Enzalutamide stada

Package leaflet: Information for the patient

Enzalutamide STADA, 160 mg, coated tablets
Enzalutamide
Please read all of this leaflet carefully before taking this medicine, because it contains important
information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm
another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.
Contents of the leaflet

1. What Enzalutamide STADA is and what it is 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 Enzalutamide STADA is and what it is 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 hormonal therapy or surgical treatment aimed at reducing testosterone levels
or
that has spread to other parts of the body and responds to hormonal therapy or surgical treatment
aimed at reducing testosterone levels
or

• in men who have previously undergone prostatectomy or radiotherapy and have rapidly rising PSA levels, but whose cancer has not spread to other parts of the body and who respond to hormonal therapy aimed at reducing 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 using 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)
during pregnancy or if there is a possibility of becoming pregnant (see "Pregnancy, breastfeeding and
fertility").

Warnings and precautions
Seizures
Seizures have been reported in 6 out of 1000 patients taking Enzalutamide STADA and in less than 3 out of 1000 patients taking placebo (see below "Enzalutamide STADA with other medicines" and section 4 "Possible side effects").
If you are taking medicines that may cause seizures or increase the risk of seizures, see below "Enzalutamide STADA with other medicines".
If a seizure occurs during treatment:
Contact your doctor immediately. Your doctor will decide whether to discontinue treatment with Enzalutamide STADA.

Posterior reversible encephalopathy syndrome (PRES)
PRES (a rare, reversible condition affecting the brain) has been rarely reported in patients treated with Enzalutamide STADA. If seizures, worsening headache, altered consciousness, blindness, or other vision disturbances occur, contact your doctor immediately (see also section 4 "Possible side effects").

Risk of new cancers (second primary malignant tumours)
There have been reports of new (secondary) cancers, including bladder and colorectal cancer, in patients treated with Enzalutamide STADA.
If gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate occur while taking Enzalutamide STADA, contact your doctor as soon as possible.

Swallowing difficulties related to the medicine formulation
Difficulty swallowing Enzalutamide-containing tablets, including choking incidents, has been reported. Tablets should be swallowed whole with sufficient water.

Before starting Enzalutamide STADA, tell your doctor if:

• the patient has ever experienced severe rash, skin peeling, blisters, and/or oral mucosal ulcers after taking Enzalutamide STADA or other medicines
• the patient is taking other anticoagulant medicines (e.g. warfarin, acenocoumarol, clopidogrel)
• the patient is undergoing chemotherapy, e.g. docetaxel
• the patient has liver disease
• the patient has kidney disease

Tell your doctor if any of the following apply: any heart or blood vessel conditions, including heart rhythm disorders (arrhythmias), or if the patient is being treated for such conditions. The risk of heart rhythm disorders may increase during treatment with Enzalutamide STADA.
If the patient is allergic to enzalutamide, a rash or swelling of the face, tongue, lips, or throat may occur. If allergy to enzalutamide or any of the other ingredients of this medicine has been diagnosed, Enzalutamide STADA must not be taken.
Serious skin reactions, including Stevens-Johnson syndrome, such as severe rash, skin peeling, blisters, and/or oral ulcers, have been reported during treatment with Enzalutamide STADA. If any of these symptoms, described in section 4, occur, contact your doctor immediately and discontinue treatment with Enzalutamide STADA.

If any of the above situations apply or if you have any doubts, consult your doctor
before taking this medicine.

Children and adolescents
This medicine is not indicated for use in children and adolescents.

Enzalutamide STADA with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Be aware of the names of the medicines being taken.
Keep a list of these medicines with you to show your doctor when a new medicine is prescribed. Do not start or stop taking any medicine without consulting the doctor who prescribed Enzalutamide STADA.

