Enzalutamide accord

Package leaflet: Information for the patient

Enzalutamide Accord, 40 mg, soft capsules
Enzalutamide
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.
Contents of the leaflet
What Enzalutamide Accord is and what it is used for
Important information before taking Enzalutamide Accord
How to take Enzalutamide Accord
Possible side effects
How to store Enzalutamide Accord
Contents of the pack and other information

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

Enzalutamide Accord contains the active substance enzalutamide. Enzalutamide Accord is used in adult men for the treatment of prostate cancer that:
no longer responds to hormonal therapy or surgical treatment aimed at reducing testosterone levels
or
has spread to other parts of the body and still responds to hormonal therapy or surgical treatment aimed at reducing testosterone levels
or

• in men who have previously undergone prostatectomy or radiotherapy and have a rapid rise in PSA levels, but whose cancer has not spread to other parts of the body and who still respond to hormonal therapy aimed at reducing testosterone levels.

How Enzalutamide Accord works
Enzalutamide Accord 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. Important information before using Enzalutamide Accord

When not to take Enzalutamide Accord
if the patient is 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 6 out of 1,000 individuals taking enzalutamide and in fewer than 3 out of 1,000 individuals taking placebo (see below "Enzalutamide Accord with other medicines" and section 4 "Possible side effects").
If the patient is taking medicines that may cause seizures or increase susceptibility to seizures, see below "Enzalutamide Accord with other medicines".
If a seizure occurs during treatment:
Contact the doctor immediately. The doctor will decide whether to discontinue treatment with Enzalutamide Accord.

Posterior reversible encephalopathy syndrome (PRES)
PRES (a rare, reversible condition affecting the brain) has been rarely reported in patients treated with enzalutamide. If seizures, worsening headache, altered consciousness, blindness, or other visual disturbances occur, contact the doctor immediately (also see section 4. "Possible side effects").

Risk of new cancers (second primary malignancies)
There have been reports of new (secondary) cancers, including bladder and colorectal cancer, in patients treated with enzalutamide.
If gastrointestinal bleeding, blood in the urine, or frequent urgent need to urinate occur while taking Enzalutamide Accord, contact the doctor as soon as possible.

Swallowing difficulties related to the formulation of the medicine
Difficulty swallowing this medicine, including choking incidents, has been reported in patients. Swallowing difficulties and choking incidents were observed more frequently in patients taking the medicine in capsule form, which may be related to the larger size of the capsules. Capsules must be swallowed whole with an adequate amount of water.
Patients who have difficulty swallowing large capsules or have a history of dysphagia may experience difficulty swallowing Enzalutamide Accord capsules and are at risk of choking. Enzalutamide Accord is also available in tablet form; please consult the doctor about this option.

Before starting Enzalutamide Accord, tell the doctor if:

• a serious rash or skin peeling, blisters, and/or oral ulcers occurred after taking Enzalutamide Accord or other medicines
• the patient is taking other medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• the patient is undergoing chemotherapy, e.g. docetaxel
• the patient has liver disease
• the patient has kidney disease

Tell the doctor if any of the following apply:
any heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or if the patient is being treated for such conditions. The risk of heart rhythm disturbances may increase during treatment with Enzalutamide Accord.
If the patient is allergic to enzalutamide, a rash or swelling of the face, tongue, lips, or throat may occur. If allergy to enzalutamide or any of the other ingredients of this medicine has been diagnosed, Enzalutamide Accord must not be taken.
Serious skin rashes, skin peeling, blisters, and/or oral ulcers, including Stevens-Johnson syndrome, have been reported during treatment with Enzalutamide Accord. If any of these symptoms associated with these serious skin reactions, described in section 4, occur, contact the doctor immediately and discontinue treatment with Enzalutamide Accord.

If any of the above situations apply or if there is any uncertainty, consult the doctor before taking this medicine.

Children and adolescents
This medicine is not intended for use in children and adolescents.

Enzalutamide Accord with other medicines
Inform the doctor about all medicines currently taken, recently taken, or planned to be taken. Know the names of all medicines being taken.
Keep a list of these medicines to show the doctor when a new medicine is prescribed. Do not start or stop taking any medicine without first consulting the doctor who prescribed Enzalutamide Accord.

Inform the doctor if taking any of the following medicines. These medicines, when taken together with Enzalutamide Accord, 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. pethidine).

Inform the doctor if taking any of the following medicines. These medicines may affect the action of Enzalutamide Accord, or Enzalutamide Accord may affect their action. This includes medicines used for:

• lowering cholesterol levels (e.g. gemfibrozil, atorvastatin, simvastatin)
• pain relief (e.g. fentanyl, tramadol)
• cancer treatment (e.g. cabazitaxel)
• epilepsy treatment (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 conditions 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 strokes (e.g. dabigatran etexilate)
• preventing organ transplant rejection (e.g. tacrolimus)

Enzalutamide Accord may affect the action of certain medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol) or may increase the risk of heart rhythm disturbances when taken with certain other medicines [e.g. methadone (used for pain relief and detoxification in drug addicts), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental illnesses)].

Inform the doctor if taking any of the medicines listed above. The dose of Enzalutamide Accord or of any other medicine being taken may need to be adjusted.

Pregnancy, breastfeeding and fertility
Enzalutamide Accord is not indicated for use in women. This medicine, if taken by pregnant women, may harm the unborn child or potentially cause miscarriage. This medicine must not be used if the woman is pregnant, could become pregnant, or is breastfeeding.
This medicine may possibly affect fertility in men.
If the patient has sexual intercourse with a woman of childbearing potential during treatment and for 3 months after treatment ends, a condom and another effective method of contraception must be used. If the patient has sexual intercourse with a pregnant woman, a condom must be used to protect the unborn child.

Caregivers of patients – see section 3 "How to take Enzalutamide Accord" for instructions on how to handle the medicine.

Driving and using machines
Enzalutamide Accord may have a moderate effect on the ability to drive and operate machinery. Seizures have been reported in patients taking Enzalutamide Accord. If there is an increased risk of seizures, consult the doctor.

Enzalutamide Accord contains sorbitol
This medicine contains 47.80 mg of sorbitol (E 420) in each soft capsule.

3. How to take Enzalutamide Accord

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
the doctor.
The recommended dose is 160 mg (four soft capsules) taken once daily at the same time each day.
Taking Enzalutamide Accord
The soft capsule should be swallowed whole with a sufficient amount of water.
Soft capsules must not be chewed, dissolved, or opened before swallowing.
Enzalutamide Accord may be taken with or without food.
Individuals other than the patient or their caregivers should not come into contact with
Enzalutamide Accord. Women who are pregnant or may become pregnant must not handle
damaged or opened Enzalutamide Accord capsules without protective gloves.
The doctor may also prescribe other medicines during treatment with Enzalutamide Accord.
Taking more Enzalutamide Accord than prescribed
If more soft capsules than prescribed have been taken, stop taking Enzalutamide Accord and contact
the doctor immediately. The risk of seizures or other adverse effects may increase.
Missing a dose of Enzalutamide Accord
If a dose of Enzalutamide Accord is missed at the usual time, the usual dose should be taken as
soon as possible.
If a dose of Enzalutamide Accord is forgotten on a given day, take the usual dose the next day.
If a dose of Enzalutamide Accord is missed for more than one day, contact the doctor immediately.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Enzalutamide Accord
Do not stop treatment unless instructed by the doctor.
Difficulty swallowing large capsules or history of dysphagia
Enzalutamide in soft capsule form must not be administered to patients who have difficulty swallowing
large capsules or who have a history of dysphagia. Enzalutamide in tablet form is recommended instead.
Patients who have difficulty swallowing large capsules or who have a history of dysphagia may have
difficulty swallowing Enzalutamide Accord soft capsules and are at risk of choking. Enzalutamide Accord
is available in tablet form; ask the doctor for this alternative.
If there are any further doubts regarding the use of this medicine, consult the doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Seizures
Seizures have been reported in 6 out of 1000 people taking enzalutamide and in fewer than 3 out of 1000 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 when there is a higher than usual risk of having a seizure.
If a seizure occurs, contact your doctor immediately. Your doctor will decide whether to discontinue treatment with Enzalutamide Accord.
Posterior reversible encephalopathy syndrome (PRES)
PRES has been rarely reported in patients treated with enzalutamide (may occur in fewer than 1 in 1000 patients); this is a rare, reversible condition affecting the brain. If seizures, worsening headache, altered consciousness, blindness, or other vision disturbances occur, contact your doctor as soon as possible.
Other adverse effects include:
Very common (may affect more than 1 in 10 people)
fatigue, falls, bone fractures, hot flushes, high blood pressure
Common (may affect fewer than 1 in 10 people)
headache, feeling of anxiety, dry skin, itching, memory impairment, arterial blockage in the heart (ischaemic heart disease), breast enlargement in men (gynaecomastia), nipple pain, restless legs syndrome (uncontrollable urge to move a body part, usually the leg), reduced concentration, forgetfulness, altered sense of taste, difficulty thinking clearly
Uncommon (may affect fewer than 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 electrocardiogram (prolongation of QT interval), difficulty swallowing this medicine, including choking, gastrointestinal discomfort 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), or other serious skin reactions presenting as reddish, flat, circular or oval-shaped 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, facial swelling, swelling of the lips, tongue and (or) throat, reduced platelet count (increasing the risk of bleeding or bruising), diarrhoea, decreased appetite
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Enzalutamide Accord

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 the stated month.
No special storage conditions are required for this medicine.
Do not take any soft capsule that is leaking, damaged, or shows signs of tampering.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Enzalutamide Accord contains
The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
The other ingredients of the soft capsule are: macrogol glyceryl caprylocaprate,
butylhydroxyanisole and butylhydroxytoluene.
The ingredients of the soft capsule shell are: gelatin, sorbitol liquid, partially dehydrated,
glycerol, titanium dioxide (E171), talc and purified water, medium-chain triglycerides.
The ingredients of the printing ink are: shellac, iron oxide black, ammonium hydroxide, propylene glycol.

What Enzalutamide Accord looks like and contents of the pack
Enzalutamide Accord is a white or almost white, opaque, elongated (20 mm length x 9 mm width) soft capsule with the imprint "JG1" in black ink.
Enzalutamide Accord is available in PVC/PCTFE/Aluminium blister packs containing 28 soft capsules in a cardboard carton. A larger pack containing 112 soft capsules (4 packs of 28) is also available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice
Poland
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola PLA
3000, Malta
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
32009, Lamia, Schimatari, Greece

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names: