ENZALUTAMIDE STADA 80 mg FILM-COATED TABLETS

2. What you need to know before you take Enzalutamide Stada

DO NOT TAKEEnzalutamide Stada

• 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 Stada” 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 Stada”).

If you have a seizure during treatment:

Consult 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 (secondary primary malignancies)

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

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

Consult your doctor before starting to take enzalutamide:

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 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, lips, tongue, or throat. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take this medicine.

Severe skin rash, skin peeling, and/or mouth ulcers, 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 the 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, consult your doctor before taking this medicine.

Children and adolescents

This medicine must not be given to children or adolescents.

Other medicines and Enzalutamide Stada

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 these with you to show your doctor when you are prescribed a new medicine. Do not start or stop taking any medicine before consulting the doctor who prescribed enzalutamide 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 with 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 pain medicines (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 illnesses)].

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.
• 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.
• In the case of female caregivers, see section 3 “How to take Enzalutamide Stada” 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 taking enzalutamide. If you have a higher risk of having seizures, you should consult your doctor.

Enzalutamide Stada 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 Stada

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor again.

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

• Swallow the tablets whole with water.
• Do not break, crush, or chew the tablets before swallowing.
• Enzalutamide can be taken with or without food.
• Enzalutamide 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 enzalutamide tablets without protection, such as gloves.

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

If you takemore Enzalutamide Stada 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, consult 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 Stada

• 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, consult your doctor immediately.
• Do not take a double doseto make up for forgotten doses.

If you stop taking Enzalutamide Stada

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, consult 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 the heart arteries (ischemic heart disease), increased breast size in men (gynecomastia), nipple pain, breast tenderness, restless legs syndrome, 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).

Rare(may affect up to 1 in 1,000 people)

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 red center surrounded by pale red rings (erythema multiforme) or other severe skin reaction that presents with red patches, not raised, in a target or circular shape on the trunk, often with central blisters, skin peeling, mouth ulcers, genital and eye ulcers that may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), rash, 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, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency’s Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enzalutamide Stada

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 blister, bottle, and carton after “EXP”. The expiry date is the last day of the month shown.

Do not remove the oxygen absorber from the bottle.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enzalutamida Stada

• The active ingredient is enzalutamida.
• Each Enzalutamida Stada 40 mg film-coated tablet contains 40 mg of enzalutamida.
• Each Enzalutamida Stada 80 mg film-coated tablet contains 80 mg of enzalutamida.

The other components are:

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

Appearance of the Product and Package Contents

The Enzalutamida STADA 40 mg tablets are yellow, round, film-coated, 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 STADA 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 STADA 80 mg tablets are yellow, oval, film-coated, 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 STADA 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

Birzebbugia BBG3000

Malta

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel, Hesse

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, A-1190

Doebling, Vienna

Austria

or

Clonmel Healthcare Limited

Waterford Road, E91 D768,

Clonmel, Tipperary

Ireland

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

Netherlands: Enzalutamide CF 40 mg, filmomhulde tabletten

Enzalutamide CF 80 mg, filmomhulde tabletten

Spain: Enzalutamida STADA 40 mg comprimidos recubiertos con película EFG

Enzalutamida STADA 80 mg comprimidos recubiertos con película EFG

Austria: Enzalutamid STADA 40 mg Filmtabletten

Enzalutamid STADA 80 mg Filmtabletten

Belgium: Enzalutamide EG 40 mg filmomhulde tabletten

Enzalutamide EG 80 mg filmomhulde tabletten

Enzalutamide EG 40 mg Filmtabletten

Enzalutamide EG 80 mg Filmtabletten

Enzalutamide EG 40 mg comprimés pelliculés

Enzalutamide EG 80 mg comprimés pelliculés

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

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

Czech Republic: Enzalutamide STADA

Germany: Enzalutamid AL 40 mg Filmtabletten

Enzalutamid AL 80 mg Filmtabletten

Denmark: Enzalutamide STADA

Estonia: Enzalutamide STADA

Greece: Enzalutamide/Stada

Finland: Enzalutamide STADA 40 mg kalvopäällysteiset tabletit

Enzalutamide STADA 80 mg kalvopäällysteiset tabletit

France: ENZALUTAMIDE EG 40 mg, comprimé pelliculé

ENZALUTAMIDE EG 80 mg, comprimé pelliculé

Croatia: Enzalutamid STADA 40 mg filmom obložene tablete

Enzalutamid STADA 80 mg filmom obložene tablete

Hungary: Enzalutamide STADA 40 mg filmtabletta

Enzalutamide STADA 80 mg filmtabletta

Ireland: Enzalutamide Clonmel 40 mg film-coated tablets

Enzalutamide Clonmel 80 mg film-coated tablets

Iceland: Enzalutamide STADA 40 mg filmuhúðaðar töflur

Enzalutamide STADA 80 mg filmuhúðaðar töflur

Italy: Enzalutamide EG

Lithuania: Enzalutamide STADA 40 mg plevele dengtos tabletes

Enzalutamide STADA 80 mg plevele dengtos tabletes

Luxembourg: Enzalutamide EG 40 mg comprimés pelliculés

Enzalutamide EG 80 mg comprimés pelliculés

Latvia: Enzalutamide STADA 40 mg apvalkotas tabletes

Enzalutamide STADA 80 mg apvalkotas tabletes

Malta: Enzalutamide Clonmel 40 mg film-coated tablets

Enzalutamide Clonmel 80 mg film-coated tablets

Norway: Enzalutamide STADA

Poland: Enzalutamide STADA

Portugal: Enzalutamida Stada

Romania: Enzalutamida Stada 40 mg comprimate filmate

Enzalutamida Stada 80 mg comprimate filmate

Sweden: Enzalutamide STADA

Slovenia: Enzalutamid STADA 40 mg filmsko obložene tablete

Enzalutamid STADA 80 mg filmsko obložene tablete

Slovakia: Enzalutamide STADA 40 mg

Enzalutamide STADA 80 mg

Date of the last revision of this leaflet:September 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.