ENZALUTAMIDE ACCORD 40 mg SOFT CAPSULES

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. Contents of the leafletWhat is Enzalutamide Accord and what is it used for
2. What you need to know before taking Enzalutamide Accord
3. How to take Enzalutamide Accord
4. Possible side effects
5. Storage of Enzalutamide Accord
6. Contents of the pack and further information

1. What is Enzalutamide Accord and what is it used for

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

• Has stopped responding to hormone therapy or surgical treatment to reduce testosterone

or

• Has spread to other parts of the body and responds to hormone therapy or surgical treatment to reduce testosterone.

How Enzalutamide Accord works

Enzalutamide Accord is a medicine that works by blocking the activity of certain hormones called androgens (such as testosterone). By blocking androgens, enzalutamide makes prostate cancer cells stop growing and dividing.

2. What you need to know before taking Enzalutamide Accord

Do not take Enzalutamide Accord

• 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, breastfeeding, and fertility")

Warnings and precautions

Seizures

Seizures have been reported in 5 out of every 1,000 people taking enzalutamide, and in less than 3 out of every 1,000 people taking placebo (see "Using Enzalutamide Accord with other medicines" below and "Possible side effects" in section 4).

If you are taking a medicine that can cause seizures or increase the risk of having seizures (see below "Other medicines and Enzalutamide Accord").

If you have a seizure during treatment:

Consult your doctor as soon as possible. Your doctor may decide that you should stop taking enzalutamide.

Posterior Reversible Encephalopathy Syndrome (PRES)

Rare cases of PRES, a rare, reversible disease that affects the brain, have been reported in patients treated with enzalutamide. If you have a seizure, 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 cancers (second primary malignancies)

There have been reports of new (second) cancers in patients treated with enzalutamide, including bladder and colon cancer.

Consult your doctor as soon as possible if you notice any signs of gastrointestinal bleeding, blood in your urine, or frequently feel an urgent need to urinate while taking enzalutamide.

Consult your doctor before starting to take Enzalutamide Accord

• If you are taking medicines to prevent blood clots (e.g., warfarin, acenocoumarol, clopidogrel)
• If you are receiving chemotherapy, such as docetaxel
• If you have liver problems
• If you have kidney problems

Tell your doctor if you have:

Any heart or blood vessel problems, including heart rhythm problems (arrhythmias), or if you are being treated with medicines to correct these problems. The risk of heart rhythm problems may be increased with the use of this medicine.

If you are allergic to enzalutamide, its administration could cause a rash or inflammation of the face, tongue, lips, or throat. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take enzalutamide.

Severe skin rashes or peeling of the skin, blistering, and/or ulcers in the mouth have been reported in association with enzalutamide treatment. Seek medical attention immediately if you notice any of these symptoms.

If any of the above applies to you or if you are unsure, consult your doctor before taking this medicine.

Children and adolescents

This medicine should not be given to children or adolescents.

Other medicines and Enzalutamide Accord

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 are taking. Carry a list of them with you to show your doctor when they prescribe you a new medicine. Do not start or stop taking any medicine before consulting the doctor who prescribed this medicine.

Tell your doctor if you are taking any of the following medicines. These medicines may increase the risk of having a seizure when taken with enzalutamide:

• 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 pain medicines (e.g., pethidine).

Tell your doctor if you are taking the following medicines. These medicines may affect the effect of enzalutamide or enzalutamide may affect 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 problems 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 problems or stroke (e.g., dabigatran etexilate)
• Prevent organ rejection (e.g., tacrolimus)

Enzalutamide 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 certain medicines (e.g., methadone [used for pain relief and as part of drug detoxification], moxifloxacin [an antibiotic], antipsychotics [used for severe mental illnesses]).

Tell your doctor if you are taking any of the above medicines. It may be necessary to adjust the dose of enzalutamide or any other medicine you are taking.

Pregnancy, breastfeeding, and fertility

• Enzalutamide is not indicated in women. This medicine may harm the fetus or cause an abortion if taken by a pregnant woman. It should not be given to pregnant women, women who may become pregnant, or women who are breastfeeding.
• This medicine may affect male fertility.
• If you have sex with a woman of childbearing age, you should use a condom and another effective contraceptive method during treatment and for 3 months after treatment with this medicine. If you have sex with a pregnant woman, you should use a condom to protect the fetus.
• In the case of female caregivers, see section 3 "How to take Enzalutamide Accord" for handling and administration recommendations.

Driving and using machines

The influence of enzalutamide on the ability to drive and use machines may be moderate. Seizures have been reported in patients who have taken enzalutamide. If you are at a higher risk of having seizures, you should consult your doctor.

Enzalutamide Accord contains sorbitol

This medicine contains 47.8 mg of sorbitol (E 420) in each soft capsule.

3. How to take Enzalutamide Accord

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor again.

The recommended dose is 160 mg (four soft capsules), taken at the same time once a day.

How to take Enzalutamide Accord

• Swallow the soft capsules whole with water.
• Do not chew, dissolve, or open the soft capsules before swallowing.
• Enzalutamide can be taken with or without food.
• Enzalutamide should not be handled by anyone other than the patient or their caregivers. Pregnant women or women who may become pregnant should not handle enzalutamide capsules without protection (e.g., gloves).

It is also possible that your doctor may prescribe other medicines while you are taking enzalutamide.

If you take more Enzalutamide Accord than you should

If you take more soft capsules than prescribed, stop taking enzalutamide and contact your doctor. You may have a higher risk of having a seizure or other side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Enzalutamide Accord

• If you forget to take enzalutamide at the usual time, take the usual dose as soon as you remember.
• If you forget to take enzalutamide for the entire day, take the usual dose the next day.
• If you forget to take enzalutamide for more than one day, consult your doctor immediately.
• Do not take a double doseto make up for the missed doses.

If you stop taking Enzalutamide Accord

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

If you have any further questions 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 gets them.

Seizures

Seizures have been reported in 5 out of every 1,000 people taking enzalutamide, and in less than 3 out of every 1,000 people taking placebo.

Seizures are more likely if you take a higher dose of this medicine than recommended, if you take certain medicines, or if you have a higher risk of having seizures.

If you have a seizure, consult your doctor as soon as possible. Your doctor may decide that you should stop taking enzalutamide.

Posterior Reversible Encephalopathy Syndrome (PRES)

Rare cases of PRES (affecting up to 1 in 1,000 people), a rare, reversible disease that affects the brain, have been reported in patients treated with enzalutamide. If you have a seizure, worsening headache, confusion, blindness, or other vision problems, contact your doctor as soon as possible.

Other possible side effects are:

Very common(may affect more than 1 in 10 people) Fatigue, falls, bone fractures, 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 heart arteries (ischemic heart disease), increase in breast size in men (gynecomastia), restless legs syndrome, loss of concentration, memory loss, change in 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, muscle weakness, back pain, changes in the electrocardiogram (QT interval prolongation), stomach upset including feeling sick (nausea), a skin reaction that causes red spots or patches on the skin, which may look like a target or a "bull's eye" with a dark red center surrounded by lighter red rings (erythema multiforme), rash, vomiting, swelling of the face, lips, tongue, and/or throat, decrease in the number of platelets in the blood (which increases the risk of bleeding or bruising), diarrhea

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online reporting system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enzalutamide Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the blister pack after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not take any soft capsule that has lost its contents, is damaged, or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Enzalutamide Accord

• The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
• The other ingredients of the soft capsule are macrogolglycerides, butylhydroxyanisole (E320), and butylhydroxytoluene (E321).
• The ingredients of the soft capsule shell are gelatin, sorbitol liquid (partially dehydrated), glycerol, titanium dioxide (E171), talc (E553b), and purified water.
• The ingredients of the ink are shellac, iron oxide black, ammonium hydroxide, and propylene glycol.

Appearance of the product and pack contents

• Enzalutamide Accord soft capsules are oblong (20 mm long and 10 mm wide), white to off-white, opaque, with "JG1" printed in black ink.
• Enzalutamide Accord is available in PVC/PCTFE-Al blister packs containing 28 soft capsules per box. Enzalutamide Accord is also available in multipacks containing 4 cartons, each containing 28 soft capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6ª planta,

08039 Barcelona,

Spain

Manufacturers:

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola

Malta

Or

Accord Healthcare Polska Sp.z.o.o.

Ul.Lutomierska 50,

95-200, Pabianice,

Poland

Or

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

Accord Healthcare single member S.A.

64th Km National Road Athens,

Lamia, Schimatari,

32009, Greece

This leaflet was last revised in: March 2024

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/