Enzalutamid Sandoz

Leaflet attached to the packaging: patient information

Enzalutamid Sandoz, 40 mg, coated tablets

Enzalutamid Sandoz, 80 mg, coated tablets

Enzalutamidum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Enzalutamid Sandoz and what is it used for
• 2. Important information before taking Enzalutamid Sandoz
• 3. How to take Enzalutamid Sandoz
• 4. Possible side effects
• 5. How to store Enzalutamid Sandoz
• 6. Contents of the pack and other information

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

Enzalutamid Sandoz contains the active substance enzalutamide. Enzalutamid Sandoz is used in adult men for the treatment of prostate cancer

• that no longer responds to hormone therapy or surgical treatment to reduce testosterone levels or
• that has spread to other parts of the body and responds to hormone therapy or surgical treatment to reduce testosterone levels or
• in which the prostate gland has been removed or the patient has undergone radiation therapy and had a rapid increase in PSA levels, but the cancer has not spread to other parts of the body and responds to hormone therapy to reduce testosterone levels.

How Enzalutamid Sandoz works

Enzalutamid Sandoz is a medicine 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 Enzalutamid Sandoz

When not to take Enzalutamid Sandoz

• in pregnancy or possibility of pregnancy (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Seizure
Seizures have been reported in 6 out of 1000 people taking enzalutamide and in less than 3 out of 1000 people taking placebo (see below "Enzalutamid Sandoz and other medicines" and in section 4 "Possible side effects").
In case of taking medicines that may cause seizures or increase the risk of seizures, see below "Enzalutamid Sandoz and other medicines".
In case of a seizure during treatment:
Contact your doctor immediately. The doctor will decide whether to stop taking Enzalutamid Sandoz.
Posterior Reversible Encephalopathy Syndrome (PRES)
In patients treated with enzalutamide, PRES (a rare, reversible brain condition) has been rarely reported (may occur less often than in 1 out of 1000 people).
If seizures, worsening headache, changes in consciousness, blindness, or other vision disturbances occur, contact your doctor immediately (see also section 4. "Possible side effects").
Risk of new tumors (second primary malignant tumors)
There have been reports of new (second) cases of cancer, including bladder and colon cancer, in patients treated with enzalutamide.
If, while taking Enzalutamid Sandoz, symptoms of gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate occur, contact your doctor as soon as possible.

Before taking Enzalutamid Sandoz, tell your doctor if:

• you have ever had a severe skin rash or skin peeling, blisters, and (or) mouth ulcers after taking Enzalutamid Sandoz or other medicines
• you are taking other medicines to prevent blood clots (e.g., warfarin, acenocoumarol, clopidogrel)
• you are undergoing chemotherapy, e.g., docetaxel
• you have liver disease
• you have kidney disease

Tell your doctor if you have any of the following:

any heart or blood vessel disease, including heart rhythm disorders (arrhythmia) or if you are being treated for these diseases. The risk of heart rhythm disorders may increase when taking Enzalutamid Sandoz.
If you are allergic to enzalutamide, you may experience a rash or swelling of the face, lips, or tongue. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take Enzalutamid Sandoz.
Severe skin rash or skin peeling, blisters, and (or) mouth ulcers, including Stevens-Johnson syndrome, have been reported in patients treated with enzalutamide. If you experience any of the symptoms of these severe skin reactions described in section 4, contact your doctor immediately and stop taking Enzalutamid Sandoz.

In case of any of the above situations or doubts, consult your doctor before taking this medicine.

Children and adolescents

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

Enzalutamid Sandoz and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You should know the names of the medicines you are taking. You should have a list of these medicines with you to show your doctor when prescribing a new medicine. Do not start or stop taking any medicine before consulting the doctor who prescribed Enzalutamid Sandoz.
Tell your doctor if you are taking any of the following medicines. These medicines, when taken with Enzalutamid Sandoz, may increase the risk of seizures:

• certain medicines used to treat asthma and other respiratory diseases (e.g., aminophylline, theophylline)
• medicines 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 pain medicines (e.g., pethidine)

Tell your doctor if you are taking any of the following medicines. These medicines may affect the action of Enzalutamid Sandoz or Enzalutamid Sandoz may affect the action of these medicines.
This applies to medicines 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 strokes (e.g., dabigatran etexilate)
• prevent rejection of a transplanted organ (e.g., tacrolimus)

Enzalutamid Sandoz may affect the action of certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol) or increase the risk of heart rhythm disorders when taken with other medicines [e.g., methadone (used to relieve pain and detoxify narcotics), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental illnesses)].
Tell your doctor if you are taking any of the above medicines. The dose of Enzalutamid Sandoz or any other medicine you are taking may need to be changed.

