ABIRATERONE 250 mg Таблетка

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1. Abiraterone Olpha 250 mg tablets, 500 mg film-coated tablets
   1. What is Abiraterone Olpha and what is it used for
   2. What you need to know before taking Abiraterone Olpha
   3. How to take Abiraterone Olpha
   4. Possible side effects
   5. How to store Abiraterone Olpha
   6. Package contents and other information

Abiraterone Olpha 250 mg tablets, 500 mg film-coated tablets

abiraterone acetate

generic medicine

Read 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 or pharmacist.
• 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 or pharmacist. See section 4

Contents of this leaflet:

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

1. What is Abiraterone Olpha and what is it used for

Abiraterone Olpha contains a medicine called abiraterone acetate. It is used for the
treatment of prostate cancer in adult men that has spread to other parts of the body.
Abiraterone Olpha stops the production of testosterone by the body; this may slow down the
growth of prostate cancer.
When Abiraterone Olpha is prescribed in the early stages of the disease, which still responds to
hormonal therapy, it is used with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe you another medicine called
prednisone or prednisolone. This medicine is used to reduce the possibility of having high
blood pressure, too much water in the body (fluid retention), or reduced levels in the blood of
a substance known as potassium.

2. What you need to know before taking Abiraterone Olpha

Do not take Abiraterone Olpha

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if pregnant. The use of Abiraterone Olpha is only indicated in men.
• if you have severe liver damage.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if you fall into any of these conditions. If you have doubts, ask your doctor
or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low potassium levels in your blood (a low potassium level can increase the risk of heart rhythm problems)
• if you have had other problems with your heart or blood vessels
• if you have an irregular or fast heartbeat
• if you are short of breath
• if you have rapidly gained weight
• if you have swelling of your feet, ankles or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about the possible effects on bones
• if you have high blood sugar levels.

Tell your doctor if you have been told you have any heart or blood vessel problems, including
problems with your heart rhythm (arrhythmia) or if you are being treated with medicines for these problems.
Tell your doctor if you have yellowing of the skin or eyes, dark coloured urine or severe nausea or
vomiting, as these could be signs or symptoms of liver problems. Rarely, a
liver function problem (called acute liver failure) can occur, which can lead
to death.
Decreases in red blood cells, decreased sexual desire (libido),
muscle weakness and/or muscle pain may occur.
Abiraterone Olpha should not be given in combination with Ra-223 due to a possible
increased risk of bone fractures or death.
If you think you are going to take Ra-223 after treatment with Abiraterone Olpha and prednisone/prednisolone,
you must wait 5 days before starting treatment with Ra-223.
If you have doubts about whether any of the points above apply to you, ask your doctor
or pharmacist before taking this medicine.

Blood monitoring
Abiraterone Olpha can affect the liver and may not have any symptoms. While taking this
medicine, your doctor will periodically perform blood tests to check for any effects
of Abiraterone Olpha on your liver.

Children and adolescents
The medicine is not indicated in children and adolescents. If Abiraterone Olpha is accidentally
swallowed by a child or adolescent, go to hospital immediately and take the

Other medicines and Abiraterone Olpha
Ask your doctor or pharmacist before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is important because Abiraterone Olpha can increase the effects of
some medicines including medicines for the heart, tranquillizers, some medicines for diabetes,
herbal medicines (for example St John's wort) and others. Your doctor may decide to
change the dose of these medicines. Also, some medicines can increase or decrease the
effects of Abiraterone Olpha. This can lead to unwanted effects or Abiraterone Olpha might
not work as well as it should.
Androgen deprivation treatment can increase the risk of heart rhythm problems.
Tell your doctor if you are taking medicines:

• used to treat heart rhythm problems (for example quinidine, procainamide, amiodarone and sotalol);
• known to increase the risk of heart rhythm problems [for example methadone (used to relieve pain and for the treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Tell your doctor if you are taking any of the medicines listed above.

Abiraterone Olpha with food
This medicine should not be taken with food (see section “Taking this
medicine”).
Taking Abiraterone Olpha with food can cause unwanted effects.

Pregnancy and breastfeeding
The use of Abiraterone Olpha is not indicated in women. This medicine can cause harm to the fetus if
taken by pregnant women.
If you have sexual intercourse with a woman of childbearing potential, you must use a condom and another
effective contraceptive measure.
If you have sexual intercourse with a pregnant woman, use a condom to protect the fetus.
Abiraterone Olpha tablets 250 mg:
Pregnant women or those who might become pregnant should wear gloves if they need to touch or
handle Abiraterone Olpha.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and operate tools or
machinery.

Abiraterone Olpha contains lactose and sodium
Abiraterone Olpha contains lactose (a type of sugar). If your doctor has told you that you have
an intolerance to some sugars, contact your doctor before taking this medicine
This medicine contains 23.2 mg of sodium (the main component of table salt) per
dose of four 250 mg tablets and 23 mg of sodium per dose of two 500 mg tablets. This
is equivalent to 1.2% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterone Olpha

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much to take
The recommended dose is 1000 mg (four Abiraterone Olpha 250 mg tablets) once a
day.
The recommended dose is 1000 mg (two Abiraterone Olpha 500 mg tablets) once a day.

Taking this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Olpha with food.Abiraterone Olpha must be taken at least two hours after a meal and no food should be consumed for at least one hour after taking Abiraterone Olpha. (see section 2 “Abiraterone Olpha with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• Abiraterone Olpha is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone following exactly the instructions of your doctor.
• You must take prednisone or prednisolone every day while taking Abiraterone Olpha.
• It may be necessary to change the amount of prednisone or prednisolone, in emergency situations. Your doctor will inform you if you need to change the amount of prednisone or prednisolone you are taking. Do not stop taking prednisone or prednisolone, unless your doctor tells you to.

The doctor may also prescribe you other medicines, while you are taking Abiraterone Olpha and prednisone or
prednisolone.

If you take more Abiraterone Olpha than you should
If you take more Abiraterone Olpha than you should, contact your doctor or go to hospital
immediately.

If you forget to take Abiraterone Olpha
If you forget to take Abiraterone Olpha or prednisone or prednisolone, take the usual dose the
next day.
If you forget to take Abiraterone Olpha or prednisone or prednisolone for more than one day, talk
to your doctor without waiting too long.

If you stop taking Abiraterone Olpha
Do not stop taking Abiraterone Olpha or prednisone or prednisolone, unless your doctor
tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, stop taking Abiraterone Olpha and contact your doctor immediately:

• muscle weakness, muscle spasms or a feeling of a pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
Very common(may affect more than 1 in 10 people)
Fluid in the legs or feet, low potassium levels in the blood, increased values in liver function tests, high blood pressure, urinary tract infection, diarrhoea.

Common(may affect up to 1 in 10 people)
High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation),
heart failure, fast heartbeat, a serious infection called sepsis, bone fractures,
indigestion, blood in your urine, rash.

Uncommon(may affect up to 1 in 100 people)
Problems with the adrenal glands (related to salt and water problems), abnormal heartbeat
(arrhythmia), muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000)
Lung irritation (also called allergic alveolitis).
Liver function problems (also called acute liver failure).

Not known(frequency cannot be estimated from the available data)
Heart attack, changes in the ECG – electrocardiogram (prolongation of the QT interval),
and serious allergic reactions with difficulty swallowing or breathing, swelling of the face, lips,
tongue or throat, or hives.
Bone loss may occur in men treated for prostate cancer. Abiraterone
Olpha in combination with prednisone or prednisolone may increase bone loss.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Abiraterone Olpha

• Keep this medicine out of the sight and reach of children.
• Abiraterone Olpha 250 mg tablets: Do not use this medicine after the expiry date which is stated on the packaging label and the bottle after EXP. The expiry date refers to the last day of that month. This medicine does not require any particular storage temperature condition. Store in the original package to protect from light.
• Abiraterone Olpha 500 mg film-coated tablets: Do not use this medicine after the expiry date which is stated on the packaging label and the blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any particular storage condition.
• Do not dispose of any medicine in water 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 Abiraterone Olpha contains
Abiraterone Olpha 250 mg tablets:

• The active ingredient is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
• The other excipients are microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose (type 2910), anhydrous colloidal silica and sodium lauryl sulfate (see section 2 “Abiraterone Olpha contains lactose and sodium”).

Abiraterone Olpha 500 mg film-coated tablets:

• The active ingredient is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.
• The other excipients are microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose (type 2910), anhydrous colloidal silica, sodium lauryl sulfate (see section 2, “Abiraterone Olpha contains lactose and sodium"). The coating contains black iron oxide (E172), red iron oxide (E172), Polyvinyl alcohol-grafted macrogol copolymer, talc and titanium dioxide (E171).

Description of the appearance of Abiraterone Olpha and package contents
Abiraterone Olpha 250 mg tablets:

• Abiraterone Olpha tablets have an oval biconvex shape, uncoated, from white to off-white in colour, with the inscription “250” on one side and smooth on the other side.
• The tablets are supplied in a 100 ml HDPE bottle with a child-proof cap (made of polypropylene, PP) with integrated desiccant. Each bottle contains 120 tablets. Each pack contains one bottle. Abiraterone Olpha 500 mg film-coated tablets:
• Abiraterone Olpha film-coated tablets are purple in colour, oval, biconvex, film-coated, with the inscription "500" on one side and smooth on the other side.
• The tablets are packaged in blisters in cardboard boxes containing 56 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Haupt Pharma Münster GmbH,
Schleebrüggenkamp 15,
48159, Münster,
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Denmark Abirateron Olpha
Czech Republic Abiraterone Olpha
Estonia Abiraterone Olpha
France Abiraterone Olpha 250 mg comprimé
Abiraterone Olpha 500 mg comprimé pelliculé
Italy Abiraterone Olpha
Latvia Abiraterone Olpha 250 mg tabletes
Abiraterone Olpha 500 mg apvalkotās tabletes
Lithuania Abiraterone Olpha 250 mg tabletės
Abiraterone Olpha 500 mg plėvele dengtos tabletės
Poland Abiraterone Olpha
Slovakia Abiraterone Olpha 250 mg tablety
Abiraterone Olpha 500 mg filmom obalené tablety
Spain Abiraterona Olpha 250 mg comprimidos EFG
Abiraterona Olpha 500 mg comprimidos recubiertos con película EFG