Label: information for the patient

Rubraca 200mg film-coated tablets

Rubraca 250mg film-coated tablets

Rubraca 300mg film-coated tablets

rucaparib

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication 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 label. See section 4.

1.What is Rubraca and how is it used

2.What you need to know before starting to take Rubraca

3.How to take Rubraca

4.Possible adverse effects

5.Storage of Rubraca

6.Contents of the package and additional information

What is Rubraca and how it works

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

Patients with changes (mutations) in certain genes called BRCA have a risk of developing a series of types of cancer. Rubraca blocks an enzyme that repairs damaged DNA in cancer cells, causing their death.

What Rubraca is used for

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

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

Consult your doctor, pharmacist or nurse before starting to take Rubraca.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Rubraca.

Blood tests

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

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

This is because Rubraca may 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, bruises or bleeding.
• low blood cell counts may 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 blood tests if you have low blood cell counts for a long time. You may need to stop taking Rubraca until your blood cell counts improve.

Be careful with direct sunlight

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

• stay away from 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 watch out for

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

Children and adolescents

Do not administer Rubraca to children under 18 years of age. This medicine has not been studied in this age group.

Other medicines and Rubraca

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine. This is because Rubraca may affect the way some other medicines work. Additionally, some other medicines may affect the way Rubraca works.

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

• blood thinners that help blood flow freely, such as warfarin
• seizure medicines used to treat seizures and epilepsy, such as phenytoin
• cholesterol-lowering medicines, such as rosuvastatin

• medicines to treat stomach problems, such as cisapride, omeprazole
• medicines to reduce the activity of the immune system, such as cyclosporine, sirolimus or tacrolimus
• medicines to treat migraines and headaches, such as dihydroergotamine or ergotamine
• medicines to treat intense pain, such as alfentanil or fentanyl
• medicines used to treat involuntary 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

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

Contraception

• Women who may become pregnant should use an effective contraceptive method:

• during treatment with Rubraca and
• for six 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 contraceptive methods.

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".

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

How much to take

• The recommended usual 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 interrupt treatment.
• Rubraca is available in 200 mg, 250 mg, or 300 mg tablets.

How to take this medication

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

If you take more Rubraca than you should

If you take more tablets than you should, consult your doctor, pharmacist, or nurse immediately. You may need medical help.

If you forget to take Rubraca

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

If you interrupt treatment with Rubraca

• It is essential to continue taking Rubraca every day as long as your doctor has prescribed it.
• Do not stop taking this medication without first talking to your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform 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 10people):

• difficulty breathing, feeling tired, pale skin, or rapid heartbeats; these may be signs of low red blood cell count (anemia)
• bleeding or bruising that takes longer than usual to stop: these may be signs of low platelet count in the blood (thrombocytopenia)
• fever or infection: these may be signs of low white blood cell count (neutropenia)

Other side effects are:

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

• nausea
• tiredness
• vomiting
• stomach pain
• changes in the perception of the taste of food
• abnormal blood test results: increased levels of liver enzymes
• loss of appetite
• diarrhea
• abnormal blood test results: increased levels of creatinine
• difficulty breathing
• dizziness
• sunburn
• heartburn
• high cholesterol levels
• skin rash

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

• dehydration
• itching
• allergic reaction (e.g., swelling on the face and eyes)
• redness, swelling, and pain in the palms of the hands and/or soles of the feet
• red patches on the skin
• obstruction 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 side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

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

What Rubraca contains

• The active ingredient is rucaparib.

Rubraca 200 mg film-coated tablets: Cada film-coated tablet contains camsilato de rucaparib equivalent to 200 mg of rucaparib.

Rubraca 250 mg film-coated tablets: Cada film-coated tablet contains camsilato de rucaparib equivalent to 250 mg of rucaparib.

Rubraca 300 mg film-coated tablets: Cada film-coated tablet contains camsilato de rucaparib equivalent to 300 mg of rucaparib.

• The other components are:

• Tablet content : microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal 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 aluminium lake (E133) and carmine 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 film-coated tablets, round and with “C2” marked on one side.
• Rubraca 250 mg film-coated tablets are white film-coated tablets, rhombic and with “C25” marked on one side.
• Rubraca 300 mg film-coated tablets are yellow film-coated tablets, oval and with “C3” marked on one side.

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

Marketing authorisation holder

pharmaand GmbH

Taborstrasse 1

1020 Vienna

Austria

Responsible for manufacturing

Almac Pharma Services Limited

Seagoe Industrial Estate,

Portadown,

Craigavon,

BT63 5UA

United Kingdom

or

Almac Pharma Services (Ireland) Ltd
Finnabair Industrial Estate
Dundalk
County Louth
A91 P9KD
Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

, Ceská republika, Danmark, Eesti, Ελλάδα, Hrvatska, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta,

Norge, Polska, Portugal, România, Slovenija, Slovenská republika,

Suomi/Finland, Sverige:

Tel: +353 16950030

Last update of this leaflet: March 2024

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/