Abiraterone vipharm

Package leaflet: Information for the patient

Abiraterone Vipharm, 500 mg, film-coated tablets
Abirateroni acetas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet contents

1. What Abiraterone Vipharm is and what it is used for
2. Important information before taking Abiraterone Vipharm
3. How to take Abiraterone Vipharm
4. Possible side effects
5. How to store Abiraterone Vipharm
6. Contents of the pack and other information

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

Abiraterone Vipharm is a medicine containing abiraterone acetate. It is used in adult
men for the treatment of metastatic prostate cancer (cancer of the prostate gland that has spread to other parts of the body). Abiraterone
Vipharm inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone Vipharm is used at an early stage of hormone-sensitive disease, it is administered together with androgen-deprivation therapy (therapy reducing testosterone levels).
During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the likelihood of developing high blood pressure, fluid retention (fluid buildup), or low blood potassium levels.

2. Important information before using Abiraterone Vipharm

When not to use Abiraterone Vipharm:

• if the patient is allergic to abiraterone or any of the other ingredients of this medicine (listed in section 6);
• in women, especially during pregnancy. Abiraterone Vipharm is used exclusively in men;
• if the patient has severe liver impairment;
• in combination with Ra-223 (used in the treatment of prostate cancer).

Do not use this medicine if any of the above situations apply to the patient. In case of
doubt, consult a doctor or pharmacist before using this medicine.
Warnings and precautions
Before starting treatment with this medicine, discuss with your doctor or pharmacist:

• if the patient has liver disease;
• if the patient has hypertension, heart failure, or low blood potassium levels (low potassium levels may increase the risk of heart rhythm disorders);
• if the patient has other heart or blood vessel diseases;
• if the patient has irregular or rapid heartbeat;
• if the patient has shortness of breath;
• if the patient’s body weight has increased rapidly;
• if the patient has swelling in the feet, ankles, or legs;
• if the patient has previously taken ketoconazole for the treatment of prostate cancer;
• the necessity of taking this medicine with prednisone or prednisolone;
• the possibility of bone-related adverse effects;
• if the patient has high blood sugar levels.

Tell your doctor if the patient has any heart or blood vessel disorders,
including heart rhythm disorders (arrhythmia), or is taking medicines for these conditions.
Tell your doctor if the patient develops yellowing of the skin or eyes, dark urine, severe
nausea or vomiting, which may be symptoms of liver dysfunction. Rarely, acute
liver failure may occur, which can lead to death.
Reduction in red blood cell count, decreased libido, muscle weakness, and/or muscle pain may occur.
Abiraterone Vipharm must not be given in combination with Ra-223 due to a possible
increased risk of bone fractures or death.
If the patient intends to receive Ra-223 after treatment with Abiraterone Vipharm
and prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 therapy.
If in doubt whether any of the above situations apply to the patient, consult a
doctor or pharmacist before using this medicine.
Blood tests
Abiraterone Vipharm may affect liver function, and the patient may not experience any
symptoms. During treatment, the doctor will periodically order blood tests to
monitor the effect of the medicine on the liver.
Children and adolescents
This medicine is not intended for use in children and adolescents. If Abiraterone Vipharm is
accidentally swallowed by a child, seek immediate medical attention at a hospital, bringing
the patient leaflet to show to the emergency room doctor.
Abiraterone Vipharm and other medicines
Before taking any medicine, consult a doctor or pharmacist.
Inform your doctor or pharmacist about all medicines the patient is currently taking or
has recently taken, as well as any medicines the patient plans to use. This is important because
Abiraterone Vipharm may enhance the effects of many medicines, including cardiac medications,
sedatives, certain antidiabetic drugs, herbal remedies (e.g. St. John's wort), and others. The doctor may
adjust the doses of these medicines. Other medicines may also increase or decrease the effect of
Abiraterone Vipharm, potentially leading to adverse effects or reduced efficacy.
Androgen suppression may increase the risk of heart rhythm disorders. Inform your doctor
if the patient is taking any of the following medicines:

• used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• that may increase the risk of heart rhythm disorders [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)].

Inform your doctor if the patient is taking any of the above-mentioned medicines.
Taking Abiraterone Vipharm with food

• This medicine must not be taken with food (see section 3, "How to take Abiraterone Vipharm").
• Taking Abiraterone Vipharm with food may cause adverse effects.

Pregnancy and breastfeeding
Abiraterone Vipharm is not used in women.
Pregnant women or women who may become pregnant should wear gloves if they must handle
Abiraterone Vipharm.
The medicine may harm the unborn child if taken by a pregnant woman.
If the patient has sexual intercourse with a woman who may become pregnant, 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.
Driving and operating machinery
It is unlikely that this medicine affects the ability to drive, use tools, or operate machinery.
Abiraterone Vipharm contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Abiraterone Vipharm contains sodium
This medicine contains 24 mg of sodium (the main component of table salt) in the dose consisting of two 500 mg tablets. This corresponds to 1% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Abiraterone Vipharm

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How much medicine to take
The recommended dose is 1000 mg (two tablets) taken once daily.

How to take the medicine
Abiraterone Vipharm is taken orally.
Abiraterone Vipharm must not be taken with food.
Take Abiraterone Vipharm at least one hour before or at least two hours after eating (see section 2, "Taking Abiraterone Vipharm with food").
Swallow the tablets whole with water.
Do not crush the tablets.

Abiraterone Vipharm is taken together with a medicine called prednisone or prednisolone.
Take prednisone or prednisolone exactly as directed by your doctor.
You must take prednisone or prednisolone every day while taking Abiraterone Vipharm.
The amount of prednisone or prednisolone taken may be adjusted if urgently needed.
Your doctor will inform you if your dose of prednisone or prednisolone needs to be changed.
Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines while you are taking Abiraterone Vipharm and prednisone or prednisolone.

Taking more Abiraterone Vipharm than prescribed
If you take more medicine than you should, contact your doctor immediately or go to the hospital.

Missing a dose of Abiraterone Vipharm
If you forget to take Abiraterone Vipharm, prednisone or prednisolone, take your usual dose the next day.
If you forget to take Abiraterone Vipharm, prednisone or prednisolone for more than one day, contact your doctor immediately.

Stopping Abiraterone Vipharm treatment
Do not stop taking Abiraterone Vipharm or prednisone or prednisolone without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The patient must stop taking Abiraterone Vipharm and immediately contact a doctor
if any of the following symptoms occur:

• Muscle weakness, muscle twitching (tremors), or rapid heartbeat (palpitations). These may be symptoms of low blood potassium levels.

Other side effects observed:
Very common (may occur in more than 1 in 10 patients):

• Swelling of the legs or feet
• Low blood potassium levels
• Increased liver function test results
• High blood pressure
• Urinary tract infections
• Diarrhoea

Common (may occur in up to 1 in 10 patients):

• High blood lipid levels
• Chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heart rate
• Severe infection, sepsis
• Bone fractures
• Indigestion
• Blood in urine
• Rash

Uncommon (may occur in up to 1 in 100 patients):

• Adrenal gland dysfunction (related to disturbances in water and electrolyte balance)
• Irregular heart rhythm (arrhythmia)
• Muscle weakness and/or muscle pain

Rare (may occur in up to 1 in 1000 patients):

• Lung inflammation (also known as allergic alveolitis)
• Acute liver failure

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

• Heart attack, changes in ECG (prolonged QT interval)
• Severe allergic reactions causing difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash

Loss of bone mass may occur in men treated for prostate cancer. Abiraterone Vipharm in combination with prednisone and prednisolone may worsen this effect.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects may also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Abiraterone Vipharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or bottle and on the
carton after "EXP" and "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Abiraterone Vipharm contains

• The active substance is abiraterone acetate.
• Each coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are:

Tablet core: monohydrate lactose, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (E 172), black iron oxide (E 172).

What Abiraterone Vipharm looks like and contents of the pack
Abiraterone Vipharm is an oval, purple, coated tablet (approximately 19 mm long and 11 mm wide), with the imprint "A7TN" on one side and "500" on the other side.
Each cardboard blister pack contains 56 or 60 coated tablets.
Each cardboard pack with single-dose blisters contains 56 x 1 or 60 x 1 coated tablet.
Each cardboard pack with a bottle contains 60 coated tablets.

Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05 – 850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: [email protected]

Manufacturer
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
Castello 1
08830 Sant Boi de Llobregat
Barcelona
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands Abirateron Vipharm 500 mg, filmomhulde tabletten
Hungary Abiraterone Vipharm 500 mg filmtabletta
Slovakia Abiraterone Vipharm 500 mg
Poland Abiraterone Vipharm
Czech Republic Abiraterone Vipharm