Tell your doctor if the patient is taking any of the following medicines. These medicines, when taken together 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 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 medicines used to treat pain (e.g. meperidine)

Tell your doctor if the patient is taking any of the following medicines. These medicines may affect the action of Enzalutamide STADA or Enzalutamide STADA may affect their action.
This includes medicines used for:

• lowering cholesterol levels (e.g. gemfibrozil, atorvastatin, simvastatin)
• pain treatment (e.g. fentanyl, tramadol)
• cancer treatment (e.g. cabazitaxel)
• epilepsy treatment (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
• treatment of certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
• treatment of sleep disorders (e.g. zolpidem)
• treatment of heart conditions or lowering blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• treatment of serious inflammatory conditions (e.g. dexamethasone, prednisolone)
• treatment of HIV infection (e.g. indinavir, ritonavir)
• treatment of bacterial infections (e.g. clarithromycin, doxycycline)
• treatment of thyroid disorders (e.g. levothyroxine)
• treatment of gout (e.g. colchicine)
• treatment of gastrointestinal disorders (e.g. omeprazole)
• prevention of heart disease or stroke (e.g. dabigatran etexilate)
• prevention of organ transplant rejection (e.g. tacrolimus)

Enzalutamide STADA may affect the action of certain medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol) or may increase the risk of heart rhythm disorders when used together with certain other medicines [e.g. methadone (used for pain relief and detoxification in drug addicts), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental illnesses)].
Tell your doctor if the patient is taking any of the medicines listed above. The dose of Enzalutamide STADA or any other medicine being taken may need to be adjusted.

Pregnancy, breastfeeding and fertility

• Enzalutamide STADA is not indicated for use in women. This medicine, if taken by a pregnant woman, may harm the unborn child or potentially cause miscarriage. This medicine must not be used if a woman is pregnant, could become pregnant, or is breastfeeding.
• This medicine may possibly affect fertility in men.
• If the patient has sexual intercourse with a woman of reproductive potential during treatment and for 3 months after treatment ends, a condom and another effective method of contraception must be used. If the patient has sexual intercourse with a pregnant woman, a condom must be used to protect the unborn child during treatment and for 3 months after treatment ends.
• Caregivers – see section 3 "How to take Enzalutamide STADA" for instructions on how to handle the medicine.

Driving and operating machinery
Enzalutamide STADA may have a moderate effect on the ability to drive and operate machinery. Seizures have been reported in patients taking Enzalutamide STADA. If there is an 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, meaning the medicine is considered "sodium-free".

3. How to take Enzalutamide STADA

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

The recommended dose is 160 mg (one 160 mg coated tablet) taken once daily at the same time each day.

Taking Enzalutamide STADA

• Swallow the tablet whole with a sufficient amount of water.
• Do not cut, crush, or chew the tablet before swallowing.
• Enzalutamide STADA may be taken with or without food.
• Individuals other than the patient or their caregivers should not come into contact with Enzalutamide STADA. Pregnant women or women who may become pregnant must not handle damaged or crushed Enzalutamide STADA tablets without protective gloves.

Your doctor may also prescribe other medicines during treatment with Enzalutamide STADA.

If you take more Enzalutamide STADA than prescribed
If you take more tablets than prescribed, stop taking Enzalutamide STADA and contact your doctor immediately. This may increase the risk of seizures or other adverse effects.

If you forget to take Enzalutamide STADA

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

Stopping Enzalutamide STADA
Do not stop treatment unless instructed by your doctor.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Seizures
Seizures have been reported in 6 out of 1000 people taking Enzalutamide STADA and in fewer than 3 out of 1000 people taking placebo.
The occurrence of seizures is more likely when taking a higher than recommended dose of this medicine, when taking certain other medicines, or in patients who have a higher than usual risk of having a seizure.
If a seizure occurs, contact your doctor immediately. Your doctor will decide whether to discontinue treatment with Enzalutamide STADA.

Posterior reversible encephalopathy syndrome (PRES)
PRES has been reported rarely in patients treated with Enzalutamide STADA (may occur in fewer than 1 in 1000 patients); this is a rare, reversible brain condition. If seizures, worsening headache, altered consciousness, blindness, or other vision disturbances occur, contact your doctor as soon as possible.

