Enzalutamide EG

Package leaflet: Information for the patient

Enzalutamide EG 40 mg film-coated tablets, 80 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

1. What Enzalutamide EG is and what it is used for
2. What you need to know before taking Enzalutamide EG
3. How to take Enzalutamide EG
4. Possible side effects
5. How to store Enzalutamide EG
6. Contents of the pack and other information

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

Enzalutamide EG contains the active substance enzalutamide. Enzalutamide EG is used to treat adult men with prostate cancer:

• whose cancer no longer responds to hormonal therapy or surgical treatment to reduce testosterone. Or
• whose cancer has spread to other parts of the body and still responds to hormonal therapy or surgical treatment to reduce testosterone. Or
• who have previously undergone prostate removal or radiotherapy and have a rapidly rising PSA (prostate-specific antigen), but whose cancer has not spread to other parts of the body and still responds to hormonal therapy to reduce testosterone.

How Enzalutamide EG works
Enzalutamide EG is a medicine that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops the growth and division of prostate cancer cells.

2. What you should know before taking Enzalutamide EG

Do not take Enzalutamide EG

• if you are allergic to enzalutamide or to any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant or may become pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Seizures
Seizures have been reported in 6 out of 1,000 patients treated with Enzalutamide EG and in fewer than 3 out of 1,000 patients treated with placebo (see ‘Other medicines and Enzalutamide EG’ below and section 4, ‘Possible side effects’).
If you are taking a medicine that may cause seizures or increase the risk of seizures (see ‘Other medicines and Enzalutamide EG’, below).
If you have a seizure during treatment:
Contact your doctor as soon as possible. Your doctor may decide that you should stop taking Enzalutamide EG.

Posterior Reversible Encephalopathy Syndrome (PRES)
Rare cases of PRES, a rare reversible condition affecting the brain, have been reported in patients treated with enzalutamide. If you experience a seizure, worsening headache, confusion, blindness or other vision problems, contact your doctor immediately (also see section 4 ‘Possible side effects’).

Risk of new tumours (secondary primary tumours)
New (secondary) tumours, including bladder and colon cancer, have been reported in patients treated with enzalutamide.
Contact your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in your urine, or if you frequently feel a strong urge to urinate while taking Enzalutamide EG.

Talk to your doctor before taking Enzalutamide EG:

• if you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel);
• if you are using a chemotherapy medicine such as docetaxel;
• if you have liver problems;
• if you have kidney problems.

Inform your doctor if you have any of the following conditions:
Any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Enzalutamide EG.
If you are allergic to enzalutamide, you may develop skin rashes or swelling of the face, tongue, lips or throat. If you are allergic to enzalutamide or to any of the other ingredients of this medicine, do not take Enzalutamide EG.
Severe skin rash or skin peeling, blisters and/or mouth ulcers have been reported in association with enzalutamide treatment. Contact your doctor immediately if you notice any of these symptoms.
If you are in any of the conditions listed above or if you are unsure, talk to your doctor before taking this medicine.

Children and adolescents
This medicine must not be used in children and adolescents.

Other medicines and Enzalutamide EG
Tell your doctor if you are taking, have recently taken or might take any other medicines.
You should know the names of all the medicines you are taking. Keep a list of them to show your doctor when you are prescribed a new medicine. Do not start or stop any treatment without first discussing it with the doctor who prescribed Enzalutamide EG.

Tell your doctor if you are taking any of the following medicines. When taken together with Enzalutamide EG, these medicines may increase the risk of seizures:

• certain medicines used to treat asthma or 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 you are taking any of the following medicines. These medicines may affect the action of Enzalutamide EG, or Enzalutamide EG may affect the action of these medicines. This includes, for example, certain 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 psychiatric 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 serious inflammatory conditions (e.g. dexamethasone, prednisolone);
• treat HIV infections (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 organ rejection (e.g. tacrolimus).

Enzalutamide EG may interfere with certain medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm problems when used together with other medicines [e.g. methadone (used to relieve pain and in drug detoxification programmes), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].
Inform your doctor if you are taking any of the medicines listed above. It may be necessary to adjust the dose of Enzalutamide EG or of any other medicine you are taking.

Pregnancy, breastfeeding and fertility

• Enzalutamide EG is not indicated for use in women. This medicine may cause harm to the unborn child or potential pregnancy loss if taken by pregnant women. It must not be taken by women who are pregnant, may become pregnant, or are breastfeeding with breast milk.
• This medicine may affect male fertility.
• If you have sexual intercourse with a woman who may become pregnant, use a condom and another effective method of contraception during treatment and for 3 months after stopping treatment. If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child during treatment and for 3 months after stopping treatment.
• If the person caring for the patient is a woman, see section 3 “How to take Enzalutamide EG” for instructions on use and handling.

Driving and using machines
Enzalutamide EG may have a moderate effect on the ability to drive and use machines. Seizures have been reported in patients taking Enzalutamide EG.
If you are at high risk of seizures, discuss this with your doctor.

Enzalutamide EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Enzalutamide EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.

The usual dose is 160 mg (four 40 mg film-coated tablets or two 80 mg film-coated tablets), taken once daily at the same time each day.

Administration of Enzalutamide EG

• Swallow the tablets whole with water.
• Do not cut, crush, or chew the tablets before swallowing.
• Enzalutamide EG may be taken with or without food.
• Enzalutamide EG must not be handled by anyone other than the patient or their caregiver. Women who are pregnant or may become pregnant must not handle crushed or damaged Enzalutamide EG tablets without wearing protective gloves or similar protection.

Your doctor may prescribe other medicines during treatment with Enzalutamide EG.

If you take more Enzalutamide EG than you should

If you take more tablets than prescribed, stop taking Enzalutamide EG and contact your doctor immediately. You may be at increased risk of seizures or other adverse effects.

If you forget to take Enzalutamide EG

• If you forget to take Enzalutamide EG at your usual time, take your usual dose as soon as you remember.
• If you forget to take Enzalutamide EG for a whole day, take your usual dose the next day.
• If you forget to take Enzalutamide EG for more than one day, speak to your doctor immediately.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Enzalutamide EG

Do not stop taking this medicine unless instructed by your doctor.

If you have any questions about how to use this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seizures
Seizures have been reported in 6 out of 1,000 patients treated with enzalutamide and in fewer than 3 out of 1,000 patients treated with placebo.
The risk of seizures is higher if you take a dose of this medicine higher than that recommended, if you take other medicines, or if you have an above-normal risk of seizures.
If you have a seizure, contact your doctor as soon as possible. Your doctor may decide that you should stop treatment with Enzalutamide EG.
Reversible posterior encephalopathy syndrome (PRES)
Rare cases of PRES (up to 1 in 1,000 people may be affected) have been reported in patients treated with enzalutamide. PRES is a rare, reversible condition affecting the brain. If you experience seizures, worsening headache, confusion, blindness, or other vision problems, contact your doctor as soon as possible.
Other possible side effects are:
Very common side effects (may affect more than 1 in 10 people)
Tiredness, falls, bone fractures, hot flushes, high blood pressure.
Common side effects (may affect up to 1 in 10 people)
Headache, anxiety, dry skin, itching, memory impairment, blockage of the heart's arteries (ischaemic heart disease), enlargement of the breast in men (gynaecomastia), nipple pain, breast tenderness, symptoms of restless legs syndrome (an uncontrollable urge to move part of the body, usually the legs), reduced concentration, forgetfulness, altered sense of taste, difficulty thinking clearly.
Uncommon side effects (may affect up to 1 in 100 people)
Hallucinations, low white blood cell count.
Side effects of unknown frequency (frequency cannot be determined from the available data)
Muscle pain, muscle cramps, muscle weakness, back pain, changes in electrocardiogram (ECG) (QT prolongation), stomach ache including feeling unwell (nausea), skin reaction causing red spots or patches on the skin which may look like a target or "bull's eye", with a dark red centre surrounded by rings of lighter red (erythema multiforme), skin rash, feeling unwell (vomiting), swelling of the face, lips, tongue and/or throat, reduced number of platelets in the blood (increased risk of bleeding or bruising), diarrhoea.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enzalutamide EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the bottle, and on the cardboard box after "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not remove the oxygen-absorbing container from the bottles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enzalutamide EG contains

• The active substance is enzalutamide.
• Each Enzalutamide EG 40 mg film-coated tablet contains 40 mg of enzalutamide.
• Each Enzalutamide EG 80 mg film-coated tablet contains 80 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), anhydrous colloidal silica (E551), microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b).
• Tablet coating: hypromellose 2910 (E464), macrogol 3350 (E1521), titanium dioxide (E171), yellow iron oxide (E172), talc (E553b).

Description of the appearance of Enzalutamide EG and the contents of the pack
Enzalutamide EG 40 mg film-coated tablets are yellow, round, film-coated tablets, marked "40" on one side, with a diameter of 10 mm.
Each pack contains 112 film-coated tablets in Al-OPA/Al/PVC blisters, or 112 x 1 film-coated tablets in unit-dose divisible Al-OPA/Al/PVC blisters.
Enzalutamide EG is also supplied in high-density polyethylene (HDPE) bottles with a white polypropylene (PP) container for oxygen absorption, and a child-resistant polypropylene (PP) closure, containing 112 film-coated tablets.
Enzalutamide EG 80 mg film-coated tablets are yellow, oval, film-coated tablets, marked "80" on one side, with dimensions of 17 mm x 9 mm.
Each pack contains 56 film-coated tablets in Al-OPA/Al/PVC blisters, or 56 x 1 film-coated tablets in unit-dose divisible Al-OPA/Al/PVC blisters.
Enzalutamide EG is also supplied in high-density polyethylene (HDPE) bottles with a white polypropylene (PP) container for oxygen absorption, and a child-resistant polypropylene (PP) closure, containing 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano

Manufacturers
Pharos MT Limited, HF62X Hal Far Industrial Estate, BBG 3000, Birzebbuga - Malta
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany
Stada Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna - Austria
Clonmel Healthcare Limited, Waterford Road E91 D768 Clonmel, Co. Tipperary – Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
NL Enzalutamide CF 40 mg; 80 mg filmomhulde tabletten
AT Enzalutamid STADA 40 mg; 80 mg Filmtabletten
BE Enzalutamide EG 40 mg; 80 mg filmomhulde tabletten
Enzalutamide EG 40 mg; 80 mg Filmtabletten
Enzalutamide EG 40 mg; 80 mg comprimés pelliculés
CY Enzalutamide/Stada 40 mg; 80 mg επικαλυμμένα με λεπτό υμένιο δισκία
CZ Enzalutamide STADA
DE Enzalutamid AL 40 mg; 80 mg Filmtabletten
Enzalutamid AL Filmtabletten
DK Enzalutamide STADA
EE Enzalutamide STADA
EL Enzalutamide/Stada
ES Enzalutamida STADA 40 mg; 80 mg comprimidos recubiertos con película EFG
FI Enzalutamide STADA 40 mg; 80 mg kalvopäällysteiset tabletit
FR ENZALUTAMIDE EG 40 mg; 80 mg comprimé pelliculé
HR Enzalutamid STADA 40 mg; 80 mg filmom obložene tablete
HU Enzalutamide STADA 40 mg; 80 mg filmtabletta
IE Enzalutamide Clonmel 40 mg; 80 mg film-coated tablets
IS Enzalutamide STADA 40 mg; 80 mg filmuhúðaðar töflur
IT Enzalutamide EG
LT Enzalutamide STADA 40 mg; 80 mg plėvele dengtos tabletės
LU Enzalutamide EG 40 mg; 80 mg comprimés pelliculés
LV Enzalutamide STADA 40 mg; 80 mg apvalkotās tabletes
MT Enzalutamide Clonmel 40 mg; 80 mg film-coated tablets
NO Enzalutamide STADA
PL Enzalutamide STADA
PT Enzalutamida Stada
RO Enzalutamidă Stada 40 mg; 80 mg comprimate filmate
SE Enzalutamide STADA
SI Enzalutamid STADA 40 mg; 80 mg filmsko obložene tablete
SK Enzalutamide STADA 40 mg; 80 mg