Enzalutamide sandoz

Package leaflet: Information for the patient

Enzalutamide Sandoz, 40 mg, film-coated tablets
Enzalutamide Sandoz, 80 mg, film-coated tablets
Enzalutamide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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 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.

Contents of the leaflet

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

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

Enzalutamide Sandoz contains the active substance enzalutamide. Enzalutamide Sandoz 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 a rapid rise in PSA levels, but whose cancer has not spread to other parts of the body and responds to hormonal therapy aimed at reducing testosterone levels.

How Enzalutamide Sandoz works
Enzalutamide Sandoz 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. Information before using Enzalutamide Sandoz

When not to take Enzalutamide Sandoz

• 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 Sandoz and in less than 3 out of 1,000 people taking placebo (see below “Enzalutamide Sandoz 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 Sandoz with other medicines”.
If a seizure occurs during treatment:
Contact your doctor immediately. Your doctor will decide whether to discontinue treatment with Enzalutamide Sandoz.

Posterior Reversible Encephalopathy Syndrome (PRES)
PRES (Posterior Reversible Encephalopathy Syndrome) has been rarely reported in patients treated with Enzalutamide Sandoz. 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 malignancies)
There have been reports of new (second) cancers, including bladder and colorectal cancer, in patients treated with Enzalutamide Sandoz.
If gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate occurs during treatment with Enzalutamide Sandoz, contact your doctor as soon as possible.

Before starting Enzalutamide Sandoz, tell your doctor if:

• you have ever had severe rash, skin peeling, blisters, and/or mouth ulcers after taking Enzalutamide Sandoz or other medicines
• you are taking other medicines that prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• you are receiving chemotherapy, e.g. docetaxel
• you have liver disease
• you have kidney disease

Tell your doctor if any of the following apply:
Any heart or blood vessel disorders, including heart rhythm disorders (arrhythmias), or if you are being treated for such conditions. The risk of heart rhythm disorders may increase during treatment with Enzalutamide Sandoz.
If you are allergic to enzalutamide, a rash or swelling of the face, tongue, lips, or throat may occur. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take Enzalutamide Sandoz.
Serious skin reactions, including skin rash, skin peeling, blisters, and/or mouth ulcers, including Stevens-Johnson syndrome, have been reported during treatment with Enzalutamide Sandoz. If any of these symptoms, related to these serious skin reactions described in section 4, occur, contact your doctor immediately and discontinue treatment with Enzalutamide Sandoz.
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 Sandoz with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Know the names of your medicines. Keep a list of them to show your doctor when a new medicine is prescribed. Do not start or stop taking any medicine without consulting your doctor who prescribed Enzalutamide Sandoz.

Tell your doctor if you are taking any of the following medicines. These medicines, when taken together with Enzalutamide Sandoz, may increase the risk of seizures:

• certain medicines used to treat asthma and other respiratory disorders (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)

Tell your doctor if you are taking any of the following medicines. These medicines may affect the action of Enzalutamide Sandoz or Enzalutamide Sandoz may affect their action. This includes medicines used to:

• lower cholesterol levels (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 conditions or lower blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• treat serious inflammatory conditions (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 transplanted organs (e.g. tacrolimus)

Enzalutamide Sandoz 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 you are taking any of the medicines listed above. The dose of Enzalutamide Sandoz or any other medicine being taken may need to be adjusted.

Pregnancy, breastfeeding and fertility

• Enzalutamide Sandoz is not indicated for use in women. This medicine, if taken by a pregnant woman, 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, you have sexual intercourse with a woman who could become pregnant, use a condom and another effective method of contraception. If you have sexual intercourse with a pregnant woman, use a condom during treatment and for 3 months after treatment ends to protect the unborn child.

• Caregivers – see section 3 “How to take Enzalutamide Sandoz”, which describes how to handle the medicine.

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

Enzalutamide Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is considered “sodium-free”.

3. How to use Enzalutamide Sandoz

This medicine must always be used 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 Sandoz

• Swallow the tablets whole with water.
• Do not cut, crush, or chew the tablets before swallowing.
• Enzalutamide Sandoz can be taken with or without food.
• Individuals other than the patient or their caregivers should not come into contact with Enzalutamide Sandoz. Women who are pregnant or may become pregnant must not handle damaged or crushed Enzalutamide Sandoz tablets without protective gloves.

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

Taking more Enzalutamide Sandoz than prescribed
If you take more tablets than prescribed, stop taking Enzalutamide Sandoz and contact your doctor immediately. The risk of experiencing a seizure or other adverse effects may increase.

Missing a dose of Enzalutamide Sandoz

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

Stopping Enzalutamide Sandoz
Do not stop treatment unless your doctor advises you to do so.
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 1,000 people taking Enzalutamide Sandoz and in fewer than 3 out of 1,000 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 individuals with an increased than usual risk of seizure.

If a seizure occurs, contact your doctor immediately. The doctor will decide whether to discontinue treatment with Enzalutamide Sandoz.

Posterior reversible encephalopathy syndrome (PRES)
PRES has been reported rarely in patients treated with Enzalutamide Sandoz (may occur in fewer than 1 in 1,000 people); it is a rare, reversible brain condition. If seizures, worsening headache, altered consciousness, blindness, or other visual disturbances occur, contact your doctor as soon as possible.

