Abiraterone richter

Patient Information Leaflet

Abiraterone Richter, 500 mg, film-coated tablets
Abiraterone acetate
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• 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 Richter is and what it is used for
2. What you need to know before taking Abiraterone Richter
3. How to take Abiraterone Richter
4. Possible side effects
5. How to store Abiraterone Richter
6. Contents of the pack and other information

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

Abiraterone Richter 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 Richter inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone Richter is used at an early stage of hormone-sensitive disease, it is given together with androgen-deprivation therapy (treatment that reduces testosterone levels).
Your doctor will also prescribe another medicine called prednisone or prednisolone to be taken during treatment with this medicine. This is to reduce the risk of high blood pressure, fluid retention (fluid buildup), or low blood potassium levels.

2. Important information before taking Abiraterone Richter

When not to take Abiraterone Richter:

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

Do not take this medicine if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions

Before starting treatment with this medicine, discuss the following with your doctor or pharmacist:

• if the patient has liver disease;
• if the patient has hypertension, heart failure, or low blood potassium levels (hypokalemia may increase the risk of cardiac arrhythmias);
• if the patient has other heart or blood vessel disorders;
• if the patient has irregular or rapid heartbeat;
• if the patient experiences shortness of breath;
• if the patient's body weight has increased rapidly;
• if the patient has swelling of 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 reactions;
• if the patient has high blood sugar levels.

Tell your doctor if you have any heart or blood vessel disorders, including cardiac arrhythmias, or if you are taking medicines for these conditions.

Tell your doctor if you develop yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver dysfunction. Rarely, liver failure (so-called acute liver failure) may occur, which can lead to death.

There may be a decrease in red blood cell count, reduced sexual desire (libido), muscle weakness, and/or muscle pain.

Abiraterone Richter 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 Richter 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, consult a doctor or pharmacist before using this medicine.

Blood tests

Abiraterone Richter 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 Richter is accidentally swallowed by a child or adolescent, seek immediate medical attention at a hospital, taking the patient leaflet along to show the emergency room doctor.

Abiraterone Richter and other medicines

Before taking any medicine, consult a doctor or pharmacist.

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This is important because Abiraterone Richter may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal remedies (e.g. St. John's wort), and others. The doctor may need to adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Richter, potentially leading to adverse effects or reduced efficacy.

Androgen suppression may increase the risk of cardiac arrhythmias. Inform your doctor if you are taking any of the following medicines:

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

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

Taking Abiraterone Richter with food

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

Pregnancy and breastfeeding

Abiraterone Richter is not for use in women.

• This medicine may harm the unborn child if taken by a pregnant woman.
• If the patient has sexual intercourse with a woman who could 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 Richter contains lactose and sodium

This medicinal product contains 240.5 mg of lactose. If the patient has been previously diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

This medicine contains 24 mg of sodium (the main component of table salt) in each dose consisting of two 500 mg tablets. This corresponds to 1% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Abiraterone Richter

This medicine should always be taken as directed by your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
How much medicine to take
The recommended dose is 1000 mg (two tablets) taken once daily.
Administration of the medicine

• Take orally.

• Do not take Abiraterone Richter with food. Taking Abiraterone Richter with food may result in more medicine being absorbed by the body than necessary, which may cause adverse effects.

• Abiraterone Richter tablets must be taken as a single daily dose on an empty stomach. Abiraterone Richter should be taken at least two hours after eating and no food should be consumed for at least one hour after taking Abiraterone Richter (see section 2, "Taking Abiraterone Richter with food").

• Swallow the tablets whole with water.

• Do not crush the tablets.

• Abiraterone Richter is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.

• Take prednisone or prednisolone every day during treatment with Abiraterone Richter.

• The dose of prednisone or prednisolone may be adjusted if necessary. Your doctor will inform you if a dose adjustment is required. Do not stop taking prednisone or prednisolone without consulting your doctor.
  Your doctor may also prescribe other medicines while you are taking Abiraterone Richter and prednisone or prednisolone.
  Taking more than the recommended dose of Abiraterone Richter
  If you take more medicine than you should, contact your doctor immediately or go to the hospital.
  Missed dose of Abiraterone Richter

• If you forget to take Abiraterone Richter, prednisone or prednisolone, take your usual dose the next day.

• If you forget to take Abiraterone Richter, prednisone or prednisolone for more than one day, contact your doctor immediately.

Stopping treatment with Abiraterone Richter
Do not stop taking Abiraterone Richter 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Abiraterone Richter and contact your doctor immediately if you notice any of the following symptoms:

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

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

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

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1000 people):

• Lung irritation (also known as allergic alveolitis).
• Liver failure (also known as acute liver failure).

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

• Heart attack, changes in ECG (electrocardiogram) – QT interval prolongation, and severe allergic reactions with 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 Richter in combination with prednisone and prednisolone may worsen loss of bone mass.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 Abiraterone Richter

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 carton after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Abiraterone Richter contains
The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate.
The other ingredients are:
monohydrate lactose, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose 2910,
sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171),
macrogol 3350, talc, red iron oxide (E 172), black iron oxide (E 172).

What Abiraterone Richter looks like and contents of the pack
Abiraterone Richter coated tablets are violet, oval-shaped, approximately 19 mm in length and 11 mm in width,
with the imprint "A7TN" on one side and "500" on the other side of the tablet.
The tablets are available in PVC/PVDC/Aluminium blister packs contained in a cardboard box. Each pack contains 60 coated tablets.

Marketing Authorisation Holder
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer
Synthon Hispania, S.L.
c/Castelló 1
Sant Boi de Llobregat,
08830 Barcelona
Spain

Synthon B.V.
Microweg 22
6545 CM Nijmegen
Netherlands

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria: Abiraterone Richter 500 mg film-coated tablets
Czech Republic: Abiraterone Richter 500 mg potahované tablety
Estonia: Abiraterone Richter
Hungary: Abiraterone Richter 500 mg filmtabletta
Latvia: Abiraterone Richter 500 mg apvalkotās tabletes
Lithuania: Abiraterone Richter 500 mg plėvele dengta tabletė
Poland: Abiraterone Richter
Romania: Abirateronă Richter 500 mg comprimate filmate

For further information about this medicinal product, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: +48 (22) 755 96 48
[email protected]