Abiraterone sun

DE/H/6983/001/IA/002

Package leaflet: Information for the

user
Abirateron SUN, 500 mg, film-coated tablets
Abirateroni acetas
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, 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.

Contents of the leaflet

1. What Abirateron SUN is and what it is used for
2. Important information before taking Abirateron SUN
3. How to take Abirateron SUN
4. Possible side effects
5. How to store Abirateron SUN
6. Contents of the pack and other information

1. What Abirateron SUN is and what it is used for

Abirateron SUN is a medicine containing 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). Abirateron SUN inhibits the production of testosterone in the body; this may slow down the progression of prostate cancer.
When Abirateron SUN is used at an early stage of hormone-sensitive disease, it is given in combination with androgen-deprivation therapy (hormonal therapy that lowers 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 blood potassium levels.

2. Important information before using Abirateron SUN

When not to use Abirateron SUN:

• 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. Abirateron SUN is intended for use in men only.
• 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

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Before starting treatment with this medicine, 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 blood potassium may increase the risk of heart rhythm disturbances)
• if the patient has other heart or blood vessel disorders
• if the patient has irregular or rapid heartbeat
• if the patient has shortness of breath
• if the patient has experienced rapid weight gain
• if the patient has swelling of the feet, ankles, or legs
• if the patient has previously taken ketoconazole for the treatment of prostate cancer
• the need to take this medicine together with prednisone or prednisolone
• the possibility of bone-related adverse effects
• if the patient has high blood sugar levels.

Inform the doctor if the patient has any heart or blood vessel disorders, including heart rhythm disturbances (arrhythmia), or is taking medicines for these conditions.

Inform the doctor if the patient develops yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver problems. Rarely, severe liver failure may occur, which can lead to death.

Possible effects include decreased red blood cell count, reduced libido, muscle weakness and/or muscle pain.

Abirateron SUN must not be given in combination with Ra-223 due to a possible increased risk of bone fractures or death.

If the patient intends to receive Ra-223 after treatment with Abirateron SUN and prednisone/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

Abirateron SUN 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 Abirateron SUN is accidentally swallowed by a child or teenager, seek immediate medical attention at a hospital and bring along the patient leaflet to show the doctor in the emergency department.

Abirateron SUN and other medicines

Before taking any medicine, consult a doctor or pharmacist.

Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use. This is important because Abirateron SUN may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal remedies (e.g. St. John's wort), and others. The doctor may need to adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abirateron SUN, which could lead to adverse effects or reduced efficacy.

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

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• used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• that may 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 the doctor if the patient is taking any of the above-mentioned medicines.

Taking Abirateron SUN with food

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

Pregnancy and breastfeeding

Abirateron SUN is not used in women.

• This 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 and 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 using machines

It is unlikely that this medicine affects the ability to drive or operate tools or machinery.

Abirateron SUN contains lactose and sodium

Abirateron SUN contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains 22 mg of sodium (the main component of table salt) in a dose consisting of two tablets. This corresponds to 1.1% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Abirateron SUN

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

How much medicine to take

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

How to take the medicine

• This medicine is for oral use.
• Abirateron SUN must not be taken with food. Taking Abirateron SUN with food may result in increased absorption of the medicine into the body compared to what is needed, which may lead to adverse effects.
• A single dose of tablets should be taken once daily on an empty stomach. Take Abirateron SUN at least one hour before or at least two hours after a meal (see section 2, "Taking Abirateron SUN with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Abirateron SUN is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• Prednisone or prednisolone must be taken daily during treatment with Abirateron SUN.

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• The amount of prednisone or prednisolone taken may need to be adjusted in an emergency. Your doctor will inform you if a change in the dose of prednisone or prednisolone is necessary. Do not stop taking prednisone or prednisolone without consulting your doctor.

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

Taking more Abirateron SUN than prescribed

If you take more medicine than you should, contact your doctor immediately or go to the nearest hospital.

Missing a dose of Abirateron SUN

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

Stopping Abirateron SUN treatment

Do not stop taking Abirateron SUN 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.
The patient should stop taking Abirateron SUN and contact a doctor immediately if any of the following symptoms occur:

• muscle weakness
• muscle twitching (tremors)
• palpitations
  These may be symptoms of low blood potassium levels.

Other adverse reactions include:
Very common (may affect more than 1 in 10 people):

• swelling of the legs or feet
• low blood potassium levels
• elevated liver function test results
• high blood pressure
• urinary tract infections
• diarrhoea

Common (may affect up to 1 in 10 people):

• high blood lipid (fat) levels
• chest pain
• heart rhythm disorders (atrial fibrillation)
• heart failure
• rapid heartbeat
• severe infection, sepsis
• bone fractures
• indigestion
• blood in the urine
• rash

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Uncommon (may affect up to 1 in 100 people):

• adrenal gland dysfunction (related to disturbances in water and electrolyte balance)
• irregular heart rhythm (arrhythmia)
• muscle weakness and/or muscle pain

Rare (may affect up to 1 in 1000 people):

• lung inflammation (also known as allergic alveolitis)
• acute liver failure

Frequency unknown (frequency cannot be estimated from 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

Loss of bone mass may occur in men treated for prostate cancer. Treatment with Abirateron SUN in combination with prednisone or prednisolone may worsen this effect.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Abirateron SUN

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 and blister after "EXP". The expiry date refers to the last day of the mentioned month.
No special storage conditions apply 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 Abirateron SUN contains

• The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, and sodium lauryl sulphate (see section 2 "Abirateron SUN contains lactose and sodium"). Coating: black iron oxide (E 172), red iron oxide (E 172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide (E 171).

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What Abirateron SUN looks like and contents of the pack
Oval, biconvex, film-coated tablets coloured violet (approximately 20.03 mm in length and 10.02 mm in width), with the imprint “S500” on one side.
Abirateron SUN is available in blister packs.
Pack sizes: cardboard box containing 56, 60 or 120 film-coated tablets, and unit dose blisters in packs containing 56 x 1, 60 x 1 and 120 x 1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
Strada Fabricii Nr. 124
400632 Cluj-Napoca
Cluj
Romania
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Germany Abirateron SUN 500 mg Filmtabletten
France ABIRATÉRONE SUN 500 mg, comprimé pelliculé
Italy Abiraterone SUN
Romania Abirateronă SUN 500 mg comprimate filmate
Spain Abiraterona SUN 500 mg comprimidos recubiertos con película
For more detailed information about this medicinal product, contact the local representative of the marketing authorisation holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Kubickiego 11
02-954 Warsaw
Poland
Tel. +48 22 642 07 75