Other adverse reactions include:

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

Common (may affect fewer than 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 fewer than 1 in 100 people):
hallucinations, low white blood cell count, increased liver enzyme levels in blood tests (a sign of liver problems).

Frequency not known (frequency cannot be estimated from available data):
muscle pain, muscle spasms, muscle weakness, back pain, changes in ECG (prolongation of QT interval), 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 round spots on the trunk, often with centrally located 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, swelling of the face, lips, tongue, and/or throat, reduced platelet count (increasing the risk of bleeding or bruising), diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Enzalutamide Sandoz

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 outer packaging following EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Enzalutamide Sandoz contains

• The active substance is enzalutamide.
  Enzalutamide Sandoz 40 mg, film-coated tablets: each film-coated tablet contains 40 mg of enzalutamide.
  Enzalutamide Sandoz 80 mg, film-coated tablets: each film-coated tablet contains 80 mg of enzalutamide.
• Other ingredients:
  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 type 2910, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), talc.

What Enzalutamide Sandoz looks like and contents of the pack
Enzalutamide Sandoz 40 mg, film-coated tablets: yellow, round, film-coated tablets, 10 mm in diameter, with the imprint “40” on one side.
Each pack of Enzalutamide Sandoz contains 112 tablets in blisters made of Aluminium-OPA/Aluminium/PVC or 112 x 1 tablet in perforated single-dose blisters made of Aluminium-OPA/Aluminium/PVC, in a cardboard box.
Enzalutamide Sandoz is also packaged in blisters made of Aluminium-OPA/Aluminium/PVC in cardboard wallets containing 28 film-coated tablets each. Each cardboard box contains 112 film-coated tablets (4 wallets).
Enzalutamide Sandoz is also packaged in high-density polyethylene (HDPE) bottles with a child-resistant polycarbonate (PP) closure, containing a white, oxygen-absorbing polycarbonate (PP) container and 112 film-coated tablets, in a cardboard box.

Enzalutamide Sandoz 80 mg, film-coated tablets: yellow, oval, film-coated tablets, 17 mm x 9 mm, with the imprint “80” on one side.
Each pack of Enzalutamide Sandoz contains 56 tablets in blisters made of Aluminium-OPA/Aluminium/PVC or 56 x 1 tablet in perforated single-dose blisters made of Aluminium-OPA/Aluminium/PVC, in a cardboard box.
Enzalutamide Sandoz is also packaged in blisters made of Aluminium-OPA/Aluminium/PVC in cardboard wallets containing 14 film-coated tablets each. Each cardboard box contains 56 film-coated tablets (4 wallets).
Enzalutamide Sandoz is also packaged in high-density polyethylene (HDPE) bottles with a child-resistant polycarbonate (PP) closure, containing a white, oxygen-absorbing polycarbonate (PP) container and 56 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. 22 209 70 00

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

For further information about this medicinal product, please contact:
Poland
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

This medicinal product is authorised in the European Economic Area member states under the following names:
Netherlands Enzalutamide SDZ 40 mg, filmomhulde tabletten
Enzalutamide SDZ 80 mg, filmomhulde tabletten
Austria Enzalutamid Sandoz GmbH 40 mg - Filmtabletten
Enzalutamid Sandoz GmbH 80 mg - Filmtabletten
Bulgaria Enzalutamide SDZ 40 mg film-coated 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
Czech Republic Enzalutamid Sandoz s.r.o.
Germany Enzalutamid HEXAL 40 mg Filmtabletten
Enzalutamid HEXAL 80 mg Filmtabletten
Denmark Enzalutamide Hexal
Greece Enzalutamide/Ebewe
Spain Enzalutamida Sandoz Farmacéutica 40 mg comprimidos recubiertos con película EFG
Enzalutamida Sandoz Farmacéutica 80 mg comprimidos recubiertos con película EFG
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
Croatia Enzalutamid Sandoz GmbH 40 mg filmom obložene tablete
Hungary Enzalutamid 1 A Pharma 40 mg filmtabletta
Enzalutamid 1 A Pharma 80 mg filmtabletta
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
Lithuania Enzalutamide Hexal 40 mg plėvele dengtos tabletės
Enzalutamide Hexal 80 mg plėvele dengtos tabletės
Latvia Enzalutamide Hexal 40 mg apvalkotās tabletes
Enzalutamide Hexal 80 mg apvalkotās tabletes
Malta Enzalutamide Ebewe 40 mg film-coated tablets
Enzalutamide Ebewe 80 mg film-coated tablets
Norway Enzalutamide Hexal
Poland Enzalutamide Sandoz
Portugal Enzalutamida Sandoz Farmacêutica
Romania Enzalutamidă Sandoz 40 mg comprimate filmate
Enzalutamidă Sandoz 80 mg comprimate filmate
Sweden Enzalutamide Hexal
Slovenia Enzalutamid Sandoz GmbH 40 mg filmsko obložene tablete
Slovakia Enzalutamid Sandoz GmbH 40 mg
Enzalutamid Sandoz GmbH 80 mg