Rubraca 250 mg film-coated tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Rubraca 200mg film-coated tablets

Rubraca 250mg film-coated tablets

Rubraca 300mg film-coated tablets

rucaparib

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Rubraca is and what it is used for

What Rubraca is and how it works

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

Patients with alterations (mutations) in certain genes called BRCA have an increased risk of developing several types of cancer. Rubraca blocks an enzyme that repairs damaged DNA in cancer cells, leading to their death.

What Rubraca is used for

Rubraca is used to treat a type of ovarian cancer. It is used as maintenance therapy following chemotherapy treatment when tumor reduction has been achieved.

2. What you need to know before taking Rubraca

Do not take Rubraca:

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

Talk to your doctor, pharmacist, or nurse before starting treatment with Rubraca.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Rubraca.

Blood tests

Your doctor or nurse will carry out blood tests to monitor 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 of:

• 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.
• low blood cell counts may be a sign of a serious bone marrow problem, such as “myelodysplastic syndrome” (MDS) or “acute myeloid leukaemia” (AML). Your doctor may perform bone marrow tests to check for any problems.

Your doctor may also carry out weekly blood tests if you have low blood cell counts for a prolonged period. Your treatment with Rubraca may be interrupted until your blood cell counts improve.

Be careful with direct sunlight

You may be more sensitive to sunlight while being treated with Rubraca. This means you should:

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

Symptoms to watch for

Talk to your doctor if you experience nausea, vomiting, diarrhoea, or abdominal pain. These may be signs and symptoms that Rubraca is affecting your stomach or intestines.

Children and adolescents

Rubraca must not be given to children or adolescents under 18 years of age. 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 need to take any other medicines. This is because Rubraca may affect how some other medicines work. Also, some other medicines may affect how Rubraca works.

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

• anticoagulant medicines that help blood flow freely, such as warfarin
• anticonvulsant medicines used to treat seizures (fits) 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 cyclosporine, sirolimus, or tacrolimus
• medicines for migraines and headaches, such as dihydroergotamine or ergotamine
• medicines for 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 for irregular heartbeats, such as digoxin or quinidine
• medicines for allergic reactions, such as astemizole or terfenadine
• medicines used to cause sleepiness 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 become pregnant, talk to 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 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 whether 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 could harm an unborn baby.

• 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 cautious 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

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

• The usual recommended dose is 600 mg twice daily. This means you take a total of 1,200 mg each day. If you experience certain adverse 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 medicine

• Take the tablets once in the morning and once in the evening, approximately 12 hours apart.
• You may 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, contact your doctor, pharmacist, or nurse immediately. You may need medical attention.

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 forgotten doses.

If you stop taking Rubraca

• It is important that you continue taking Rubraca every day as prescribed by your doctor.
• Do not stop taking this medicine without first talking to your doctor.

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

4. Possible adverse effects

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

Tell your doctor immediately if you notice any of the following adverse effects: you may need urgent medical treatment:

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

• difficulty breathing, feeling tired, pale skin, or rapid heartbeat; these may be signs of a low red blood cell count (anaemia)
• bleeding or bruising for longer than usual when injured; these may be signs of a low platelet count in the blood (thrombocytopenia)
• fever or infection; these may be signs of a low white blood cell count (neutropenia)

Other adverse effects include:

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

• nausea
• tiredness
• vomiting
• stomach pain
• changes in taste perception
• abnormal blood tests: increased liver enzyme levels
• loss of appetite
• diarrhoea
• 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 on 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 leukaemia” (AML) (see section 2)
• mouth sores

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the bottle and carton following EXP. The expiry date is the last day of the month indicated.

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 and packaging that you no longer need. This 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 components 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), aluminium lake of brilliant blue FCF (E133) and aluminium lake of indigo carmine (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).

What Rubraca looks like and contents of the pack

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

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

The following pack sizes are available:

• 1 carton containing 1 bottle (60 film-coated tablets)
• 1 carton containing 2 bottles (120 film-coated tablets)

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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) Ltd

Finnabair Industrial Estate

Dundalk

County Louth

A91 P9KD

Ireland

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium, Czech Republic, Denmark, Estonia, Greece, Croatia, Ireland, Iceland, Cyprus, Latvia, Lithuania, Luxembourg/Luxembourg, Hungary, Malta, Netherlands, Norway, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland/Finland, Sweden:

Tel: 0080077889944

Date of the most recent review of this leaflet:

Other sources of information

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