Enzalutamide Stada

Leaflet attached to the packaging: patient information

Enzalutamide STADA, 40 mg, coated tablets

Enzalutamide STADA, 80 mg, coated tablets

Enzalutamide

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.
In case of any doubts, consult a 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 Enzalutamide Stada and what is it used for
• 2. Important information before taking Enzalutamide Stada
• 3. How to take Enzalutamide Stada
• 4. Possible side effects
• 5. How to store Enzalutamide Stada
• 6. Contents of the packaging and other information

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

Enzalutamide Stada contains the active substance enzalutamide. Enzalutamide Stada 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 men who have had their prostate gland removed or have undergone radiation 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 Enzalutamide Stada works

Enzalutamide Stada 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 Stada

When not to take Enzalutamide Stada

if the patient is allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6)
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 Stada and in less than 3 out of 1000 people taking placebo (see below "Enzalutamide Stada 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 Stada 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 Stada.
Posterior Reversible Encephalopathy Syndrome (PRES)
PRES has been rarely reported in patients treated with Enzalutamide Stada (may occur less frequently than 1 in 1000 people); it is a rare, reversible condition of the brain. If seizures, worsening headache, altered mental status, blindness, or other vision changes occur, the patient should contact their doctor immediately.

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 Stada.
If the patient experiences symptoms of gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate while taking Enzalutamide Stada, they should contact their doctor as soon as possible.

Before starting Enzalutamide Stada, the patient should tell their doctor if:

• they have ever had a severe skin rash or skin peeling or blisters or mouth sores after taking Enzalutamide Stada 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 Stada.
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 Stada.
Severe skin rash or skin peeling or blisters or mouth sores, including Stevens-Johnson syndrome, have been reported in patients treated with Enzalutamide Stada. If any of these symptoms occur, the patient should contact their doctor immediately and stop taking Enzalutamide Stada.

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 Stada 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 before consulting their doctor, who prescribed Enzalutamide Stada.
The patient should tell their doctor if they are taking any of the following medicines. These medicines, when taken with Enzalutamide Stada, 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 Stada or Enzalutamide Stada may affect the action of these medicines.
This includes 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 Stada 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 for pain relief and detoxification in opioid addiction), 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 Stada or any other medicine being taken may need to be changed.

Pregnancy, breastfeeding, and fertility

• Enzalutamide Stada is not intended for use in women.This medicine, when taken by women during pregnancy, may harm the unborn baby 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 has sex with a woman of childbearing age during treatment and for 3 months after stopping treatment, they should use a condom and another effective method of contraception. If the patient has sex with a pregnant woman, they should use a condom to protect the unborn baby.

Driving and using machines

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

Enzalutamide Stada contains sodium

This 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 Stada

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient 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 Stada

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

The doctor may also prescribe other medicines while taking Enzalutamide Stada.

Taking more Enzalutamide Stada than prescribed

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

Missing a dose of Enzalutamide Stada

• If the patient forgets to take Enzalutamide Stada at the scheduled time, they should take the usual dose as soon as possible.
• If the patient forgets to take Enzalutamide Stada on a given day, they should take the usual dose the next day.
• If the patient forgets to take Enzalutamide Stada 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 Enzalutamide Stada

The patient should not stop treatment unless their doctor decides to do so.
In case of further doubts about the use of this medicine, the patient should consult their doctor.

4. Possible side effects

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

Seizures

Seizures have been reported in 5 out of 1000 people taking Enzalutamide Stada 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, or 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 Stada.

Posterior Reversible Encephalopathy Syndrome (PRES)

PRES has been rarely reported in patients treated with Enzalutamide Stada (may occur less frequently than 1 in 1000 people); it is a rare, reversible condition of the brain. If seizures, worsening headache, altered mental status, blindness, or other vision changes 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 less than 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 less than 1 in 100 people)
hallucinations, low white blood cell count, increased liver enzyme activity in blood tests (indicating liver disease)
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), skin rash causing red spots or areas on the skin, or other severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or other skin reactions, such as erythema multiforme

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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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, more information can be gathered on the safety of this medicine.

5. How to store Enzalutamide Stada

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Do not remove the oxygen absorber from the bottles.
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 Stada contains

The active substance is enzalutamide.
Each Enzalutamide Stada 40 mg coated tablet contains 40 mg of enzalutamide.
Each Enzalutamide Stada 80 mg coated tablet contains 80 mg of enzalutamide.
The other ingredients are:

• Tablet core: methacrylic acid and ethyl acrylate copolymer (1:1) type A (contains sodium lauryl sulfate and polysorbate 80), colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Tablet coating: hypromellose 2910, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), talc.

