TATICA 500 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. TATICA, 250 mg, film-coated tablets
3. TATICA, 500 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What Tatica is and what it is used for
5. What you need to know before you take Tatica
   1. Do not take Tatica
   2. Warnings and precautions
   3. Blood tests
   4. Children and adolescents
   5. Tatica with other medicines
   6. Tatica with food
   7. Pregnancy and breast-feeding
   8. Tatica is not used in women.
   9. Driving and using machines
   10. Tatica contains lactose and sodium
6. How to take Tatica
   1. How much to take
   2. How to take it
   3. If you take more Tatica than you should
   4. If you forget to take Tatica
   5. If you stop taking Tatica
7. Possible side effects
   1. Stop taking Tatica and contact your doctor straight away if you notice any of the following:
   2. Other side effects:
   3. Reporting of side effects
8. How to store Tatica
9. Contents of the pack and other information
   1. What Tatica contains
   2. What Tatica looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
   6. TATICA is approved in the following countries:
   7. Date of last revision of the leaflet: 23.06.2022

Package Leaflet: Information for the User

TATICA, 250 mg, film-coated tablets

TATICA, 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Tatica is and what it is used for

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

When Tatica 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 retention (edema), or low potassium levels in the blood.

2. What you need to know before you take Tatica

Do not take Tatica

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6);
• in women, especially during pregnancy, as abiraterone is only used in men;
• if you have severe liver damage;
• in combination with a medicine called Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Tatica.

Warnings and precautions

Before taking this medicine, discuss 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 abnormal heart rhythms);
• if you have had other heart problems or blood vessel problems;
• if you have an irregular or fast heart rhythm;
• if you have shortness of breath;
• if you have gained weight in a short period;
• if you have swelling of your feet, ankles, or legs;
• if you have taken a medicine called ketoconazole in the past for the treatment of prostate cancer;
• if you need to take this medicine with prednisone or prednisolone;
• if there is a possibility of side effects related to bones;
• if you have high blood sugar levels.

Tell your doctor if you have any heart or blood vessel problems, including abnormal heart rhythms (arrhythmia) or if you are taking medicines for these conditions. 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 may occur, which may be life-threatening. There may be a decrease in the number of red blood cells, decreased sex drive, muscle weakness, and/or muscle pain. Abiraterone must not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death. Before starting planned Ra-223 therapy after treatment with abiraterone and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment. If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before taking Tatica.

Blood tests

Abiraterone 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 your liver.

Children and adolescents

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

Tatica with other medicines

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 any medicines you plan to take. This is important because abiraterone 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 dose of these medicines. Other medicines may also increase or decrease the effect of abiraterone. This may result in side effects or abiraterone not working properly. Androgen deprivation therapy may increase the risk of abnormal heart rhythms. Tell your doctor if you are taking medicines:

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

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

Tatica with food

• Do not take this medicine with food (see section 3, "How to take Tatica").
• Taking Tatica with food may cause side effects.

Pregnancy and breast-feeding

Tatica 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 or other effective birth control method.
• 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.

Tatica contains lactose and sodium

• 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 less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to take Tatica

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

How much to take

The recommended dose is 1000 mg (four 250 mg tablets or two 500 mg tablets) taken once a day.

How to take it

• Take by mouth.
• Do not take Tatica with food.
• Take Tatica at least 1 hour before or at least 2 hours after food (see section 2, "Tatica with food").
• Swallow the tablets whole with a glass of water.
• Do not crush the tablets.
• Tatica is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as directed by your doctor.
• Take prednisone or prednisolone every day while taking Tatica.
• The amount of prednisone or prednisolone you take may be changed if necessary. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without talking to your doctor. Your doctor may also prescribe other medicines while you are taking Tatica and prednisone or prednisolone.

If you take more Tatica than you should

If you take more Tatica than you should, talk to a doctor or go to a hospital straight away.

If you forget to take Tatica

• If you forget to take Tatica or prednisone or prednisolone, take your normal dose the next day.
• If you forget to take Tatica or prednisone or prednisolone for more than one day, talk to your doctor straight away.

If you stop taking Tatica

Do not stop taking Tatica or prednisone or prednisolone without talking to your doctor. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Stop taking Tatica and contact your doctor straight away 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 side effects:

Very common(may affect more than 1 in 10 people):
Swelling of the feet or ankles, low potassium levels in the blood, high liver enzyme levels, high blood pressure, urinary tract infections, diarrhea.
Common(may affect up to 1 in 10 people):
High levels of lipids in the blood, chest pain, abnormal heart rhythms (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 gland problems (related to electrolyte imbalance), abnormal heart rhythm (arrhythmia), muscle weakness, and/or muscle pain.
Rare(may affect up to 1 in 1,000 people):
Lung inflammation (also known as allergic alveolitis).
Acute liver failure.
Frequency not known(cannot be estimated from the available data):
Heart attack, changes in the ECG (prolonged QT interval), and 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. Tatica containing abiraterone in combination with prednisone and prednisolone may increase bone loss.

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 Tatica

• 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 conditions 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 Tatica contains

• The active substance is abiraterone acetate. Each tablet contains 250 mg or 500 mg of abiraterone acetate.
• The other ingredients are: Tablet core: croscarmellose sodium, sodium lauryl sulfate, povidone K-30, microcrystalline cellulose type 102, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (see section 2, "Tatica contains lactose and sodium"). Opadry II 85F200051 Purple coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc. Only for 500 mg: red iron oxide (E 172), black iron oxide (E 172).

What Tatica looks like and contents of the pack

Tatica 250 mg is a white or almost white, oval, film-coated tablet with "250" engraved on one side.
Tatica 500 mg is a purple, oval, film-coated tablet with "500" engraved on one side.
The tablets are provided in:

• blister packs of 112 and 120 film-coated tablets in a cardboard box for the 250 mg strength;
• blister packs of 56 and 60 film-coated tablets in a cardboard box for the 500 mg strength.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus

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

TATICA is approved in the following countries:

Netherlands
TATICA 250 mg, 500 mg film-coated tablets
Bulgaria
Татика 250 mg, 500 mg филмирани таблетки
TATICA 250 mg, 500 mg film-coated tablets
Czech Republic
TATICA
Hungary
TATICA 250 mg, 500 mg filmtabletta
Lithuania
TATICA 250 mg, 500 mg plėvele dengtos tabletės
Latvia
TATICA 250 mg, 500 mg apvalkotās tabletes
Poland
TATICA
Romania
TATICA 250 mg, 500 mg comprimate filmate
Slovakia
TATICA 250 mg, 500 mg filmom obalené tablety
France
ABIRATERONE BIOGARAN 500 mg, comprimé pelliculé

Date of last revision of the leaflet: 23.06.2022