Enzalutamide stada

Package leaflet: Information for the patient

Enzalutamide STADA, 40 mg, film-coated tablets
Enzalutamide STADA, 80 mg, film-coated tablets
Enzalutamide
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, 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.
Leaflet contents

1. What Enzalutamide STADA is and what it is used for
2. What you need to know 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:
which no longer responds to hormonal therapy or surgical treatment aimed at reducing testosterone levels
or
which 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 radiation therapy 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 1,000 people taking Enzalutamide STADA and in fewer than 3 out of 1,000 people 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 visual 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 (second) cancers, including bladder and colorectal cancer, in patients treated with Enzalutamide STADA.
If gastrointestinal bleeding, blood in the urine, or frequent and urgent need to urinate occur while taking Enzalutamide STADA, contact your doctor as soon as possible.

Swallowing difficulties related to the formulation of the medicine
Difficulty swallowing enzalutamide-containing medicines, including choking incidents, has been reported in patients. Swallowing difficulties and choking incidents were observed more frequently in patients taking the medicine in capsule form, which may be related to the larger size of the capsule. Tablets should be swallowed whole with sufficient water.

Before starting Enzalutamide STADA, inform your doctor if:

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

Inform your doctor if any of the following apply: any heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or if the patient is being treated for such conditions. The risk of heart rhythm disturbances 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. Do not take Enzalutamide STADA if you are allergic to enzalutamide or any of the other ingredients of this medicine.
Serious rash, skin peeling, blisters, and/or oral ulcers, including Stevens-Johnson syndrome, have been reported during treatment with Enzalutamide STADA. If any of these symptoms associated with these severe skin reactions described in section 4 occur, contact your doctor immediately and discontinue 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 intended for use in children and adolescents.

Enzalutamide STADA with other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take. Be aware of the names of your medicines. Keep a list of these medicines 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.

Inform your doctor if you are 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 pain medicines (e.g. meperidine)

Inform your doctor if you are 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 (e.g. gemfibrozil, atorvastatin, simvastatin)
• pain relief (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 diseases 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 stomach 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 increase the risk of heart rhythm disturbances when used with certain other medicines [e.g. methadone (used for pain relief and detoxification in drug addicts), moxifloxacin (an antibiotic), antipsychotics (used to treat severe mental illnesses)].

Inform your doctor if you are 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 pregnant women, may harm the unborn child or possibly cause miscarriage. Do not use this medicine if you are pregnant, could become pregnant, or are breastfeeding.
• This medicine may possibly affect fertility in men.
• If, during treatment and for 3 months after treatment ends, the patient has sexual intercourse with a woman of childbearing age, a condom and another effective method of contraception should be used. If the patient has sexual intercourse with a pregnant woman, a condom should be used to protect the unborn child.
• 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, i.e. 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 (four 40 mg coated tablets or two 80 mg coated tablets), 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 tablets 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. Women who are pregnant or 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 you should
If you take more tablets than prescribed, stop taking Enzalutamide STADA and contact your doctor immediately. The risk of experiencing a seizure or other adverse effects may increase.

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Seizures
Seizures have been reported in 5 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, taking certain other medicines, or when there is 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 out of 1000 people); 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 side effects include:
Very common (may affect more than 1 in 10 people)
fatigue, falls, bone fractures, hot flushes, high blood pressure
Common (may affect up to 1 in 10 people)
headache, feeling anxious, dry skin, itching, memory impairment, blockage of 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 thinking clearly (rational thinking)
Uncommon (may affect up to 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 (cannot be estimated from the available data)
muscle pain, muscle spasms, muscle weakness, back pain, changes in electrocardiogram (prolongation of QT interval), 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 centre surrounded by pale red rings (erythema multiforme), or other severe skin reactions appearing as reddish, flat, target-shaped or round spots 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 (increasing the risk of bleeding or bruising), diarrhoea, loss of appetite
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enzalutamide STADA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle, and cardboard
box after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply 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. Package contents and other information

What Enzalutamide STADA contains
The active substance is enzalutamide.
Each Enzalutamide STADA 40 mg film-coated tablet contains 40 mg of enzalutamide.
Each Enzalutamide STADA 80 mg film-coated tablet contains 80 mg of enzalutamide.
The other ingredients are:

• Tablet core: methacrylic acid and 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 40 mg film-coated tablets are yellow, round, film-coated tablets with the engraved mark "40" on one side, 10 mm in diameter.
Each Enzalutamide STADA pack contains 112 film-coated tablets in blisters made of Aluminium-OPA/Aluminium/PVC in a cardboard box, or 112 x 1 film-coated tablets in perforated single-dose blisters made of Aluminium-OPA/Aluminium/PVC 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 polypropylene (PP) cap, containing 112 film-coated tablets in a cardboard box.
Enzalutamide STADA 80 mg film-coated tablets are yellow, oval, film-coated tablets with the engraved mark "80" on one side, measuring 17 mm x 9 mm.
Each Enzalutamide STADA pack contains 56 film-coated tablets in blisters made of Aluminium-OPA/Aluminium/PVC in a cardboard box, or 56 x 1 film-coated tablets in perforated single-dose blisters made of Aluminium-OPA/Aluminium/PVC 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 polypropylene (PP) cap, containing 56 film-coated tablets 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.
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

For further information about this medicine, 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 medicine is authorised in the European Economic Area countries 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