ЕНЗАЛУТАМІД 40 MG Soft capsule

Зміст інструкції

1. Enzalutamide Accord 40 mg soft capsules
   1. What is Enzalutamide Accord and what it is used for
   2. What you need to know before you take
   3. Contents of the pack and other information
2. Enzalutamide Accord is available in PVC/PCTFE-Alu blisters containing 28 capsules

Enzalutamide Accord 40 mg soft capsules

enzalutamide

Generic medicine

Read 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 questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

What Enzalutamide Accord is and what it is used for
What you need to know before you take Enzalutamide Accord
Contents of the pack and other information

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

Enzalutamide Accord contains the active substance enzalutamide. Enzalutamide Accord is used for
the treatment of adult men with prostate cancer who:
No longer respond to hormone therapy or surgical treatment to reduce testosterone
Or
Has spread to other parts of the body and responds to hormone therapy or surgical
treatment to reduce testosterone.

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 stops the growth and
division of prostate cancer cells.

2. What you need to know before you take

Do not take Enzalutamide Accord
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 might become pregnant (see "Pregnancy, breastfeeding and
fertility").

Warnings and precautions
Convulsions
In 5 patients out of 1,000 treated with Enzalutamide Accord and in less than 3 patients out of 1,000 treated with
placebo, episodes of convulsions have been reported (see “Other medicines and Enzalutamide Accord” below
and section 4, “Possible side effects”).
If you are taking a medicine that can cause convulsions or increase your predisposition to convulsions
(see “Other medicines and Enzalutamide Accord”, below).
If you have a convulsive episode during treatment:
Consult your doctor as soon as possible. The doctor may decide that you should stop taking
Enzalutamide Accord.
In patients treated with Enzalutamide Accord, rare cases of PRES have been reported, a rare reversible condition
that involves the brain. If you have convulsions, 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 tumors (secondary primary tumors)
New (secondary) tumors including bladder and colon cancer have been reported in patients treated
with Enzalutamide Accord.
Contact your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in the
urine or if you frequently feel an urgent need to urinate while taking Enzalutamide Accord.
Talk to your doctor before taking Enzalutamide Accord:
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 disorders. The risk of heart rhythm problems may
increase with the use of Enzalutamide Accord.
If you are allergic to enzalutamide, you may experience skin rashes, 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 Accord.
Severe skin rash or skin exfoliation, rash with blisters and/or mouth ulcers have been reported
in association with treatment with Enzalutamide Accord. Contact
your doctor immediately if you notice any of these symptoms.

If you are in any of the conditions listed above or if you are not sure, talk to your doctor
before taking this medicine.
Children and adolescents
This medicine should not be used by children and adolescents.

Other medicines and Enzalutamide Accord
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. Keep a list of
these with you to show to the doctor when you are prescribed a new medicine. Do not start or stop
therapy before talking to the doctor who prescribed Enzalutamide Accord.
Tell your doctor if you are taking any of the following medicines. If they are taken in
concomitance with Enzalutamide Accord, the following medicines may increase the risk of
convulsions:
some medicines used to treat asthma or other respiratory diseases (e.g.
aminophylline, theophylline)
medicines used to treat some psychiatric disorders, such as depression and
schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium,
chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine,
maprotiline, mirtazapine)
some medicines used to treat pain (e.g. pethidine)
Tell your doctor if you are taking any of the following medicines. These medicines may
affect the action of Enzalutamide Accord, or Enzalutamide Accord may affect the action of
these medicines:
This is the case, for example, with some medicines used for:
treating pain (e.g. fentanyl, tramadol)
treating cancer (e.g. cabazitaxel)
treating some psychiatric disorders such as severe forms of anxiety or schizophrenia (e.g. diazepam,
midazolam, haloperidol)
treating sleep disorders (e.g. zolpidem)
treating heart disease or lowering blood pressure (e.g. bisoprolol, digoxin,
diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
treating HIV infections (e.g. indinavir, ritonavir)
treating thyroid disorders (e.g. levothyroxine)
treating gout (e.g. colchicine)
treating stomach disorders (e.g. omeprazole)
preventing heart disease or stroke (e.g. dabigatran etexilate)
preventing organ rejection (e.g. tacrolimus)
Enzalutamide Accord 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 other medicines [e.g. methadone (used
to relieve pain and in drug detoxification programs), moxifloxacin
(an antibiotic), antipsychotics (used for severe mental illness)].
Tell your doctor if you are taking any of the medicines listed above. It may be
necessary to adjust the dose of Enzalutamide Accord or any other medicine you are
taking.

Enzalutamide Accord is not indicated for women.This medicine can cause harm to the
unborn child or potential pregnancy interruptions if taken by pregnant women. It should not
be taken by women who are pregnant, might become pregnant or are
breastfeeding. This medicine may affect male fertility.
If you have sexual intercourse with a woman who might 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
Accord” for instructions on use and handling.

Driving and using machines
Enzalutamide Accord may moderately impair the ability to drive and operate
machinery. Convulsions have been reported in patients taking Enzalutamide Accord.
If you are at high risk of convulsions, talk to your doctor.
This medicine contains 47.80 mg of sorbitol (E 420) per soft capsule.
Take this medicine exactly as your doctor has told you. If you have any doubts ask
your doctor.
The usual dose is 160 mg (four soft capsules), taken once a day at the same time.
Swallow the soft capsules whole with water.
Do not chew, crush or open the soft capsules before swallowing.
Enzalutamide Accord can be taken with or without food.
Enzalutamide Accord should not be handled by people other than the patient
himself or the person caring for him. Women who are pregnant or who might become
pregnant should not handle damaged or
open Enzalutamide Accord capsules without wearing protection, such as gloves.
Your doctor may also prescribe other medicines during treatment with Enzalutamide Accord.

If you take more Enzalutamide Accord than you should
If you take more soft capsules than prescribed, stop taking Enzalutamide
Accord and contact your doctor. You may be exposed to an increased risk of convulsions or other
side effects.

If you forget to take Enzalutamide Accord
If you forget to take Enzalutamide Accord at the usual time, take your usual dose
as soon as you remember.
If you forget to take Enzalutamide Accord for the whole day, take your dose
the next day as usual.
If you forget to take Enzalutamide Accord for more than one day, talk to your
doctor immediately.

Do not take a double doseto make up for a missed dose.

If you stop taking Enzalutamide Accord
Do not stop this medicine unless your doctor tells you to.
If you have any questions about taking this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.

Convulsions
Convulsive episodes have been reported in 5 patients out of 1,000 treated with Enzalutamide Accord and in less than 3
patients out of 1,000 treated with placebo.
The risk of convulsions is higher if you take a dose of this medicine higher than
recommended, if you take other medicines or if you have a higher than normal risk of convulsions.

If you have a convulsive episode, contact your doctor as soon as possible. The doctor may decide that you should
stop taking Enzalutamide Accord.
Rare cases of PRES (affecting up to 1 in 1,000 people) have been reported in patients treated with Enzalutamide Accord, a rare reversible condition that involves the brain. If you
have convulsions, worsening headache, confusion, blindness or other vision problems, contact
your doctor as soon as possible.

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 problems, blockage of the heart
arteries (ischemic heart disease), increased breast size in men (gynecomastia),
symptoms of restless legs syndrome (uncontrollable need to move a part of
the body, usually the legs), reduced concentration, forgetfulness, altered sense of taste

Uncommon side effects(may affect up to 1 in 100 people)
Hallucinations, difficulty thinking clearly, low number of white blood cells

Side effects of unknown frequency(frequency cannot be estimated based on available
data)
Muscle pain, muscle cramps, muscle weakness, back pain, changes
in the electrocardiogram (ECG) (prolongation of the QT interval), stomach pain including feeling
unwell (nausea), skin reaction causing red spots or patches on the skin that may
look like a target or “bull’s-eye”, with a dark red center surrounded by rings of
light red color (erythema multiforme), rash, feeling sick (vomiting), swelling of the face,
lips, tongue and/or throat, reduced number of platelets in the blood (increased
risk of bleeding or bruising), diarrhea.
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system reported on the Website:
By reporting side effects you can help provide more information on the safety of
this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date of expiry that is stated on the carton and on
the blister after Exp. The expiry date refers to the last day of that month.
Do not use soft capsules that are leaking, are damaged or show signs of tampering.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Enzalutamide Accord contains
The active ingredient is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
The other components of the soft capsule are caprylocaproyl macrogol glycerides,
butylated hydroxyanisole (E 320), and butylated hydroxytoluene (E 321).
The components of the soft capsule shell are gelatin, partially dehydrated sorbitol liquid (E 420), glycerol, titanium dioxide (E 171), talc (E 553b) and purified water.
The ink components are: shellac, black iron oxide, ammonium hydroxide and propylene glycol.
Enzalutamide Accord soft capsules are oblong soft capsules (20 mm in length and 10 mm in thickness) from white to off-white in colour with “JG1” imprinted in black ink.

Enzalutamide Accord is available in PVC/PCTFE-Alu blisters containing 28 capsules

soft capsules per pack. Enzalutamide Accord is also available in multiple packs
comprising 4 boxes, each containing 28 soft capsules.
Not all packs may be marketed.
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, S/N,
Edifici Est 6 planta,
08039 Barcelona,
Spain
Accord Healthcare Polska Sp.z.o.o
Ul Lutomierska 50, Pabianice
95200 Poland
Accord Healthcare B.V.
Winthontlaan 200,
Utrecht, 3526 KV
Netherlands
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari,
32009, Greece
Austria Enzalutamide Accord 40 mg soft capsules
Belgium Enzalutamide Accord 40 mg soft capsules
Germany Enzalutamide Accord 40 mg soft capsules
Estonia Enzalutamide Accord 40 mg soft capsules
Lithuania Enzalutamide Accord 40 mg soft capsules
Latvia Enzalutamide Accord 40 mg soft capsules
Czech Republic Enzalutamide Accord 40 mg soft capsules
Accord Healthcare B.V., Netherlands
Croatia Enzalutamide Accord 40 mg soft capsules
Hungary Enzalutamide Accord 40 mg soft capsules
Poland Enzalutamide Accord
Romania Enzalutamide Accord 40 mg soft capsules
Accord Healthcare Polska Sp. z o.o.,
Poland
France Enzalutamide Accord 40 mg, soft capsules
Accord Healthcare France SAS,
France
Cyprus Enzalutamide Accord 40 mg soft capsules
Accord Healthcare S.L.U., Spain
Greece Enzalutamide Accord 40 mg soft capsules
Spain Enzalutamida Accord 40 mg generic soft capsules
Portugal Enzalutamide Accord
Ireland Enzalutamide Accord 40 mg soft capsules
Accord Healthcare Ireland Limited,
Ireland