Enzalutamide Accord

Package Leaflet: Information for the Patient

Enzalutamide Accord, 40 mg, Soft Capsules

Enzalutamide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor.
This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Table of Contents of the Leaflet

What is Enzalutamide Accord and what is it used for
Important information before taking Enzalutamide Accord
How to take Enzalutamide Accord
Possible side effects
How to store Enzalutamide Accord
Contents of the pack and other information

1. What is Enzalutamide Accord and What is it Used For

Enzalutamide Accord contains the active substance enzalutamide. Enzalutamide Accord is used in adult men for the treatment of prostate cancer that:
is no longer responding to hormone therapy or surgical treatment to reduce testosterone levels
or
has spread to other parts of the body and is responding to hormone therapy or surgical treatment to reduce testosterone levels.

How Enzalutamide Accord Works

Enzalutamide Accord is a medication that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide inhibits the growth and division of prostate cancer cells.

2. Important Information Before Taking Enzalutamide Accord

When Not to Take Enzalutamide Accord

if you are allergic to enzalutamide or any of the other ingredients of this medication (listed in section 6),
if you are pregnant or may become pregnant (see "Pregnancy, Breast-feeding and Fertility").

Warnings and Precautions

Seizure
Seizures have been reported in 5 out of 1000 people taking Enzalutamide Accord and in less than 3 out of 1000 people taking placebo (see also "Enzalutamide Accord and other medications" and section 4 "Possible side effects").
If you are taking medications that may cause seizures or increase the risk of seizures, see "Enzalutamide Accord and other medications" below.
In case of a seizure during treatment:
Contact your doctor immediately. The doctor will decide whether to stop taking Enzalutamide Accord.
Posterior Reversible Encephalopathy Syndrome (PRES)
Rare cases of PRES (a rare, reversible condition affecting the brain) have been reported in patients treated with Enzalutamide Accord. If seizures, worsening headache, altered mental status, blindness, or other vision changes occur, contact your doctor immediately (see also section 4 "Possible side effects").
Risk of New Tumors (Second Primary Malignancies)
There have been reports of new (second) cases of cancer, including bladder and colon cancer, in patients treated with Enzalutamide Accord.
If you experience symptoms of gastrointestinal bleeding, blood in urine, or frequent urgent need to urinate while taking Enzalutamide Accord, contact your doctor as soon as possible.
Before starting Enzalutamide Accord, tell your doctor if you:
are taking other medications to prevent blood clots (e.g., warfarin, acenocoumarol, clopidogrel)
are undergoing chemotherapy, e.g., docetaxel
have liver disease
have kidney disease
Tell your doctor if you have any of the following conditions:
any heart or blood vessel disease, including irregular heart rhythm (arrhythmia) or are being treated for these conditions. The risk of irregular heart rhythm may increase when taking Enzalutamide Accord.
If you are allergic to enzalutamide, you may experience a rash or swelling of the face, lips, or tongue. If you have an allergy to enzalutamide or any of the other ingredients of this medication, do not take Enzalutamide Accord.
Severe skin rash or peeling, blisters, and (or) mouth sores have been reported in patients treated with Enzalutamide Accord. If you experience any of these symptoms, contact your doctor immediately.

In Case of Any of the Above Situations or Doubts, Consult a Doctor Before Taking this Medication.

Children and Adolescents

This medication is not intended for use in children and adolescents.

Enzalutamide Accord and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take. You should know the names of the medications you are taking.
Keep a list of these medications with you to show your doctor when prescribing a new medication. Do not start or stop taking any medication before consulting the doctor who prescribed Enzalutamide Accord.
Tell your doctor if you are taking any of the following medications. These medications, when taken with Enzalutamide Accord, may increase the risk of seizures:
certain medications used to treat asthma and other respiratory diseases (e.g., aminophylline, theophylline);
medications used to treat certain mental disorders, such as depression and schizophrenia (e.g., clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine);
certain medications used to treat pain (e.g., pethidine).
Tell your doctor if you are taking any of the following medications. These medications may affect the action of Enzalutamide Accord or Enzalutamide Accord may affect the action of these medications.
This includes medications used to:
lower cholesterol levels (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 mental disorders, such as severe anxiety or schizophrenia (e.g., diazepam, midazolam, haloperidol)
treat sleep disorders (e.g., zolpidem)
treat heart disease or lower blood pressure (e.g., bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
treat severe inflammatory diseases (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 disease or stroke (e.g., dabigatran etexilate)
prevent rejection of a transplanted organ (e.g., tacrolimus)
Enzalutamide Accord may affect the action of certain medications used to treat irregular heart rhythm (e.g., quinidine, procainamide, amiodarone, and sotalol) or increase the risk of irregular heart rhythm when taken with other medications [e.g., methadone (used for pain relief and detoxification in drug addicts), moxifloxacin (an antibiotic), antipsychotic medications (used to treat severe mental illness)].
Tell your doctor if you are taking any of the above medications. The dose of Enzalutamide Accord or any other medication you are taking may need to be changed.

Pregnancy, Breast-feeding, and Fertility

Enzalutamide Accord is not intended for use in women.This medication, when taken by women during pregnancy, may harm the unborn baby or cause miscarriage. Do not take this medication if you are pregnant, may become pregnant, or are breast-feeding.
This medication may affect fertility in men.
If you engage in sexual activity with a woman of childbearing age during treatment and for 3 months after stopping treatment, use a condom and another effective method of contraception. If you engage in sexual activity with a pregnant woman, use a condom to protect the unborn baby.
Caregivers - see section 3 "How to take Enzalutamide Accord", which describes how to handle the medication.

Driving and Using Machines

Enzalutamide Accord may have a moderate effect on your ability to drive and use machines. Seizures have been reported in patients taking Enzalutamide Accord.
If you are at increased risk of seizures, consult your doctor.

Enzalutamide Accord Contains Sorbitol

This medication contains 47.80 mg of sorbitol (E 420) per soft capsule.

3. How to Take Enzalutamide Accord

Always take this medication exactly as your doctor has told you.
In case of doubts, consult a doctor.
The recommended dose is 160 mg (four soft capsules), taken at the same time once a day.

Taking Enzalutamide Accord

Swallow the soft capsule whole with water.
Do not chew, dissolve, or open the soft capsule before swallowing.
Enzalutamide Accord can be taken with or without food.
People other than the patient or their caregivers should not handle Enzalutamide Accord. Women who are pregnant or may become pregnant should not touch damaged or opened Enzalutamide Accord capsules without protective gloves.
Your doctor may also prescribe other medications while taking Enzalutamide Accord.

Taking More than the Recommended Dose of Enzalutamide Accord

In case of taking more than the prescribed number of soft capsules, stop taking Enzalutamide Accord and contact your doctor. The risk of seizures or other side effects may increase.

Missing a Dose of Enzalutamide Accord

If you forget to take Enzalutamide Accord at the scheduled time, take the usual dose as soon as possible.
If you forget to take Enzalutamide Accord for a day, take the usual dose the next day.
If you forget to take Enzalutamide Accord for more than a day, contact your doctor immediately.
Do not take a double doseto make up for a missed dose.

Stopping Enzalutamide Accord

Do not stop treatment unless your doctor decides to.
In case of any further doubts about taking this medication, consult a doctor.

4. Possible Side Effects

Like all medications, Enzalutamide Accord can cause side effects, although not everybody gets them.

Seizures

Seizures have been reported in 5 out of 1000 people taking Enzalutamide Accord and in less than 3 out of 1000 people taking placebo.
The occurrence of seizures is more likely when taking more than the recommended dose of this medication, taking certain other medications, or having a higher-than-usual risk of seizures.
If a seizure occurs, contact your doctor immediately. The doctor will decide whether to stop taking Enzalutamide Accord.

Posterior Reversible Encephalopathy Syndrome (PRES)

Rare cases of PRES (a rare, reversible condition affecting the brain) have been reported in patients treated with Enzalutamide Accord; it may occur less frequently than in 1 out of 1000 people. If seizures, worsening headache, altered mental status, blindness, or other vision changes occur, contact your doctor immediately.

Other Side Effects Include:

Very Common(may affect more than 1 in 10 people)
fatigue, dizziness, bone fractures, hot flushes, high blood pressure
Common(may affect less than 1 in 10 people)
headache, feeling anxious, dry skin, itching, memory impairment, coronary artery disease, breast enlargement in men (gynecomastia), restless legs syndrome, decreased concentration, forgetfulness, change in taste
Uncommon(may affect less than 1 in 100 people)
hallucinations, difficulty thinking clearly, low white blood cell count
Frequency Not Known(frequency cannot be estimated from the available data)
muscle pain, muscle spasms, muscle weakness, back pain, changes in electrocardiogram (QT interval prolongation), stomach upset, including nausea, skin rash causing red patches or areas with a target-like appearance, vomiting, swelling of the face, lips, tongue, and (or) throat, decreased platelet count (which may increase the risk of bleeding or bruising), diarrhea

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Enzalutamide Accord

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
No special precautions for storage are necessary.
Do not take any soft capsule that is damaged, broken, or shows signs of opening.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Enzalutamide Accord Contains

The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
The other ingredients of the soft capsule are: macrogolglycerides, butylhydroxyanisole, and butylhydroxytoluene.
The ingredients of the soft capsule shell are: gelatin, sorbitol, liquid, partially dehydrated, glycerol, titanium dioxide (E171), talc, and purified water, triglycerides of medium-chain fatty acids.
The ingredients of the ink are: shellac, iron oxide black, ammonium hydroxide, propylene glycol.

What Enzalutamide Accord Looks Like and Contents of the Pack

Enzalutamide Accord is a white or almost white, opaque, elongated (20 mm long x 9 mm wide) soft capsule with the imprint "JG1" in black ink.
Enzalutamide Accord is available in a blister pack of 28 soft capsules in a cardboard box. Also available is a multipack containing 112 (4 packs of 28) soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola PLA
3000, Malta
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
32009, Lamia, Schimatari, Greece

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet: May 2025