Active ingredient
- enzalutamide
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.
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/1/13/846/001.
Xtandi 40mg soft capsules
Package leaflet: Information for the patient
Xtandi 40 mg soft capsules
enzalutamide
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 Xtandi is and what it is used for
2. What you need to know before you take Xtandi
3. How to take Xtandi
4. Possible side effects
5. How to store Xtandi
6. Contents of the pack and other information
1. What Xtandi is and what it is used for
Xtandi contains the active substance enzalutamide. Xtandi is used to treat adult men with prostate cancer that no longer responds to androgen deprivation therapy.
How Xtandi works
Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.
2. What you need to know before you take Xtandi
Do not take Xtandi:
Warnings and precautions
Seizures
Seizures were reported in 4 in every 1,000 people taking Xtandi, and fewer than one in every 1,000 people taking placebo (see ‘Other medicines and Xtandi’ below and section 4 ‘Possible side effects’).
If you are taking a medicine that can cause seizures or that can increase the susceptibility for having seizures (see ‘Other medicines and Xtandi’ below)
If you have a seizure during treatment:
See your doctor as soon as possible. Your doctor may decide that you should stop taking Xtandi.
Posterior reversible encephalopathy syndrome (PRES)
There have been rare reports of PRES, a rare, reversible condition involving the brain, in patients treated with Xtandi. If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible. (See also section 4 ‘Possible side effects’).
Talk to your doctor before taking Xtandi
Please tell your doctor if you have any of the following:
Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Xtandi.
If you are allergic to enzalutamide, this may result in a rash or swelling of the face, tongue, lip or throat. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take Xtandi.
If any of the above applies to you or you are not sure, talk to your doctor before taking this medicine.
Children and adolescents
This medicine is not for use in children and adolescents.
Other medicines and Xtandi
Tell your doctor if you are taking, have recently taken or might take any other medicines. You need to know the names of the medicines you take. Keep a list of them with you to show to your doctor when you are prescribed a new medicine. You should not start or stop taking any medicine before you talk with the doctor that prescribed Xtandi.
Tell your doctor if you are taking any of the following medicines. When taken at the same time as Xtandi, these medicines may increase the risk of a seizure:
Tell your doctor if you are taking the following medicines. These medicines may influence the effect of Xtandi, or Xtandi may influence the effect of these medicines.
This includes certain medicines used to:
Xtandi might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other medicines (e.g. methadone, used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Tell your doctor if you are taking any of the medicines listed above. The dose of Xtandi or any other medicines that you are taking may need to be changed.
Pregnancy, breast-feeding and fertility
Driving and using machines
This medicine has moderate effect on your ability to drive or use any tools or machines as the side effects of Xtandi include psychiatric and neurological events including seizure. If you are at higher risk of seizures, talk to your doctor.
Xtandi contains sorbitol
This medicine contains 57.8 mg sorbitol (a type of sugar) per soft capsule. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Xtandi
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The usual dose is 160 mg (four soft capsules), taken at the same time once a day.
Taking Xtandi
Your doctor may also prescribe other medicines while you are taking Xtandi.
If you take more Xtandi than you should
If you take more soft capsules than prescribed, stop taking Xtandi and contact your doctor. You may have an increased risk of seizure or other side effects.
If you forget to take Xtandi
If you stop taking Xtandi
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seizures
Seizures were reported in 4 in every 1,000 people taking Xtandi, and in fewer than one in every 1,000 people taking placebo.
Seizures are more likely if you take more than the recommended dose of this medicine, if you take certain other medicines, or if you are at higher than usual risk of seizure.
If you have a seizure, see your doctor as soon as possible. Your doctor may decide that you should stop taking Xtandi.
Posterior Reversible Encephalopathy Syndrome (PRES)
There have been rare reports of PRES (may affect up to 1 in 1,000 people), a rare, reversible condition involving the brain, in patients treated with Xtandi. If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible.
Other possible side effects include:
Very common (may affect more than 1 in 10 people)
Tiredness, broken bones, hot flushes, high blood pressure
Common (may affect up to 1 in 10 people)
Headache, fall, feeling anxious, dry skin, itching, difficulty remembering, blockage of the arteries in the heart (ischemic heart disease), breast enlargement in men (gynaecomastia), symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg), reduced concentration, forgetfulness
Uncommon (may affect up to 1 in 100 people)
Hallucinations, difficulty thinking clearly, low white blood cell count
Not known (frequency cannot be estimated from the available data)
Muscle pain, muscle spasms, muscular weakness, back pain, changes in ECG (QT prolongation), upset stomach including feeling sick (nausea), rash, being sick (vomiting), swelling of the face, lips, tongue and/or throat, reduction in blood platelets (which increases risk of bleeding or bruising), diarrhoea
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the Yellow Card Scheme at: 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 Xtandi
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 cardboard wallet and outer 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 take any soft capsule that is leaking, damaged, or shows signs of tampering.
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 Xtandi contains
What Xtandi looks like and contents of the pack
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 10/2018.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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