Abiraterone Olainfarm

Leaflet accompanying the packaging: patient information

Abiraterone Olainfarm, 250 mg, tablets

Abiraterone acetate

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Abiraterone Olainfarm is a medicine that contains abiraterone acetate. It is used in adult men for the treatment of 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 that responds to hormonal therapy, it is given together with therapy that reduces testosterone levels (androgen suppression therapy).
During treatment with this medicine, the doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention, or low potassium levels in the blood.

2. Important information before taking the medicine

When not to take Abiraterone Olainfarm

• 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 Olainfarm is used only in men;
• if the patient has severe liver damage;
• in combination with the medicine Ra-223 (used to treat prostate cancer). This medicine should not be taken if any of the above situations apply to the patient. In case of doubts, the patient should consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Abiraterone Olainfarm, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver disease;
• if the patient has 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 disorders);

if the patient has other heart diseases or blood vessel disorders;

• if the patient has an irregular or rapid heart rhythm;
• if the patient has 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 taken ketokonazole 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 the patient has high blood sugar levels. The patient should tell their doctor if they have any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or if they are taking medicines for these conditions. The patient should tell their doctor if they have yellowing of the skin or eyes, dark urine, severe nausea, or vomiting, which may be signs of liver function disorders. Rarely, acute liver failure may occur, which can be life-threatening. There may be a decrease in the number of red blood cells, decreased libido, muscle weakness, and (or) muscle pain. Abiraterone Olainfarm should not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death. If the patient plans to take Ra-223 after treatment with Abiraterone Olainfarm and prednisone or prednisolone, they should wait 5 days before starting Ra-223 treatment. In case of doubts whether any of the above situations apply to the patient, they should consult a doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone Olainfarm may affect liver function, and the patient may not have any symptoms. During treatment with this medicine, the doctor will periodically prescribe 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, the patient should immediately go to the hospital, taking the patient information leaflet to show it to the doctor in the emergency room.

Other medicines and Abiraterone Olainfarm

Before taking any medicine, the patient should consult a doctor or pharmacist.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is important because Abiraterone Olainfarm may enhance the effect of many medicines, including heart medicines, sedatives, some antidiabetic medicines, herbal medicines (e.g., St. John's Wort), and others. The 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 inadequate effect of Abiraterone Olainfarm.
Androgen suppression may increase the risk of heart rhythm disorders. The patient should tell their doctor if they are taking medicines:

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

The patient should tell their doctor if they are taking any of the above medicines.

Abiraterone Olainfarm with food

The medicine should not be taken with food (see section 3, "How to take Abiraterone Olainfarm").
Taking Abiraterone Olainfarm with food may cause side effects.

Pregnancy and breastfeeding

Abiraterone Olainfarm is not used in women. This medicine may harm an unborn child if taken by a pregnant woman.
If the patient has sexual intercourse with a woman who may become pregnant, they should use a condom and another effective method of contraception.
If the patient has sexual intercourse with a pregnant woman, they should use a condom to protect the unborn child.
Pregnant or potentially pregnant women should use protective gloves when handling Abiraterone Olainfarm 250 mg tablets.

Driving and using machines

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

Abiraterone Olainfarm contains lactose and sodium

Abiraterone Olainfarm contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains 23.2 mg of sodium (a major component of common salt) in a dose of four 250 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

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult a doctor or pharmacist.

How much medicine to take

The recommended dose is 1000 mg (four 250 mg tablets) taken once a day.

How to take the medicine

• The medicine should be taken orally.
• Abiraterone Olainfarm should not be taken with food.

Abiraterone Olainfarm should be taken at least one hour before or two hours after eating (see section 2, "Abiraterone Olainfarm with food").

• The tablets should be swallowed whole with water.
• The tablets should not be crushed.
• Abiraterone Olainfarm is taken with a medicine called prednisone or prednisolone. The patient should take prednisone or prednisolone according to the doctor's instructions.
• The patient should take prednisone or prednisolone every day while taking Abiraterone Olainfarm.
• The amount of prednisone or prednisolone taken may be changed if necessary. The doctor will inform the patient if there is a need to change the dose of prednisone or prednisolone. The patient should not stop taking prednisone or prednisolone without consulting their doctor.

The doctor may also prescribe other medicines to the patient taking Abiraterone Olainfarm and prednisone or prednisolone.

Taking more Abiraterone Olainfarm than prescribed

If the patient takes more medicine than they should, they should immediately consult a doctor or go to the hospital.

Missing a dose of Abiraterone Olainfarm

• If the patient forgets to take Abiraterone Olainfarm, prednisone, or prednisolone, they should take the usual dose the next day.
• If the patient forgets to take Abiraterone Olainfarm, prednisone, or prednisolone for more than one day, they should immediately consult a doctor.

Stopping treatment with Abiraterone Olainfarm

The patient should not stop taking Abiraterone Olainfarm or prednisone or prednisolone without consulting their doctor.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Abiraterone Olainfarm can cause side effects, although not everybody gets them.

The patient should stop taking Abiraterone Olainfarm and immediately consult a doctor if they experience any of the following symptoms:

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

Other observed side effects:

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

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

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

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

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

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

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

• 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 enhance this effect.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Abiraterone Olainfarm

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month.
There are no special storage precautions for this medicine. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Abiraterone Olainfarm contains

• The active substance of the medicine is abiraterone acetate. Each tablet contains 250 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").

What Abiraterone Olainfarm looks like and contents of the pack

• Abiraterone Olainfarm, 250 mg, tablets are white or almost white, oval, biconvex, uncoated tablets with "250" engraved on one side and smooth on the other side.
• The tablets are packed in a 100 ml HDPE bottle with a polypropylene child-resistant closure and an integrated desiccant. Each bottle contains 120 tablets. Each carton contains one bottle.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized 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 250 mg comprimé
Italy
Abiraterone Olainfarm
Latvia
Abiraterone Olainfarm 250 mg tablets
Lithuania
Abiraterone Olainfarm 250 mg tabletės
Poland
Abiraterone Olainfarm
Slovakia
Abiraterone Olainfarm 250 mg tablets
Spain
Abiraterona Olainfarm 250 mg comprimidos EFG

Date of last revision of the leaflet: