XTANDI 40 mg Soft Capsule

Зміст інструкції

1. Xtandi 40 mg soft capsules
   1. What is Xtandi and what is it used for
   2. What you need to know before taking Xtandi
   3. How to take Xtandi
   4. Possible side effects
   5. How to store Xtandi
   6. Package contents and other information
2. Xtandi 40 mg film-coated tablets, 80 mg film-coated tablets
   1. What is Xtandi and what is it 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. Content of the pack and other information

Xtandi 40 mg soft capsules

enzalutamide

Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of 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 is Xtandi and what is it used for

Xtandi contains the active substance enzalutamide. Xtandi is used for the treatment of adult men
with prostate cancer:

• Who no longer respond to hormone therapy or surgical treatment to reduce testosterone Or
• Who have spread to other parts of the body and respond to hormone therapy or surgical treatment to reduce testosterone. Or
• For those who have previously undergone prostate removal or radiotherapy and have a rapidly increasing PSA, but the cancer has not spread to other parts of the body and responds to hormone therapy to reduce 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 the growth and division of prostate cancer cells.

2. What you need to know before taking Xtandi

Do not take Xtandi

• if you are allergic to enzalutamide or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or might become pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Seizures
In 6 out of 1,000 patients treated with Xtandi and in less than 3 out of 1,000 patients treated with placebo, seizures were
reported (see ‘Other medicines and Xtandi’ below and section 4, ‘Possible side effects’).
If you are taking a medicine that can cause seizures or increase your risk of 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.
Reversible posterior encephalopathy syndrome (PRES)
Rare cases of PRES, a rare reversible condition involving the brain, have been reported in patients treated with Xtandi. If you have seizures, worsening headache, confusion, blindness or other
vision problems, contact your doctor as soon as possible (see also section 4 ‘Possible side
effects’).
Risk of new tumors (second primary tumors)
New (second) tumors including bladder and colon cancer have been reported in patients treated
with Xtandi.
Contact your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in
your urine or if you frequently feel an urgent need to urinate while taking Xtandi.
Difficulty swallowing related to the product formulation
Cases of patients experiencing difficulty swallowing this medicine, including choking, have been reported. Difficulty swallowing and choking cases have been observed more
commonly in patients taking the capsules and may be related to the larger
size of the product. Swallow the capsules whole with sufficient amount of water.
If you have difficulty swallowing large capsules or have a history of dysphagia, you may have
difficulty swallowing Xtandi capsules and be at risk of choking. An alternative may be
taking Xtandi tablets, ask your doctor.
Talk to your doctor before taking Xtandi:

• if you have previously developed a severe skin rash or skin exfoliation, blisters and/or mouth ulcers after taking Xtandi or other medicines
• if you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• if you are using a chemotherapy medicine such as docetaxel
• if you have liver problems
• if you have kidney problems.

Tell your doctor if you have any of the following conditions:
Any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if
you are being treated with medicines for these disorders. The risk of heart rhythm problems may
increase with the use of Xtandi.
If you are allergic to enzalutamide, you may develop skin rashes, or your face, tongue,
lips or throat may swell. If you are allergic to enzalutamide or to any of the other ingredients of this
medicine, do not take Xtandi.
Severe skin rash or skin exfoliation, blisters and/or mouth ulcers, including Stevens-Johnson syndrome, have been reported in association with treatment with Xtandi. Stop using
Xtandi and contact your doctor immediately if you notice any of the symptoms associated with these severe skin reactions described in section 4.

If you are in any of the conditions listed above or if 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 should know the names of the medicines you are taking. Keep a list of these with you to
show your doctor when a new medicine is prescribed. Do not start or stop
therapy before talking to your doctor who prescribed Xtandi.
Tell your doctor if you are taking any of the following medicines. If taken in
combination with Xtandi, the following medicines may increase the risk of seizures:

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

Tell your doctor if you are taking any of the following medicines. These medicines may
affect the action of Xtandi, or Xtandi may affect the action of these medicines:
This applies, for example, to some medicines used for:

• lowering cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin)
• treating pain (e.g. fentanyl, tramadol)
• treating cancer (e.g. cabazitaxel)
• treating epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproate)
• treating some mental disorders such as severe anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
• treating sleep disorders (e.g. zolpidem)
• treating heart disease or lowering blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• treating severe inflammatory diseases (e.g. dexamethasone, prednisolone)
• treating HIV infections (e.g. indinavir, ritonavir)
• treating bacterial infections (e.g. clarithromycin, doxycycline)
• treating thyroid disorders (e.g. levothyroxine)
• treating gout (e.g. colchicine)
• treating stomach disorders (e.g. omeprazole)
• preventing heart disease or stroke (e.g. dabigatran etexilate)
• preventing organ rejection (e.g. tacrolimus)

Xtandi may interfere with some medicines used to treat heart rhythm problems (e.g.
quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm
problems when used with some medicines [e.g. methadone (used to relieve
pain and in drug detoxification programs), moxifloxacin (an antibiotic),
antipsychotics (used for severe mental illness)].
Tell your doctor if you are taking any of the medicines listed above. It may be necessary
to adjust the dose of Xtandi or any other medicine you are taking.

Pregnancy, breastfeeding and fertility

• Xtandi is not indicated for women.This medicine can cause harm to the unborn child or potential pregnancy interruptions if taken by pregnant women. It should not be taken by women who are pregnant, might become pregnant or are breastfeeding.
• This medicine may affect male fertility.
• If you have sexual intercourse with a woman who could become pregnant, use a condom and another effective method of contraception during treatment and for 3 months after stopping treatment. If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.
• If the patient is cared for by a woman, see section 3 “How to take Xtandi” for instructions on use and handling.

Driving and using machines
Xtandi may moderately impair the ability to drive and operate machines. Seizures have
been reported in patients taking Xtandi.
If you are at high risk of seizures, talk to your doctor.

Xtandi contains sorbitol
This medicine contains 57.8 mg of sorbitol (a type of sugar) per soft capsule.

3. How to take Xtandi

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor.
The usual dose is 160 mg (four soft capsules), taken once a day at the same time.

Taking Xtandi

• Swallow the soft capsules whole with a sufficient amount of 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 anyone other than the patient themselves or their caregiver. Women who are pregnant or who may become pregnant should not handle damaged or opened Xtandi capsules without wearing protection, such as gloves.

Your doctor may also prescribe other medicines during treatment with Xtandi.

If you take more Xtandi than you should
If you take more soft capsules than prescribed, stop treatment with Xtandi and contact your
doctor. You may be exposed to an increased risk of seizures or other undesirable 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 next day.
• If you forget to take Xtandi for more than one day, talk to your doctor immediately.
• Do not take a double doseto make up for the missed dose.

If you stop taking Xtandi
Do not stop this medicine unless your doctor tells you to.

If you have difficulty swallowing large capsules or have a history of dysphagia
Enzalutamide capsules should not be administered to patients who have difficulty
swallowing large capsules and patients with dysphagia. It is recommended to use enzalutamide
tablets instead.
If you have difficulty swallowing large capsules or have a history of dysphagia, you may
have difficulty swallowing Xtandi capsules and be at risk of choking. An alternative could
be taking Xtandi tablets, consult your doctor.
If you have any doubts about using this medicine, ask your doctor.

4. Possible side effects

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

Seizures
Seizure episodes have been reported in 6 patients out of 1,000 treated with Xtandi and in less than 3 patients out of

• 1,000 treated with placebo. The risk of seizures is higher if you take a dose of this medicine that is higher than the recommended dose, if you take other medicines, or if you are at a higher risk of seizures than normal.

If you have a seizure, contact your doctor as soon as possible. Your doctor may decide that you need to
stop taking Xtandi.

Reversible Posterior Encephalopathy Syndrome (PRES)
Rare cases of PRES (up to 1 in 1,000 people may be affected) have been reported in patients treated with Xtandi, a rare, reversible condition involving the brain. If you have seizures, worsening headache, confusion, blindness, or other vision problems, contact your doctor as
soon as possible.

Other possible side effects are:
Very common side effects(may affect more than 1 in 10 people)
Fatigue, falls, bone fractures, hot flushes, high blood pressure

Common side effects(may affect up to 1 in 10 people)
Headache, anxiety, dry skin, itching, memory problems, blockage of the heart arteries
(ischemic heart disease), increased breast volume in men (gynecomastia),
nipple pain, breast tenderness, symptoms of restless legs syndrome
(uncontrollable need to move a part of the body, usually the legs), reduced
concentration, forgetfulness, altered sense of taste, difficulty thinking clearly

Uncommon side effects(may affect up to 1 in 100 people)
Hallucinations, low number of white blood cells, increased levels of liver enzymes in
blood tests (a sign of liver problems)

Side effects of unknown frequency(frequency cannot be estimated based on available data)
Muscle pain, muscle cramps, muscle weakness, back pain, changes
in the electrocardiogram (ECG) (QT prolongation), difficulty swallowing this medicine,
including choking, stomach pain including feeling unwell (nausea), skin reaction causing spots or patches of red on the skin that may look like a target or
“bull’s-eye”, with a dark red center surrounded by rings of light red color (erythema
multiforme) or another serious skin reaction that presents as reddish, non-raised patches on
the trunk, similar to a target or circular, often with central blisters, skin peeling,
mouth, throat, nose, genital and eye ulcers, which may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), rash, feeling unwell (vomiting), swelling
of the face, lips, tongue and/or throat, reduced number of blood platelets
(increased risk of bleeding or bruising), diarrhea, loss of appetite.

Reporting of side effects
If you get any side effects, talk to your doctor. You can also report side effects directly through the national reporting system reported in Annex V. 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 packaging and
on the pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not take soft capsules that are leaking liquid, are damaged or show signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xtandi contains

• The active ingredient is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
• The other components of the soft capsule are macrogol-8-caprylocaproyl glycerides, butylated hydroxyanisole (E320), and butylated hydroxytoluene (E321).
• The components of the soft capsule shell are gelatin, sorbitol and sorbitan solution (see paragraph 2), glycerol, titanium dioxide (E171), and purified water.
• The ink components are: black iron oxide (E172) and polyvinyl acetate phthalate.

Description of the appearance of Xtandi and package contents

• Xtandi soft capsules are oblong soft capsules, white to off-white in color (approximately 20 mm x 9 mm) with "ENZ" imprinted on one side.
• Each pack contains 112 soft capsules in 4 blisters/containers of 28 soft capsules each.

Marketing authorisation holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
Netherlands

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Lietuva
Astellas Pharma d.o.o.
Tel: +370 37408681

България
Астелас Фарма ЕООД
Тел.: + 359 2 862 53 72

België/Belgique/Belgien
Astellas Pharma B.V. Branch
Tél/Tel: + 32 (0)2 5580710

Luxembourg/Luxemburg
Astellas Pharma B.V. Branch
Belgique/Belgien
Tél/Tel: + 32 (0)2 5580710

Česká republika
Astellas Pharma s.r.o.
Tel: + 420 221 401 500

Magyarország
Astellas Pharma Kft.
Tel.: + 36 1 577 8200

Danmark
Astellas Pharma a/s
Tlf.: + 45 43 430355

Malta
Astellas Pharmaceuticals AEBE
Tel: + 30 210 8189900

Deutschland
Astellas Pharma GmbH
Tel: + 49 (0)89 454401

Nederland
Astellas Pharma B.V.
Tel: + 31 (0)71 5455745

Eesti
Astellas Pharma d.o.o.
Tel: + 372 6056014

Norge
Astellas Pharma
Tlf: + 47 66 76 46 00

Österreich
Astellas Pharma Ges.m.b.H.
Tel: + 43 (0)1 8772668

Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ: + 30 210 8189900

España
Astellas Pharma S.A.
Tel: + 34 91 4952700

Polska
Astellas Pharma Sp.z.o.o.
Tel.: + 48 225451 111

France
Astellas Pharma S.A.S.
Tél: + 33 (0)1 55917500

Portugal
Astellas Farma, Lda.
Tel: + 351 21 4401300

Hrvatska
Astellas d.o.o.
Tel: + 385 1 670 01 02

România
S.C.Astellas Pharma SRL
Tel: + 40 (0)21 361 04 95

Ireland
Astellas Pharma Co. Ltd.
Tel: + 353 (0)1 4671555

Slovenija
Astellas Pharma d.o.o.
Tel: + 386 14011 400

Ísland
Vistor hf
Sími: + 354 535 7000

Slovenská republika
Astellas Pharma s.r.o.,
Tel: + 421 2 4444 2157

Italia
Astellas Pharma S.p.A.
Tel: + 39 (0)2 921381

Suomi/Finland
Astellas Pharma
Puh/Tel: + 358 (0)9 85606000

Κύπρος
Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ: + 30 210 8189900

Sverige
Astellas Pharma AB
Tel: + 46 (0)40-650 15 00

Latvija
Astellas Pharma d.o.o.
Tel: + 371 67619365
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

Xtandi 40 mg film-coated tablets, 80 mg film-coated tablets

enzalutamide

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of 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 is Xtandi and what is it used for

Xtandi contains the active substance enzalutamide. Xtandi is used for the treatment of adult men
with prostate cancer:

• Who no longer respond to hormone therapy or surgical treatment to reduce testosterone Or
• Whose cancer has spread to other parts of the body and responds to hormone therapy or surgical treatment to reduce testosterone. Or
• For those who have previously undergone prostate removal or radiotherapy and have a rapidly increasing PSA, but the cancer has not spread to other parts of the body and responds to hormone therapy to reduce 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 the growth and division of prostate cancer cells.

2. What you need to know before you take Xtandi

Do not take Xtandi

• if you are allergic to enzalutamide or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or might become pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Convulsions
In 6 out of 1,000 patients treated with Xtandi and in less than 3 out of 1,000 patients treated with placebo, episodes of convulsions were reported (see ‘Other medicines and Xtandi’ below and section 4, ‘Possible side effects’).
If you are taking a medicine that can cause convulsions or increase your predisposition to convulsions
(see 'Other medicines and Xtandi', below).
If you have a convulsion during treatment:
See your doctor as soon as possible. Your doctor may decide that you should stop taking
Xtandi.
Reversible posterior encephalopathy syndrome (PRES)
Rare cases of PRES, a rare reversible condition involving the brain, have been reported in patients treated with Xtandi. If you have convulsions, worsening headache, confusion, blindness or other
vision problems, contact your doctor as soon as possible (see also section 4 ‘Possible side effects’).
Risk of new tumors (secondary primary tumors)
New (secondary) tumors including bladder and colon cancer have been reported in patients treated
with Xtandi.
Contact your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in your
urine or if you frequently feel an urgent need to urinate while taking Xtandi.
Difficulty swallowing related to the product formulation
Cases of patients experiencing difficulty swallowing this medicine, including cases of
choking, have been reported. Swallowing difficulties and choking cases have been observed more
commonly in patients taking the capsules and may be related to the larger
size of the product. Swallow the tablets whole with sufficient amount of water.
Talk to your doctor before taking Xtandi:

• if you have previously developed a severe skin rash or exfoliation of the skin, blisters and/or mouth ulcers after taking Xtandi or other medicines
• if you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• if you are using a chemotherapy medicine such as docetaxel
• if you have liver problems
• if you have kidney problems.

Tell your doctor if you have any of the following conditions:
Any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if
you are being treated for these disorders. The risk of heart rhythm problems may
increase with the use of Xtandi.
If you are allergic to enzalutamide, you may develop skin rashes, or your face, tongue,
lips or throat may swell. If you are allergic to enzalutamide or to any of the other ingredients of this
medicine, do not take Xtandi.
Severe skin rash or exfoliation of the skin, blisters and/or mouth ulcers, including Stevens-Johnson syndrome, have been reported in association with treatment with Xtandi. Stop using
Xtandi and see your doctor immediately if you notice any of the symptoms associated with these severe skin reactions described in section 4.

If you are in any of the conditions listed above or if you are not sure, talk to your
doctor before taking this medicine.
Children and adolescents
This medicine should not be used by children and adolescents.

Other medicines and Xtandi
Tell your doctor if you are taking, have recently taken or might take any other
medicines. You should know the names of the medicines you are taking. Keep a list of these with you to
show to your doctor when a new medicine is prescribed. Do not start or stop
therapy before talking to your doctor who prescribed Xtandi.
Tell your doctor if you are taking any of the following medicines. If they are taken in
concomitance with Xtandi, the following medicines may increase the risk of convulsions:

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

Tell your doctor if you are taking any of the following medicines. These medicines may
affect the action of Xtandi, or Xtandi may affect the action of these medicines:
This is the case, for example, with some medicines used for:

