RUBRACA 200 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Rubraca 200mg film-coated tablets

Rubraca 250mg film-coated tablets

Rubraca 300mg film-coated tablets

rucaparib

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.

Contents of the pack

1. What is Rubraca and what is it used for
2. What you need to know before you take Rubraca
3. How to take Rubraca
4. Possible side effects
5. Storage of Rubraca
6. Contents of the pack and other information

1. What is Rubraca and what is it used for

What is Rubraca and how does it work

Rubraca contains the active substance rucaparib. Rubraca is a cancer medicine, also known as a “PARP (poly(adenosine diphosphate-ribose) polymerase) inhibitor”.

Patients with changes (mutations) in certain genes called BRCA are at risk of developing several types of cancer. Rubraca blocks an enzyme that repairs damaged DNA in cancer cells, causing them to die.

What is Rubraca used for

Rubraca is used to treat a type of ovarian cancer. It is used as maintenance therapy after treatment with chemotherapy when the tumor has been reduced.

2. What you need to know before you take Rubraca

Do not take Rubraca:

• if you are allergic to rucaparib or any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding

Talk to your doctor, pharmacist, or nurse before taking Rubraca.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Rubraca.

Blood tests

Your doctor or nurse will perform blood tests to check your blood cell counts:

• before treatment with Rubraca
• every month during treatment with Rubraca

This is because Rubraca can cause low blood cell counts:

• red blood cells, white blood cells, or platelets. See section 4 for more information. Signs and symptoms of low blood cell counts include fever, infection, bruising, or bleeding.
• a low blood cell count can be a sign of a serious bone marrow problem, such as “myelodysplastic syndrome” (MDS) or “acute myeloid leukemia” (AML). Your doctor may perform bone marrow tests to check for any problems.

Your doctor may also perform weekly tests if you have low blood cell counts for a long time. You may have your treatment with Rubraca interrupted until your blood cell count improves.

Be careful with direct sunlight

You may get sunburned more easily during treatment with Rubraca. This means you should:

• stay out of direct sunlight and do not use sunlamps while taking Rubraca
• wear clothing that covers your head, arms, and legs
• use a sunscreen and lip balm with a sun protection factor (SPF) of 50 or higher.

Symptoms to look out for

Talk to your doctor if you notice upset stomach (nausea), vomiting, diarrhea, or stomach pain. These can be signs and symptoms that Rubraca is affecting your stomach or intestines.

Children and adolescents

Rubraca should not be given to children under 18 years. This medicine has not been studied in this age group.

Other medicines and Rubraca

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Rubraca can affect the way some other medicines work. Also, some other medicines can affect the way Rubraca works.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• blood-thinning medicines that help your blood flow freely, such as warfarin
• anti-epileptic medicines used to treat seizures (convulsions) and epilepsy, such as phenytoin
• medicines to lower cholesterol levels in the blood, such as rosuvastatin

• medicines for stomach problems, such as cisapride, omeprazole
• medicines to reduce the activity of the immune system, such as cyclosporin, sirolimus, or tacrolimus
• medicines to treat migraines and headaches, such as dihydroergotamine or ergotamine
• medicines to treat severe pain, such as alfentanil or fentanyl
• medicines used to treat uncontrolled movements or mental disorders, such as pimozide
• medicines to lower blood sugar levels and treat diabetes, such as metformin
• medicines to treat irregular heartbeats, such as digoxin or quinidine
• medicines to treat allergic reactions, such as astemizole or terfenadine
• medicines used to induce sleep or drowsiness, such as midazolam
• medicines used to relax muscles, such as tizanidine
• medicines used to treat asthma, such as theophylline

Pregnancy, breastfeeding, and contraception

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

• Rubraca is not recommended during pregnancy. This is because it may harm the unborn baby.
• In women who can become pregnant, a pregnancy test is recommended before starting treatment with Rubraca.

Breastfeeding

• Do not breastfeed during treatment with Rubraca and for 2 weeks after taking the last dose. This is because it is not known if rucaparib passes into breast milk.

Contraception

• Women who can become pregnant must use an effective method of contraception (birth control):

• during treatment with Rubraca and
• for 6 months after taking the last dose of Rubraca.

This is because rucaparib may affect the fetus.

• Talk to your doctor or pharmacist about the most effective methods of contraception.

Driving and using machines

Rubraca may affect your ability to drive or use tools or machines. Be careful if you feel tired or nauseous.

Rubraca contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Rubraca

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

How much to take

• The recommended dose is 600 mg twice a day. This means you take a total of 1,200 mg each day. If you experience certain side effects, your doctor may recommend a lower dose or temporarily stop treatment.
• Rubraca is available as 200 mg, 250 mg, or 300 mg film-coated tablets.

How to take this medicine

• Take the tablets once in the morning and once in the evening, approximately 12 hours apart.
• You can take the tablets with or without food.
• If you vomit after taking Rubraca, do not take an extra dose. Take your next dose at the usual time.

If you take more Rubraca than you should

If you take more tablets than you should, talk to your doctor, pharmacist, or nurse immediately. You may need medical attention.

If you forget to take Rubraca

• If you forget a dose, skip the missed dose. Then take your next dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Rubraca

• It is important that you keep taking Rubraca every day while your doctor has prescribed it for you.
• Do not stop taking this medicine without talking to your doctor first.

If you have any further questions on the use of this product, 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 immediately if you notice any of the following side effects: you may need urgent medical treatment:

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

• difficulty breathing, feeling tired, pale skin, or fast heart rate; these can be signs of low red blood cell count (anemia)
• bleeding or bruising for longer than usual if you are injured: these can be signs of low platelet count in the blood (thrombocytopenia)
• fever or infection: these can be signs of low white blood cell count (neutropenia)

Other side effects are:

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

• nausea
• fatigue
• vomiting
• stomach pain
• changes in taste
• abnormal blood tests: increased liver enzyme levels
• loss of appetite
• diarrhea
• abnormal blood tests: increased creatinine levels
• difficulty breathing
• dizziness
• sunburn
• heartburn
• high cholesterol levels
• skin rash

Common(may affect up to 1 in 10 people):

• dehydration
• itching
• allergic reaction (e.g., swelling of the face and eyes)
• redness, swelling, and pain in the palms of the hands and/or soles of the feet
• red spots on the skin
• blockage of the small or large intestine
• Serious bone marrow problems, such as “myelodysplastic syndrome” (MDS) or “acute myeloid leukemia” (AML) (see section 2)
• mouth sores

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 the website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rubraca

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 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. Contents of the pack and other information

What Rubraca contains

• The active substance is rucaparib.

Rubraca 200 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate equivalent to 200 mg of rucaparib.

Rubraca 250 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate equivalent to 250 mg of rucaparib.

Rubraca 300 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate equivalent to 300 mg of rucaparib.

• The other ingredients are:

• Tablet core: microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica, and magnesium stearate.
• Tablet coating:
• Rubraca 200 mg film-coated tablets:

polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminum lake (E133), and carmine indigo aluminum lake (E132).

• Rubraca 250 mg film-coated tablets:

polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b).

• Rubraca 300 mg film-coated tablets:

polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and yellow iron oxide (E172).

Appearance of Rubraca and contents of the pack

• Rubraca 200 mg film-coated tablets are blue, round, and marked with “C2” on one side.
• Rubraca 250 mg film-coated tablets are white, diamond-shaped, and marked with “C25” on one side.
• Rubraca 300 mg film-coated tablets are yellow, oval, and marked with “C3” on one side.

Rubraca is supplied in plastic bottles. Each bottle contains 60 film-coated tablets.

Marketing authorization holder

pharmaand GmbH

Taborstrasse 1

1020 Vienna

Austria

Manufacturer

Almac Pharma Services Limited

Seagoe Industrial Estate,

Portadown,

Craigavon,

BT63 5UA

United Kingdom

or

Almac Pharma Services (Ireland) LtdFinnabair Industrial EstateDundalkCounty LouthA91 P9KDIreland

You can request more information about this medicine from the local representative of the marketing authorization holder:

Czech Republic, Denmark, Estonia, Greece, Croatia, Iceland, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta,

Norway, Poland, Portugal, Romania, Slovenia, Slovakia, Finland, Sweden:

Tel: +353 16950030

Date of last revision of this leaflet: March 2024

Other sources of information

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