Zejula 100 mg comprimidos recubiertos con pelicula

Prescribing Information for the Patient

Zejula 100 mg Film-Coated Tablets

niraparib

Read this entire prescribing information carefully before starting to take this medicine, as it contains important information for you.

• Keep this prescribing information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.

What is Zejula and how it works

Zejula contains the active ingredient called niraparib. Niraparib is a type of anticancer medication 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 damaged DNA in cancer cells cannot be repaired. This results in the death of tumor cells, which helps control cancer.

What is Zejula used for

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

Zejula is used for cancer that has:

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

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

Consult your doctor, pharmacist or nursebeforestarting to take this medicine orwhileyou are taking this medicine, if any of the following conditions apply to you:

Low blood cell count

Zejula reduces the blood cell count, for example, the number of red blood cells (anemia), the number of white blood cells (neutropenia) or the number of platelets (thrombocytopenia). Among the signs and symptoms that need to be monitored are fever or infection, and abnormal bruising or bleeding (see section 4 for more information). Your doctor will make regular blood tests during your treatment.

MDS/AML syndrome

Rarely, low blood cell count can be a sign of more serious bone marrow problems, such as "MDS" (myelodysplastic syndrome) or "AML" (acute myeloid leukemia). Your doctor may want to analyze 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 measure your blood pressure regularly during your treatment. They may also give you a medicine to treat high blood pressure and, if necessary, adjust your Zejula dose. Your doctor may advise you to monitor your blood pressure at home and instruct you to contact them in case of high blood pressure.

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 old should not receive Zejula. This medicine has not been studied in this age group.

Other medicines and Zejula

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Pregnancy

Zejula should not be taken during pregnancy, as it may harm the baby. If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor before taking this medicine.

If you are a woman who may become pregnant, you must use a highly effective contraceptive method while taking Zejula, and you must continue to use a highly effective contraceptive method for 6 months after taking the last dose. Your doctor will ask you to confirm that you are not pregnant by a pregnancy test before starting treatment. Contact your doctor immediately if you become pregnant while taking Zejula.

Lactation

Zejula should not be taken if you are breastfeeding, as it is not known if it passes into breast milk. If you are breastfeeding, you should stop before starting Zejula treatment, and you should not breastfeed again until 1 month after taking the last dose. Consult your doctor before taking this medicine.

Driving and operating machines

When taking Zejula, you may feel weak, dizzy, tired or nauseous, which may affect your ability to drive and operate machines. Be cautious when driving or operating machines.

Zejula contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended initial 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 initial 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 recurred (relapsed)

The recommended initial 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 approximately at the same time every day. If you take Zejula before bedtime, it may help you cope with nausea.

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

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

Your doctor will see you regularly, and you will continue to take Zejula as normal as long as you benefit and do not experience unacceptable adverse effects.

If you take more Zejula than you should

If you take a higher-than-normal dose, consult 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 missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may 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 need urgent medical treatment:

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

• Cardinal or bleeding for a longer time than usual if you are injured: these may be signs of low platelet count (thrombocytopenia).
• Difficulty breathing, feeling very tired, having pale skin or an elevated heart rate may be signs of low red blood cell count (anemia).
• Fever or infection: low white blood cell count (neutropenia) may increase the risk of infection. Symptoms may include fever, chills, feeling weak or confused, cough, pain or burning sensation while urinating. Some infections may be severe and life-threatening.
• Decreased number of white blood cells in the blood (leucopenia).

Common(may affect up to 1 in 10 people)

• Allergic reaction (including a severe allergic reaction that may put your life at risk). Symptoms include raised, itchy skin rash (urticarial hives) and swelling, sometimes of the face or mouth (angioedema), which may cause difficulty breathing and collapse or loss of consciousness.
• Low blood cell count due to a bone marrow problem or blood cancer originating in the bone marrow, such as myelodysplastic syndrome (SMD) or acute myeloid leukemia (AML).

Uncommon(may affect up to 1 in 100 people)

• Fever with low white blood cell count (neutropenic fever).
• Decreased number of red blood cells, white blood cells, and platelets (pancytopenia).

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

• A sudden increase in blood pressure, which may be a medical emergency that could cause organ damage or put your life at risk.
• A brain condition with symptoms including seizures (convulsions), headache, confusion, and changes in vision (posterior reversible encephalopathy syndrome or PRES), which is a medical emergency that could cause organ damage or put your life at risk.

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

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

• Feeling unwell (nausea)
• Decreased number of white blood cells in the blood
• Decreased number of platelets in the blood
• Decreased number of red blood cells in the blood (anemia)
• Feeling tired
• Feeling weak
• Constipation
• Vomiting
• Abdominal pain
• Difficulty sleeping
• Headache
• Decreased appetite
• Runny nose or nasal congestion
• Diarrhea
• Shortness of breath
• Back pain
• Joint pain
• Hypertension
• Indigestion (dyspepsia)
• Dizziness
• Cough
• Urinary tract infection
• Palpitations (feeling of an irregular heartbeat).

Common(may affect up to 1 in 10 people)

• Sunburn-like 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 lungs, bronchitis
• Abdominal swelling
• Feeling anxious, nervous, or worried
• Feeling sad, depressed
• Nosebleed
• Weight loss
• Muscle pain
• Cognitive impairment (deterioration of concentration, understanding, memory, and thought)
• Redness in the eyes (conjunctivitis)
• Fast heart rate that may cause dizziness, chest pain, or difficulty breathing
• Dry mouth
• Inflammation of the mouth and/or digestive tract
• Rash
• Increased values in blood tests
• Abnormal blood test results
• Unpleasant taste in the mouth.

Uncommon(may affect up to 1 in 100 people)

• Confusion
• Inflammation of the lungs that may cause shortness of breath and difficulty breathing (non-infectious pneumonitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report them directly through the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD and the blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect the tablets from water absorption in high humidity conditions.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Zejula

• The active ingredient is niraparib. Each film-coated tablet contains tosilate of niraparib 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 colloidal silica.

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

This medicine contains lactose. For more information, see section 2.

Appearance of Zejula and contents of the package

Zejula 100 mg film-coated tablets are grey film-coated, oval-shaped 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 cartons of:

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

Only some package sizes may be marketed.

Marketing Authorization Holder

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Responsible for manufacturing

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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.