• lowering cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin)
• treating pain (e.g. fentanyl, tramadol)
• treating cancer (e.g. cabazitaxel)
• treating epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproate)
• treating some psychiatric disorders such as severe forms of anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
• treating sleep disorders (e.g. zolpidem)
• treating heart disease or lowering blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• treating severe inflammatory diseases (e.g. dexamethasone, prednisolone)
• treating HIV infections (e.g. indinavir, ritonavir)
• treating bacterial infections (e.g. clarithromycin, doxycycline)
• treating thyroid disorders (e.g. levothyroxine)
• treating gout (e.g. colchicine)
• treating stomach disorders (e.g. omeprazole)
• preventing heart disease or stroke (e.g. dabigatran etexilate)
• preventing organ rejection (e.g. tacrolimus)

Xtandi may interfere with some medicines used to treat heart rhythm problems (e.g.
quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm
problems when used with some medicines [e.g. methadone (used to relieve
pain and in drug detoxification programmes), moxifloxacin (an antibiotic),
antipsychotics (used for severe mental illnesses)].
Tell your doctor if you are taking any of the medicines listed above. It may be necessary to
adjust the dose of Xtandi or any other medicine you are taking.

Pregnancy, breastfeeding and fertility

• Xtandi is not indicated for women.This medicine can cause harm to the unborn child or potential pregnancy interruptions if taken by pregnant women. It should not be taken by women who are pregnant, might become pregnant or are breastfeeding.
• This medicine may have an effect on male fertility.
• If you have sexual intercourse with a woman who could become pregnant, use a condom and another effective method of contraception during treatment and for 3 months after stopping treatment. If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.
• If the patient caregiver is a woman, see section 3 “How to take Xtandi” for instructions on use and handling.

Driving and using machines
Xtandi may moderately impair the ability to drive and operate machines. Convulsions have been
reported in patients taking Xtandi.
If you are at high risk of convulsions, talk to your doctor.

Xtandi contains sodium
This medicine contains less than 1 mmol (less than 23 mg) of sodium per film-coated
tablet, i.e. essentially ‘sodium-free’.

3. How to take Xtandi

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The usual dose is 160 mg (four film-coated tablets of 40 mg or two film-coated tablets of
80 mg), taken once a day at the same time.

Taking Xtandi

• Swallow the tablets whole with a sufficient amount of water.
• Do not cut, crush, or chew the tablets before swallowing.
• Xtandi can be taken with or without food.
• Xtandi should not be handled by people other than the patient themselves or their caregiver. Women who are pregnant or who may become pregnant should not handle broken or damaged Xtandi tablets without wearing protection, such as gloves.

Your doctor may also prescribe you other medicines during treatment with Xtandi.

If you take more Xtandi than you should
If you take more tablets than prescribed, stop treatment with Xtandi and contact your
doctor. You may be exposed to an increased risk of seizures or other undesirable 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 next day.
• If you forget to take Xtandi for more than one day, talk to your doctor immediately.
• Do not take a double doseto make up for the missed dose.

If you stop taking Xtandi
Do not stop this medicine unless requested by your doctor.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

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

Seizures
Seizure episodes have been reported in 6 patients out of 1,000 treated with Xtandi and in less than 3 patients out of

• 1,000 treated with placebo.

The risk of seizures is higher if you take a dose of this medicine that is higher than the
recommended dose, if you take other medicines, or if you are at a higher risk of seizures than
normal.

If you have a seizure, contact your doctor as soon as possible. Your doctor may decide that you need to
stop treatment with Xtandi.

Reversible Posterior Encephalopathy Syndrome (PRES)
Rare cases of PRES (up to 1 in 1,000 people may be affected) have been reported in patients treated with Xtandi, a rare, reversible condition involving the brain. If you have seizures, worsening headache, confusion, blindness, or other vision problems, contact your doctor as
soon as possible.

Other possible side effects are:
Very common side effects(may affect more than 1 in 10 people)
Fatigue, falls, bone fractures, hot flushes, high blood pressure

Common side effects(may affect up to 1 in 10 people)
Headache, anxiety, dry skin, itching, memory problems, blockage of the heart arteries
(ischemic heart disease), increased breast size in men (gynecomastia),
nipple pain, breast tenderness, restless legs syndrome symptoms
(uncontrollable need to move a part of the body, usually the legs), reduced
concentration, forgetfulness, altered sense of taste, difficulty thinking clearly

Uncommon side effects(may affect up to 1 in 100 people)
Hallucinations, low white blood cell count, increased liver enzyme levels in
blood tests (a sign of liver problems)

