Enzalutamide Sandoz GmbH

Package leaflet: Information for the patient

Enzalutamide Sandoz GmbH 40 mg film-coated tablets, 80 mg film-coated tablets

Generic 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What Enzalutamide Sandoz GmbH is and what it is used for

Enzalutamide Sandoz GmbH contains the active substance enzalutamide. Enzalutamide Sandoz GmbH 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 prostatectomy 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 Sandoz GmbH works
Enzalutamide Sandoz GmbH 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 need to know before taking Enzalutamide Sandoz GmbH

Do not take Enzalutamide Sandoz GmbH:

• 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 and in fewer than 3 out of 1,000 patients treated with placebo (see 'Other medicines and Enzalutamide Sandoz GmbH' 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 Sandoz GmbH', below).
If you experience a seizure during treatment:
Contact your doctor as soon as possible. Your doctor may decide that you should stop taking Enzalutamide Sandoz GmbH.
Reversible posterior encephalopathy syndrome (PRES)
Rare cases of PRES, a rare reversible condition affecting the brain, have been reported in patients treated with enzalutamide. If you have a seizure, worsening headache, confusion, blindness or other vision problems, contact your doctor immediately (see also 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 the urine, or if you frequently feel a strong urge to urinate while taking Enzalutamide Sandoz GmbH.
Talk to your doctor before taking Enzalutamide Sandoz GmbH:

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

Tell 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 Sandoz GmbH.
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 Sandoz GmbH.
Severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers have been reported in association with enzalutamide treatment. Seek immediate medical attention if you notice any of these symptoms.
If any of the above conditions apply to you 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 Sandoz GmbH
Tell your doctor if you are taking, have recently taken or might take any other medicines. You should know the names of the medicines you are taking. Keep a list of them to show your doctor whenever you are prescribed a new medicine. Do not start or stop any treatment without first discussing it with the doctor who prescribed Enzalutamide Sandoz GmbH.
Tell your doctor if you are taking any of the following medicines. If taken together with Enzalutamide Sandoz GmbH, the following 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 Sandoz GmbH, or Enzalutamide Sandoz GmbH may affect the action of these medicines:
These include certain medicines used for:

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

Enzalutamide Sandoz GmbH 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 Sandoz GmbH or of any other medicine you are taking.
Pregnancy, breastfeeding and fertility

• Enzalutamide Sandoz GmbH is not intended 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 who 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 patient's caregiver is a woman, see section 3 “How to take Enzalutamide Sandoz GmbH” for instructions on use and handling.

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

Take this medicine exactly as prescribed 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 Sandoz GmbH

• Swallow the tablets whole with water.
• Do not cut, crush, or chew the tablets before swallowing.
• Enzalutamide Sandoz GmbH may be taken with or without food.
• Enzalutamide Sandoz GmbH must not be handled by anyone other than the patient or their caregiver. Women who are pregnant or who could become pregnant must not handle broken or damaged Enzalutamide Sandoz GmbH tablets unless wearing protective equipment, such as gloves.

Your doctor may prescribe other medicines to be taken during treatment with Enzalutamide Sandoz GmbH.

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

If you forget to take Enzalutamide Sandoz GmbH

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

If you stop taking Enzalutamide Sandoz GmbH
Do not stop taking this medicine unless instructed to do so 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 patients out of 1,000 treated with enzalutamide and in fewer than 3 patients out of 1,000 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 are exposed to a higher than 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 Sandoz GmbH.

Posterior reversible encephalopathy syndrome (PRES)
Rare cases of PRES have been reported in patients treated with enzalutamide (up to 1 in 1,000 people may be affected), a rare reversible condition affecting the brain. If you experience seizures, worsening headache, confusion, blindness, or other vision problems, contact your doctor immediately.

Other possible side effects are:

Very common side effects (may affect more than 1 in 10 people)
Fatigue, 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 arteries (ischaemic heart disease), breast enlargement 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 estimated from the available data)
Muscle pain, muscle cramps, muscle weakness, back pain, changes in the electrocardiogram (ECG) (QT prolongation), stomach pain 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 colour (erythema multiforme), skin rash, feeling unwell (vomiting), swelling of the face, lips, tongue and/or throat, reduced number of blood platelets (increased risk of bleeding or bruising), diarrhoea.

Reporting of side effects
If you get any side effects, including ones 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 Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, bottle, and 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 medicines 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 Sandoz GmbH contains

• The active substance is enzalutamide.
• Enzalutamide Sandoz GmbH 40 mg film-coated tablets contain 40 mg of enzalutamide.
• Enzalutamide Sandoz GmbH 80 mg film-coated tablets contain 80 mg of enzalutamide.

The other components are:

• Tablet core: methacrylic acid-ethyl acrylate copolymer (1:1) Type A (contains 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) and talc (E553b).

Description of the appearance of Enzalutamide Sandoz GmbH and contents of the pack
40 mg film-coated tablets
Enzalutamide Sandoz GmbH 40 mg film-coated tablets are yellow, round, with "40" engraved on one side, and have a diameter of 10 mm.
Each pack of Enzalutamide Sandoz GmbH contains 112 film-coated tablets in blisters made of Aluminium-OPA/Alu/PVC or 112 x 1 film-coated tablets in unit-dose divisible blisters made of Aluminium-OPA/Alu/PVC.
Enzalutamide Sandoz GmbH is also available in wallet containers containing 28 film-coated tablets per blister. Each pack contains 112 film-coated tablets (4 wallet containers).
Enzalutamide Sandoz GmbH is also available in HDPE bottles with a white oxygen-absorbing container made of polypropylene (PP), and a child-resistant closure made of polypropylene (PP), containing 112 film-coated tablets.

80 mg film-coated tablets
Enzalutamide Sandoz GmbH 80 mg film-coated tablets are yellow, oval-shaped, with "80" engraved on one side, and have dimensions of 17 x 9 mm.
Each pack of Enzalutamide Sandoz GmbH contains 56 film-coated tablets in blisters made of Aluminium-OPA/Alu/PVC or 56 x 1 film-coated tablets in unit-dose divisible blisters made of Aluminium-OPA/Alu/PVC.
Enzalutamide Sandoz GmbH is also available in wallet containers containing 14 film-coated tablets per blister. Each pack contains 56 film-coated tablets (4 wallet containers).
Enzalutamide Sandoz GmbH is also available in HDPE bottles with a white oxygen-absorbing container made of polypropylene (PP), and a child-resistant closure made of polypropylene (PP), containing 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse, 10
6250 Kundl
Austria
Representative for Italy:
Sandoz S.p.A., Viale Luigi Sturzo 43, 20154 Milano

Manufacturer
Lek Pharmaceuticals, d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia
Pharos MT Limited
HF62X Qasam Industrijali Hal Far
BBG 3000 Hal Far, Birzebbuga
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Enzalutamid Sandoz GmbH 40 mg - Filmtabletten
Enzalutamid Sandoz GmbH 80 mg - Filmtabletten
Bulgaria Enzalutamide SDZ 40 mg filmcoated tablets
Ензалутамид SDZ 40 mg филмирани таблетки
Cyprus Enzalutamide Ebewe 40 mg επικαλυμμένα με λεπτό υμένιο δισκία
Enzalutamide Ebewe 80 mg επικαλυμμένα με λεπτό υμένιο δισκία
Croatia Enzalutamid Sandoz GmbH 40 mg filmom obložene tablete
Enzalutamid Sandoz GmbH 80 mg filmom obložene tablete
Denmark Enzalutamide Hexal
Finland Enzalutamide Hexal 40 mg tabletti kalvopäällysteinen
Enzalutamide Hexal 80 mg tabletti kalvopäällysteinen
France ENZALUTAMIDE GNR 40 mg, comprimé pelliculé
ENZALUTAMIDE GNR 80 mg, comprimé pelliculé
Germany Enzalutamid HEXAL 40 mg Filmtabletten
Enzalutamid HEXAL 80 mg Filmtabletten
Greece Enzalutamide/Ebewe
Ireland Enzalutamide Rowex 40 mg film-coated tablets
Enzalutamide Rowex 80 mg film-coated tablets
Iceland Enzalutamide Hexal 40 mg filmuhúðaðar töflur
Enzalutamide Hexal 80 mg filmuhúðaðar töflur
Italy Enzalutamide Sandoz GmbH
Latvia Enzalutamide Hexal 40 mg apvalkotās tablets
Enzalutamide Hexal 80 mg apvalkotās tabletes
Lithuania Enzalutamide Hexal 40 mg plėvele dengtos tabletės
Enzalutamide Hexal 80 mg plėvele dengtos tabletės
Malta Enzalutamide Ebewe 40 mg film coated tablets
Enzalutamide Ebewe 80 mg film coated tablets
Norway Enzalutamide Hexal
Netherlands Enzalutamide SDZ 40 mg, filmomhulde tabletten
Enzalutamide SDZ 80 mg, filmomhulde tabletten
Poland Enzalutamide Sandoz
Portugal Enzalutamida Sandoz Farmacêutica
Norway Enzalutamide Sandoz GmbH
Czech Republic Enzalutamide Sandoz s.r.o.
Slovakia Enzalutamid Sandoz GmbH 40 mg
Enzalutamid Sandoz GmbH 80 mg
Romania Enzalutamidă Sandoz 40 mg, comprimate filmate
Enzalutamidă Sandoz 80 mg, comprimate filmate
Slovenia Enzalutamid Sandoz GmbH 40 mg filmsko obložene tablete
Enzalutamid Sandoz GmbH 80 mg filmsko obložene tablete
Spain Enzalutamida Sandoz Farmacéutica 40 mg comprimidos recubiertos con película EFG
Enzalutamida Sandoz Farmacéutica 80 mg comprimidos recubiertos con película EFG
Sweden Enzalutamide Hexal
Hungary Enzalutamid 1 A Pharma 40 mg filmtabletta
Enzalutamid 1 A Pharma 80 mg filmtabletta