Other adverse reactions include:

Very common (may occur in more than 1 in 10 people)
fatigue, falls, bone fractures, hot flushes, high blood pressure.

Common (may occur in fewer than 1 in 10 people)
headache, feeling anxious, dry skin, itching, memory impairment, blocked arteries in the heart (ischaemic heart disease), breast enlargement in men (gynaecomastia), nipple pain, breast tenderness, restless legs syndrome (uncontrollable urge to move part of the body, usually the leg), reduced concentration, forgetfulness, change in taste sensation, difficulty with clear (rational) thinking.

Uncommon (may occur in fewer than 1 in 100 people)
hallucinations, low white blood cell count, increased liver enzyme activity in blood tests (a sign 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), difficulty swallowing this medicine, including choking, stomach discomfort including nausea, skin reaction causing red spots or areas with a target-like appearance, with a dark red center surrounded by pale red rings (erythema multiforme), or other severe skin reactions presenting as reddish, flat, circular or target-shaped rashes on the trunk, often with central blisters, skin peeling, ulceration of the mouth, throat, nose, genital organs, and eyes, which may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), rash, vomiting, facial swelling, swelling of the lips, tongue and (or) throat, reduced platelet count (which increases the risk of bleeding or bruising), diarrhoea, decreased appetite.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

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 cardboard
package after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Do not remove the oxygen absorber from the bottles.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Enzalutamide STADA contains
The active substance is enzalutamide.
Each coated tablet contains 160 mg of enzalutamide.
The other components are:

• Tablet core: methacrylic acid-ethyl acrylate copolymer (1:1) type A (containing sodium lauryl sulfate and polysorbate 80), colloidal anhydrous 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 160 mg coated tablets are yellow, oval, film-coated tablets, embossed with the
marking "160" on one side, measuring 23 mm x 11 mm.
Each pack of Enzalutamide STADA contains 28 or 56 film-coated tablets in blisters made of
Aluminium/OPA/Aluminium/PVC, packed in a cardboard box, or 28 x 1, 56 x 1 film-coated tablet in
perforated unit-dose blisters made of Aluminium/OPA/Aluminium/PVC, packed in a cardboard box.
Enzalutamide STADA is also available in multi-packs containing 84 tablets (2 packs of 42) in blisters
made of Aluminium/OPA/Aluminium/PVC, packed in a cardboard box, or in multi-packs containing
84 x 1 (2 packs of 42 x 1) film-coated tablets in perforated unit-dose blisters made of
Aluminium/OPA/Aluminium/PVC, packed in a cardboard box.
Enzalutamide STADA is also available in high-density polyethylene (HDPE) bottles with a
polypropylene (PP) container containing an oxygen-absorbing agent and a child-resistant PP cap,
containing 28 film-coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
PharOS MT Ltd.
HF62X, Qasam Industrijali Hal Far
BBG3000 Hal Far, Birzebbugia
Malta
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
PharOS Pharmaceutical Oriented Servises Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone
144 52 Metamorfossi
Greece
Clonmel Healthcare Ltd.
Waterford Road
E91 D768 Clonmel, Co. Tipperary
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area member states under the following names:
Belgium Enzalutamide EG 160 mg film-coated tablets
Spain Enzalutamida STADA 160 mg comprimidos recubiertos con película
Netherlands Enzalutamide CF 160 mg, filmomhulde tabletten
Ireland Enzalutamide Clonmel 160 mg film-coated tablets
Luxembourg
Malta Enzalutamide Clonmel 160 mg film-coated tablets
Germany Enzalutamid STADA 160 mg Filmtabletten
Poland Enzalutamide STADA
Portugal Enzalutamida Stada
Romania Enzalutamidă Stada 160 mg comprimate filmate
Slovenia Enzalutamid STADA 160 mg filmsko obložene tablete
Slovakia Enzalutamide STADA 160 mg
Hungary Enzalutamide STADA 160 mg filmtabletta