Pregnancy, breastfeeding, and fertility

• Enzalutamid Sandoz is not intended for use in women.This medicine, when taken by pregnant women, may harm the unborn child or cause miscarriage. Do not take this medicine if you are pregnant, may become pregnant, or are breastfeeding.

This medicine may affect fertility in men.

• If, during treatment and for 3 months after stopping treatment, the patient has sexual intercourse with a woman of childbearing age, a condom and another effective contraceptive method should be used. If the patient has sexual intercourse with a pregnant woman, a condom should be used during treatment and for 3 months after stopping treatment to protect the unborn child.
• Carers of patients - see section 3 "How to take Enzalutamid Sandoz", which describes how to handle the medicine.

Driving and using machines

Enzalutamid Sandoz may have a moderate effect on the ability to drive and use machines. Seizures have been reported in patients taking Enzalutamid Sandoz.
In case of increased risk of seizures, consult your doctor.

Enzalutamid Sandoz contains lactose

If you have previously been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

Enzalutamid Sandoz contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Enzalutamid Sandoz

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor.
The recommended dose is 160 mg (four 40 mg coated tablets or two 80 mg coated tablets), taken at the same time once a day.

Taking Enzalutamid Sandoz

• Swallow the tablet whole with water.
• Do not divide, crush, or chew the tablets before swallowing.
• Enzalutamid Sandoz can be taken with or without food.
• People other than the patient or their carers should not come into contact with Enzalutamid Sandoz. Women who are pregnant or may become pregnant should not touch damaged or broken Enzalutamid Sandoz tablets without protective gloves.

Your doctor may also prescribe other medicines while taking Enzalutamid Sandoz.

Taking more Enzalutamid Sandoz than prescribed

In case of taking more capsules than prescribed, stop taking Enzalutamid Sandoz and contact your doctor. The risk of seizures or other side effects may increase.

Missing a dose of Enzalutamid Sandoz

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

Stopping Enzalutamid Sandoz

Do not stop treatment unless your doctor decides to.
If you have any further doubts about taking this medicine, consult your doctor.

4. Possible side effects

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

Seizure

Seizures have been reported in 6 out of 1000 people taking enzalutamide and in less than 3 out of 1000 people taking placebo.
Seizures are more likely to occur when taking more than the recommended dose of this medicine, taking certain other medicines, and when the risk of seizures is higher than usual.
If a seizure occurs, contact your doctor immediately. The doctor will decide whether to stop taking Enzalutamid Sandoz.

Posterior Reversible Encephalopathy Syndrome (PRES)

In patients treated with enzalutamide, PRES (a rare, reversible brain condition) has been rarely reported (may occur less often than in 1 out of 1000 people).
If seizures, worsening headache, changes in consciousness, blindness, or other vision disturbances 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 up to 1 in 10 people):
headache, feeling anxious, dry skin, itching, memory impairment, coronary artery disease, breast enlargement in men (gynecomastia), breast pain, nipple tenderness, restless legs syndrome, decreased concentration, forgetfulness, changes in taste, difficulty thinking clearly.
Uncommon(may affect up to 1 in 100 people):
hallucinations, low white blood cell count, increased liver enzyme activity in blood tests (indicating liver problems).
Frequency not known(frequency cannot be estimated from the available data):
muscle pain, muscle spasms, muscle weakness, back pain, changes in ECG (QT interval prolongation), stomach upset, including nausea, skin reaction causing red spots or areas with a target-like appearance, or other severe skin reactions, including Stevens-Johnson syndrome, rash, vomiting, swelling of the face, lips, or tongue, decreased platelet count (which may increase the risk of bleeding or bruising), diarrhea.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enzalutamid Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, cardboard box, blister, and bottle after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Enzalutamid Sandoz contains

• The active substance of the medicine is enzalutamide. Enzalutamid Sandoz 40 mg, coated tablets: each coated tablet contains 40 mg of enzalutamide. Enzalutamid Sandoz 80 mg, coated tablets: each coated tablet contains 80 mg of enzalutamide.
• Other ingredients:
• tablet core: octano-hypromellose, lactose monohydrate, sodium croscarmellose, microcrystalline cellulose, magnesium stearate
• tablet coating: hypromellose type 2910, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Enzalutamid Sandoz looks like and contents of the pack

Enzalutamid Sandoz 40 mg, coated tablets are yellow, round, biconvex coated tablets with "EN" engraved on one side and "40" on the other, diameter: 11 mm.
Enzalutamid Sandoz 80 mg, coated tablets: are yellow, oval, biconvex coated tablets with "EN" engraved on one side and "80" on the other, length: 17 mm; width: 9 mm.
The medicine is packaged in PVC/PVDC/Aluminum blisters or in an HDPE bottle with a desiccant (silica gel), closed with a polypropylene cap with a child-resistant closure, with an induction-sealed liner, in a cardboard box.
Enzalutamid Sandoz 40 mg, coated tablets are packaged in cardboard boxes containing 28 or 112 coated tablets (in blisters or in blisters placed in a cardboard box), 28 x 1 or 112 x 1 coated tablet (in perforated single-dose blisters) or 112 coated tablets (in a bottle).
Enzalutamid Sandoz 80 mg, coated tablets are packaged in cardboard boxes containing 14 or 56 coated tablets (in blisters or in blisters placed in a cardboard box), 14 x 1 or 56 x 1 coated tablet (in perforated single-dose blisters) or 56 coated tablets (in a bottle).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Manufacturer

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57
Ljubljana 1526
Slovenia

Lek Pharmaceuticals d.d.

Trimlini 2D; 9220
Lendava
Slovenia
To obtain more detailed information about this medicine, please contact:

Poland

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Enzalutamide Sandoz 40 mg, film-coated tablets
Enzalutamide Sandoz 40 mg, film-coated tablets
Austria
Enzalutamid Sandoz 40 mg - film-coated tablets
Enzalutamid Sandoz 80 mg - film-coated tablets
Bulgaria
Enzalutamide Sandoz 40 mg film-coated tablets
Enzalutamide Sandoz 40 mg, филмирани таблетки
Cyprus
Enzalutamide/Sandoz
Germany
Enzalutamid HEXAL 40 mg, film-coated tablets, ENR: 7013025
Enzalutamid HEXAL 80 mg, film-coated tablets, ENR: 7013026
Denmark
Enzalutamide Sandoz
Estonia
Enzalutamide Sandoz
Spain
Enzalutamida Sandoz 40 mg, film-coated tablets, EFG
Enzalutamida Sandoz 80 mg, film-coated tablets, EFG
Finland
Enzalutamide Sandoz 40 mg tablet, film-coated
Enzalutamide Sandoz 80 mg tablet, film-coated
France
ENZALUTAMIDE SANDOZ 40 mg, film-coated tablet
ENZALUTAMIDE SANDOZ 80 mg, film-coated tablet
Greece
Enzalutamide/Sandoz
Croatia
Enzalutamid Sandoz 40 mg film-coated tablets
Enzalutamid Sandoz 80 mg film-coated tablets
Hungary
Enzalutamid Sandoz 40 mg, film-coated tablet
Enzalutamid Sandoz 80 mg, film-coated tablet
Iceland
Enzalutamide Sandoz
Ireland
Enzalutamide Rowex, 40 mg film-coated tablets
Enzalutamide Rowex, 80 mg film-coated tablets
Italy
Enzalutamide Sandoz
Lithuania
Enzalutamide Sandoz 40 mg, film-coated tablets
Enzalutamide Sandoz 80 mg, film-coated tablets
Latvia
Enzalutamide Sandoz 40 mg, film-coated tablets
Enzalutamide Sandoz 80 mg, film-coated tablets
Malta
Enzalutamide Sandoz 40 mg film-coated tablets
Enzalutamide Sandoz 80 mg film-coated tablets
Norway
Enzalutamide Sandoz
Poland
Enzalutamid Sandoz
Romania
Enzalutamidă Sandoz 40 mg, film-coated tablets
Enzalutamidă Sandoz 80 mg, film-coated tablets
Sweden
Enzalutamide Sandoz
Slovenia
Enzalutamid Sandoz 40 mg, film-coated tablets
Enzalutamid Sandoz 80 mg, film-coated tablets
Slovakia
Enzalutamid Sandoz 40 mg, film-coated tablets
Enzalutamid Sandoz 80 mg, film-coated tablets
Date of last revision of the leaflet:02/2025