Enzalutamide Stada

Package Leaflet: Information for the Patient

Enzalutamide STADA, 40 mg, coated tablets

Enzalutamide STADA, 80 mg, coated tablets

Enzalutamide

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

Keep this package leaflet, so you can read it again if you need to. If you have any further questions, ask your doctor. This medicine has been prescribed to you personally. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this package leaflet, tell your doctor. See section 4.

Table of Contents of the Package 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 pack 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: which no longer responds to hormone therapy or surgical treatment to reduce testosterone levels, or which 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 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 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 you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6), during pregnancy or if you may become pregnant (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 you are taking medicines that may cause seizures or increase the risk of seizures, see below "Enzalutamide Stada and other medicines". If you experience a seizure during treatment: Contact your doctor immediately. The doctor will decide whether to stop taking Enzalutamide Stada. Posterior Reversible Encephalopathy Syndrome (PRES), Rarely, patients treated with Enzalutamide Stada have reported PRES (a rare, reversible condition affecting the brain). If you experience seizures, worsening headache, changes in mental status, blindness, or other vision changes, 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 Stada. If you experience symptoms of gastrointestinal bleeding, blood in urine, or frequent urgent need to urinate while taking Enzalutamide Stada, contact your doctor as soon as possible. Before starting treatment with Enzalutamide Stada, tell your doctor if:

• you have ever had a severe skin rash or skin peeling or blisters or mouth sores after taking Enzalutamide Stada 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 conditions: any heart or blood vessel disease, including irregular heartbeat (arrhythmia) or if you are being treated for these conditions. The risk of irregular heartbeat may increase when taking Enzalutamide Stada. If you are allergic to enzalutamide, you may experience 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 Enzalutamide Stada. Serious skin rash or skin peeling or blisters or mouth sores, including Stevens-Johnson syndrome, have been reported in patients treated with Enzalutamide Stada. If you experience any of these symptoms, related to these severe skin reactions, described in section 4, contact your doctor immediately and stop taking Enzalutamide Stada.

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.

Enzalutamide Stada and other medicines

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

• 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, as they may affect the action of Enzalutamide Stada or Enzalutamide Stada may affect the action of these medicines. This includes 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 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 other medicines [e.g., methadone (used to relieve pain and for detoxification in opioid addiction), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental illness)]. Tell your doctor if you are taking any of these medicines. The dose of Enzalutamide Stada or the other medicine 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. Do not take this medicine if you are pregnant, may become pregnant, or are breastfeeding.

This medicine may affect fertility in men. If you are having sex with a woman of childbearing age during treatment and for 3 months after stopping treatment, use a condom and another effective method of contraception. If you are having sex with a pregnant woman, use a condom to protect the unborn baby. Caregivers - see section 3 "How to take Enzalutamide Stada", which describes how to handle the medicine.

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. If you are at increased risk of seizures, consult your doctor.

Enzalutamide Stada contains sodium

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

3. How to take Enzalutamide Stada

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 Enzalutamide Stada

• Swallow the tablet whole with water.
• Do not cut, crush, or chew the tablet before swallowing.
• Enzalutamide Stada can be taken with or without food.
• People other than the patient or their caregivers should not handle Enzalutamide Stada. Women who are pregnant or may become pregnant should not touch damaged or broken Enzalutamide Stada tablets without protective gloves.

Your doctor may also prescribe other medicines while you are taking Enzalutamide Stada.

Taking more Enzalutamide Stada than prescribed

If you take more tablets than prescribed, stop taking Enzalutamide Stada and contact your doctor. The risk of seizures or other side effects may increase.

Missing a dose of Enzalutamide Stada

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

Stopping treatment with Enzalutamide Stada

Do not stop treatment unless your doctor tells you to. If you have any further questions about the use of this medicine, ask your 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. The risk of seizures is higher when taking more than the recommended dose of this medicine, taking certain other medicines, or having a higher-than-usual risk of seizures. If you experience a seizure,contact your doctor immediately. The doctor will decide whether to stop taking Enzalutamide Stada.

Posterior Reversible Encephalopathy Syndrome (PRES)

Rarely, patients treated with Enzalutamide Stada have reported PRES (a rare, reversible condition affecting the brain). If you experience seizures, worsening headache, changes in mental status, blindness, or other vision changes, contact your doctor immediately.

Other side effects include:

Very common(may affect more than 1 in 10 people) fatigue, dizziness, 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, 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 disease) Frequency not known(frequency cannot be estimated from available data) muscle pain, muscle spasms, muscle weakness, back pain, changes in electrocardiogram (QT interval prolongation), skin rash causing red patches or areas with a red border, or other severe skin reactions, including Stevens-Johnson syndrome, vomiting, swelling of the face, lips, tongue, or throat, decreased platelet count (increasing the risk of bleeding or bruising), diarrhea

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor. You can also report side effects directly to the national reporting system: Department of Medicines Monitoring, 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. You can also report side effects to the marketing authorization holder.

5. How to store Enzalutamide Stada

Keep this medicine out of the 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. 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 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 - ethyl acrylate copolymer (1:1) type A (contains sodium lauryl sulfate and polysorbate 80), silica, colloidal anhydrous, 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, 10 mm in diameter. Each pack of Enzalutamide Stada contains 112 coated tablets in aluminum-OPA/Aluminum/PVC blisters in a carton or 112 x 1 coated tablets in perforated unit dose blisters 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 cap, child-resistant, containing 112 coated tablets in a carton. Enzalutamide Stada 80 mg coated tablets are yellow, oval, coated tablets, with "80" engraved on one side, 17 mm x 9 mm in size. Each pack of Enzalutamide Stada contains 56 coated tablets in aluminum-OPA/Aluminum/PVC blisters in a carton or 56 x 1 coated tablets in perforated unit dose blisters 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 cap, child-resistant, 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