ENZALUTAMIDE SANDOZ 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Enzalutamide Sandoz 40 mg film-coated tablets EFG

Enzalutamide Sandoz 80 mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medication 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Enzalutamide Sandoz is and what it is used for
2. What you need to know before taking Enzalutamide Sandoz

1. How to take Enzalutamide Sandoz
2. Possible side effects

1. Storage of Enzalutamide Sandoz
2. Contents of the pack and further information

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

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

• that has stopped responding to hormone therapy or surgical treatment to reduce testosterone,

or

• that has spread to other parts of the body and responds to hormone therapy or surgical treatment to reduce testosterone,

or

• who have undergone previous prostate removal or radiation and have a rapid increase in PSA, but the cancer has not spread to other parts of the body and responds to hormone therapy to reduce testosterone.

How Enzalutamide Works

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

2. What you need to know before taking Enzalutamide Sandoz

Do not take Enzalutamide Sandoz

• 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, Breastfeeding, and Fertility").

Warnings and Precautions

Seizures

Seizures have been reported in 6 out of 1,000 people taking enzalutamide, and in less than 3 out of 1,000 people taking placebo (see "Other Medications and Enzalutamide Sandoz" below and "Possible Side Effects" in section 4).

If you are taking a medication that can cause seizures or increase the risk of seizures (see "Other Medications and Enzalutamide Sandoz" below).

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 (Secondary Primary Malignancies)

Reports of new (secondary) cancers have been made 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 the urine, or frequently feel an urgent need to urinate while taking enzalutamide.

Consult your doctor before starting Enzalutamide Sandoz:

• If you have ever developed severe skin rashes or skin peeling, blistering, and/or ulcers in the mouth after taking enzalutamide or other medications.

• If you are taking medications 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.

Please inform your doctor if you have any of the following conditions:

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

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 medication, do not take this medication.

Severe skin rashes or skin peeling, blistering, and/or ulcers in the mouth, including Stevens-Johnson syndrome, have been reported in association with enzalutamide treatment. Stop using enzalutamide and seek immediate medical attention if you notice any of these symptoms related to these severe skin reactions described in section 4.

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

Children and Adolescents

This medication should not be given to children or adolescents.

Other Medications and Enzalutamide Sandoz

Inform your doctor if you are taking, have recently taken, or may need to take any other medication. You need to know the names of the medications you are taking. Carry a list of them with you to show your doctor when they prescribe a new medication. Do not start or stop taking any medication before consulting the doctor who prescribed this medication.

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

• Certain medications used to treat asthma and other respiratory diseases (e.g., aminophylline, theophylline).
• Medications 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 medications for pain treatment (e.g., pethidine).

Inform your doctor if you are taking the following medications. These medications may affect the effect of enzalutamide or enzalutamide may affect the effect of these medications.

This includes certain medications 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, valproic acid),
• treating certain psychiatric disorders such as severe anxiety or schizophrenia (e.g., diazepam, midazolam, haloperidol),
• treating sleep disorders (e.g., zolpidem),

• treating heart problems or lowering blood pressure (e.g., bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil),
• treating severe inflammatory diseases (e.g., dexamethasone, prednisolone),

• treating HIV infection (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 problems or stroke (e.g., dabigatran etexilate),
• preventing organ rejection (e.g., tacrolimus).

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

Inform your doctor if you are taking any of the above medications. It may be necessary to modify the dose of enzalutamide or any other medication you are taking.

Pregnancy, Breastfeeding, and Fertility

• Enzalutamide is not indicated in women. This medication may be harmful to the fetus or may cause an abortion if taken by a pregnant woman. It should not be administered to pregnant women, women who may become pregnant, or women who are breastfeeding.

• It is possible that this medication 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 medication. If you have sex with a pregnant woman, you should use a condom to protect the fetus during treatment and for 3 months after treatment with this medication.

• In the case of female caregivers, see section 3 "How to Take Enzalutamide Sandoz" for handling and use 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 have a higher risk of having seizures, you should consult your doctor.

Enzalutamide Sandoz contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Enzalutamide Sandoz contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to Take Enzalutamide Sandoz

Follow the exact instructions for administration of this medication as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is 160 mg (four 40 mg film-coated tablets or two 80 mg film-coated tablets), taken at the same time once a day.

How to Take Enzalutamide Sandoz

• Swallow the tablets whole with water.

• Do not break, crush, or chew the tablets before swallowing.
• This medication can be taken with or without food.
• This medication should not be handled by anyone other than the patient or their caregivers. Pregnant women or women who may become pregnant should not handle broken or damaged tablets of this medication without protection, such as gloves.

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

If you take more Enzalutamide Sandoz than you should

If you take more tablets 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 medication and the amount ingested.

If you forget to take Enzalutamide Sandoz

• 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 forgotten doses.

If you stop treatment with Enzalutamide Sandoz

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

If you have any other questions about the use of this medication, ask your doctor.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Seizures

Seizures have been reported in 6 out of 1,000 people taking enzalutamide, and in less than 3 out of 1,000 people taking placebo.

Seizures are more likely if you take a dose of this medication higher than recommended, if you take certain medications, 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 flashes, high blood pressure.

Common(may affect up to 1 in 10 people)

Headache, feeling anxious, dry skin, itching, difficulty remembering, blockage of heart arteries (ischemic heart disease), breast enlargement in men (gynecomastia), nipple pain, breast tenderness, restless legs syndrome, lack of concentration, memory loss, change in taste, difficulty thinking clearly.

Uncommon(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).

Frequency Not Known(frequency cannot be estimated from available data)

Muscle pain, muscle spasms, muscle weakness, back pain, changes in electrocardiogram (QT interval prolongation), stomach discomfort 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), another severe skin reaction that presents with reddish patches, not raised, target-like or circular on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genitals, and eyes that may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), rash, feeling sick (vomiting), swelling of the face, lips, tongue, and/or throat, decrease in blood platelet count (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 side effects not listed in this package 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 medication.

5. Storage of Enzalutamide Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton, blister pack, and bottle after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. If in doubt, consult your pharmacist about how to dispose of the packaging and unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Enzalutamida Sandoz

The active ingredient is enzalutamida.

Enzalutamida Sandoz 40 mg film-coated tablets: Each film-coated tablet contains 40 mg of enzalutamida.

Enzalutamida Sandoz 80 mg film-coated tablets: Each film-coated tablet contains 80 mg of enzalutamida.

The other components (excipients) are:

• Tablet core: succinate hypromellose acetate, lactose monohydrate, sodium croscarmellose (E468), microcrystalline cellulose (E460), and magnesium stearate (E470b).

• Coating material: hypromellose (E464), macrogol, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the Product and Container Content

Enzalutamida Sandoz 40 mg film-coated tablets are film-coated tablets, round, yellow, biconvex with the engraving “EN” on one face and “40” on the other face, with a diameter of 11 mm.

Enzalutamida Sandoz 80 mg film-coated tablets are film-coated tablets, oval, yellow, biconvex, with the engraving “EN” on one face and “80” on the other face, with a length of 17 mm and a width of 9 mm.

This medicinal product is available in PVC/PVDC/Aluminum blisters or HDPE bottles with a desiccant (silica gel), with a child-resistant closure and a polypropylene screw cap, with a thermosealed induction line.

Enzalutamida Sandoz 40 mg film-coated tablets are presented in cardboard boxes containing 28 or 112 film-coated tablets (in blisters or blisters that incorporate a pocket cardboard box), 28x1 or 112x1 film-coated tablets (unit dose precut blisters) or 112 film-coated tablets (in a bottle).

Enzalutamida Sandoz 80 mg film-coated tablets are presented in cardboard boxes containing 14 or 56 film-coated tablets (in blisters or blisters that incorporate a pocket cardboard box), 14x1 or 56x1 film-coated tablets (unit dose precut blisters) or 56 film-coated tablets (in a bottle).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmaceútica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57

Ljubljana 1526

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D;

9220 Lendava, Pomurska

Slovenia

Date of the Last Revision of this Leaflet: 02/2025.

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