Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xtandi

Document Subject

Generated Narrative: MedicinalProductDefinition mp0f22d445f37b02d3c837ebc1451981fc

identifier: http://ema.europa.eu/identifier/EU/1/13/846/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xtandi - 40 mg soft capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0f22d445f37b02d3c837ebc1451981fc

identifier: http://ema.europa.eu/identifier/EU/1/13/846/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - xtandi

Attesters

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

Xtandi contains the active substance enzalutamide. Xtandi is used to treat adult men with prostate cancer that:

• No longer responds to a hormone therapy or surgical treatment to lower testosterone Or
• Has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone.

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.

Do not take Xtandi

• If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6)
• If you are pregnant or may become pregnant (see Pregnancy, breast-feeding and fertility ) Warnings and precautions Seizures Seizures were reported in 5 in every 1,000 people taking Xtandi, and fewer than 3 in every 1,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 ).

Risk of new cancers (second primary malignancies) There have been reports of new (second) cancers including cancer of the bladder and colon in patients treated with Xtandi.

See your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in the urine, or frequently feel an urgent need to urinate when taking Xtandi.

Talk to your doctor before taking Xtandi

• If you are taking any medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• If you use chemotherapy like docetaxel
• If you have problems with your liver
• If you have problems with your kidneys

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.

Serious skin rash or skin peeling, blistering and/or mouth sores have been reported in association with Xtandi treatment. Seek medical attention immediately if you notice any of these symptoms.

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:

• Certain medicines used to treat asthma and other respiratory diseases (e.g. aminophylline, theophylline).
• Medicines used to treat certain psychiatric disorders such as depression and schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
• Certain medicines for the treatment of pain (e.g. pethidine).

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:

• Lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin)
• Treat pain (e.g. fentanyl, tramadol)
• Treat cancer (e.g. cabazitaxel)
• Treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
• Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
• Treat sleep disorders (e.g. zolpidem)
• Treat heart conditions or lower blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone)
• Treat HIV infection (e.g. indinavir, ritonavir)
• Treat bacterial infections (e.g. clarithromycin, doxycycline)
• Treat thyroid disorders (e.g. levothyroxine)
• Treat gout (e.g. colchicine)
• Treat stomach disorders (e.g. omeprazole)
• Prevent heart conditions or strokes (e.g. dabigatran etexilate)
• Prevent organ rejection (e.g. tacrolimus)

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

• Xtandi is not for use in women. This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant. It must not be taken by women who are pregnant, may become pregnant, or who are breast-feeding.
• This medicine could possibly have an effect on male fertility.
• If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method, during treatment and for 3 months after treatment with this medicine. If you are having sex with a pregnant woman, use a condom to protect the unborn child.
• Female caregivers see section 3 How to take Xtandi for handling and use. Driving and using machines Xtandi may have moderate influence on the ability to drive and use machines. Seizures have been reported in patients taking Xtandi. 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.

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

• Swallow the soft capsules whole with water.
• Do not chew, dissolve or open the soft capsules before swallowing.
• Xtandi can be taken with or without food.
• Xtandi should not be handled by persons other than the patient or his caregivers. Women who are or may become pregnant should not handle damaged or opened Xtandi capsules without wearing protection like gloves.

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 forget to take Xtandi at the usual time, take your usual dose as soon as you remember.
• If you forget to take Xtandi for the whole day, take your usual dose the following day.
• If you forget to take Xtandi for more than one day, talk to your doctor immediately.
• Do not take a double dose to make up for the dose you forgot. 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seizures Seizures were reported in 5 in every 1,000 people taking Xtandi, and in fewer than 3 in every 1,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, fall, broken bones, hot flushes, high blood pressure

Common (may affect up to 1 in 10 people)
Headache, 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, change in sense of taste

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), a skin reaction that causes red spots or patches on the skin that may look like a target or bulls-eye with a dark red centre surrounded by paler red rings (erythema multiforme), 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Xtandi contains

• The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
• The other ingredients of the soft capsule are caprylocaproyl macrogol-8 glycerides, butylhydroxyanisole (E320), and butylhydroxytoluene (E321).
• The ingredients of the soft capsule shell are gelatin, sorbitol sorbitan solution (see section 2), glycerol, titanium dioxide (E171), and purified water.
• The ingredients of the ink are iron oxide black (E172) and polyvinyl acetate phthalate. What Xtandi looks like and contents of the pack
• Xtandi soft capsules are white to off-white, oblong soft capsules (approximately 20 mm by 9 mm) with ENZ written on one side.
• Each carton contains 112 soft capsules in 4 blister wallets of 28 soft capsules each. Marketing Authorisation Holder and Manufacturer

Astellas Pharma Europe B.V. Sylviusweg 2333 BE Leiden The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Astellas Pharma B.V. Branch T l/Tel: + 32 (0)2 5580Lietuva Biocodex UAB Tel: + 370 37 408

Te .: + 359 2 862 53 Luxembourg/Luxemburg Astellas Pharma B.V.Branch Belgique/Belgien T l/Tel: + 32 (0)2 5580 esk republika Astellas Pharma s.r.o. Tel: + 420 221 401 Magyarorsz g Astellas Pharma Kft. Tel.: + 36 1 577 8Danmark Astellas Pharma a/s Tlf: + 45 43 430Malta Astellas Pharmaceuticals AEBE Tel: + 30 210 8189Deutschland Astellas Pharma GmbH Tel: + 49 (0)89 454Nederland Astellas Pharma B.V. Tel: + 31 (0)71 5455Eesti Biocodex O
Tel: + 372 6 056 Norge Astellas Pharma
Tlf: + 47 66 76 46
Astellas Pharmaceuticals AEBE : + 30 210 8189 sterreich Astellas Pharma Ges.m.b.H. Tel: + 43 (0)1 8772Espa a Astellas Pharma S.A. Tel: + 34 91 4952Polska Astellas Pharma Sp.z.o.o. Tel.: + 48 225451 France Astellas Pharma S.A.S. T l: + 33 (0)1 55917Portugal Astellas Farma, Lda. Tel: + 351 21 4401Hrvatska Astellas d.o.o. Tel: + 385 1 670 01 Rom nia S.C.Astellas Pharma SRL Tel: + 40 (0)21 361 04 95 /96 /Ireland Astellas Pharma Co. Ltd. Tel: + 353 (0)1 4671Slovenija Astellas Pharma d.o.o. Tel: + 386 14011 sland Vistor hf S mi: + 354 535 7Slovensk republika Astellas Pharma s.r.o.,
Tel: + 421 2 4444 2Italia Astellas Pharma S.p.A. Tel: + 39 02 921Suomi/Finland Astellas Pharma Puh/Tel: + 358 (0)9 85606
Astellas Pharmaceuticals AEBE

: + 30 210 8189Sverige Astellas Pharma AB Tel: + 46 (0)40-650 15 Latvija Biocodex SIA Tel: + 371 67 619United Kingdom (Northern Ireland) Astellas Pharma Co., Limited Tel: +353 (0)1 4671Free call from Northern Ireland: 0800 783 5This leaflet was last revised in MM/YYYY.

Detailed information on this medicine is available on the European Medicines Agency web site: