ENZALUTAMIDE SANDOZ 80 mg FILM-COATED TABLETS

2. What you need to know before you take Enzalutamide Sandoz

Do not take Enzalutamide Sandoz

• 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 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 medicines and Enzalutamide Sandoz” below and “Possible side effects” in section 4).

If you are taking a medicine that may cause seizures or may increase the risk of having seizures (see below “Other medicines and Enzalutamide Sandoz”).

If you have a seizure during treatment:

Talk to 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 cancer and colon cancer.

Talk to 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.

Talk to your doctor before taking Enzalutamide Sandoz:

• If you have ever developed severe skin rash, blistering, or peeling of the skin after taking enzalutamide or other medicines.

• 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.

Please inform 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 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 swelling of the face, lips, tongue, or throat. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take this medicine.

Severe skin rashes, blistering, or peeling of the skin, including Stevens-Johnson syndrome, have been reported in association with enzalutamide treatment. Stop using enzalutamide and seek medical attention immediately 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 not sure, talk to your doctor before taking this medicine.

Children and adolescents

This medicine should not be given to children or adolescents.

Other medicines and Enzalutamide Sandoz

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 he prescribes you a new medicine. Do not start or stop taking any medicine before talking to the doctor who prescribed it for you.

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 any of 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 illness)].

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, breast-feeding and fertility

• Enzalutamide is not indicated in women. This medicine may harm the fetus or cause abortion if taken by a pregnant woman. It should not be given to pregnant women, women who may become pregnant, or women who are breast-feeding.

• It is possible that 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 during treatment and for 3 months after treatment with this medicine.

• 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 taking enzalutamide. If you have a higher risk of having seizures, you should talk to your doctor.

Enzalutamide Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

Enzalutamide Sandoz contains sodium

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

3. How to take Enzalutamide Sandoz

Take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor.

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 medicine can be taken with or without food.
• This medicine 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 medicine without protection, such as gloves.

It is also possible that your doctor may prescribe other medicines 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 medicine and the amount taken.

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 whole day, take the usual dose the next day.

• If you forget to take enzalutamide for more than one day, talk to your doctor immediately.
• Do not take a double doseto make up for forgotten doses.

If you stop taking Enzalutamide Sandoz

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 medicine higher than recommended, if you take certain medicines, or if you have a higher risk of having seizures.

If you have a seizure, talk to 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 heart arteries (ischemic heart disease), breast swelling in men (gynecomastia), nipple pain, breast tenderness, restless legs syndrome (an uncontrollable need to move a part of the body, usually the legs), 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 the available data)

Muscle pain, muscle spasms, muscle weakness, back pain, changes in 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), 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 of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enzalutamide Sandoz

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 carton, blister pack, and on the bottle after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Container Contents 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:

• Core of the tablet: 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 Contents

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 in 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.