Abiraterone glenmark

Patient Information Leaflet: Instructions for the User

Abiraterone Glenmark, 250 mg, tablets
Abirateroni acetas
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Table of Contents

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

Abiraterone Glenmark contains the active substance 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 Glenmark inhibits the production of testosterone in the body; this may slow down the progression of prostate cancer.

When Abiraterone Glenmark is used at an early stage of hormone-sensitive disease, it is administered in combination with androgen deprivation therapy (treatment that reduces 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 potassium levels in the blood.

2. Important information before using Abiraterone Glenmark

When not to use Abiraterone Glenmark

• 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 Glenmark is intended for use only in men.
• if the patient has severe liver impairment.
• in combination with Ra-223 (used in the treatment of prostate cancer).

Do not use this medicine 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 Abiraterone Glenmark, discuss the following with your doctor or
pharmacist:

• if the patient has liver diseases
• if the patient has high blood pressure, heart failure, or low blood potassium levels (low blood potassium may increase the risk of heart rhythm disturbances)
• 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 a medicine called 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.

Tell your doctor if you have been diagnosed with any heart or blood vessel conditions, including heart rhythm disorders (arrhythmia), or if you are taking medicines for these conditions.
Tell your doctor if you develop yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be symptoms of liver disease. Rarely, liver function disorders (known as acute liver failure) may occur, which could lead to death.
Reduction in red blood cell count, decreased libido, muscle weakness, and/or muscle pain may occur.
Do not use Abiraterone Glenmark in combination with Ra-223 due to an increased risk of bone fractures or death.
If the patient plans to receive Ra-223 after treatment with Abiraterone Glenmark 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 Glenmark may affect liver function, and the patient may not experience any symptoms. During treatment with this medicine, the treating physician will periodically order blood tests to monitor the medicine’s effect on the liver.
Children and adolescents
This medicine is not intended for use in children and adolescents. If Abiraterone Glenmark is accidentally swallowed by a child, seek immediate medical attention at a hospital emergency department, taking the patient leaflet along to show the doctor.
Abiraterone Glenmark and other medicines
Before taking any medicine, consult your doctor or pharmacist.
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use. This is important because Abiraterone Glenmark may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal medicines (e.g. St John's wort Hypericum perforatum), and others. Your doctor may adjust the doses of these medicines. Also, certain medicines may increase or decrease the effect of Abiraterone Glenmark. This may lead to adverse reactions or reduced effectiveness of Abiraterone Glenmark.
Androgen suppression may increase the risk of heart rhythm disturbances. Inform your doctor if the patient is taking any of the following medicines:

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

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

Pregnancy and breastfeeding
Abiraterone Glenmark is not intended for use in women.
Women who are pregnant or may be pregnant should wear protective gloves when
handling or coming into contact with Abiraterone Glenmark.
The medicine may harm the unborn child if taken by a pregnant woman.
If the patient has sexual intercourse with a woman who may become pregnant, a condom or other effective contraceptive method 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 will affect the ability to drive or operate tools or machinery.
Abiraterone Glenmark contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Abiraterone Glenmark, 250 mg, tablets
This medicine contains less than 1 mmol (23 mg) of sodium in the dose consisting of four 250 mg tablets, meaning the medicine is considered "sodium-free".

3. How to use Abiraterone Glenmark

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
What dose should be used
The recommended dose is 1000 mg (four tablets of 250 mg strength) taken once daily.
How to take this medicine
This medicine should be taken by mouth.
Abiraterone Glenmark must not be taken with food. Taking Abiraterone Glenmark with food may lead to greater absorption of the medicine than necessary, which could result in adverse effects.
Abiraterone Glenmark should be taken as a single daily dose on an empty stomach. Abiraterone Glenmark must be taken at least two hours after eating, and food may be consumed at least one hour after taking Abiraterone Glenmark (see section 2, “Abiraterone Glenmark with food”).
The tablets should be swallowed whole with water.
Do not crush the tablets.
Abiraterone Glenmark is taken together with a medicine called prednisone or prednisolone. Prednisone or prednisolone should be used exactly as prescribed by your doctor.
Prednisone or prednisolone should be taken every day during treatment with Abiraterone Glenmark.
The dose of prednisone or prednisolone may be adjusted if necessary. Your doctor will inform you if any dose adjustment of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone unless instructed by your doctor.
Your doctor may also prescribe other medicines during treatment with Abiraterone Glenmark and prednisone or prednisolone.
Taking more than the recommended dose of Abiraterone Glenmark
If you take more than the prescribed dose of this medicine, contact your doctor immediately or go to hospital.
Missing a dose of Abiraterone Glenmark
If you forget to take Abiraterone Glenmark, prednisone or prednisolone, take your usual dose the next day.
If you forget to take Abiraterone Glenmark, prednisone or prednisolone for more than one day, contact your doctor immediately.
Stopping treatment with Abiraterone Glenmark
Do not stop taking Abiraterone Glenmark 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Abiraterone Glenmark must be discontinued and the patient should immediately contact a
physician if any of the following symptoms occur:

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

Other adverse reactions include:
Very common (may occur in more than 1 in 10 patients):

• Swelling of the legs or feet
• Low blood potassium levels
• Increased liver function test results
• High blood pressure
• Urinary tract infections
• Diarrhea

Common (may occur in up to 1 in 10 patients):

• High blood lipid levels
• Chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat
• Severe infection known as sepsis
• Bone fractures
• Indigestion
• Blood in the urine
• Rash

Uncommon (may occur in up to 1 in 100 patients):

• Adrenal gland dysfunction (related to disturbances in water and electrolyte balance)
• Irregular heartbeat (arrhythmia)
• Muscle weakness and/or muscle pain

Rare (may occur in up to 1 in 1000 patients):

• Lung inflammation (also known as allergic alveolitis)
• Acute liver failure

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

• 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 Glenmark used concomitantly with prednisone or prednisolone may exacerbate loss of bone mass.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform a physician or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309
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 the 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 stated on the outer carton or on the bottle label following: EXP. The expiry date refers to the last day of the mentioned month.
No special storage conditions apply 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. These measures will help protect the environment.

6. Contents of the package 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 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 in length and 9.5 mm in width, with the imprint “ATN” 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
The Netherlands
Glenmark Pharmaceuticals s.r.o.
Fibichova 143/II, 566 17 Vysoké Mýto
Czech Republic
Glenmark Arzneimittel GmbH
Industriestr. 31, Gröbenzell, 82194
Germany

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonińskiego 3
00-728 Warsaw
Email: [email protected]