Abiraterone msn

Package leaflet: Information for the user

Abiraterone MSN, 250 mg, film-coated tablets
Abiraterone MSN, 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• 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 Abiraterone MSN is and what it is used for
2. Important information before taking Abiraterone MSN
3. How to take Abiraterone MSN
4. Possible side effects
5. How to store Abiraterone MSN
6. Contents of the pack and other information

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

Abiraterone MSN 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). Abiraterone MSN inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone MSN 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 likelihood of high blood pressure, fluid retention (fluid build-up), or low potassium levels in the blood.

2. Important information before using Abiraterone MSN

When not to use Abiraterone MSN

• if the patient is allergic (hypersensitive) to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• in women, particularly during pregnancy. Abiraterone MSN is intended for use in men only.
• if the patient has severe liver impairment.
• in combination with the medicine Ra-223 (used in the treatment of prostate cancer).

This medicine should not be used if any of the above situations apply. If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions

Before starting treatment with this medicine, discuss the following 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 levels 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's body weight has increased rapidly
• 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 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 the doctor if the patient has any heart or blood vessel disorders, including heart rhythm disturbances (arrhythmia), or is taking medicines for these conditions.

Tell 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, acute liver failure may occur, which can lead to death.

A decrease in red blood cell count, reduced libido, muscle weakness and/or muscle pain may occur.

Abiraterone MSN 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 Abiraterone MSN and prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 treatment.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using this medicine.

Blood tests

Abiraterone MSN may affect liver function, and the patient may not experience any symptoms. During treatment, the doctor 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 MSN is accidentally swallowed by a child, seek immediate medical attention at a hospital, bringing the patient leaflet to show the emergency room doctor.

Abiraterone MSN and other medicines

Before taking any medicine, consult a doctor or pharmacist.

Tell the 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 MSN may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic medicines, 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 Abiraterone MSN, potentially leading 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:

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

Abiraterone MSN and food

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

Pregnancy and breastfeeding

Abiraterone MSN is not used in women.

• This medicine may harm the unborn child if taken by a pregnant woman.
• Pregnant women or women who may be pregnant should wear protective gloves when handling or coming into contact with Abiraterone MSN.
• If the patient has sexual intercourse with a woman who may become pregnant, a condom must be used in combination with another effective contraceptive method.
• 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, use tools, or operate machinery.

Abiraterone MSN contains lactose and sodium

• Abiraterone MSN contains lactose. If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• This medicine contains 27 mg of sodium (the main component of table salt) in the daily dose of 1000 mg (four 250 mg tablets or two 500 mg tablets). This corresponds to 1.35% of the maximum recommended daily sodium intake in the adult diet.

3. How to take Abiraterone MSN

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
How much medicine to take
The recommended dose is 1000 mg (four tablets of 250 mg or two tablets of 500 mg) taken once daily.
Taking this medicine

• This medicine should be taken by mouth.
• Abiraterone MSN must not be taken with food. Taking Abiraterone MSN with food may result in more medicine being absorbed by the body than necessary, which could lead to unwanted side effects.
• Abiraterone MSN tablets should be taken as a single dose once daily on an empty stomach. Abiraterone MSN should be taken at least two hours after eating, and food should not be consumed for at least one hour after taking Abiraterone MSN (see section 2, "Taking Abiraterone MSN with food").
• Tablets should be swallowed whole with water.
• Tablets must not be crushed.
• Abiraterone MSN is taken together with a medicine called prednisone or prednisolone. You must take prednisone or prednisolone exactly as prescribed by your doctor.
• You must take prednisone or prednisolone every day during treatment with Abiraterone MSN.
• The dose of prednisone or prednisolone may be adjusted if necessary.

Your doctor will inform you if there is a need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without consulting your doctor.
Your doctor may also prescribe other medicines to you while you are taking Abiraterone MSN and prednisone or prednisolone.
Taking more Abiraterone MSN than prescribed
If you take more medicine than you should, contact your doctor immediately or go to the nearest hospital.
Missing a dose of Abiraterone MSN

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

Stopping Abiraterone MSN treatment
Do not stop taking Abiraterone MSN or prednisone or prednisolone without consulting your doctor.
If you have any further questions about the use of 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 must stop taking Abiraterone MSN and contact a doctor immediately
if any of the following symptoms occur:

• Muscle weakness, muscle twitching, or rapid heartbeat (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, increased liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may affect up to 1 in 10 people):
High blood lipid levels, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat, severe infections known as sepsis, bone fractures, indigestion, blood in urine, rash.
Uncommon (may affect up to 1 in 100 people):
Adrenal gland dysfunction (related to disturbances in water and electrolyte balance), 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).
Liver failure (also known as acute liver failure).
Frequency not known (cannot be estimated from available data):
Heart attack, changes in ECG (prolongation of QT interval), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
In men treated for prostate cancer, loss of bone mass may occur. Abiraterone MSN in combination with prednisone or prednisolone may worsen loss of bone mass.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 this medicine.

5. How to store Abiraterone MSN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP. The expiry date refers to the last day of the mentioned month.
• No special storage instructions 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 pack and other information

What Abiraterone MSN contains

• The active substance is abiraterone acetate.
• Each coated tablet contains 250 mg of abiraterone acetate, equivalent to 223 mg of abiraterone.
• Each coated tablet contains 500 mg of abiraterone acetate, equivalent to 446 mg of abiraterone.
• Other ingredients: lactose monohydrate, sodium croscarmellose (E 468), hypromellose 2910, 3 mPa.s (E 464), sodium lauryl sulfate, microcrystalline cellulose (E 460), colloidal anhydrous silica (E 551), magnesium stearate (E 470b), polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), iron oxide red (E 172), iron oxide yellow (E 172) – for 250 mg strength only, iron oxide black (E 172) – for 500 mg strength only (see section 2, "Abiraterone MSN contains lactose and sodium").

What Abiraterone MSN looks like and contents of the pack
[250 mg]: Abiraterone MSN tablets are oval, film-coated, beige-colored tablets, approximately 16 mm in length and 9 mm in width, with the imprint “MA” on one side and “21” on the other side.
[500 mg]: Abiraterone MSN tablets are oval, film-coated, purple-colored tablets, approximately 20 mm in length and 10 mm in width, with the imprint “MA” on one side and “22” on the other side.

Pack sizes:
250 mg:
Blister packs containing 120 film-coated tablets, in a cardboard box.
Perforated single-dose blisters containing 120 x 1 film-coated tablet, in a cardboard box.
500 mg:
Blister packs containing 60 film-coated tablets, in a cardboard box.
Perforated single-dose blisters containing 56 x 1, 60 x 1, or 112 x 1 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
Netherlands: Abirateron MSN 250 mg filmomhulde tabletten
Abirateron MSN 500 mg filmomhulde tabletten
Bulgaria: Абиратерон MSN 250 mg филмирани таблетки
Абиратерон MSN 500 mg филмирани таблетки
Czech Republic: Abiraterone MSN
Hungary: Abiraterone MSN 250 mg filmtabletta
Abiraterone MSN 500 mg filmtabletta
Croatia: Abirateron MSN 250 mg filmom obložene tablete
Abirateron MSN 500 mg filmom obložene tablete
Poland: Abiraterone MSN
Romania: Abirateronă MSN 250 mg comprimate filmate
Abirateronă MSN 500 mg comprimate filmate
Slovenia: Abirateron MSN 250 mg filmsko obložene tablete
Abirateron MSN 500 mg filmsko obložene tablete
Slovakia: Abiraterón MSN