Abiraterone olpha

Package leaflet: Information for the user

Abiraterone Olpha, 250 mg, 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 personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Abiraterone Olpha is and what it is used for
2. Important information before taking 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 Abiraterone Olpha is and what it is used for

Abiraterone Olpha 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 Olpha works by inhibiting the production of testosterone in the body; this may slow down the progression of prostate cancer.
When Abiraterone Olpha is used at an early stage of hormone-sensitive disease, it is given in combination with androgen-deprivation therapy (treatment that lowers testosterone levels).
During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of developing high blood pressure, fluid retention (fluid buildup), or low potassium levels in the blood.

2. Important information before using the medicine

When not to use Abiraterone Olpha

• 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 Olpha 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). This medicine should not be used 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 Abiraterone Olpha, discuss the following with your doctor or pharmacist:

• if the patient has liver disease;
• if the patient has high blood pressure, heart failure, or low blood potassium levels (low potassium levels may increase the risk of heart rhythm disorders);
• if the patient has had 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 of the feet, ankles, or legs;
• if the patient has previously used ketoconazole in the treatment of prostate cancer;
• the necessity of taking this medicine together with prednisone or prednisolone;
• the possibility of bone-related adverse effects;
• if the patient has high blood sugar levels. Inform the doctor if the patient has any heart or blood vessel disorders, including heart rhythm disturbances (arrhythmia), or is taking medicines for these conditions. Inform the doctor if the patient develops yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver dysfunction. Rarely, acute liver failure may occur, which can lead to death. A decrease in red blood cell count, reduced libido, muscle weakness, and/or muscle pain may occur. Abiraterone Olpha must not be administered in combination with Ra-223 due to a possible increased risk of bone fractures or death. If the patient plans to receive Ra-223 after treatment with Abiraterone Olpha and prednisone or 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 Olpha may affect liver function, and the patient may not experience any symptoms. During treatment with this medicine, 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 Olpha is accidentally swallowed by a child, seek immediate medical attention at a hospital, taking the patient leaflet along to show the emergency room doctor.

Other medicines and Abiraterone Olpha
Before taking any medicine, consult a doctor or pharmacist.
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is important because Abiraterone Olpha 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 adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Olpha, potentially leading to adverse effects or reduced efficacy of Abiraterone Olpha.

Androgen suppression may increase the risk of heart rhythm disturbances. Inform the 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 disturbances [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)].

Inform the doctor if the patient is taking any of the above-mentioned medicines.

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

Pregnancy and breastfeeding
Abiraterone Olpha 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 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.
Pregnant women or women who could be pregnant should wear protective gloves if they need to handle or come into contact with Abiraterone Olpha 250 mg tablets.

Driving and operating machinery
It is unlikely that this medicine affects the ability to drive or operate tools and machinery.

Abiraterone Olpha contains lactose and sodium
Abiraterone Olpha contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains 23.2 mg of sodium (the main component of table salt) in the dose contained in four 250 mg tablets. This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Abiraterone Olpha

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 (four 250 mg tablets) taken once daily.

How to take Abiraterone Olpha

• Take orally.
• Abiraterone Olpha must not be taken with food. Taking Abiraterone Olpha with food may result in more medicine being absorbed by the body than necessary, which could lead to adverse effects. Abiraterone Olpha tablets should be taken as a single dose once daily on an empty stomach. Abiraterone Olpha should be taken at least two hours after eating, and food should not be consumed for at least one hour after taking Abiraterone Olpha (see section 2, "Taking Abiraterone Olpha with food"). Swallow the tablets whole with water.
• Do not crush the tablets.
• Abiraterone Olpha is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as prescribed by your doctor.
• Take prednisone or prednisolone every day during treatment with Abiraterone Olpha.
• The dose of prednisone or prednisolone may be adjusted if necessary. 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 Olpha and prednisone or prednisolone.

Taking more Abiraterone Olpha than prescribed

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

Missing a dose of Abiraterone Olpha

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

Stopping Abiraterone Olpha treatment

Do not stop taking Abiraterone Olpha 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 must stop taking Abiraterone Olpha and contact your doctor immediately
if you experience any of the following symptoms:

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

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

• Swelling of the legs or feet,
• Low blood potassium levels,
• Increased liver function test parameters,
• 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,
• Fast heartbeat,
• Severe infection – 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 inflammation (also known as allergic alveolitis),
• Acute liver failure.

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

• Myocardial infarction (heart attack),
• Changes in ECG (prolongation of 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 Olpha in combination with prednisone and prednisolone may worsen this effect.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can 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: +48 22 4921301; fax: +48 22 4921309, 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 Olpha

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the label of the bottle following "EXP". The expiry date refers to the last day of the specified month.
There are no special storage temperature requirements for this medicine. Store in the original packaging to protect from light.
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 Olpha contains

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

What Abiraterone Olpha looks like and contents of the pack
­ Abiraterone Olpha 250 mg tablets are white or almost white, oval, biconvex, uncoated tablets with the imprint “250” on one side and smooth on the other side.
­ The tablets are placed in a 100 ml HDPE bottle with a child-resistant polpropylene cap and an integrated desiccant. Each bottle contains 120 tablets. Each cardboard box contains one bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Abirateron Olpha
Czech Republic Abiraterone Olpha
Estonia Abiraterone Olpha
France Abiraterone Olpha 250 mg comprimé
Italy Abiraterone Olpha
Latvia Abiraterone Olpha 250 mg tabletes
Lithuania Abiraterone Olpha 250 mg tabletės
Poland Abiraterone Olpha
Slovakia Abiraterone Olpha 250 mg tablety
Spain Abiraterona Olpha 250 mg comprimidos EFG