Enzalutamide sandoz polska

Package leaflet: Information for the patient

Enzalutamide Sandoz Polska, 40 mg, soft capsules
Enzalutamidum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Enzalutamide Sandoz Polska is and what it is used for

Enzalutamide Sandoz Polska contains the active substance enzalutamide. This medicine is used
in adult men for the treatment of prostate cancer which:

• no longer responds to hormonal therapy or surgical treatment aimed at reducing testosterone levels
• has spread to other parts of the body and responds to hormonal therapy or surgical treatment aimed at reducing testosterone levels
• in men who have previously undergone prostatectomy or radiation therapy and have a rapid rise in PSA (Prostate Specific Antigen) levels, but the cancer has not spread to other parts of the body and responds to hormonal therapy aimed at reducing testosterone levels.

How Enzalutamide Sandoz Polska works
Enzalutamide Sandoz Polska is a medicine that works by blocking the activity of hormones
called androgens (such as testosterone). By blocking androgens, enzalutamide inhibits the growth
and division of prostate cancer cells.

2. What you need to know before taking Enzalutamide Sandoz Polska
When not to take Enzalutamide Sandoz Polska

• if you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6).
• during pregnancy or if there is a possibility of becoming pregnant (see "Pregnancy, breastfeeding and fertility")

Warnings and precautions
Seizures
Seizures have been reported in 5 out of 1,000 individuals taking enzalutamide and in fewer than 3 out of 1,000 individuals
taking placebo (see below "Enzalutamide Sandoz Polska and other medicines" and
section 4 "Possible side effects").
If you are taking medicines that may cause seizures or increase susceptibility to
seizures, see below "Enzalutamide Sandoz Polska and other medicines".
If a seizure occurs during treatment:
contact your doctor immediately. Your doctor will decide whether to discontinue this
medicine.
Posterior Reversible Encephalopathy Syndrome (PRES)
PRES has been rarely reported in patients treated with enzalutamide. If you experience
seizures, worsening headache, altered consciousness, blindness, or other visual disturbances,
contact your doctor immediately (see also section 4. "Possible side effects").
Risk of new cancers (second primary malignant tumours)
There have been reports of new (second) cancers, including bladder and colorectal cancer, in patients treated with enzalutamide.
If, during treatment with Enzalutamide Sandoz Polska, you experience symptoms of gastrointestinal bleeding, blood in the urine, or a frequent urgent need to urinate, contact your doctor as soon as possible.
Before starting Enzalutamide Sandoz Polska, tell your doctor:

• if you have ever had a severe skin rash, skin peeling, blistering, and/or oral ulcers after taking Enzalutamide Sandoz Polska or other medicines
• if you are taking other medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• if you are undergoing chemotherapy, e.g. docetaxel
• if you have liver diseases
• if you have kidney diseases

Tell your doctor if any of the following apply:
Any heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or
if you are being treated for such conditions. The risk of heart rhythm disorders may increase during
treatment with Enzalutamide Sandoz Polska.
If you are allergic to enzalutamide, a skin rash or swelling of the face, tongue, lips, or throat may occur. If you have a known allergy to enzalutamide or any of the other ingredients
of this medicine, do not take this medicine.
Serious skin rashes or skin peeling, blistering, and/or oral ulcers, including Stevens-Johnson syndrome, have been reported with enzalutamide treatment. If any of the symptoms related to serious skin reactions described
in section 4 occur, stop taking Enzalutamide Sandoz Polska and contact your doctor immediately.
If any of the above situations apply or if you have any doubts, consult your doctor before taking this medicine.
Children and adolescents
This medicine is not indicated for use in children and adolescents.
Enzalutamide Sandoz Polska and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Know the names of the medicines you are taking. Keep a list of these medicines with you to show your doctor when a new medicine is prescribed. Do not start or stop taking any medicine without first consulting the doctor who prescribed it.
Tell your doctor if you are taking any of the following medicines. These medicines, when taken together with Enzalutamide Sandoz Polska, 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 Sandoz Polska or Enzalutamide Sandoz Polska may affect the action of these
medicines.
This includes medicines used for:

• lowering cholesterol levels (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 diseases or lowering blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• treating serious inflammatory conditions (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 gastrointestinal disorders (e.g. omeprazole)
• preventing heart disease or stroke (e.g. dabigatran etexilate)
• preventing organ transplant rejection (e.g. tacrolimus)

Enzalutamide Sandoz Polska may affect the action of certain medicines used to treat
heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol) or increase
the risk of heart rhythm disorders when taken with certain other medicines [e.g. methadone
(used for pain relief and detoxification in addicts), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental illnesses)].
Tell your doctor if you are taking any of the medicines listed above. The dose of Enzalutamide Sandoz Polska or any other medicine being taken may need to be adjusted.
Pregnancy, breastfeeding and fertility

• Enzalutamide Sandoz Polska is not indicated for use in women. This medicine, if taken by women during pregnancy, may have harmful effects on the unborn child or potentially cause miscarriage. You must not use this medicine if you are pregnant, could become pregnant, or are breastfeeding.

• This medicine may likely affect fertility in men.

• If, during treatment and for 3 months after treatment ends, you have sexual intercourse with a woman who could become pregnant, you must use a condom and another effective method of contraception. If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.

• Patient caregivers - see section 3 "How to take Enzalutamide Sandoz Polska" for instructions on how to handle the medicine.

Driving and operating machinery
Enzalutamide Sandoz Polska may have a moderate effect on the ability to drive and operate machinery. Seizures have been reported in patients taking enzalutamide.
If you are at increased risk of seizures, consult your doctor.
Enzalutamide Sandoz Polska contains sorbitol
This medicine contains 91.6 mg of sorbitol (a type of sugar) per capsule. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Enzalutamide Sandoz Polska

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
The recommended dose is 160 mg (four soft capsules) taken at the same time once daily.
Taking Enzalutamide Sandoz Polska medicine

• Soft capsules should be swallowed whole with water.
• Do not chew, crush, or open soft capsules before swallowing.
• Enzalutamide Sandoz Polska may be taken with or without food.
• Individuals other than the patient or their caregivers should not come into contact with Enzalutamide Sandoz Polska.
• Pregnant women or women who may become pregnant should not handle damaged or opened enzalutamide capsules without protective gloves.

Your doctor may also prescribe other medicines during treatment with Enzalutamide Sandoz Polska.
Taking more Enzalutamide Sandoz Polska than prescribed
If you take more soft capsules than prescribed, stop taking Enzalutamide Sandoz Polska and contact
your doctor immediately. The risk of seizure or other adverse effects may increase.
Missing a dose of Enzalutamide Sandoz Polska

• If the patient forgets to take Enzalutamide Sandoz Polska at the scheduled time, the usual dose should be taken as soon as possible.
• If the patient forgets to take Enzalutamide Sandoz Polska on a given day, the usual dose should be taken the next day.
• If the patient forgets to take Enzalutamide Sandoz Polska for more than one day, contact the doctor immediately.
• Do not take a double dose to make up for a missed dose. Stopping Enzalutamide Sandoz Polska treatment Do not stop treatment unless instructed by your doctor.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Seizures
Seizures have been reported in 5 out of 1,000 people taking enzalutamide and in fewer than 3 out of 1,000 people taking placebo.
The occurrence of seizures is more likely when taking a higher than recommended dose of this medicine, taking certain other medicines, or in individuals with an increased risk of seizure.
If a seizure occurs, contact your doctor immediately. Your doctor will decide whether to discontinue treatment with Enzalutamide Sandoz Polska.

Posterior reversible encephalopathy syndrome (PRES)
PRES has been reported rarely in patients treated with enzalutamide (may occur less frequently than in 1 out of 1,000 people); this is a rare, reversible brain condition. If seizures, worsening headache, altered consciousness, blindness, or other vision disturbances occur, contact your doctor as soon as possible.

Other adverse reactions include:
Very common (may occur in more than 1 out of 10 people):

• fatigue,
• falling, bone fracture,
• hot flushes,
• high blood pressure.

Common (may occur in not more than 1 out of 10 people):

• headache,
• feeling of anxiety,
• dry skin, itching,
• memory disturbances,
• blockage of arteries in the heart (ischaemic heart disease),
• breast enlargement in men (gynaecomastia),
• nipple pain, breast tenderness,
• restless legs syndrome (uncontrollable urge to move part of the body, usually the leg),
• decreased concentration,
• forgetfulness,
• change in taste sensation,
• difficulty with clear (rational) thinking.

Uncommon (may occur in not more than 1 out of 100 people):

• hallucinations,
• low white blood cell count,
• increased liver enzyme activity in blood tests (indicating liver disease).

Frequency not known (frequency cannot be estimated from available data):

• muscle pain, muscle cramps, muscle weakness, back pain,
• changes in ECG recording (prolongation of QT interval),
• indigestion, including nausea,
• skin reaction causing red spots or lesions with a target-like appearance, with a dark red center surrounded by pale red rings (erythema multiforme),
• other severe skin reaction characterized by reddish, flat, target-like or circular spots on the trunk, often with central blisters, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes, which 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 (increasing the risk of bleeding or bruising),
• diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Enzalutamide Sandoz Polska

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not take a soft capsule if it is leaking, damaged, or shows signs of damage.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect
the environment.

6. Contents of the package and other information

What Enzalutamide Sandoz Polska contains

• The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
• The other ingredients of the soft capsule are: macrogolglycerides of caprylic and caproic acids, butylhydroxyanisole (E 320) and butylhydroxytoluene (E 321).
• The ingredients of the soft capsule shell are: gelatin, sorbitol, partially dehydrated liquid (see section 2), glycerol (E 422), titanium dioxide (E 171) and purified water.

What Enzalutamide Sandoz Polska looks like and contents of the pack
Enzalutamide Sandoz Polska soft capsules are white to off-white, opaque, elongated, with a length of 22.0 (± 2.5) mm and a width of 9.5 (± 2.5) mm, containing a colourless to slightly yellow, clear liquid.
Each cardboard box contains blisters of 4 soft capsules, in pack sizes of 28, 112, and 120 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. 22 209 70 00

Manufacturers
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA 3000,
Malta
Lek Pharmaceuticals d.d.
Verovškova ulica 57,
1526 Ljubljana,
Slovenia
Adalvo Ltd.
Malta Life Sciences Park, Building 1,
Level 4, Sir Temi Zammit Buildings,
San Ġwann SĠN 3000,
Malta

This medicinal product is authorised in the European Economic Area under the following names:
Finland Enzalutamide 1A Farma 40 mg soft capsule
Lithuania Enzalutamide Sandoz Polska Sp. z o.o. 40 mg soft capsules
Latvia Enzalutamide Sandoz Polska Sp. z o.o. 40 mg soft capsules
Poland Enzalutamide Sandoz Polska