What Enzalutamide Stada looks like and contents of the pack

Enzalutamide Stada 40 mg coated tablets are yellow, round, coated tablets, with "40" engraved on one side, with a diameter of 10 mm.
Each pack of Enzalutamide Stada contains 112 coated tablets in blisters of aluminum-OPA/Aluminum/PVC in a carton or 112 x 1 coated tablets in perforated unit dose blisters of aluminum-OPA/Aluminum/PVC in a carton. Enzalutamide Stada is also available in high-density polyethylene (HDPE) bottles with a polypropylene (PP) container containing an oxygen absorber and a PP child-resistant cap, containing 112 coated tablets in a carton.
Enzalutamide Stada 80 mg coated tablets are yellow, oval, coated tablets, with "80" engraved on one side, with dimensions of 17 mm x 9 mm.
Each pack of Enzalutamide Stada contains 56 coated tablets in blisters of aluminum-OPA/Aluminum/PVC in a carton or 56 x 1 coated tablets in perforated unit dose blisters of aluminum-OPA/Aluminum/PVC in a carton. Enzalutamide Stada is also available in high-density polyethylene (HDPE) bottles with a polypropylene (PP) container containing an oxygen absorber and a PP child-resistant cap, containing 56 coated tablets in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer

PharOS MT Ltd.
HF62, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Stada Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Clonmel Healthcare Ltd.
Waterford Road
E91 D768 Clonmel, Co. Tipperary
Ireland
To obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

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

Austria
Enzalutamid STADA 40 mg Filmtabletten
Enzalutamid STADA 80 mg Filmtabletten
Belgium
Enzalutamide EG 40 mg filmomhulde tabletten
Enzalutamide EG 80 mg filmomhulde tabletten
Enzalutamide EG 40 mg Filmtabletten
Enzalutamide EG 80 mg Filmtabletten
Enzalutamide EG 40 mg comprimés pelliculés
Enzalutamide EG 80 mg comprimés pelliculés
Croatia
Enzalutamid STADA 40 mg filmom obložene tablete
Enzalutamid STADA 80 mg filmom obložene tablete
Cyprus
Enzalutamide/Stada 40 mg επικαλυμμένα με λεπτό υμένιο δισκία
Enzalutamide/Stada 80 mg επικαλυμμένα με λεπτό υμένιο δισκία
Czech Republic
Enzalutamid STADA
Denmark
Enzalutamide STADA
Estonia
Enzalutamide STADA
Finland
Enzalutamide STADA 40 mg kalvopäällysteiset tabletit
Enzalutamide STADA 80 mg kalvopäällysteiset tabletit
France
ENZALUTAMIDE EG 40 mg, comprimé pelliculé
ENZALUTAMIDE EG 80 mg, comprimé pelliculé
Greece
Enzalutamide/Stada
Spain
Enzalutamida STADA 40 mg comprimidos recubiertos con película EFG
Enzalutamida STADA 80 mg comprimidos recubiertos con película EFG
Netherlands
Enzalutamide CF 40 mg, filmomhulde tabletten
Enzalutamide CF 80 mg, filmomhulde tabletten
Ireland
Enzalutamide Clonmel 40 mg film-coated tablets
Enzalutamide Clonmel 80 mg film-coated tablets
Iceland
Enzalutamide STADA 40 mg filmuhúðaðar töflur
Enzalutamide STADA 80 mg filmuhúðaðar töflur
Lithuania
Enzalutamide STADA 40 mg plėvele dengtos tabletės
Enzalutamide STADA 80 mg plėvele dengtos tabletės
Luxembourg
Enzalutamide EG 40 mg comprimés pelliculés
Enzalutamide EG 80 mg comprimés pelliculés
Latvia
Enzalutamide STADA 40 mg apvalkotās tabletes
Enzalutamide STADA 80 mg apvalkotās tabletes
Malta
Enzalutamide Clonmel 40 mg film-coated tablets
Enzalutamide Clonmel 80 mg film-coated tablets
Germany
Enzalutamid AL 40 mg Filmtabletten
Enzalutamid AL 80 mg Filmtabletten
Norway
Enzalutamide STADA
Poland
Enzalutamide STADA
Portugal
Enzalutamida Stada
Romania
Enzalutamidă Stada 40 mg comprimate filmate
Enzalutamidă Stada 80 mg comprimate filmate
Sweden
Enzalutamide STADA
Slovenia
Enzalutamid STADA 40 mg filmsko obložene tablete
Enzalutamid STADA 80 mg filmsko obložene tablete
Slovakia
Enzalutamide STADA 40 mg
Enzalutamide STADA 80 mg
Hungary
Enzalutamide STADA 40 mg filmtabletta
Enzalutamide STADA 80 mg filmtabletta
Italy
Enzalutamide EG

Date of last revision of the leaflet: