Abiraterone Olpha

Package leaflet: Information for the user

Abiraterone Olpha 250 mg tablets, 500 mg film-coated tablets

abiraterone acetate
equivalent medicine
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 contains a medicine called abiraterone acetate. It is used for the
treatment of prostate cancer in adult men in whom the cancer has spread to other parts of the body.
Abiraterone Olpha stops the body from producing testosterone; this may slow down the
growth of prostate cancer.
When Abiraterone Olpha is prescribed at the initial stage of the disease that still responds to
hormonal therapy, it is used together with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe another medicine called
prednisone or prednisolone. This medicine helps reduce the chance of developing high blood
pressure, too much fluid in the body (fluid retention), or low levels in the blood of a
chemical known as potassium.

2. What you should know before taking Abiraterone Olpha

Do not take Abiraterone Olpha

• if you are allergic to abiraterone acetate or to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if pregnant. Abiraterone Olpha is intended only for use in men.
• if you have severe liver damage.
• in combination with Ra-223 (used to treat prostate cancer).

Do not take this medicine if any of these conditions apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure, heart failure, or low blood potassium levels (low potassium levels may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or rapid heartbeat
• if you have shortness of breath
• if you have gained weight rapidly
• if you have swelling in your feet, ankles, or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about possible effects on bones
• if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorders, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions.

Inform your doctor if you develop yellowing of the skin or eyes, dark-coloured urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, liver function problems (called acute liver failure) may occur, which can lead to death.

Reduction in red blood cells, decreased sexual desire (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 you are considering taking Ra-223 after treatment with Abiraterone Olpha and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

Abiraterone Olpha may affect the liver and may not cause symptoms. While taking this medicine, your doctor will periodically perform blood tests to monitor for any effects of Abiraterone Olpha on the liver.

Children and adolescents

This medicine is not indicated for use in children and adolescents. If Abiraterone Olpha is accidentally ingested by a child or adolescent, go to hospital immediately and bring the package leaflet to show the emergency doctor.

Other medicines and Abiraterone Olpha

Ask your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Abiraterone Olpha may increase the effects of certain medicines, including heart medications, tranquilizers, some diabetes medicines, herbal remedies (e.g. St. John’s wort), and others. Your doctor may decide to adjust the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone Olpha. This could lead to unwanted side effects or Abiraterone Olpha may not work as effectively.

Androgen deprivation therapy may increase the risk of heart rhythm problems.

Inform your doctor if you are taking medicines:

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

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

Abiraterone Olpha with food

This medicine must not be taken with food (see section “How to take this medicine”).

Taking Abiraterone Olpha with food may cause adverse effects.

Pregnancy and breastfeeding

Abiraterone Olpha is not indicated for use in women. This medicine may cause harm to the unborn baby if taken during pregnancy.

If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.

If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn baby.

Abiraterone Olpha 250 mg tablets:

Pregnant women or women who may be pregnant must wear gloves if they need to touch or handle Abiraterone Olpha.

Driving and using machines

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

Abiraterone Olpha contains lactose and sodium

Abiraterone Olpha contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

This medicine contains 23.2 mg of sodium (a main component of table salt) per four 250 mg tablets and 23 mg of sodium per two 500 mg tablets. This corresponds to 1.2% of the maximum daily recommended sodium intake for an adult.

3. How to take Abiraterone Olpha

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much to take
The recommended dose is 1000 mg (four Abiraterone Olpha 250 mg tablets) once daily.
The recommended dose is 1000 mg (two Abiraterone Olpha 500 mg tablets) once daily.

How to take this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Olpha with food. Abiraterone Olpha must be taken at least two hours after eating, and you must not eat for at least one hour after taking Abiraterone Olpha. (See section 2 “Abiraterone Olpha with food”).
• Swallow the tablets whole with some water.
• Do not break the tablets.
• Abiraterone Olpha is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You must take prednisone or prednisolone every day while you are taking Abiraterone Olpha.
• Your dose of prednisone or prednisolone may need to be adjusted in certain emergency situations. Your doctor will inform you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

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

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

If you forget to take Abiraterone Olpha
If you forget to take Abiraterone Olpha or prednisone or prednisolone, take your usual dose the next day.
If you forget to take Abiraterone Olpha or prednisone or prednisolone for more than one day, speak to your doctor without delay.

