InfoCons Consumer Protection informs you – Zejula – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse .
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 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. PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired. This results in tumour cell death, helping to control the cancer.

What Zejula is used for

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

Zejula is used for cancer that has :

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before or while taking this medicine if any of the following could apply to you:

Low blood- cell counts Zejula lowers your blood- cell counts, such as your red blood- cell count (anaemia), white blood -cell 65 count (neutropenia), or blood- platelet count (thrombocytopenia). Signs and symptoms you need to look out for include fever or infection, and abnormal bruising or bleeding (see section 4 for more information). Your doctor will test your blood regularly throughout your treatment.

Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood- cell counts may be a sign of more serious problems with the bone marrow such as ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukaemia’ (AML). Your doctor may want to test your bone marrow to check for these problems.

High blood pressure Zejula can cause high blood pressure, which in some cases, could be severe. Your doctor will measure your blood pressure regularly throughout your treatment. He or she may also give you medicine to treat high blood pressure and adjust your Zejula dose, if necessary. Your doctor may advise home blood pressure monitoring and instruction on when to contact him or her in case of a rise in blood pressure.

Posterior reversible e ncephalopathy syndrome (PRES) A rare neurological side effect named PRES has been associated with Zejula treatment. If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.

Children and adolescents

Children and adolescents under 18 years of age should not be given Zejula. The safety and efficacy of Zejula have not been established 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.

Zejula can affect how other medicines work. It is particularly important that you mention any medicines containing the active substance, metformin (used to lower blood sugar), as your doctor may need to adjust the dose of metformin .

Pregnancy

Zejula should not be taken during pregnancy as it could harm your baby. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are a woman who could become pregnant you must use highly effective contraception while you are taking Zejula, and you must continue to use highly effective contraception for 6 month s after taking your last dose. Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting your treatment. Contact your doctor straightaway if you become pregnant while you are taking Zejula.

Breast -feeding Zejula should not be taken if you are breast -feeding as it is not known if it passes into breast milk. If you are breast -feeding, you must stop before you start taking Zejula and you must not begin breast -feeding again until 1 month after taking your last dose. Ask your doctor for advice before taking this medicine.

Driving and using machines

When you are taking Zejula it may make you feel weak, unfocused, tired or dizzy and therefore influence your ability to drive and use machines. Observe caution when driving or using machines.

66 Zejula contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

💊 3. How to take Zejula

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For ovarian cancer that has responded to the first treatment with platinum -based chemotherapy The recommended starting dose is 200 mg (two 100 mg tablets), taken together once a day, without food (at least 1 hour before or 2 hours after a meal) or with a light meal . If you weigh ≥ 77 kg and have platelet count ≥ 150,000/μL before starting treatment, the recommended starting dose is 300 mg (three 100 mg tablets), taken together once a day without food (at least 1 hour before or 2 hours after a meal) or with a light meal .

For ovarian cancer that has come back (recurred) The recommended starting dose is 300 mg (three 100 mg tablets), taken together once a day without food (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 you to manage nausea.

Your doctor may adjust your starting dose if you have problems with your liver.

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

Your doctor will check you on a regular basis, and you will normally continue to take Zejula as long as you experience benefit, and do not suffer unacceptable side effects.

If you take more Zejula than you should

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

If you forget to take Zejula

Do not take an additional dose if you miss a dose or vomit after taking Zejula. Take your next dose at its scheduled time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on 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.

Tell your doctor straight away 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 for longer than usual if you hurt yourself — these may be signs of a low blood platelet count (thrombocytopenia).
• Being short of breath, feeling very tired, having pale skin, or fast heartbeat — these may be signs of a low red blood cell count (anaemia).
• Fever or infection – low white blood cell count (neutropenia) can increase your risk for infection. Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine. Some infections can be serious and may lead to death.

67 • Reduction in the number of white 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). Signs include raised and itchy rash (hives) and swelling —sometimes of the face or mouth (angioedema), causing difficulty in breathing, and collapse or loss of consciousnes s.
• Low blood cell counts due to a problem in the bone marrow or blood cancer starting from the bone marrow ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukaemia’ (AML).

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

• A sudden increase in blood pressure, which may be a medical emergency that could lead to organ damage or can be life-threatening.
• A brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES), which is a medical emergency that could lead to organ damage or can be life-threatening.

Talk to your doctor if you get any other side effects. These can include:

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

• Feeling sick (nausea)
• Decreased number of white cells in the blood
• Decreased number of platelets in the blood
• Decreased number of red cells in the blood (anaemia)
• Feeling tired
• Feeling of weakness
• Constipation
• Vomiting
• Stomach pain
• Inability to sleep
• Headache
• Decreased appetite
• Runny or stuffy nose
• Diarrhoea
• Shortness of breath
• Back pain
• Joint pain
• High blood pressure
• Indigestion (dyspepsia)
• Dizziness
• Cough
• Urinary tract infection
• Palpitations (feeling like your heart is skipping beats or beating harder than usual)

Common (may affect up to 1 in 10 people)

• Sunburn-like reactions following exposure to light
• Swelling in the feet, ankles, legs, and/or hands
• Low potassium levels in the blood
• Inflammation or swelling of the air passages between the mouth and nose and the lungs, bronchitis
• Abdominal bloating
• Feeling of worry, nervousness, or unease 68 • Feelings of sadness, depressed
• Nose bleed
• Decrease in weight
• Muscle pain
• Impaired concentration, understanding, memory and thinking (cognitive impairment)
• Pink eye
• Fast heart beat may cause dizziness, chest pain or breathlessness
• Dry mouth
• Inflammation of the mouth and/or digestive tract
• Rash
• Elevated blood tests
• Abnormal blood tests
• Abnormal taste in mouth

Uncommon (may affect up to 1 in 100 people)

• Confusional state
• Inflammation of the lungs which can cause shortness of breath and difficulty breathing (non- infectious pneumonitis)

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 via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 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 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 package to protect the tablets from absorption of water under high humidity conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Zejula contains

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

Tablet core: crospovidone , lactose monohydrate, magnesium stearate, microcrystalline cellulose (E 460), povidone (E 1201), colloidal hydrated silica.

Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), black iron oxide (E 172).

69 This medicine contains lactose – see section 2 for more information.

What Zejula looks like and contents of the pack

Zejula 100 mg film -coated tablets are grey, oval-shaped, film-coated tablet debossed with “100” on one side and “Zejula” on the other. The film -coated tablets are packed in blister packs or child- resistant blister packs of

• 84 film -coated tablets
• 56 film -coated tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin 24 Ireland D24 YK11

Manufacturer

GlaxoSmithKline Trading Services L imited 12 Riverwalk Citywest Business Campus Dublin 24 Ireland D24 YK11 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0) 10 85 52 00 Lietuva GlaxoSmithKline Trading Services Limited Tel: + 370 80000334 България GlaxoSmithKline Trading Services Limited Teл.: + 359 80018205 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 Trading Services Limited Tel.: + 36 80088309 Danmark GlaxoSmithKline Pharma A/S Tlf.: + 45 36 35 91 00 [email protected] Malta GlaxoSmithKline Trading Services 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 Trading Services 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 Trading Services Limited Tel: +385 800787089 Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 România GlaxoSmithKline Trading Services Limited Tel: + 40 800672524 Slovenija GlaxoSmithKline Trading Services Limited Tel: + 386 80688869 Ísland Vistor e hf.

Sími: + 354 535 7000 Slovenská republika GlaxoSmithKline Trading Services 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 Trading Services Limited Τηλ: + 357 80070017 Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 [email protected] Latvija GlaxoSmithKline Trading Services Limited Tel: + 371 80205045 71 This leaflet was last revised in MM/YYYY .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Zejula (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1235).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.