Enzalutamide Sandoz

Italy
Brand name Enzalutamide Sandoz
Form tablets, film-coated
Active substance / Dosage
ENZALUTAMIDE
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
L02BB04
Registration number 050782
Manufacturer SANDOZ S.P.A.

Table of Contents

Patient Information Leaflet

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

Equivalent medicinal product
Please read all of this leaflet carefully before you start 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 effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

  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 to
treat adult men with prostate cancer that:

  • no longer responds to hormonal therapy or surgical treatment to reduce testosterone, or
  • has spread to other parts of the body and still responds to hormonal therapy or surgical treatment to reduce testosterone

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 stops the growth and division of
prostate cancer cells.

2. What you need to know before taking Enzalutamide Sandoz

Do not take Enzalutamide Sandoz:

  • 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 could become pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Seizures
Seizures have been reported in 5 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" below and section 4, "Possible side effects").
If you are taking a medicine that may cause seizures or increase your susceptibility to seizures (see "Other medicines and Enzalutamide Sandoz" 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 Sandoz.

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 (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 immediately if you notice signs of gastrointestinal bleeding, blood in your urine, or if you frequently feel a strong urge to urinate while taking Enzalutamide Sandoz.

Talk to your doctor before taking Enzalutamide Sandoz if:

  • you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
  • you are using a chemotherapy medicine such as docetaxel
  • you have liver problems
  • 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.
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.
Severe skin rash or skin peeling, skin rash with 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 any of the conditions listed above 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
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 when you are prescribed a new medicine. Do not start or stop any treatment without first talking to the doctor who prescribed Enzalutamide Sandoz.
Tell your doctor if you are taking any of the following medicines. If taken together with Enzalutamide Sandoz, these medicines may increase the risk of seizures:

  • Some 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).
  • Some 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, or Enzalutamide Sandoz may affect the action of these medicines:
These include some 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 problems (e.g. omeprazole)
  • Treating heart disease or stroke (e.g. dabigatran etexilate)
  • Preventing organ rejection (e.g. tacrolimus)

Enzalutamide Sandoz may interfere with some 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)].
Tell your doctor if you are taking any of the medicines listed above. It may be necessary to adjust the dose of Enzalutamide Sandoz or of any other medicine you are taking.

Pregnancy, breastfeeding and fertility

  • Enzalutamide Sandoz 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, could become pregnant, or who are breastfeeding with breast milk.

  • This medicine may affect male fertility.

  • If you have sexual intercourse with a woman who could become pregnant, use a condom and another effective contraceptive method 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.

  • If the patient is being cared for by a woman, see section 3 “How to take Enzalutamide Sandoz” for instructions on use and handling.

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

Enzalutamide Sandoz contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Enzalutamide Sandoz 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

Take this medicine exactly as your doctor has told you. If you are not sure, 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.

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.
  • Enzalutamide Sandoz tablets should 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 tablets without wearing protective covering, such as gloves.

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

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

If you forget to take Enzalutamide Sandoz

  • If you forget to take Enzalutamide Sandoz at your usual time, take your usual dose as soon as you remember.
  • If you forget to take Enzalutamide Sandoz for a whole day, take your usual dose the next day.
  • If you forget to take Enzalutamide Sandoz 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
Do not stop taking this medicine unless your doctor tells you to.
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 5 out of 1,000 patients treated with Enzalutamide Sandoz 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 greater than the recommended dose, if you take other medicines, or if you have an increased risk of seizures compared to normal.
If you have a seizure, contact your doctor as soon as possible. Your doctor may decide that you should stop treatment with Enzalutamide Sandoz.
Posterior reversible encephalopathy syndrome (PRES)
Rare cases of PRES have been reported in patients treated with Enzalutamide Sandoz (up to 1 in 1,000 people may be affected), a rare reversible condition affecting the brain. If you experience seizures, worsening headaches, confusion, blindness, or other vision problems, contact your doctor immediately.
Other possible side effects include:
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 disturbances, blockage of the heart arteries (ischaemic heart disease), breast enlargement in men (gynaecomastia), symptoms of restless legs syndrome (uncontrollable urge to move part of the body, usually the legs), reduced concentration, forgetfulness, altered sense of taste
Uncommon side effects (may affect up to 1 in 100 people)
Hallucinations, difficulty thinking clearly, 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 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 any 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, the cardboard outer, the blister pack, and the bottle after "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of 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 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.

The other components are:

  • Tablet core: hypromellose acetate succinate, lactose monohydrate, croscarmellose sodium (E468), microcrystalline cellulose (E460), and magnesium stearate (E470b)
  • Tablet coating: hypromellose (E464), macrogol, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Description of the appearance of Enzalutamide Sandoz and contents of the pack
Enzalutamide Sandoz 40 mg film-coated tablets are yellow, round, biconvex film-coated tablets, marked “EN” on one side and “40” on the other. Diameter: 11 mm.
Enzalutamide Sandoz 80 mg film-coated tablets are yellow, oval, biconvex film-coated tablets, marked “EN” on one side and “80” on the other. Length: 17 mm; width: 9 mm.
This medicinal product is packaged in PVC/PVDC/aluminum blisters or in HDPE bottles with desiccant (silica gel), closed with a child-resistant screw cap made of polypropylene and sealed with a heat-sealed closure.
Enzalutamide Sandoz 40 mg film-coated tablets are supplied in a box containing 28 or 112 film-coated tablets (in blisters or blisters within a wallet pack), 28x1 or 112x1 film-coated tablets (in unit-dose divisible blisters), or 112 film-coated tablets (in a bottle).
Enzalutamide Sandoz 80 mg film-coated tablets are supplied in a box containing 14 or 56 film-coated tablets (in blisters or blisters within a wallet pack), 14x1 or 56x1 film-coated tablets (in unit-dose divisible blisters), or 56 film-coated tablets (in a bottle).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

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

This medicinal product is authorized in the European Economic Area Member States under the following names:
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
Croatia Enzalutamid Sandoz 40 mg filmom obložene tablete
Enzalutamid Sandoz 80 mg filmom obložene tablete
Denmark Enzalutamide Sandoz
Estonia Enzalutamide Sandoz
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
Germany Enzalutamid HEXAL 40 mg Filmtabletten
Enzalutamid HEXAL 80 mg Filmtabletten
Greece Enzalutamide/Sandoz
Ireland Enzalutamide Rowex 40 mg film-coated tablets
Enzalutamide Rowex 80 mg film-coated tablets
Iceland Enzalutamide Sandoz
Italy Enzalutamide Sandoz
Latvia Enzalutamide Sandoz 40 mg apvalkotās tablets
Enzalutamide Sandoz 80 mg apvalkotās tabletes
Lithuania Enzalutamide Sandoz 40 mg plėvele dengtos tabletės
Enzalutamide Sandoz 80 mg plėvele dengtos tabletės
Malta Enzalutamide Sandoz 40 mg film coated tablets
Enzalutamide Sandoz 80 mg film coated tablets
Norway Enzalutamide Sandoz
Netherlands Enzalutamide Sandoz 40 mg, filmomhulde tabletten
Enzalutamide Sandoz 40 mg, filmomhulde tabletten
Poland Enzalutamid Sandoz
Norway Enzalutamide Sandoz
Czech Republic Enzalutamide Sandoz
Slovakia Enzalutamid Sandoz 40 mg filmom obalené tablety
Enzalutamid Sandoz 80 mg filmom obalené tablety
Romania Enzalutamidă Sandoz 40 mg, comprimate filmate
Enzalutamidă Sandoz 80 mg, comprimate filmate
Slovenia Enzalutamid Sandoz 40 mg filmsko obložene tablete
Enzalutamid Sandoz 80 mg filmsko obložene tablete
Spain Enzalutamida Sandoz 40 mg comprimidos recubiertos con película EFG
Enzalutamida Sandoz 80 mg comprimidos recubiertos con película EFG
Sweden Enzalutamide Sandoz
Hungary Enzalutamid Sandoz 40 mg filmtabletta
Enzalutamid Sandoz 80 mg filmtabletta