blood cell count (neutropenia) can increase the risk of infection. Signs may include fever, chills, feeling weak or confused, cough, pain or burning sensation when urinating. Some infections may be severe and may result in death.
• Decrease in white blood cells in the blood (leukopenia)

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Fever with low white blood cell count (febrile neutropenia)
• Reduction in white blood cells, red blood cells, and platelets (pancytopenia)

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

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

If you experience any other side effect, contact your doctor. Other side effects include:
Very common (may affect more than 1 in 10 people)

• Nausea
• Decrease in white blood cells in the blood
• Decrease in platelets in the blood
• Decrease in red blood cells in the blood (anemia)
• Feeling tired
• Feeling weak
• Constipation
• Vomiting
• Stomach pain
• Trouble sleeping
• Headache
• Reduced appetite
• Runny or stuffy nose
• Diarrhea
• Shortness of breath
• Back pain
• Joint pain
• High blood pressure
• Indigestion (dyspepsia)
• Dizziness
• Cough
• Urinary tract infection
• Palpitations (awareness of heart beating irregularly or more forcefully than normal)

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 swelling
• Worry, nervousness, or restlessness
• Feeling of sadness, depression
• Nosebleeds
• Weight loss
• Muscle pain
• Problems with concentration, understanding, memory, and thinking (cognitive impairment)
• Red eyes
• Rapid heartbeat that may cause dizziness, chest pain, or shortness of breath
• Dry mouth
• Inflammation of the mouth and/or digestive tract
• Rash
• Blood tests showing elevated values
• Abnormal blood tests
• Altered sense of taste

Uncommon (may affect up to 1 in 100 people)

• Confusional state
• Inflammation of the lungs that may cause shortness of breath and breathing difficulties (non-infectious pneumonia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 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 carton and on the blister after Exp. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater 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 Zejula contains

• The active substance is niraparib. Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib.

• The other components (excipients) are: capsule contents: magnesium stearate, lactose monohydrate; capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102); printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525),
  iron oxide black (E 172), sodium hydroxide (E 524), povidone (E 1201) and titanium dioxide (E 171).
  This medicinal product contains lactose and tartrazine; for further information, see section 2.
  Description of the appearance of Zejula and package contents
  Zejula hard capsules consist of an opaque white body and an opaque violet cap. On the opaque white body of the capsule, '100 mg' is printed in black ink, and on the violet cap of the capsule, 'Niraparib' is printed in white ink. The capsules contain a white or almost white powder.
  The hard capsules are packaged in single-dose blisters of:

• 84 × 1 hard capsule

• 56 × 1 hard capsule

• 28 × 1 hard capsule

Not all pack sizes may be marketed.
Marketing Authorization Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11
Manufacturer
GlaxoSmithKline Trading Services Ltd.
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline Trading Services Limited
Tél/Tel: + 32 (0) 10 85 52 00 Tel: + 370 80000334
България Luxembourg/Luxemburg
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00
Česká republika Magyarország
GlaxoSmithKline, s.r.o. GlaxoSmithKline Trading Services Limited
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]
Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]
Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]
Eesti Norge
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00
Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]
España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]
France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]
Hrvatska România
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel: +385 800787089 Tel: + 40 800672524
Ireland Slovenija
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000 Tel: + 386 80688869
Ísland Slovenská republika
Vistor ehf. GlaxoSmithKline Trading Services Limited
Sími: + 354 535 7000 Tel: + 421 800500589
Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741111 Puh/Tel: + 358 (0)10 30 30 30
Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]
Latvija
GlaxoSmithKline Trading Services Limited
Tel: + 371 80205045
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Patient Information Leaflet

Zejula 100 mg film-coated tablets

niraparib
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Zejula is and what it is used for

What Zejula is and how it works
Zejula contains the active substance niraparib. Niraparib is a type of anti-cancer medicine called a PARP inhibitor—an enzyme known as [poly(adenosine diphosphate-ribose)] polymerase. PARP helps cells repair damaged DNA, so by inhibiting PARP, Zejula prevents the repair of DNA in cancer cells. This leads to the death of cancer cells and helps control the tumor.

What Zejula is used for
Zejula is used in adult women to treat cancer of the ovary, fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or peritoneum (the membrane lining the abdominal cavity).

Zejula is used for cancers that:

• have responded to initial platinum-based chemotherapy, or
• have recurred (come back) after the cancer previously responded to standard platinum-based chemotherapy.

2. What you should know before taking Zejula

Do not take Zejula

• if you are allergic to niraparib or to 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 levels of blood cells
Zejula reduces levels of blood cells, such as red blood cells (anaemia), white blood cells (neutropenia),
or platelets (thrombocytopenia). Signs and symptoms to monitor include fever or infection and unusual
bruising or bleeding tendencies (for more information see section 4). Your doctor will regularly perform
blood tests throughout your treatment.
Myelodysplastic syndrome/acute myeloid leukaemia
In rare cases, low blood cell counts may be a sign of more serious bone marrow problems, such as
‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukaemia’ (AML). Your doctor may request a
bone marrow examination to detect any such conditions.
High blood pressure
Zejula can cause increased blood pressure, which in some cases may be severe. Your doctor will
regularly monitor your blood pressure throughout treatment. They may also prescribe medication to treat
high blood pressure and adjust your Zejula dose if necessary. Your doctor may recommend that you
monitor your blood pressure at home and will advise you when to contact them if your blood pressure rises.
Reversible posterior encephalopathy syndrome (PRES)
A rare neurological side effect called PRES has been associated with treatment with Zejula. Contact your
doctor if you experience headache, vision changes, confusion, or seizures, with or without high blood
pressure.
Children and adolescents
Zejula must not be administered to individuals under 18 years of age. This medicine has not been studied
in this age group.
Other medicines and Zejula
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Zejula can affect how other medicines work. It is particularly important to inform your doctor about any
medicines containing the active substance metformin (used to lower blood sugar levels), as your doctor
may need to adjust the dose of metformin.
Pregnancy
You must not take Zejula during pregnancy because it could harm the unborn baby. If you are pregnant,
suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before
starting this medicine.
If you are a woman of childbearing potential, you must use a highly effective method of contraception while
taking Zejula and continue using it for 6 months after taking the last dose. Your doctor will require a
pregnancy test to confirm you are not pregnant before starting treatment. If you become pregnant during
treatment with Zejula, contact your doctor immediately.
Breastfeeding
You must not take Zejula if you are breastfeeding, as it is unknown whether Zejula passes into breast milk.
If you are breastfeeding, you must stop before starting Zejula and must not resume breastfeeding until 1
month after taking the last dose. Consult your doctor before taking this medicine.
Driving and using machines
When taking Zejula, you may experience weakness, difficulty concentrating, fatigue, or dizziness, which
could affect your ability to drive or operate machinery. Exercise caution when driving or using machines.
Zejula contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Zejula

Take this medicine exactly as directed by 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 starting dose is 200 mg, which corresponds to two 100 mg tablets taken together once daily, taken on an empty stomach (at least 1 hour before or 2 hours after a meal) or with a light meal. If you weigh ≥ 77 kg and have a platelet count ≥ 150,000/μL before starting treatment, the recommended starting dose is 300 mg, which corresponds to three 100 mg tablets taken together once daily, taken on an empty stomach (at least 1 hour before or 2 hours after a meal) or with a light meal.

For recurrent ovarian cancer (relapse)
The recommended starting dose is 300 mg, which corresponds to three 100 mg tablets taken together once daily, taken on an empty stomach (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 starting dose if you have liver problems.

Your doctor may recommend a lower dose if you experience side effects (such as nausea, fatigue, abnormal bleeding/bruising, anemia).

Your doctor will monitor you periodically, and usually you will continue taking Zejula for 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 prescribed dose, contact your doctor immediately.

If you forget to take Zejula
Do not take an extra dose if you miss 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 forgotten dose.

If you have any questions about the use of 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.
Contact your doctor immediately if you notice any of the following serious side effects;
you may need urgent 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 platelet count (thrombocytopenia).
• Shortness of breath, feeling very tired, pale skin, or a fast heartbeat; these may be signs of a low red blood cell count (anemia).
• Fever or infection; a low white blood cell count (neutropenia) can increase the risk of infection. Signs may include fever, chills, feeling weak or confused, cough,
  pain or burning sensation when passing urine. Some infections can be severe and may result in death.
• Decrease in the number of white blood cells in the blood (leukopenia)

Common (may affect up to 1 in 10 people)

• Allergic reaction (including severe, life-threatening allergic reaction). Signs include raised, itchy rash (urticaria), swelling—sometimes of the face or mouth (angioedema)—causing difficulty breathing, collapse, or loss of consciousness.
• Low blood cell count due to a problem in the bone marrow or a blood tumor originating in the bone marrow: “myelodysplastic syndrome” (MDS) or “acute myeloid leukemia” (AML).

Uncommon (may affect up to 1 in 100 people)

• Fever with low white blood cell count (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)

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

If you experience any other side effects, contact your doctor. Other side effects 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
• Inability to sleep
• Headache
• Reduced appetite
• Runny or stuffy nose
• Diarrhea
• Shortness of breath
• Back pain
• Joint pain
• High blood pressure
• Indigestion (dyspepsia)
• Dizziness
• Cough
• Urinary tract infection
• Palpitations (awareness of heartbeats, feeling that the heart is missing beats or beating harder 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 respiratory passages between the mouth and nose and the lungs, bronchitis
• Abdominal swelling
• 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 may cause dizziness, chest pain, or shortness of breath
• Dry mouth
• Inflammation of the mouth and/or digestive tract
• Rash
• Blood tests showing elevated values
• Abnormal blood tests
• Altered taste sensation

Uncommon (may affect up to 1 in 100 people)

• Confusional state
• Inflammation of the lungs which may cause shortness of breath and breathing difficulties (non-infectious pneumonia)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
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 Zejula

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect the tablets from moisture absorption under conditions of high humidity.
Do not dispose of any medicine via wastewater 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 Zejula contains

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

Tablet core: crospovidone, monohydrate lactose, 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 medicinal product contains lactose; for more information, see section 2.
Description of the appearance of Zejula and pack contents
The 100 mg film-coated tablets of Zejula are grey, oval-shaped, and marked with
“100” on one side and “Zejula” on the other.
The film-coated tablets are packed in blisters or in child-resistant blisters containing:

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

Not all pack sizes may be marketed.
Marketing Authorization Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11
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 medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline Trading Services Limited
Tél/Tel: + 32 (0) 10 85 52 00 Tel: + 370 80000334
България Luxembourg/Luxemburg
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00
Česká republika Magyarország
GlaxoSmithKline, s.r.o. GlaxoSmithKline Trading Services Limited
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]
Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]
Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]
Eesti Norge
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00
Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]
España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]
France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]
Hrvatska România
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel: +385 800787089 Tel: + 40 800672524
Ireland Slovenija
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000 Tel: + 386 80688869
Ísland Slovenská republika
Vistor ehf. GlaxoSmithKline Trading Services Limited
Sími: + 354 535 7000 Tel: + 421 800500589
Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741111 Puh/Tel: + 358 (0)10 30 30 30
Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]
Latvija
GlaxoSmithKline Trading Services Limited
Tel: + 371 80205045
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .