Enzalutamide Viatris

Patient Information Leaflet

Enzalutamide Viatris 40 mg film-coated tablets, 80 mg film-coated tablets, 160 mg film-coated tablets

enzalutamide
Please read all of this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

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

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

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

• Whose cancer no longer responds to hormonal therapy or surgical treatment to reduce testosterone, or
• Whose cancer has spread to other parts of the body and still responds to hormonal therapy or surgical treatment to reduce testosterone, or
• Who have previously undergone prostate removal or radiotherapy and have a rapidly rising PSA, but whose cancer has not spread to other parts of the body and still responds to hormonal therapy to reduce testosterone.

How Enzalutamide Viatris works
Enzalutamide Viatris 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 should know before taking Enzalutamide Viatris

Do not take Enzalutamide Viatris

• 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
Seizure events have been reported in 6 out of 1,000 patients treated with Enzalutamide Viatris and in fewer than 3 out of 1,000 patients treated with placebo (see "Other medicines and Enzalutamide Viatris" 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 Viatris", below).
If you experience a seizure during treatment:
Contact your doctor as soon as possible. Your doctor may decide that you should stop taking Enzalutamide Viatris.

Reversible posterior encephalopathy syndrome (PRES)
Rare cases of PRES, a rare reversible condition affecting the brain, have been reported in patients treated with Enzalutamide Viatris. If you have seizures, worsening headaches, 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 Viatris.
Contact your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in your urine, or if you frequently feel a strong urge to urinate while taking Enzalutamide Viatris.

Swallowing difficulties related to product formulation
Cases of patients experiencing difficulty swallowing this medicine, including choking incidents, have been reported. Swallowing difficulties and choking incidents have been observed more frequently in patients taking capsules and may be related to the larger size of the product. Swallow the tablets whole with sufficient water.

Talk to your doctor before taking Enzalutamide Viatris:

• if you have previously developed severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Enzalutamide Viatris or other medicines
• if you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• if you are using a chemotherapy drug such as docetaxel
• if you have liver problems
• if 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 Viatris.
If you are allergic to enzalutamide, you may experience skin rash 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 Viatris.
Severe skin rash or skin peeling, blisters and/or mouth ulcers, including Stevens-Johnson syndrome, have been reported in association with treatment with Enzalutamide Viatris. Stop using Enzalutamide Viatris and contact your doctor immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4.
If you are in any of the conditions listed above 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 Viatris
Tell your doctor if you are taking, have recently taken, or might take any other medicines. You should know the names of all the medicines you are taking. Keep a list of them to show your doctor when prescribed a new medicine. Do not start or stop any therapy without first discussing it with the doctor who prescribed Enzalutamide Viatris.

Tell your doctor if you are taking any of the following medicines. If taken together with Enzalutamide Viatris, the following medicines 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 your doctor if you are taking any of the following medicines. These medicines may affect the action of Enzalutamide Viatris, or Enzalutamide Viatris may affect the action of these medicines:
For example, certain medicines used to:

• lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin)
• treat pain (e.g. fentanyl, tramadol)
• treat cancer (e.g. cabazitaxel)
• treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproate)
• treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
• treat sleep disorders (e.g. zolpidem)
• treat heart disease or lower blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• treat severe inflammatory conditions (e.g. dexamethasone, prednisolone)
• treat HIV infections (e.g. indinavir, ritonavir)
• treat bacterial infections (e.g. clarithromycin, doxycycline)
• treat thyroid disorders (e.g. levothyroxine)
• treat gout (e.g. colchicine)
• treat stomach disorders (e.g. omeprazole)
• prevent heart disease or stroke (e.g. dabigatran etexilate)
• prevent organ rejection (e.g. tacrolimus)

Enzalutamide Viatris may interfere with certain 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 certain 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 Viatris or of any other medicine you are taking.

Pregnancy, breastfeeding and fertility

• Enzalutamide Viatris 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 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 method of contraception 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’s caregiver is a woman, see section 3 “How to take Enzalutamide Viatris” for instructions on use and handling.

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

Enzalutamide Viatris 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 Viatris

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The usual dose is 160 mg (four 40 mg film-coated tablets, or two 80 mg film-coated tablets, or one 160 mg film-coated tablet), taken once daily at the same time each day.

Taking Enzalutamide Viatris

• Swallow the tablets whole with a sufficient amount of water.
• Do not cut, crush, or chew the tablets before swallowing.
• Enzalutamide Viatris may be taken with or without food.
• Enzalutamide Viatris must 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 Viatris tablets without wearing protective gloves or other protection.

Your doctor may prescribe other medicines to be taken during treatment with Enzalutamide Viatris.

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

If you forget to take Enzalutamide Viatris

• If you forget to take Enzalutamide Viatris at your usual time, take your normal dose as soon as you remember.
• If you forget to take Enzalutamide Viatris for an entire day, take your normal dose the next day.
• If you forget to take Enzalutamide Viatris 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 Viatris
Do not stop taking this medicine unless instructed by your doctor.
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 everyone will experience them.

Seizures
Seizure events have been reported in 6 out of 1,000 patients treated with Enzalutamide Viatris 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 exceeding the recommended dose, if you take other medicines, or if you have a higher than normal risk of seizures.
If you experience a seizure, contact your doctor as soon as possible. Your doctor may decide that you should stop treatment with Enzalutamide Viatris.

Posterior reversible encephalopathy syndrome (PRES)
Rare cases of PRES have been reported in patients treated with Enzalutamide Viatris (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 are:

Very common side effects (may affect more than 1 in 10 people)
Fatigue, 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 impairment, blockage of the heart arteries (ischaemic heart disease), breast enlargement in men (gynaecomastia), nipple pain, breast tenderness, symptoms of restless legs syndrome (an uncontrollable urge to move part of the body, usually the legs), reduced concentration, forgetfulness, altered sense of taste, difficulty thinking clearly.

Uncommon side effects (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).

Side effects of unknown frequency (frequency cannot be determined from the available data)
Muscle pain, muscle cramps, muscle weakness, back pain, changes in electrocardiogram (ECG) (QT prolongation), difficulty swallowing this medicine, including choking, stomach discomfort including 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 (erythema multiforme), or another serious skin reaction presenting with flat reddish spots on the trunk, similar to a target or circular, often with central blisters, skin peeling, mouth ulcers, sores in the throat, nose, genitals and eyes, which may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), rash, malaise (vomiting), swelling of the face, lips, tongue and/or throat, reduced number of blood platelets (increased risk of bleeding or bruising), diarrhoea, reduced appetite.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enzalutamide Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Viatris contains
The active substance is enzalutamide.
Each film-coated tablet of Enzalutamide Viatris 40 mg contains 40 mg of enzalutamide.
Each film-coated tablet of Enzalutamide Viatris 80 mg contains 80 mg of enzalutamide.
Each film-coated tablet of Enzalutamide Viatris 160 mg contains 160 mg of enzalutamide.
The other components are:

• Tablet core: methacrylic acid-ethyl acrylate copolymer (1:1) Type A (also containing sodium lauryl sulfate and polysorbate 80), anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose (see section 2, “Enzalutamide Viatris contains sodium”), and magnesium stearate.
• Tablet coating: hypromellose 2910, macrogol MW 3350, titanium dioxide (E171), iron oxide yellow (E172), and talc.

Description of the appearance of Enzalutamide Viatris and contents of the pack
Enzalutamide Viatris 40 mg film-coated tablets (tablets) are yellow, round, marked with “40” on one side, and have a diameter of approximately 10 mm. They are available in cartons containing 112-tablet blisters, calendar blister packs containing 112 tablets, or unit-dose blisters containing 1 x 112 tablets.
Enzalutamide Viatris 80 mg film-coated tablets (tablets) are yellow, oval, marked with “80” on one side, and measure approximately 17 mm x 9 mm. They are available in cartons containing 56-tablet blisters, calendar blister packs containing 56 tablets, or unit-dose blisters containing 1 x 56 tablets.
Enzalutamide Viatris 160 mg film-coated tablets (tablets) are yellow, oval, marked with “160” on one side, and measure approximately 23 mm x 11 mm. They are available in cartons containing 28-tablet blisters, calendar blister packs containing 28 tablets, or unit-dose blisters containing 1 x 28 tablets.
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 on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

България
Майлан ЕОД
Тел.: +359 2 44 55 400

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Danmark
Viatris ApS
Tlf.: +45 28 11 69 32

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Eesti
Viatris OÜ
Tel: +372 6363 052

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

France
Viatris Santé
Tél: +33 4 37 25 75 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

Ireland
Viatris Limited
Tel: +353 1 8711600

Ísland
Icepharma hf.
Sími: +354 540 8000

Italia
Viatris Italia S.r.l.
Tel: +39 (0)2 612 46921

Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

Latvija
Viatris SIA
Tel: +371 676 055 80

Lietuva
Viatris UAB
Tel: +370 5 205 1288

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00 (Belgique/Belgien)

Magyarország
Viatris Healthcare Kft.
Tel.: +36 1 465 2100

Malta
V.J. Salomone Pharma Ltd
Tel: +356 21 22 01 74

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Norge
Viatris AS
Tlf: +47 66 75 33 00

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

Polska
Viatris Healthcare Sp. z o.o.
Tel.: +48 22 546 64 00

Portugal
Mylan, Lda.
Tel: +351 214 127 200

România
BGP Products SRL
Tel: +40 372 579 000

Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.