Abiraterone Olainfarm

Package Leaflet: Information for the Patient

Abiraterone Olainfarm, 500 mg, Film-Coated Tablets

Abiraterone acetate

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 them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

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

Abiraterone Olainfarm is a medicine that contains the active substance abiraterone acetate. It is used in adult men to treat prostate cancer that has spread to other parts of the body. Abiraterone Olainfarm works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.

When Abiraterone Olainfarm is used at an early stage of the disease in patients who are responding to hormone therapy, it is given together with a therapy that lowers testosterone levels (androgen deprivation therapy).

During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid build-up in the body (fluid retention), or low potassium levels in the blood.

2. Before you take Abiraterone Olainfarm

When not to take Abiraterone Olainfarm

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6);
• in women, especially if pregnant. Abiraterone Olainfarm is for use in men only;
• if you have severe liver damage;
• in combination with a medicine called Ra-223 (used to treat prostate cancer). You must not take this medicine if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Abiraterone Olainfarm, discuss this with your doctor or pharmacist:

• if you have liver disease;
• if you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of heart rhythm problems);

if you have other heart problems or blood vessel problems;

• if you have an irregular or fast heart rhythm;
• if you have shortness of breath;
• if your body weight has increased in a short time;
• if you have swelling of the feet, ankles, or legs;
• if you have taken ketoconazole in the past to treat prostate cancer;
• the need to take this medicine with prednisone or prednisolone;
• the possibility of side effects related to bones;
• if you have high blood sugar levels. You should tell your doctor if you have any heart or blood vessel problems, including heart rhythm problems (arrhythmia), or if you are taking medicines for these conditions. You should tell your doctor if you have yellowing of the skin or eyes, dark urine, severe nausea, or vomiting, which may be signs of liver problems. Rarely, acute liver failure can occur, which can be life-threatening. There may be a decrease in red blood cell count, decreased sex drive, muscle weakness, and/or muscle pain. Abiraterone Olainfarm must not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death. If you plan to take Ra-223 after treatment with Abiraterone Olainfarm and prednisone or prednisolone, you should wait 5 days before starting Ra-223 treatment. If you are in doubt whether any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone Olainfarm may affect liver function, and you may not have any symptoms. During treatment with this medicine, your doctor will periodically order blood tests to check the effect of the medicine on the liver.

Children and adolescents

This medicine is not used in children and adolescents. If Abiraterone Olainfarm is accidentally swallowed by a child, you should immediately go to the hospital, taking this leaflet with you to show to the doctor.

Other medicines and Abiraterone Olainfarm

Before taking any medicine, consult your doctor or pharmacist.

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as medicines you plan to take. This is important because Abiraterone Olainfarm may increase the effects of many medicines, including heart medicines, sedatives, certain diabetes medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may change the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Olainfarm. This may result in side effects or Abiraterone Olainfarm not working properly.

Androgen deprivation therapy may increase the risk of heart rhythm problems. You should tell your doctor if you are taking medicines:

• used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that may increase the risk of heart rhythm problems [e.g., methadone (pain reliever and used to treat addiction), moxifloxacin (antibiotic), antipsychotic medicines (used to treat severe mental disorders)].

You should tell your doctor if you are taking any of the above medicines.

Abiraterone Olainfarm with food

Do not take this medicine with food (see section 3, "How to take Abiraterone Olainfarm").

Taking Abiraterone Olainfarm with food may cause side effects.

Pregnancy and breast-feeding

Abiraterone Olainfarm is not used in women. This medicine may harm an unborn child if taken by a pregnant woman.

If you have sex with a woman who may become pregnant, you should use a condom and another effective method of birth control.

If you have sex with a pregnant woman, you should use a condom to protect the unborn child.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use tools or machines.

Abiraterone Olainfarm contains lactose and sodium

Abiraterone Olainfarm contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains 23 mg of sodium (a major component of cooking salt) in a dose of two 500 mg tablets. This corresponds to 1.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Abiraterone Olainfarm

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How much to take

The recommended dose is 1000 mg (two 500 mg tablets) taken once a day.

How to take Abiraterone Olainfarm

• Take by mouth.
• Do not take Abiraterone Olainfarm with food.

Take Abiraterone Olainfarm at least 1 hour before or 2 hours after food (see section 2, "Taking Abiraterone Olainfarm with food").

• Swallow the tablets whole with a glass of water.
• Do not crush the tablets.
• Take Abiraterone Olainfarm with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as directed by your doctor.
• Take prednisone or prednisolone every day while taking Abiraterone Olainfarm.
• The amount of prednisone or prednisolone you take may need to be changed in case of an emergency. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines for you to take with Abiraterone Olainfarm and prednisone or prednisolone.

If you take more Abiraterone Olainfarm than you should

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

If you forget to take Abiraterone Olainfarm

• If you forget to take Abiraterone Olainfarm, prednisone, or prednisolone, take your normal dose the next day.
• If you forget to take Abiraterone Olainfarm, prednisone, or prednisolone for more than one day, contact your doctor immediately.

If you stop taking Abiraterone Olainfarm

Do not stop taking Abiraterone Olainfarm or prednisone or prednisolone without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Abiraterone Olainfarm and contact your doctor immediately if you notice any of the following:

• muscle weakness, trembling (tremors), or heart pounding (palpitations). These may be signs of low potassium levels in the blood.

Other observed side effects:

Very common(may affect more than 1 in 10 people):

• swelling of the feet or ankles,
• low potassium levels in the blood,
• increased liver enzymes,
• high blood pressure,
• urinary tract infections,
• diarrhea.

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

• high lipid levels in the blood,
• chest pain,
• heart rhythm problems (atrial fibrillation),
• heart failure,
• fast heart rate,
• severe infection - sepsis,
• bone fractures,
• indigestion,
• blood in the urine,
• rash.

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

• adrenal problems (related to electrolyte imbalance),
• abnormal heart rhythm (arrhythmia),
• muscle weakness and/or muscle pain.

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

• lung inflammation (also known as allergic alveolitis)
• acute liver failure.

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

• heart attack,
• changes in ECG (QT interval prolongation)
• severe allergic reactions, causing difficulty swallowing or breathing, swelling of the face, lips, tongue, or throat, or itchy rash.

Bone loss may occur in men treated for prostate cancer. Abiraterone Olainfarm in combination with prednisone and prednisolone may increase this effect.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the "Contact" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Olainfarm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Medicines should 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 Olainfarm contains

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose type 2910, colloidal anhydrous silica, and sodium lauryl sulfate (see section 2, "Abiraterone Olainfarm contains lactose and sodium"). The tablet coating contains: black iron oxide (E172), red iron oxide (E172), copolymer of methacrylic acid and acrylic acid, talc, and titanium dioxide (E171).

What Abiraterone Olainfarm looks like and contents of the pack

• Abiraterone Olainfarm, 500 mg, film-coated tablets are purple, oval, biconvex film-coated tablets with "500" debossed on one side and plain on the other side.
• The tablets are packaged in a blister pack in a cardboard box containing 56 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

AS Olainfarm,
Rupnicu iela 5,
LV-2114, Olaine,
Latvia
Email: [email protected]

Manufacturer

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

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark
Abirateron AET
Czech Republic
Abiraterone Olainfarm
Estonia
Abiraterone Olainfarm
France
Abiraterone AET 500 mg film-coated tablet
Italy
Abiraterone Olainfarm
Latvia
Abiraterone Olainfarm 500 mg film-coated tablets
Lithuania
Abiraterone Olainfarm 500 mg film-coated tablets
Poland
Abiraterone Olainfarm
Slovakia
Abiraterone Olainfarm 500 mg film-coated tablets
Spain
Abiraterona Olainfarm 500 mg film-coated tablets

Date of last revision of the leaflet: