Abiraterone glenmark

Patient Information Leaflet

Abiraterone Glenmark 500 mg film-coated tablets
Abiraterone acetate
Please 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Abiraterone Glenmark is and what it is used for
2. What you need to know 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 the progression of prostate cancer.
When Abiraterone Glenmark is used at an early stage of hormone-sensitive disease, it is given in combination with androgen deprivation therapy (therapy that reduces testosterone levels).
While taking 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 build-up), 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, particularly during pregnancy. Abiraterone Glenmark is used only in men.
• if the patient has severe liver impairment.
• in combination with Ra-223 (used in the treatment of prostate cancer).

Do not take 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 with your doctor or pharmacist:

• if the patient has liver disease
• if the patient has high blood pressure, heart failure, or low blood potassium levels (low potassium levels may increase the risk of heart rhythm disturbances)
• if the patient has other heart or blood vessel diseases
• if the patient has irregular or rapid heartbeat
• if the patient experiences shortness of breath
• if the patient has experienced rapid weight gain
• if the patient has swelling in the feet, ankles, or legs
• if the patient previously took a medicine called ketoconazole for the treatment of prostate cancer
• the necessity of taking this medicine 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 signs of liver disease. Rarely, liver function disorders (referred to as acute liver failure) may occur, which could lead to death.

There may be a decrease in red blood cell count, reduced libido, muscle weakness, and/or muscle pain.

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, wait at least 5 days 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 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 Glenmark is accidentally swallowed by a child, go immediately to the hospital emergency department, taking the patient leaflet along to show the doctor.

Abiraterone Glenmark and other medicines

Before taking any medicine, consult a doctor or pharmacist.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is important because Abiraterone Glenmark may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal remedies (e.g. St John's wort Hypericum perforatum), and others. The doctor may need to adjust the doses of these medicines. Also, some medicines may increase or decrease the effect of Abiraterone Glenmark, which could lead to adverse effects or reduced efficacy of Abiraterone Glenmark.

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

• used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• 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 medicines listed above.

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 used 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 could become pregnant, a condom or 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 or operate tools or machinery.

Abiraterone Glenmark contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Abiraterone Glenmark, 500 mg, film-coated tablets
This medicine contains 24 mg of sodium (the main component of table salt) in each dose consisting of two 500 mg tablets. This corresponds to 1% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Abiraterone Glenmark

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
What dose should be taken
The recommended dose is 1000 mg (two 500 mg tablets) taken once daily.
How to take this medicine
This medicine is for oral use.
Abiraterone Glenmark must not be taken with food. Taking Abiraterone Glenmark with food may
increase absorption of the medicine more than necessary, which could lead to 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 should not be consumed until at
least one hour after taking Abiraterone Glenmark (see section 2, "Abiraterone Glenmark with food").
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 taken 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 Abiraterone Glenmark than prescribed
If you take more Abiraterone Glenmark than prescribed, contact your doctor immediately or go to
the nearest hospital.
If you miss 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 Abiraterone Glenmark treatment
Do not stop taking Abiraterone Glenmark, 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 side effects

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

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

Other side effects 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
• Diarrhoea

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 heart rhythm (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 the available data):

• Heart attack, changes in ECG (QT interval prolongation)
• Severe allergic reactions causing difficulty in 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 side effects
If any side effects occur, including any not listed in this leaflet, the patient should inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to 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 stated on the outer carton or blister after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via the sewage system 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, 500 mg, film-coated tablets

• The active substance is abiraterone acetate.
• Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate (tablet core); polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), red iron oxide (E 172), and black iron oxide (E 172) (tablet coating).

What Abiraterone Glenmark looks like and contents of the pack
Abiraterone Glenmark, 500 mg, film-coated tablets
Abiraterone Glenmark, 500 mg are violet, oval film-coated tablets, approximately 19 mm in length and 11 mm in width, with the imprint “A7TN” on one side and “500” on the other side.
Each blister contains 60 film-coated tablets. The film-coated tablets may be packed in transparent or opaque (white) blisters.

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 further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekonskiego 3
00-728 Warsaw
Email: [email protected]