Enzalutamide sandoz

Patient Information Leaflet

Enzalutamid Sandoz, 40 mg, film-coated tablets
Enzalutamid Sandoz, 80 mg, film-coated tablets
Enzalutamidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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 someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet Contents

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

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

Enzalutamid Sandoz contains the active substance enzalutamide. Enzalutamid 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 still responds to hormonal therapy or surgical treatment aimed at reducing testosterone levels, or
• in whom the prostate gland has previously been removed or who have undergone radiotherapy, have a rapid rise in PSA levels, but the cancer has not spread to other parts of the body and still responds to hormonal therapy aimed at reducing testosterone levels.

How Enzalutamid Sandoz works
Enzalutamid 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. Important information before using Enzalutamid Sandoz

When not to take Enzalutamid 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 and in fewer than 3 out of 1,000 people taking placebo (see below "Enzalutamid Sandoz with other medicines" and section 4 "Possible side effects").
If the patient is taking medicines that may cause seizures or increase the risk of seizures, see below "Enzalutamid Sandoz with other medicines".
If a seizure occurs during treatment:
Contact the doctor immediately. The doctor will decide whether to discontinue treatment with Enzalutamid Sandoz.

Posterior Reversible Encephalopathy Syndrome (PRES)
Rare cases of PRES (Posterior Reversible Encephalopathy Syndrome) – a rare, reversible condition affecting the brain – have been reported in patients treated with enzalutamide.
If seizures, worsening headache, altered consciousness, blindness or other visual disturbances occur, contact the 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.
If gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate occur while taking Enzalutamid Sandoz, contact the doctor as soon as possible.

Before starting Enzalutamid Sandoz, tell the doctor if:

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

Tell the doctor if any of the following apply:
any heart or blood vessel diseases, including heart rhythm disorders (arrhythmias), or if the patient is being treated for such conditions. The risk of heart rhythm disturbances may increase during treatment with Enzalutamid Sandoz.
If the patient is allergic to enzalutamide, a skin rash or swelling of the face, tongue, lips or throat may occur. If the patient is allergic to enzalutamide or any of the other ingredients of this medicine, Enzalutamid Sandoz must not be taken.
Serious skin rashes, skin peeling, blisters and/or oral mucosal ulcers, including Stevens-Johnson syndrome, have been reported during treatment with enzalutamide. If any of the symptoms related to these serious skin reactions described in section 4 occur, contact the doctor immediately and discontinue treatment with Enzalutamid Sandoz.
If any of the above situations apply or if in doubt, consult the doctor before taking this medicine.

Children and adolescents
This medicine is not intended for use in children and adolescents.

Enzalutamid Sandoz and other medicines
Tell the doctor about all medicines the patient is currently taking, has recently taken or plans to take. The patient should know the names of all medicines being taken. Keep a list of these medicines and show it to the doctor when a new prescription is issued. Do not start or stop taking any medicine without first consulting the doctor who prescribed Enzalutamid Sandoz.

Tell the doctor if the patient is taking any of the following medicines. These medicines, when taken together with Enzalutamid Sandoz, 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 medicines used to treat pain (e.g. meperidine)

Tell the doctor if the patient is taking any of the following medicines. These medicines may affect the action of Enzalutamid Sandoz or Enzalutamid Sandoz may affect their action. This includes medicines used for:

• lowering cholesterol levels (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 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 gastrointestinal disorders (e.g. omeprazole)
• prevention of heart disease or stroke (e.g. dabigatran etexilate)
• prevention of organ transplant rejection (e.g. tacrolimus)

Enzalutamid 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 disturbances when used with certain other medicines [e.g. methadone (used for pain relief and detoxification in drug addiction), moxifloxacin (an antibiotic), antipsychotics (used to treat severe mental illnesses)].
Tell the doctor if the patient is taking any of the medicines listed above. The dose of Enzalutamid Sandoz or of any other medicine being taken may need to be adjusted.

Pregnancy, breastfeeding and fertility

• Enzalutamid 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. This medicine must not be used if the woman is pregnant, may become pregnant, or is breastfeeding.

• This medicine may possibly affect fertility in men.

• If the patient has sexual intercourse with a woman of reproductive age during treatment and for 3 months after treatment ends, a condom and another effective method of contraception must be used. If the patient has sexual intercourse with a pregnant woman, a condom must be used during treatment and for 3 months after treatment ends to protect the unborn child.

• Caregivers – see section 3 "How to take Enzalutamid Sandoz" for instructions on how to handle the medicine.

Driving and operating machinery
Enzalutamid Sandoz may have a moderate effect on the ability to drive and operate machinery. Seizures have been reported in patients taking Enzalutamid Sandoz. If there is an increased risk of seizures, consult the doctor.

Enzalutamid Sandoz contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Enzalutamid Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to use Enzalutamid Sandoz

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, 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 Enzalutamid Sandoz

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

Your doctor may also prescribe other medicines during treatment with Enzalutamid Sandoz.
Taking more Enzalutamid Sandoz than prescribed
If you take more soft capsules than prescribed, stop taking Enzalutamid Sandoz and contact your doctor immediately. This may increase the risk of seizures or other adverse effects.
Missing a dose of Enzalutamid Sandoz

• If you forget to take Enzalutamid Sandoz at your usual time, take the usual dose as soon as possible.
• If you forget to take Enzalutamid Sandoz on a given day, take the usual dose the next day.
• If you miss taking Enzalutamid Sandoz for more than one day, contact your doctor immediately.
• Do not take a double dose to make up for a missed dose.
  Stopping Enzalutamid Sandoz Do not stop treatment unless your doctor tells 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 experiences them.
Seizure
Seizures have been reported in 6 out of 1,000 people taking enzalutamide 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, taking certain other medicines, or having a higher than usual risk of seizure.
If a seizure occurs, contact your doctor immediately. Your doctor will decide whether to discontinue treatment with Enzalutamid Sandoz.
Posterior reversible encephalopathy syndrome (PRES)
PRES has been reported rarely in patients treated with enzalutamide (may occur less frequently than in 1 out of 1,000 people); 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, falls, bone fractures, hot flushes, high blood pressure.
Common (may affect up to 1 in 10 people):
headache, feeling anxious, 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 part of the body, usually the leg), reduced concentration, forgetfulness, change in taste perception, difficulty with clear (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 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 lesions with a target-like appearance, with a dark red center surrounded by pale red rings (erythema multiforme), or other serious skin reactions presenting as reddish, flat, disc-shaped 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, facial swelling, swelling of 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 not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring of 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 Enzalutamid Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, cardboard container,
blister pack, and bottle after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required 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. Such measures will help
protect the environment.

6. Contents of the Package and Other Information

What Enzalutamid Sandoz Contains

• The active substance is enzalutamide.
  Enzalutamid Sandoz 40 mg, film-coated tablets: each film-coated tablet contains 40 mg of enzalutamide.
  Enzalutamid Sandoz 80 mg, film-coated tablets: each film-coated tablet contains 80 mg of enzalutamide.
• Other ingredients:
  • Tablet core: hypromellose acetate succinate, lactose monohydrate, sodium croscarmellose, microcrystalline cellulose, magnesium stearate
  • Tablet coating: hypromellose type 2910, polyethylene glycol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172)

What Enzalutamid Sandoz Looks Like and Contents of the Pack
Enzalutamid Sandoz 40 mg, film-coated tablets are yellow, round, biconvex, film-coated tablets with the imprint "EN" on one side and "40" on the other, diameter: 11 mm.
Enzalutamid Sandoz 80 mg, film-coated tablets are yellow, oval, biconvex, film-coated tablets with the imprint "EN" on one side and "80" on the other, length: 17 mm; width: 9 mm.
The medicine is packaged in PVC/PVDC/Aluminium blisters or in HDPE bottles with a desiccant (silica gel), closed with a child-resistant polypropylene cap, and sealed with an induction-sealed liner, all contained in a cardboard box.
Enzalutamid Sandoz 40 mg, film-coated tablets are available in cardboard boxes containing 28 or 112 film-coated tablets (in blister or in blister placed in a cardboard sleeve), 28 x 1 or 112 x 1 film-coated tablet (in perforated single-dose blisters), or 112 film-coated tablets (in a bottle).
Enzalutamid Sandoz 80 mg, film-coated tablets are available in cardboard boxes containing 14 or 56 film-coated tablets (in blister or in blister placed in a cardboard sleeve), 14 x 1 or 56 x 1 film-coated tablet (in perforated single-dose blisters), or 56 film-coated tablets (in a bottle).
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, Poland

Manufacturer
Lek Pharmaceuticals, d.d.
Verovskova Ulica 57
Lublana 1526
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D; 9220
Lendava
Slovenia

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

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands Enzalutamide Sandoz 40 mg, filmomhulde tabletten
Enzalutamide Sandoz 80 mg, filmomhulde tabletten
Austria Enzalutamid Sandoz 40 mg - Filmtabletten
Enzalutamid Sandoz 80 mg - Filmtabletten
Bulgaria Enzalutamide Sandoz 40 mg filmcoated tablets
Ензалутамид Сандоз 40 mg, филмирани таблетки
Cyprus Enzalutamide/Sandoz
Germany Enzalutamid HEXAL 40 mg, Filmtabletten, ENR: 7013025
Enzalutamid HEXAL 80 mg, Filmtabletten, ENR: 7013026
Denmark Enzalutamide Sandoz
Estonia Enzalutamide Sandoz
Spain Enzalutamida Sandoz 40 mg, comprimidos recubiertos con película, EFG
Enzalutamida Sandoz 80 mg, comprimidos recubiertos con película, EFG
Finland Enzalutamide Sandoz 40 mg tabletti, kalvopäällysteinen
Enzalutamide Sandoz 80 mg tabletti, kalvopäällysteinen
France ENZALUTAMIDE SANDOZ 40 mg, comprimé pelliculé
ENZALUTAMIDE SANDOZ 80 mg, comprimé pelliculé
Greece Enzalutamide/Sandoz
Croatia Enzalutamid Sandoz 40 mg filmom, obložene tablete
Enzalutamid Sandoz 80 mg filmom, obložene tablete
Hungary Enzalutamid Sandoz 40 mg, filmtabletta
Enzalutamid Sandoz 80 mg, filmtabletta
Iceland Enzalutamide Sandoz
Ireland Enzalutamide Rowex, 40 mg film-coated tablets
Enzalutamide Rowex, 80 mg film-coated tablets
Italy Enzalutamide Sandoz
Lithuania Enzalutamide Sandoz 40 mg plėvele dengtos tabletės
Enzalutamide Sandoz 80 mg plėvele dengtos tabletės
Latvia Enzalutamide Sandoz 40 mg, apvalkotās tablets
Enzalutamide Sandoz 80 mg, apvalkotās tabletes
Malta Enzalutamide Sandoz 40 mg film-coated tablets
Enzalutamide Sandoz 80 mg film-coated tablets
Norway Enzalutamide Sandoz
Poland Enzalutamid Sandoz
Romania Enzalutamidă Sandoz 40 mg, comprimate filmate
Enzalutamidă Sandoz 80 mg, comprimate filmate
Sweden Enzalutamide Sandoz
Slovenia Enzalutamid Sandoz 40 mg filmsko obložene tablete
Enzalutamid Sandoz 80 mg filmsko obložene tablete
Slovakia Enzalutamid Sandoz 40 mg filmom obalené tablety
Enzalutamid Sandoz 80 mg filmom obalené tablety