Enzalutamide sandoz

Patient Information Leaflet

Enzalutamide Sandoz, 160 mg, film-coated tablets
Enzalutamidum
Please read all of 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 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 them 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 Sandoz is and what it is used for
2. What you need to know 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 in whom the cancer has not spread to other parts of the body and who respond 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 1000 people taking Enzalutamide Sandoz and in fewer than 3 out of 1000 people taking placebo (see below "Enzalutamide Sandoz and 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 and 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 has been rarely reported in patients treated with Enzalutamide Sandoz. 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 Sandoz.
If you experience symptoms of gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate while taking Enzalutamide Sandoz, contact your doctor as soon as possible.

Swallowing difficulties related to the medicine formulation
There have been reports of patients experiencing difficulty swallowing enzalutamide tablets, including choking incidents. Tablets should be swallowed whole with sufficient water.

Before starting Enzalutamide Sandoz, tell your doctor if:

• you have ever had severe rash or skin peeling, blisters, and/or mouth ulcers after taking Enzalutamide Sandoz or other medicines
• you are taking other medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• you are undergoing 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 diseases, 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 rashes, skin peeling, blisters, and/or mouth ulcers, including Stevens-Johnson syndrome, have been reported during treatment with Enzalutamide Sandoz. If any of these symptoms, described in section 4 as serious skin reactions, occur, contact your doctor immediately and stop taking 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 and other medicines
Tell 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 them 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 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 conditions (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. pethidine)

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 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 stomach disorders (e.g. omeprazole)
• prevention of heart disease or stroke (e.g. dabigatran etexilate)
• prevention of organ transplant rejection (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 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)].
Tell your doctor if you are taking any of the medicines listed above. The dose of Enzalutamide Sandoz or any other medicine you are taking may need to be adjusted.

Pregnancy, breastfeeding and fertility

• Enzalutamide Sandoz is not indicated for use in women. This medicine, if taken by women during pregnancy, 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 affect fertility in men.
• If you have sexual intercourse with a woman who could become pregnant during treatment and for 3 months after treatment ends, you must use a condom and another effective method of contraception. If you have sexual intercourse with a pregnant woman, you must use a condom during treatment and for 3 months after treatment ends to protect the unborn child.
• Patient caregivers – see section 3 "How to take Enzalutamide Sandoz" for instructions on 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 coated tablet, i.e. it is considered "sodium-free".

3. How to use Enzalutamide Sandoz

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 Sandoz

• Swallow the tablets whole with a sufficient amount of 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 should 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 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 patients taking Enzalutamide Sandoz and in fewer than 3 out of 1000 patients 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. 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 out of 1000 patients); it 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 affect more than 1 in 10 people):
fatigue, dizziness, bone fracture, hot flushes, high blood pressure.

Common (may affect fewer than 1 in 10 people):
headache, feeling of anxiety, dry skin, itching, memory disturbances, 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 a body part, usually the leg), reduced concentration, forgetfulness, change in taste perception, difficulty in clear (rational) thinking.

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

Frequency not known (frequency cannot be estimated from the available data):
muscle pain, muscle cramps, muscle weakness, back pain, changes in ECG (prolongation of QT interval), difficulty swallowing this medicine, including choking, stomach upset 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 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, facial swelling, swelling of 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 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 the 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 and outer packaging following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
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 160 mg, film-coated tablets: each film-coated tablet contains 160 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 (E 551), microcrystalline cellulose PH 102 (E 460), sodium croscarmellose (E 468), magnesium stearate (E 470b).
  Tablet coating: hypromellose 2910 (E 464), macrogol 3350 (E 1521), titanium dioxide (E 171), yellow iron oxide (E 172), talc (E 553b).

What Enzalutamide Sandoz looks like and contents of the pack
Enzalutamide Sandoz 160 mg, film-coated tablets: yellow, oval, film-coated tablets measuring 23 mm x 11 mm, with "160" embossed on one side.
Each Enzalutamide Sandoz pack contains 28 or 56 tablets in blisters made of Aluminium/OPA/Aluminium/PVC, or 28 x 1, 56 x 1 tablet in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC, packed 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
Birzebbuga BBG 3000
Malta
PharOS Pharmaceutical Oriented Servises Ltd.
Lesvou Street End
Thesi Loggos Industrial Zone
144 52 Metamorfossi
Greece
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia

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

This medicine is authorised for marketing in the European Economic Area under the following names:
Netherlands: Enzalutamide SDZ 160 mg, filmomhulde tabletten
Austria: Enzalutamid Sandoz GmbH 160 mg - Filmtabletten
Czech Republic: Enzalutamid Sandoz s.r.o.
Germany: Enzalutamid HEXAL 160 mg Filmtabletten
Greece: Enzalutamide/Ebewe
France: ENZALUTAMIDE GNR 160 mg, comprimé pelliculé
Hungary: Enzalutamid 1 A Pharma 160 mg filmtabletta
Lithuania: Enzalutamide Hexal 160 mg plėvele dengtos tabletės
Latvia: Enzalutamide Hexal 160 mg apvalkotās tabletes
Poland: Enzalutamide Sandoz
Romania: Enzalutamidă Sandoz 160 mg comprimate filmate
Slovenia: Enzalutamid Sandoz GmbH 160 mg filmsko obložene tablete
Slovakia: Enzalutamid Sandoz GmbH 160 mg