ENZALUTAMIDE VIATRIS 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Enzalutamida Viatris 40 mg film-coated tablets

Enzalutamida Viatris 80 mg film-coated tablets

enzalutamida

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 further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Enzalutamida Viatris and what is it used for

Enzalutamida Viatris contains the active substance enzalutamida. Enzalutamida Viatris is used to treat adult men with prostate cancer:

• That has stopped responding to hormone therapy or surgical treatment to reduce testosterone.

Or

• That has spread to other parts of the body and responds to hormone therapy or surgical treatment to reduce testosterone.

Or

• That have undergone previous prostate removal or radiation and have a rapid increase in PSA, but the cancer has not spread to other parts of the body and responds to hormone therapy to reduce testosterone.

How Enzalutamida Viatris works

Enzalutamida Viatris is a medicine that works by blocking the activity of certain hormones called androgens (such as testosterone). By blocking androgens, enzalutamida makes prostate cancer cells stop growing and dividing.

2. What you need to know before you take Enzalutamida Viatris

Do not take Enzalutamida Viatris

• if you are allergic to enzalutamida or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or may become pregnant (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Seizures

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

If you are taking a medicine that can cause seizures or that can increase the risk of having seizures (see “Other medicines and Enzalutamida Viatris” below).

If you have a seizure during treatment:

Consult your doctor as soon as possible. Your doctor may decide that you should stop taking Enzalutamida Viatris.

Posterior Reversible Encephalopathy Syndrome (PRES)

Rare cases of PRES, a rare, reversible disease that affects the brain, have been reported in patients treated with Enzalutamida Viatris. 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)

Reports of new (second) cancers have been received in patients treated with Enzalutamida Viatris, 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 Enzalutamida Viatris.

Difficulty swallowing related to the product formulation

Cases of patients who have experienced difficulty swallowing this medicine, including choking, have been reported. Difficulty swallowing and choking episodes were more frequently observed in patients receiving capsules, which may be related to the larger size of the product. Swallow the tablets whole with a sufficient amount of water.

Consult your doctor before starting Enzalutamida Viatris

• if you have ever developed severe skin rashes or skin peeling, blistering, and/or ulcers in the mouth after taking Enzalutamida Viatris 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.

Tell your doctor if you have:

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 Enzalutamida Viatris.

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

Severe skin rashes or skin peeling, blistering, and/or ulcers in the mouth, including Stevens-Johnson syndrome, have been reported in association with Enzalutamida Viatris treatment. Stop using Enzalutamida Viatris 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 administered to children or adolescents.

Other medicines and Enzalutamida Viatris

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 you are prescribed a new medicine. Do not start or stop taking any medicine before consulting the doctor who prescribed Enzalutamida Viatris.

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 Enzalutamida Viatris:

• 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 Enzalutamida Viatris or Enzalutamida Viatris 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)

Enzalutamida Viatris 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 Enzalutamida Viatris or any other medicine you are taking.

Pregnancy, breastfeeding and fertility

• Enzalutamida Viatris is not indicated in women. This medicine may be harmful to the fetus or may cause abortion if taken by a pregnant woman. It must not be administered to pregnant women, women who may become pregnant, or women who are breastfeeding.
• 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.
• In the case of female caregivers, see section 3 “How to take Enzalutamida Viatris” for handling and use recommendations.

Driving and using machines

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

Enzalutamida Viatris 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 Enzalutamida Viatris

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, 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 Enzalutamida Viatris

• Swallow the tablets whole with a sufficient amount of water.
• Do not break, crush, or chew the tablets before swallowing.
• Enzalutamida Viatris can be taken with or without food.
• Enzalutamida Viatris 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 Enzalutamida Viatris tablets without protection (e.g., gloves).

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

If you take more Enzalutamida Viatris than you should

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

If you forget to take Enzalutamida Viatris

• If you forget to take Enzalutamida Viatris at the usual time, take the usual dose as soon as you remember.
• If you forget to take Enzalutamida Viatris for the whole day, take the usual dose the next day.
• If you forget to take Enzalutamida Viatris for more than one day, consult your doctor immediately.
• Do not take a double doseto make up for forgotten doses.

If you stop taking Enzalutamida Viatris

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 Enzalutamida Viatris, 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 risk than usual 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 Enzalutamida Viatris.

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 Enzalutamida Viatris. 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 (ischemic heart disease), breast swelling 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).

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), difficulty swallowing this medicine, including choking, 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 other 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, vomiting, swelling of the face, lips, tongue, and/or throat, decreased platelet count in the blood (which increases the risk of bleeding or bruising), diarrhea, decreased appetite.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enzalutamida Viatris

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 and blister after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should 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. Packaging Contents and Additional Information

Composition of Enzalutamida Viatris

The active ingredient is enzalutamida.

Each Enzalutamida Viatris 40 mg film-coated tablet contains 40 mg of enzalutamida.

Each Enzalutamida Viatris 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 (also contains sodium lauryl sulfate and polysorbate 80), anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose (see section 2, "Enzalutamida Viatris contains sodium") and magnesium stearate.
• Tablet coating: hypromellose 2910, macrogol MW 3350, titanium dioxide (E171), yellow iron oxide (E172) and talc.

Appearance of Enzalutamida Viatris and Packaging Contents

The Enzalutamida Viatris 40 mg film-coated tablets are round, yellow, with the engraving "40" on one side and a diameter of approximately 10 mm. They are available in packs containing 112 tablets in blisters, 112 tablets in calendar blisters or 1 x 112 tablets in unit dose blisters.

The Enzalutamida Viatris 80 mg film-coated tablets are oval, yellow, with the engraving "80" on one side and dimensions of approximately 17 mm x 9 mm. They are available in packs containing 56 tablets in blisters, 56 tablets in calendar blisters or 1 x 56 tablets in unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate, Birzebbugia BBG3000, Malta

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.