Abiraterone olpha

Package leaflet: Information for the patient

Abiraterone Olpha, 500 mg, film-coated tablets
abiraterone acetate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Abiraterone Olpha is and what it is used for
2. What you need to know 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 inhibits the production of testosterone in the body; this may slow 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 high blood pressure, fluid retention (fluid buildup), or low blood potassium levels.

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 diseases;
• 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 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 taken ketoconazole for 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 disorders (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 symptoms of liver dysfunction. Acute liver failure, which may lead to death, is rare but possible. Decreased red blood cell count, reduced libido, muscle weakness, and/or muscle pain may occur. Abiraterone Olpha 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 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, bringing the patient leaflet to show to the doctor in the emergency department.

Other medicines and Abiraterone Olpha
Before taking any medicine, consult a doctor or pharmacist.
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. This is important because Abiraterone Olpha may enhance the effects of many medicines, including those for heart conditions, sedatives, certain antidiabetic medicines, 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 Olpha, potentially leading to adverse effects or reduced efficacy of Abiraterone Olpha.

Androgen suppression may increase the risk of heart rhythm disorders. Inform the doctor if the patient is taking:

• medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• medicines 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 the doctor if the patient is taking any of the above-mentioned medicines.

Abiraterone Olpha and 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 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 Olpha contains lactose and sodium
Abiraterone Olpha contains monohydrate lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains 23 mg of sodium (the main component of table salt) in the dose contained in two 500 mg tablets. This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Abiraterone Olpha

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

How much medicine to take

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

Taking this medicine

• Take orally.
• Abiraterone Olpha must not be taken with food. Taking Abiraterone Olpha with food may result in more of the medicine being absorbed by the body than intended, which could lead to adverse effects.
• Abiraterone Olpha tablets should be taken as a single daily dose 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. You must take prednisone or prednisolone as directed by your doctor.
• You must take prednisone or prednisolone every day during treatment with Abiraterone Olpha.
• The dose of prednisone or prednisolone may need to be adjusted in certain circumstances. Your doctor will inform you if any changes to your prednisone or prednisolone dose are required. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines while you are taking Abiraterone Olpha together with prednisone or prednisolone.

Taking more Abiraterone Olpha than prescribed

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

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 how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
You must stop taking Abiraterone Olpha and contact your doctor immediately
if you experience any of the following symptoms:

• muscle weakness, muscle tremors, or heart palpitations. These may be symptoms of low blood potassium levels.

Other observed adverse effects:
Very common (may occur in 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,
• diarrhoea.

Common (may occur in no more than 1 in 10 people):

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

Uncommon (may occur in no more than 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 occur in no more than 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):

• myocardial infarction,
• changes in ECG (prolongation of QT interval),
• severe allergic reactions causing difficulty swallowing or breathing, facial, lip, tongue or throat swelling, 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Abiraterone Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions 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. Doing so helps protect the environment.

6. Contents of the pack and other information

What Abiraterone Olpha contains

• The active substance is abiraterone acetate. Each coated tablet contains 500 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"). Film-coating: black iron oxide (E172), red iron oxide (E172), polyethylene glycol-grafted polyvinyl alcohol copolymer, talc, titanium dioxide (E171).

What Abiraterone Olpha looks like and contents of the pack

• Abiraterone Olpha 500 mg film-coated tablets are violet, oval, biconvex film-coated tablets, marked with "500" on one side and smooth on the other side.
• The tablets are packed in blisters within cardboard boxes containing 56 or 60 film-coated tablets.

Not all pack sizes may be marketed.

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 Member States of the European Economic Area under the following names:
Denmark Abirateron Olpha
Czech Republic Abiraterone Olpha
Estonia Abiraterone Olpha
France Abiraterone Olpha 500 mg comprimé pelliculé
Italy Abiraterone Olpha
Latvia Abiraterone Olpha 500 mg apvalkotās tabletes
Lithuania Abiraterone Olpha 500 mg plėvele dengtos tabletės
Poland Abiraterone Olpha
Slovakia Abiraterone Olpha 500 mg filmom obalené tablety
Spain Abiraterona Olpha 500 mg comprimidos recubiertos con película EFG