Abiraterone Glenmark

Package Leaflet: Information for the User

Abiraterone Glenmark, 250 mg, 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Abiraterone Glenmark contains the active substance abiraterone acetate. It is used in adult men in the treatment of prostate cancer that has spread to other parts of the body. Abiraterone Glenmark works by stopping the production of testosterone in the body; this can slow down the growth of the prostate cancer.
When Abiraterone Glenmark 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 reduces testosterone levels (androgen suppression 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 (oedema), or low potassium levels in the blood.

2. Before you take Abiraterone Glenmark

When not to take Abiraterone Glenmark

• 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. Abiraterone Glenmark is only used in men.
• if you have severe liver damage.
• in combination with Ra-223 (used in the treatment of prostate cancer).

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

Warnings and precautions

Before taking Abiraterone Glenmark, tell 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 rapid heart rhythm
• if you have shortness of breath
• if your body weight has increased in a short time
• if you have swelling of the feet, ankles, or legs
• if you have taken a medicine called ketoconazole in the past to treat prostate cancer
• the need to take this medicine with prednisone or prednisolone
• the possibility of bone-related side effects
• if you have high blood sugar levels.

Tell your doctor if you have been told 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, liver problems (called acute liver failure) may occur, which may be life-threatening.
There may be a decrease in red blood cells, decreased sex drive, muscle weakness, and/or muscle pain.
Do not take Abiraterone Glenmark in combination with Ra-223 due to an increased risk of bone fractures or death.
If you plan to take Ra-223 after treatment with Abiraterone Glenmark and prednisone or prednisolone, you should wait 5 days before starting Ra-223 treatment.
If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone Glenmark 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 Glenmark is accidentally swallowed by a child, seek immediate medical attention at a hospital emergency department, taking this leaflet with you to show to the doctor.

Abiraterone Glenmark 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 Glenmark may increase the effects of many medicines, including heart medicines, sedatives, certain anti-diabetic medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may change the doses of these medicines. Also, some medicines may increase or decrease the effects of Abiraterone Glenmark, which may cause side effects or the medicine to not work properly.
Androgen suppression 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);
• known to increase the risk of abnormal heart rhythms [e.g., methadone (a pain reliever and used to treat addiction), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental disorders)].

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

Abiraterone Glenmark with food

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

Pregnancy and breastfeeding

Abiraterone Glenmark is not used in women.

Women who are pregnant or may become pregnant should wear protective gloves when handling Abiraterone Glenmark.

The 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.

Abiraterone Glenmark contains lactose and sodium

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.
Abiraterone Glenmark, 250 mg, tablets
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to take Abiraterone Glenmark

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

How much to take

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

How to take this medicine

This medicine should be taken by mouth.
Do not take Abiraterone Glenmark with food.Taking Abiraterone Glenmark with food may cause more of the medicine to be absorbed than necessary, which may cause side effects.
Abiraterone Glenmark should be taken as a single dose once daily on an empty stomach. Abiraterone Glenmark must be taken at least 2 hours after eating, and food can be taken at least 1 hour after taking Abiraterone Glenmark (see section 2, "Abiraterone Glenmark with food").
Swallow the tablets whole with water.
Do not crush the tablets.
Abiraterone Glenmark is taken with a medicine called prednisone or prednisolone. Prednisone or prednisolone should be taken as directed by your doctor.
Prednisone or prednisolone should be taken every day while taking Abiraterone Glenmark.
The amount of prednisone or prednisolone taken may be changed if necessary. Your doctor will inform you if a change in the dose of prednisone or prednisolone is needed. Do not stop taking prednisone or prednisolone unless your doctor tells you to.
Your doctor may also prescribe other medicines for you to take while taking Abiraterone Glenmark and prednisone or prednisolone.

If you take more Abiraterone Glenmark than you should

If you take more than the recommended dose, contact your doctor immediately or go to the hospital.

If you forget to take Abiraterone Glenmark

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

If you stop taking Abiraterone Glenmark

Do not stop taking Abiraterone Glenmark or prednisone or prednisolone without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Abiraterone Glenmark and contact your doctor immediately 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 include:

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 lipid levels in the blood
• chest pain, abnormal heart rhythms (atrial fibrillation), heart failure, rapid 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 rhythms (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 ECG (prolonged QT interval)
• 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 Glenmark taken with prednisone or prednisolone may increase bone loss.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Abiraterone Glenmark

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 or label 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 Abiraterone Glenmark contains

Abiraterone Glenmark, 250 mg, tablets

• The active substance is abiraterone acetate.
• Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose type 102, sodium croscarmellose, povidone type K29/K32, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.

What Abiraterone Glenmark looks like and contents of the pack

Abiraterone Glenmark, 250 mg, tablets
Abiraterone Glenmark, 250 mg, are white or almost white, oval tablets, approximately 16 mm long and 9.5 mm wide, with "ATN" engraved on one side and "250" on the other side.
Each pack contains one bottle with 120 tablets.

Marketing Authorisation Holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer

Synthon Hispania, S.L.
C/ Castelló 1, 08830 Sant Boi de Llobregat, Barcelona
Spain
Synthon B.V.
Microweg 22, 6545 CM Nijmegen
Netherlands
Glenmark Pharmaceuticals s.r.o.
Fibichova 143/II, 566 17 Vysoké Mýto
Czech Republic
Glenmark Arzneimittel GmbH
Industriestr. 31, Gröbenzell, 82194
Germany

For further information on this medicine, contact your local representative of the Marketing Authorisation Holder:

Glenmark Pharmaceuticals Sp. z o. o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: poland.receptionist@glenmarkpharma.com

Date of last revision of the leaflet: