ENZALUTAMIDE SANDOZ 40 mg FILM-COATED TABLETS

2. What you need to know before you take Enzalutamide Sandoz Pharmaceutical

Do not take Enzalutamide Sandoz Pharmaceutical

• If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6).

• If you are pregnant or may become pregnant (see “Pregnancy, breast-feeding and fertility”).

Warnings and precautions

Seizures

Seizures have been reported in 6 out of 1,000 people taking enzalutamide, and in less than 3 out of 1,000 people taking placebo (see “Other medicines and Enzalutamide Sandoz Pharmaceutical” below and “Possible side effects” in section 4).

If you are taking a medicine that may cause seizures or may increase the risk of having seizures (see below “Other medicines and Enzalutamide Sandoz Pharmaceutical”).

If you have a seizure during treatment:

Talk to your doctor as soon as possible. Your doctor may decide that you should stop taking enzalutamide.

Posterior Reversible Encephalopathy Syndrome (PRES)

Rare cases of PRES, a rare, reversible disease that affects 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 as soon as possible. (See also section 4 “Possible side effects”).

Risk of new cancers (second primary malignancies)

There have been reports of new (second) cancers in patients treated with enzalutamide, including bladder and colon cancer.

Talk to your doctor as soon as possible if you notice any signs of gastrointestinal bleeding, blood in your urine, or frequently feel an urgent need to urinate while taking enzalutamide.

Talk to your doctor before starting to take enzalutamide:

• If you have ever developed severe skin rashes or skin peeling or blistering or ulcers in the mouth after taking enzalutamide or other medicines,

• If you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel),

• If you are receiving chemotherapy, such as docetaxel,
• If you have liver problems,
• If you have kidney problems.

Please inform 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 to correct these disorders. The risk of heart rhythm problems may be increased with the use of enzalutamide.

If you are allergic to enzalutamide, its administration could cause a rash or swelling of the face, tongue, lips, or throat. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take this medicine.

Severe skin rashes or skin peeling or blistering or ulcers in the mouth, including Stevens-Johnson syndrome, have been reported in association with enzalutamide treatment. Stop using enzalutamide and seek medical attention immediately if you notice any of these symptoms related to these severe skin reactions described in section 4.

If any of the above applies to you or if you are not sure, talk to your doctor before taking this medicine.

Children and adolescents

This medicine must not be given to children or adolescents.

Other medicines and Enzalutamide Sandoz Pharmaceutical

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You need to know the names of the medicines you are taking. Carry a list of them with you to show your doctor when he prescribes you a new medicine. Do not start or stop taking any medicine before talking to the doctor who prescribed it for you.

Tell your doctor if you are taking any of the following medicines. These medicines may increase the risk of having a seizure when taken at the same time as enzalutamide:

• 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 for pain treatment (e.g. pethidine).

Tell your doctor if you are taking any of the following medicines. These medicines may affect the effect of enzalutamide or enzalutamide may affect the effect of these medicines.

This includes 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 problems or lowering blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil),
• treating severe inflammatory diseases (e.g. dexamethasone, prednisolone),

• treating HIV infection (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),

• preventing heart problems or stroke (e.g. dabigatran etexilate),
• preventing organ rejection (e.g. tacrolimus).

Enzalutamide 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 with certain medicines [e.g. methadone (used for pain relief and as part of drug detoxification), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illness)].

Tell your doctor if you are taking any of the above medicines. It may be necessary to adjust the dose of enzalutamide or any other medicine you are taking.

Pregnancy, breast-feeding and fertility

• Enzalutamide is not indicated in women. This medicine may harm the fetus or cause abortion if taken by a pregnant woman. It must not be given to pregnant women, women who may become pregnant, or women who are breast-feeding.

• It is possible that this medicine may affect male fertility.
• If you have sex with a woman of childbearing age, you must use a condom and another effective contraceptive method during treatment and for 3 months after treatment with this medicine. If you have sex with a pregnant woman, you must use a condom to protect the fetus during treatment and for 3 months after treatment with this medicine.

• In the case of female caregivers, see section 3 “How to take Enzalutamide Sandoz” for handling and administration recommendations.

Driving and using machines

The influence of enzalutamide on the ability to drive and use machines may be moderate. Seizures have been reported in patients who have taken enzalutamide. If you are at a higher risk of having seizures, you should talk to your doctor.

Enzalutamide Sandoz Pharmaceutical contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Enzalutamide Sandoz Pharmaceutical

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor.

The recommended dose is 160 mg (four 40 mg film-coated tablets or two 80 mg film-coated tablets), taken at the same time once a day.

How to take Enzalutamide Sandoz Pharmaceutical

• Swallow the tablets whole with water.

• Do not break, crush, or chew the tablets before swallowing.
• This medicine can be taken with or without food.
• This medicine should not be handled by anyone other than the patient or their caregivers. Pregnant women or women who may become pregnant should not handle broken or damaged tablets of this medicine without protection, such as gloves.

It is also possible that your doctor may prescribe you other medicines while you are taking enzalutamide.

If you take more Enzalutamide Sandoz Pharmaceutical than you should

If you take more tablets than prescribed, stop taking enzalutamide and contact your doctor. You may have a higher risk of having a seizure or other side effects.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Enzalutamide Sandoz Pharmaceutical

• If you forget to take enzalutamide at the usual time, take the usual dose as soon as you remember.
• If you forget to take enzalutamide for the whole day, take the usual dose the next day.

• If you forget to take enzalutamide for more than one day, talk to your doctor immediately.
• Do not take a double doseto make up for forgotten doses.

If you stop taking Enzalutamide Sandoz Pharmaceutical

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions on the use of 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 out of 1,000 people taking enzalutamide, and in less than 3 out of 1,000 people taking placebo.

Seizures are more likely if you take a dose of this medicine higher than recommended, if you take certain medicines, or if you have a higher than usual risk of having a seizure.

If you have a seizure, talk to your doctor as soon as possible. Your doctor may decide that you should stop taking enzalutamide.

Posterior Reversible Encephalopathy Syndrome (PRES)

Rare cases of PRES (affecting up to 1 in 1,000 people), a rare, reversible disease that affects 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 as soon as possible.

Other possible side effects are:

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, difficulty remembering, blockage of heart arteries (ischaemic heart disease), breast enlargement in men (gynaecomastia), nipple pain, breast tenderness, symptoms of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the legs), lack of concentration, memory loss, change in taste, difficulty thinking clearly.

Uncommon(may affect up to 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 the available data) Muscle pain, muscle spasms, muscle weakness, back pain, changes in the electrocardiogram (QT interval prolongation), stomach upset including feeling sick (nausea), a skin reaction that causes red spots or patches on the skin, which may look like a target or a “bull's eye” with a dark red center surrounded by lighter red rings (erythema multiforme), or another severe skin reaction that presents with red patches, not raised, target-like or circular on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes that may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), rash, discomfort (vomiting), swelling of the face, lips, tongue, and/or throat, decrease in the number of platelets in the blood (which increases the risk of bleeding or bruising), diarrhea.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enzalutamide Sandoz Pharmaceutical

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister pack, and bottle after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Do not remove the oxygen absorber from the bottle.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enzalutamida Sandoz Pharmaceutical

• The active ingredient is enzalutamide.
• Enzalutamida Sandoz Pharmaceutical 40 mg: Each film-coated tablet contains 40 mg of enzalutamide.
• Enzalutamida Sandoz Pharmaceutical 80 mg: Each film-coated tablet contains 80 mg of enzalutamide.

The other components are:

• Tablet core: Copolymer of methacrylic acid and ethyl acrylate (1:1) Type A (contains sodium lauryl sulfate and polysorbate 80), anhydrous colloidal silica (E551), microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b).
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• Coating material: Hypromellose 2910 (E464), macrogol 3350 (E1521), titanium dioxide (E171), yellow iron oxide (E172), talc (E553b).

Product Appearance and Package Contents

The Enzalutamida Sandoz Pharmaceutical 40 mg tablets are yellow, round, film-coated (tablets), engraved with "40" on one side, with a diameter of 10 mm.

Each box contains 112 film-coated tablets in aluminum-OPA/Al/PVC blisters or 112 x 1 film-coated tablets in precut unit-dose aluminum-OPA/Al/PVC blisters.

Enzalutamida Sandoz Pharmaceutical 40 mg is also available in pocket cardboard boxes including a 28-tablet aluminum-OPA/Al/PVC blister. Each box contains 112 film-coated tablets (4 pocket boxes).

Enzalutamida Sandoz Pharmaceutical 40 mg is also available in high-density polyethylene (HDPE) bottles with a white oxygen-absorbing polypropylene (PP) cap, closed with a child-resistant polypropylene (PP) cap, containing 112 film-coated tablets.

The Enzalutamida Sandoz Pharmaceutical 80 mg tablets are yellow, oval, film-coated (tablets), engraved with "80" on one side, with dimensions 17 mm x 9 mm.

Each box contains 56 film-coated tablets in aluminum-OPA/Al/PVC blisters or 56 x 1 film-coated tablets in precut unit-dose aluminum-OPA/Al/PVC blisters.

Enzalutamida Sandoz Pharmaceutical 80 mg is also available in pocket cardboard boxes including a 14-tablet aluminum-OPA/Al/PVC blister. Each box contains 56 film-coated tablets (4 pocket boxes).

Enzalutamida Sandoz Pharmaceutical 80 mg is also available in high-density polyethylene (HDPE) bottles with a white oxygen-absorbing polypropylene (PP) cap, closed with a child-resistant polypropylene (PP) cap, containing 56 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmaceútica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57

Ljubljana 1526

Slovenia

o

PHAROS MT LIMITED

HF62 Hal Far Industrial Estate

Birzebburgia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Enzalutamid HEXAL 40 mg Filmtabletten

Enzalutamid HEXAL 80 mg Filmtabletten

Austria: Enzalutamid Sandoz GmbH 40 mg - Filmtabletten

Enzalutamid Sandoz GmbH 80 mg – Filmtabletten

Bulgaria: ??????????? ?????? 40 mg ????????? ????????

Cyprus: Enzalutamide Ebewe 40 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Enzalutamide Ebewe 80 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Croatia: Enzalutamid Pharos 40 mg filmom obložene tablete

Enzalutamid Pharos 80 mg filmom obložene tablete

Denmark: Enzalutamide Hexal

Slovakia: Enzalutamid Sandoz GmbH 40 mg

Enzalutamid Sandoz GmbH 80 mg

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

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

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 Hexal

Latvia: Enzalutamide PharOS 40 mg apvalkotas tabletes

Enzalutamide PharOS 80 mg apvalkotas tabletes

Lithuania: Enzalutamide PharOS 40 mg plevele dengtos tabletes

Enzalutamide PharOS 80 mg plevele dengtos tabletes

Malta: Enzalutamide Ebewe 40 mg film-coated tablets

Enzalutamide Ebewe 80 mg film-coated tablets

Norway: Enzalutamide Hexal

Netherlands: Enzalutamide Sandoz 40 mg, filmomhulde tabletten

Enzalutamide Sandoz 80 mg, filmomhulde tabletten

Poland: Enzalutamide Sandoz GmbH

Portugal: Enzalutamida Sandoz Farmacêutica

Czech Republic: Enzalutamid Sandoz s.r.o.

Romania: Enzalutamida PharOS 40 mg comprimate filmate

Enzalutamida PharOS 80 mg comprimate filmate

Sweden: Enzalutamide Hexal 40 mg filmdragerade tabletter

Enzalutamide Hexal 80 mg filmdragerade tabletter

Date of the last revision of this leaflet:11/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.