ZEJULA 100 mg HARD CAPSULES

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 abnormal bleeding (see section 4 for more information). Your doctor will regularly perform blood tests during your treatment.

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 examine your bone marrow to detect these problems.

High blood pressure

Zejula can cause an increase in blood pressure, which in some cases can be severe. Your doctor will regularly check your blood pressure during your treatment. 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 give you instructions to contact them if your blood pressure increases.

Posterior reversible encephalopathy syndrome (PRES)

A rare neurological side effect called PRES has been associated with Zejula treatment. 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), as your doctor may need to adjust the dose of metformin.

Pregnancy

Do not take Zejula during pregnancy, as it may harm the 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 must continue to use a highly effective method of birth control for 6 months after taking the last dose. Your doctor will ask you to confirm that you are not pregnant through 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 whether it passes into breast milk. If you are breast-feeding, you must stop before starting to take Zejula and must not breast-feed again until 1 month after taking the 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.

Zejula contains tartrazine (E102)

It may cause allergic reactions.

3. How to take Zejula

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

For ovarian cancer that has responded to first-line treatment with platinum-based chemotherapy

The recommended starting dose is 200 mg (two 100 mg capsules) taken together once a day, 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 a day, with or without food.

For ovarian cancer that has come back (recurred)

The recommended starting dose is 300 mg (three 100 mg capsules) taken together once a day, with or without food.

Take Zejula at about the same time every day. If you take Zejula at bedtime, it may help you cope with nausea.

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

Swallow the capsules whole with some water. Do not chew or crush the capsules. This will ensure that the medicine works as well as possible.

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

Your doctor will see you regularly, and you will keep taking Zejula as long as you are benefiting from it and not experiencing 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 the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

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.

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).
• Difficulty breathing, feeling very tired, pale skin, or a fast heart rate can 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 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 originating in the bone marrow, 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 could 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 could cause organ damage or be life-threatening.

Tell your doctor if you experience 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 (anemia)
• 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
• Palpitations (feeling of rapid or irregular heartbeat).

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 of abdominal bloating
• Feeling anxious, nervous, or restless
• Feeling sad, depressed
• Nosebleeds
• Weight loss
• Muscle pain
• Decline in concentration, understanding, memory, and thinking (cognitive impairment)
• Pink eyes (conjunctivitis)
• Fast heart rate 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)

• State of confusion
• 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 CAD and on the blister after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

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. Container contents and additional information

Zejula composition

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

• The other components (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)

Printing ink: 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 medicinal product contains lactose and tartrazine. For more information, see section 2.

Appearance of Zejula and container contents

Zejula hard capsules have a white opaque body and a purple opaque cap. The body of the capsule, white opaque, is printed with "100 mg" in black ink, and the cap of the capsule, purple, is printed with "Niraparib" in white ink. The capsules contain a white to off-white powder.

The hard capsules are packaged in unit dose blister packs of:

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

Only some 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation 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.