If you stop taking Abiraterone Olpha
Do not stop taking Abiraterone Olpha or prednisone or prednisolone unless your doctor tells you to.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the side effects listed below, stop taking Abiraterone Olpha and contact a doctor immediately:

• muscle weakness, muscle spasms, or a sensation of pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
Very common (may affect more than 1 in 10 people)
Fluid retention in the legs or feet, low potassium levels in the blood, increased liver function test values, high blood pressure, urinary tract infection, diarrhoea.
Common (may affect up to 1 in 10 people)
High levels of fats in the blood, chest pain, irregular heart rhythm (atrial fibrillation), heart failure, rapid heartbeat, severe infection called sepsis, bone fractures, indigestion, blood in the urine, skin rash.
Uncommon (may affect up to 1 in 100 people)
Problems with the adrenal glands (related to salt and water imbalances), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect up to 1 in 1,000 people)
Lung irritation (also known as allergic alveolitis).
Liver function problems (also known as acute liver failure).
Not known (frequency cannot be estimated from the available data)
Heart attack, changes in the ECG (electrocardiogram) – prolongation of the QT interval, and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.
Loss of bone tissue may occur in men being treated for prostate cancer. Abiraterone Olpha in combination with prednisone or prednisolone may increase bone tissue loss.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Olpha

• Keep this medicine out of the sight and reach of children.
• Abiraterone Olpha 250 mg tablets: Do not use this medicine after the expiry date stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage temperature conditions. Store in the original packaging to protect from light.
• Abiraterone Olpha 500 mg film-coated tablets: Do not use this medicine after the expiry date stated on the carton and blister label after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Abiraterone Olpha contains
Abiraterone Olpha 250 mg tablets:

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

Abiraterone Olpha 500 mg film-coated tablets:

• The active substance is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.
• The other excipients are microcrystalline cellulose, croscarmellose sodium, monohydrate lactose, magnesium stearate, hypromellose (type 2910), anhydrous colloidal silica, and sodium lauryl sulfate (see section 2, “Abiraterone Olpha contains lactose and sodium”). The coating contains black iron oxide (E172), red iron oxide (E172), grafted poly(vinyl alcohol) copolymer, talc, and titanium dioxide (E171).

Description of the appearance of Abiraterone Olpha and package contents
Abiraterone Olpha 250 mg tablets:

• Abiraterone Olpha tablets are oval, biconvex, uncoated tablets, white to off-white in colour, with the inscription “250” engraved on one side and smooth on the other side.
• The tablets are supplied in a 100 ml HDPE bottle with a child-resistant cap (made of polypropylene, PP) and an integrated desiccant. Each bottle contains 120 tablets. Each carton contains one bottle.

Abiraterone Olpha 500 mg film-coated tablets:

• Abiraterone Olpha film-coated tablets are purple, oval, biconvex, film-coated tablets, with the inscription “500” engraved on one side and smooth on the other side.
• The tablets are packaged in blisters in 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

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
Abiraterone Olpha 500 mg comprimé pelliculé
Italy Abiraterone Olpha
Latvia Abiraterone Olpha 250 mg tabletes
Abiraterone Olpha 500 mg apvalkotās tabletes
Lithuania Abiraterone Olpha 250 mg tabletės
Abiraterone Olpha 500 mg plėvele dengtos tabletės
Poland Abiraterone Olpha
Slovakia Abiraterone Olpha 250 mg tablety
Abiraterone Olpha 500 mg filmom obalené tablety
Spain Abiraterona Olpha 250 mg comprimidos EFG
Abiraterona Olpha 500 mg comprimidos recubiertos con película EFG