Side effects of unknown frequency(frequency cannot be estimated based on available data)
Muscle pain, muscle cramps, muscle weakness, back pain, changes
in the electrocardiogram (ECG) (QT prolongation), difficulty swallowing this
medicine, including choking, stomach pain including feeling unwell (nausea),
skin reaction causing blotches or patches of red on the skin that may look like a
target or “bull's-eye”, with a dark red center surrounded by rings of light red
color (erythema multiforme) or another severe skin reaction presenting with reddish patches that are not raised on the trunk, similar to a target or circular, often with central blisters, skin peeling,
mouth, throat, nose, genital and eye sores, which may be preceded by fever and
flu-like symptoms (Stevens-Johnson syndrome), rash, feeling unwell (vomiting),
swelling of the face, lips, tongue and/or throat, reduced number of platelets in the
blood (increased risk of bleeding or bruising), diarrhea, decreased appetite.

Reporting of side effects
If you get any side effects, talk to your doctor. You can also report side effects directly through the national reporting system reported in Annex V. 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 packaging and
on the pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Xtandi contains
The active ingredient is enzalutamide.
Each film-coated tablet containing 40 mg contains 40 mg of enzalutamide.
Each film-coated tablet containing 80 mg contains 80 mg of enzalutamide.
The other components of the film-coated tablets are:

• Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate
• Tablet coating: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Xtandi and contents of the pack
Xtandi 40 mg film-coated tablets are film-coated tablets, yellow, round with
engraved E 40. Each pack contains 112 tablets in 4 blisters/containers of 28 tablets
each.
Xtandi 80 mg film-coated tablets are film-coated tablets, yellow, oval with engraved E

• 80. Each pack contains 56 tablets in 4 blisters/containers of 14 tablets each.

Marketing authorisation holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
Netherlands

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
Netherlands
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Astellas Pharma B.V. Branch
Tél/Tel: + 32 (0)2 5580710

Lietuva
Astellas Pharma d.o.o.
Tel: +370 37408681

България
Астелас Фарма ЕООД
Teл.: + 359 2 862 53 72

Luxembourg/Luxemburg
Astellas Pharma B.V. Branch
Belgique/Belgien
Tél/Tel: + 32 (0)2 5580710

Česká republika
Astellas Pharma s.r.o.
Tel: + 420 221 401 500

Magyarország
Astellas Pharma Kft.
Tel.: + 36 1 577 8200

Danmark
Astellas Pharma a/s
Tlf.: + 45 43 430355

Malta
Astellas Pharmaceuticals AEBE
Tel: + 30 210 8189900

Deutschland
Astellas Pharma GmbH
Tel: + 49 (0)89 454401

Nederland
Astellas Pharma B.V.
Tel: + 31 (0)71 5455745

Eesti
Astellas Pharma d.o.o.
Tel: + 372 6056014

Norge
Astellas Pharma
Tlf: + 47 66 76 46 00

Österreich
Astellas Pharma Ges.m.b.H.
Tel: + 43 (0)1 8772668

Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ: + 30 210 8189900

España
Astellas Pharma S.A.
Tel: + 34 91 4952700

Polska
Astellas Pharma Sp.z.o.o.
Tel.: + 48 225451 111

France
Astellas Pharma S.A.S.
Tél: + 33 (0)1 55917500

Portugal
Astellas Farma, Lda.
Tel: + 351 21 4401300

Hrvatska
Astellas d.o.o.
Tel: + 385 1 670 01 02

România
S.C.Astellas Pharma SRL
Tel: + 40 (0)21 361 04 95

Ireland
Astellas Pharma Co. Ltd.
Tel: + 353 (0)1 4671555

Slovenija
Astellas Pharma d.o.o.
Tel: + 386 14011 400

Ísland
Vistor hf
Sími: + 354 535 7000

Slovenská republika
Astellas Pharma s.r.o.,
Tel: + 421 2 4444 2157

Italia
Astellas Pharma S.p.A.
Tel: + 39 (0)2 921381

Suomi/Finland
Astellas Pharma
Puh/Tel: + 358 (0)9 85606000

Κύπρος
Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ: + 30 210 8189900

Sverige
Astellas Pharma AB
Tel: + 46 (0)40-650 15 00

Latvija
Astellas Pharma d.o.o.
Tel: + 371 67619365
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .