Enzalutamide Sandoz

Leaflet accompanying the packaging: patient information

Enzalutamide Sandoz, 40 mg, coated tablets

Enzalutamide Sandoz, 80 mg, coated tablets

Enzalutamide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Enzalutamide Sandoz and what is it used for
• 2. Important information before taking Enzalutamide Sandoz
• 3. How to take Enzalutamide Sandoz
• 4. Possible side effects
• 5. How to store Enzalutamide Sandoz
• 6. Contents of the packaging and other information

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

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

• 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 men who have had their prostate gland removed and have had radiation therapy and have 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 Enzalutamide Sandoz works

Enzalutamide 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 Enzalutamide Sandoz

When not to take Enzalutamide Sandoz

• if the patient is allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6).
• in pregnancy or if pregnancy is possible (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Seizure
Seizures have been reported in 6 out of 1000 people taking Enzalutamide Sandoz and in less than 3 out of 1000 people taking placebo (see below "Enzalutamide Sandoz and other medicines" and in section 4 "Possible side effects").
If the patient is taking medicines that may cause seizures or increase the risk of seizures, see below "Enzalutamide Sandoz and other medicines".
In case of a seizure during treatment:
The patient should contact their doctor immediately. The doctor will decide whether to stop taking Enzalutamide Sandoz.
Posterior Reversible Encephalopathy Syndrome (PRES)
PRES has been rarely reported in patients treated with Enzalutamide Sandoz. If seizures, worsening headache, disturbances of consciousness, blindness, or other visual disturbances occur, the patient should contact their 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 Sandoz.
If the patient experiences symptoms of gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate while taking Enzalutamide Sandoz, they should contact their doctor as soon as possible.
Before starting treatment with Enzalutamide Sandoz, the patient should tell their doctor if:

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

The patient should tell their doctor if they have any of the following conditions:
Any heart or blood vessel disease, including irregular heartbeat (arrhythmia) or if they are being treated for these conditions. The risk of irregular heartbeat may increase when taking Enzalutamide Sandoz.
If the patient is allergic to enzalutamide, they may experience a rash or swelling of the face, lips, tongue, or throat. If an allergy to enzalutamide or any of the other ingredients of this medicine is suspected, the patient should not take Enzalutamide Sandoz.
Severe skin rash or skin peeling, blisters, and (or) mouth sores, including Stevens-Johnson syndrome, have been reported in patients treated with Enzalutamide Sandoz. If any of these symptoms occur, the patient should contact their doctor immediately and stop taking Enzalutamide Sandoz.

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

Children and adolescents

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

Enzalutamide Sandoz and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should know the names of the medicines they are taking. The patient should have a list of these medicines with them to show their doctor when they are prescribed a new medicine. The patient should not start or stop taking any medicine without consulting their doctor, who prescribed Enzalutamide Sandoz.
The patient should tell their doctor if they are taking any of the following medicines. These medicines, when taken with Enzalutamide 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)

The patient should tell their doctor if they are taking any of the following medicines. These medicines may affect the action of Enzalutamide Sandoz or Enzalutamide 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 stroke (e.g., dabigatran etexilate)
• prevent rejection of a transplanted organ (e.g., tacrolimus)

Enzalutamide Sandoz may affect the action of certain medicines used to treat irregular heartbeat (e.g., quinidine, procainamide, amiodarone, and sotalol) or increase the risk of irregular heartbeat when taken with certain other medicines [e.g., methadone (used to relieve pain and for detoxification in drug addicts), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental illness)].
The patient should tell their doctor if they are taking any of the above medicines. The dose of Enzalutamide Sandoz or any other medicine being taken may need to be changed.

Pregnancy, breastfeeding, and fertility

• Enzalutamide Sandoz is not intended for use in women.This medicine, when taken by pregnant women, may harm the unborn child or cause miscarriage. This medicine should not be taken if the woman is pregnant, may become pregnant, or is breastfeeding.

This medicine may affect fertility in men.
If the patient is having sex with a woman who may become pregnant, they should use a condom and another effective method of contraception during treatment and for 3 months after stopping treatment. If the patient is having sex with a pregnant woman, they should use a condom during treatment and for 3 months after stopping treatment to protect the unborn child.
Caregivers of patients - see section 3 "How to take Enzalutamide Sandoz", which describes how to handle the medicine.

Driving and using machines

Enzalutamide Sandoz may have a moderate influence on the ability to drive and use machines. Seizures have been reported in patients taking Enzalutamide Sandoz.
In case of increased risk of seizures, the patient should consult their doctor.

Enzalutamide Sandoz contains sodium

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

3. How to take Enzalutamide Sandoz

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their 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 Enzalutamide Sandoz

• The tablets should be swallowed whole, with water.
• The tablets should not be cut, crushed, or chewed before swallowing.
• Enzalutamide Sandoz can be taken with or without food.
• People other than the patient or their caregivers should not come into contact with Enzalutamide Sandoz. Women who are pregnant or may become pregnant should not touch damaged or broken Enzalutamide Sandoz tablets without protective gloves.

The doctor may also prescribe other medicines while the patient is taking Enzalutamide Sandoz.

Taking more Enzalutamide Sandoz than prescribed

In case of taking more capsules than prescribed, the patient should stop taking Enzalutamide Sandoz and contact their doctor. The risk of seizures or other side effects may increase.

Missing a dose of Enzalutamide Sandoz

• If the patient forgets to take Enzalutamide Sandoz at the scheduled time, they should take the usual dose as soon as possible.
• If the patient forgets to take Enzalutamide Sandoz on a given day, they should take the usual dose the next day.
• If the patient forgets to take Enzalutamide Sandoz for more than one day, they should contact their doctor immediately.
• The patient should not take a double doseto make up for a missed dose.

Stopping treatment with Enzalutamide Sandoz

The patient should not stop treatment unless their doctor decides to do so.
If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Enzalutamide Sandoz can cause side effects, although not everybody gets them.

Seizures

Seizures have been reported in 6 out of 1000 people taking Enzalutamide Sandoz and in less than 3 out of 1000 people taking placebo.
The risk of seizures is higher 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, the patient should contact their doctor immediately. The doctor will decide whether to stop taking Enzalutamide Sandoz.

Posterior Reversible Encephalopathy Syndrome (PRES)

PRES has been rarely reported in patients treated with Enzalutamide Sandoz (may occur in less than 1 in 1000 people); it is a rare, reversible brain condition. If seizures, worsening headache, disturbances of consciousness, blindness, or other visual disturbances occur, the patient should contact their 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 pain, restless legs syndrome, decreased concentration, forgetfulness, change in taste, difficulty thinking clearly.
Uncommon(may affect up to 1 in 100 people):
hallucinations, low white blood cell count, elevated liver enzymes 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, or other severe skin reactions, including skin peeling, mouth sores, genital, and eye ulcers, which may be preceded by fever and flu-like symptoms, rash, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. 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 medicine.

5. How to store Enzalutamide Sandoz

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister, carton, bottle, and outer packaging after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Enzalutamide Sandoz contains

• The active substance is enzalutamide. Enzalutamide Sandoz 40 mg, coated tablets: each coated tablet contains 40 mg of enzalutamide. Enzalutamide Sandoz 80 mg, coated tablets: each coated tablet contains 80 mg of enzalutamide.
• Other ingredients: Tablet core: methacrylic acid and ethyl acrylate copolymer (1:1) Type A (contains sodium lauryl sulfate and polysorbate 80), colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Tablet coating: hypromellose type 2910, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), talk.

What Enzalutamide Sandoz looks like and contents of the pack

Enzalutamide Sandoz, 40 mg, coated tablets: yellow, round, coated tablets, 10 mm in diameter, with "40" engraved on one side.
Each pack of Enzalutamide Sandoz contains 112 tablets in aluminum-OPA/Aluminum/PVC blisters or 112 x 1 tablet in perforated unit dose blisters of aluminum-OPA/Aluminum/PVC in a carton.
Enzalutamide Sandoz is also packaged in aluminum-OPA/Aluminum/PVC blisters in carton wallets containing 28 coated tablets. Each carton contains 112 coated tablets (4 wallets).
Enzalutamide Sandoz is also packaged in high-density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) closures, containing a white, polypropylene (PP) oxygen absorber, and 112 coated tablets, in a carton.
Enzalutamide Sandoz, 80 mg, coated tablets: yellow, oval, coated tablets, 17 mm x 9 mm, with "80" engraved on one side.
Each pack of Enzalutamide Sandoz contains 56 tablets in aluminum-OPA/Aluminum/PVC blisters or 56 x 1 tablet in perforated unit dose blisters of aluminum-OPA/Aluminum/PVC in a carton.
Enzalutamide Sandoz is also packaged in aluminum-OPA/Aluminum/PVC blisters in carton wallets containing 14 coated tablets. Each carton contains 56 coated tablets (4 wallets).
Enzalutamide Sandoz is also packaged in high-density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) closures, containing a white, polypropylene (PP) oxygen absorber, and 56 coated tablets, in a carton.
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
tel. 22 209 70 00
Manufacturer
Pharos MT Limited
HF62X
Qasam Industrijali Hal Far
BBG 3000 Hal Far, Birzebbuga
Malta
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia
To obtain more detailed information on this medicine, the patient should 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 SDZ 40 mg, film-coated tablets
Enzalutamide SDZ 80 mg, film-coated tablets
Austria
Enzalutamid Sandoz GmbH 40 mg - Filmtabletten
Enzalutamid Sandoz GmbH 80 mg - Filmtabletten
Bulgaria
Enzalutamide SDZ 40 mg film-coated tablets
Enzalutamide SDZ 40 mg филмирани таблетки.
Cyprus
Enzalutamide Ebewe 40 mg επικαλυμμένα με λεπτό υμένιο δισκία
Enzalutamide Ebewe 80 mg επικαλυμμένα με λεπτό υμένιο δισκία
Czech Republic
Enzalutamid Sandoz s.r.o.
Germany
Enzalutamid HEXAL 40 mg Filmtabletten
Enzalutamid HEXAL 80 mg Filmtabletten
Denmark
Enzalutamide Hexal
Greece
Enzalutamide/Ebewe
Spain
Enzalutamida Sandoz Farmacéutica 40 mg comprimidos recubiertos con película EFG
Enzalutamida Sandoz Farmacéutica 80 mg comprimidos recubiertos con película EFG
Finland
Enzalutamide Hexal 40 mg tabletti kalvopäällysteinen
Enzalutamide Hexal 80 mg tabletti kalvopäällysteinen
France
ENZALUTAMIDE GNR 40 mg, comprimé pelliculé
ENZALUTAMIDE GNR 80 mg, comprimé pelliculé
Croatia
Enzalutamid Sandoz GmbH 40 mg filmom obložene tablete
Hungary
Enzalutamid 1 A Pharma 40 mg filmtabletta
Enzalutamid 1 A Pharma 80 mg filmtabletta
Ireland
Enzalutamide Rowex 40 mg film-coated tablets
Enzalutamide Rowex 80 mg film-coated tablets
Iceland
Enzalutamide Hexal 40 mg filmuhúðaðar töflur
Enzalutamide Hexal 80 mg filmuhúðaðar töflur
Italy
Enzalutamide Sandoz GmbH
Lithuania
Enzalutamide Hexal 40 mg plėvele dengtos tabletės
Enzalutamide Hexal 80 mg plėvele dengtos tabletės
Latvia
Enzalutamide Hexal 40 mg apvalkotās tabletes
Enzalutamide Hexal 80 mg apvalkotās tabletes
Malta
Enzalutamide Ebewe 40 mg film-coated tablets
Enzalutamide Ebewe 80 mg film-coated tablets
Norway
Enzalutamide Hexal
Poland
Enzalutamide Sandoz
Portugal
Enzalutamida Sandoz Farmacêutica
Romania
Enzalutamidă Sandoz 40 mg comprimate filmate
Enzalutamidă Sandoz 80 mg comprimate filmate
Sweden
Enzalutamide Hexal
Slovenia
Enzalutamid Sandoz GmbH 40 mg filmsko obložene tablete
Slovakia
Enzalutamid Sandoz GmbH 40 mg
Enzalutamid Sandoz GmbH 80 mg
Date of last revision of the leaflet:11/2024