Active ingredient
- rucaparib camsylate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/17/1250/003.
Rubraca 200mg, 250mg and 300mg film-coated tablets
Package leaflet: Information for the patient
Rubraca 200 mg film-coated tablets
Rubraca 250 mg film-coated tablets
Rubraca 300 mg film-coated tablets
rucaparib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Rubraca is and what it is used for
2. What you need to know before you take 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 anti-cancer medicine, also known as a ‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor’.
Patients with changes (mutations) in genes called BRCA are at risk of developing a number of types of cancer. Rubraca blocks an enzyme that repairs damaged DNA in the cancer cells, resulting in their death.
What Rubraca is used for
Rubraca is used to treat a type of cancer of the ovary. It is used after the cancer has responded to previous chemotherapy treatments.
Rubraca can be used as maintenance therapy immediately after a course of chemotherapy that has caused the tumour to shrink.
Rubraca can also be used if your cancer has progressed after chemotherapy has been used and you have an abnormality of the BRCA gene.
If you take Rubraca because your cancer has progressed you will need to have a clinical test to identify an abnormality in the BRCA gene.
2. What you need to know before you take Rubraca
Do not take Rubraca
If you are not sure, talk to your doctor, pharmacist or nurse before taking Rubraca.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before or during taking Rubraca.
Blood tests
Your doctor or nurse will perform blood tests to check your blood cell-counts:
This is because Rubraca can cause low blood counts of:
Your doctor may also do weekly tests, if you have low blood cell counts for a long time. They may stop treatment with Rubraca until your blood cell counts improve.
Take care in direct sunlight
You may get sunburn more easily during treatment with Rubraca. This means you should:
Symptoms you should be aware of
Talk to your doctor if you feel sick (nauseous), have been sick (vomiting) or you have had diarrhoea. These may be signs and symptoms that Rubraca is affecting your stomach.
Children and adolescents
Children under 18 years of age should not be given Rubraca, This medicine has not been studied in this age group.
Other medicines and Rubraca
Tell your doctor, pharmacist or nurse 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, pharmacist or nurse if you are taking any of the following medicines:
Pregnancy, breast-feeding and contraception
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.
Pregnancy
Breast-feeding
Contraception
This is because rucaparib may affect the unborn baby.
Driving and using machines
Rubraca may affect your ability to drive or use tools or machines. Take care if you feel tired or feel sick (nauseous).
Information on other ingredients in this medicine
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Rubraca
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure.
How much to take
Taking this medicine
If you take more Rubraca than you should
If you take more tablets than you should, tell your doctor, pharmacist or nurse straight away. You may need medical help.
If you forget to take Rubraca
If you stop taking Rubraca
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.
Tell your doctor straight away 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):
Other side effects include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store 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 bottle and the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Rubraca contains
What Rubraca looks like and contents of the pack
Rubraca is supplied in plastic bottles. Each bottle contains 60 film-coated tablets.
Marketing Authorisation Holder
Manufacturer
or
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 01/2021
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
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