ZEJULA 100 MG FILM-COATED TABLETS

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 you start taking this medicine or while you are taking it, if any of the following apply to you:

Low blood cell count

Zejula reduces the number of blood cells, such as red blood cells (anemia), white blood cells (neutropenia), or platelets (thrombocytopenia). Signs and symptoms to look out for include fever or infection, and bruising or bleeding more easily than normal (see section 4 for more information). Your doctor will do regular blood tests while you are taking this medicine.

Myelodysplastic syndrome/acute myeloid leukaemia

Rarely, a low blood cell count can 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 do a bone marrow test to check for these problems.

High blood pressure

Zejula can cause an increase in blood pressure, which can be severe in some cases. Your doctor will check your blood pressure regularly while you are taking this medicine. They may also give you a medicine to treat high blood pressure and, if necessary, adjust your dose of Zejula. Your doctor may advise you to check your blood pressure at home and tell you what to do if your blood pressure goes up.

Posterior reversible encephalopathy syndrome (PRES)

A rare neurological side effect called PRES has been reported with Zejula. If you have a headache, changes in vision, confusion, or seizures with or without high blood pressure, contact your doctor.

Children and adolescents

Children under 18 years should not take Zejula. 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.

Zejula may affect how other medicines work. It is especially important to mention any medicine that contains the active substance metformin (used to lower blood sugar levels), as your doctor may need to adjust your metformin dose.

Pregnancy

Do not take Zejula if you are pregnant, as it may harm your baby. If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before taking this medicine.

If you are a woman who could become pregnant, you must use a highly effective method of birth control while taking Zejula and for 6 months after your last dose. Your doctor will ask you to confirm you are not pregnant with a pregnancy test before starting treatment. Contact your doctor immediately if you become pregnant while taking Zejula.

Breast-feeding

Do not take Zejula 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 starting to take Zejula and not start breast-feeding again until 1 month after your last dose. Talk to your doctor before taking this medicine.

Driving and using machines

While taking Zejula, you may feel weak, dizzy, tired, or nauseous, and this may affect your ability to drive or 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 sugars, talk to them before taking this medicine.

3. How to take Zejula

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, talk to your doctor or pharmacist again.

For ovarian cancer that has responded to first-line 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 a 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 about the same time every day. If you take Zejula at bedtime, it may help with nausea.

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

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

Your doctor will see you regularly, and you will keep taking Zejula as long as you are benefiting from it and not having unacceptable side effects.

If you take more Zejula than you should

If you take a higher dose than normal, talk to your doctor immediately.

If you forget to take Zejula

Do not take another dose if you forget a dose or vomit after taking Zejula. Take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you have any other 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 for a longer time than usual if you are injured: these can be signs of a low platelet count (thrombocytopenia).
• Feeling short of breath, feeling very tired, having pale skin, or a fast heart rate can be signs of a low red blood cell count (anaemia).
• Fever or infection: a low white blood cell count (neutropenia) can increase the risk of infection. Signs can include fever, chills, feeling weak or confused, cough, pain or burning when urinating. Some infections can be serious and life-threatening.
• Low white blood cell count (leucopenia).

Common(may affect up to 1 in 10 people)

• Allergic reaction (including a severe allergic reaction that can be life-threatening). Signs include a raised, itchy rash (hives) and swelling, sometimes of the face or mouth (angioedema), which can cause difficulty breathing and collapse or loss of consciousness.
• Low blood cell count due to a problem with the bone marrow or blood cancer, such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).

Uncommon(may affect up to 1 in 100 people)

• Fever with a low white blood cell count (febrile neutropenia).
• Low red blood cell, white blood cell, and platelet count (pancytopenia).

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

• A sudden increase in blood pressure, which can be a medical emergency that can cause organ damage or 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 can cause organ damage or be life-threatening.

Talk to your doctor if you have any other side effects. These may include:

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

• Feeling sick (nausea)
• Low white blood cell count
• Low platelet count
• Low red blood cell count (anaemia)
• Feeling tired
• Feeling weak
• Constipation
• Vomiting
• Stomach pain
• Difficulty sleeping
• Headache
• Loss of appetite
• Runny or stuffy nose
• Diarrhoea
• Shortness of breath
• Back pain
• Joint pain
• High blood pressure
• Indigestion (dyspepsia)
• Dizziness
• Cough
• Urinary tract infection
• Pounding or racing heartbeat (palpitations).

Common(may affect up to 1 in 10 people)

• Sunburn-type reaction after exposure to light
• Swelling of the feet, ankles, legs, and/or hands
• Low potassium levels in the blood
• Inflammation or swelling of the airways between the mouth and nose and the lungs, bronchitis
• Feeling bloated
• Feeling anxious, nervous, or uneasy
• Feeling sad, depressed
• Nosebleeds
• Weight loss
• Muscle pain
• Decline in concentration, understanding, memory, and thinking (cognitive impairment)
• Pink eye (conjunctivitis)
• Fast heartbeat that can cause dizziness, chest pain, or difficulty breathing
• Dry mouth
• Inflammation of the mouth and/or digestive tract
• Rash
• Increased blood test results
• Abnormal blood test results
• Unusual taste in the mouth.

Uncommon(may affect up to 1 in 100 people)

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

Reporting of side effects

If you experience 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. Storage of 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 after EXP and on the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Keep the blister in the outer carton to protect the tablets from moisture in high humidity conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Zejula Composition

• The active ingredient is niraparib. Each film-coated tablet contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib.

• The other components (excipients) are:

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

Appearance of Zejula and Package Contents

Zejula 100 mg film-coated tablets are gray, oval, film-coated tablets marked with "100" on one side and "Zejula" on the other.

The film-coated tablets are packaged in blisters or child-resistant blisters, in packs of:

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

Only some pack sizes may be marketed.

Marketing Authorization 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, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.