Package leaflet: information for the user

Abiraterone Medical Valley, 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 other people, even if their symptoms are the same.
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Abiraterone Medical Valley is and what it is used for
Important information before taking Abiraterone Medical Valley
How to take Abiraterone Medical Valley
Possible side effects
How to store Abiraterone Medical Valley
Contents of the pack and other information

1. What Abiraterone Medical Valley is and what it is used for
Abiraterone Medical Valley contains an active substance called abiraterone acetate. It is used in adult males for the treatment of metastatic prostate cancer. This medicine inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When this medicine is used at an early stage of hormone-sensitive disease, it is given together with therapy that reduces testosterone levels (androgen suppression therapy).
While taking this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the likelihood of developing high blood pressure, fluid retention (fluid buildup), or low potassium levels in the blood.

2. Important information before taking Abiraterone Medical Valley

When not to take Abiraterone Medical Valley

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. This medicine is intended for use in men only;
in patients with 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 you. If in doubt, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting Abiraterone Medical Valley, discuss with your doctor or pharmacist:

if you have liver diseases
if you have high blood pressure, heart failure, or low blood potassium levels (low blood potassium may increase the risk of heart rhythm disturbances)
if you have previously had other heart or blood vessel diseases
if you have irregular or rapid heartbeat
if you have shortness of breath
if your body weight has increased rapidly
if you have swelling in your feet, ankles, or legs
if you have previously taken ketoconazole for the treatment of 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 previously had any heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or if you have been treated with medicines used 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 function disorders. Rarely, acute liver failure may occur, which can lead to death.
A decrease in red blood cell count, reduced sex drive (libido), muscle weakness and (or) muscle pain may occur.
Abiraterone Medical Valley must not be used in combination with Ra-223 due to the possible increased risk of bone fractures or death.
If you plan to take Ra-223 after treatment with Abiraterone Medical Valley and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.
If you are in doubt whether any of the above situations apply to you, consult your doctor or pharmacist before taking this medicine.
Blood tests
Abiraterone Medical Valley may affect liver function, and you may not have any symptoms. During treatment, your 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 Medical Valley is accidentally swallowed by a child, go to hospital immediately, taking this patient leaflet with you to show the doctor in the emergency department.
Abiraterone Medical Valley with other medicines
Before taking any medicine, consult your doctor or pharmacist.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This is important because Abiraterone Medical Valley may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal medicines (e.g. St. John's wort), and others. Your doctor may need to adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Medical Valley, which could lead to side effects or reduced effectiveness of Abiraterone Medical Valley.
Androgen suppression may increase the risk of heart rhythm disturbances. Tell your doctor if you are taking medicines:

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 drug used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe mental disorders)].

Tell your doctor if you are taking any of the medicines listed above.
Abiraterone Medical Valley and food

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

Pregnancy and breastfeeding
Abiraterone Medical Valley is not used in women.

This medicine may harm the unborn child if taken by a pregnant woman.
If you have sexual intercourse with a woman who could become pregnant, you must use a condom or another effective method of contraception.
If you have sexual intercourse with a pregnant woman, you must use a condom to protect the unborn child.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive, use tools, or operate machinery.
Abiraterone Medical Valley contains lactose and sodium

Abiraterone Medical Valley contains lactose (a type of sugar). If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
This medicine contains 24 mg of sodium (the main component of table salt) in each two-tablet dose. This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Abiraterone Medical Valley

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
What dose to take
The recommended dose is 1000 mg (two tablets) once daily.
Taking Abiraterone Medical Valley

This medicine should be taken by mouth.
Abiraterone Medical Valley must not be taken with food. Taking Abiraterone Medical Valley with food may cause more of the medicine to be absorbed by the body than necessary, which may lead to adverse effects.
Abiraterone Medical Valley tablets should be taken as a single daily dose on an empty stomach. Abiraterone Medical Valley should be taken at least two hours after eating, and food should not be consumed for at least one hour after taking Abiraterone Medical Valley (see section 2, “Abiraterone Medical Valley with food”).
Tablets should be swallowed whole with water.
Do not crush the tablets.
Abiraterone Medical Valley is taken together with a medicine called prednisone or prednisolone. You must take prednisone or prednisolone as directed by your doctor.
Prednisone or prednisolone should be taken daily during treatment with Abiraterone Medical Valley.
The amount of prednisone or prednisolone taken may be adjusted if necessary. Your doctor will inform you if a change in dose of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines to patients taking Abiraterone Medical Valley
and prednisone or prednisolone.
Taking more Abiraterone Medical Valley than prescribed
If you take more medicine than you should, contact your doctor immediately or go to hospital.
Missing a dose of Abiraterone Medical Valley

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

Stopping Abiraterone Medical Valley
Do not stop taking Abiraterone Medical Valley 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 they do not occur in everyone.
The patient should stop taking Abiraterone Medical Valley and immediately contact a doctor if any of the following symptoms occur:

Muscle weakness, muscle tremors (trembling), or heart palpitations. These may be symptoms of low potassium levels in the blood.

Additional adverse reactions include:
Very common (may affect more than 1 in 10 people):
Swelling of the legs or feet, low potassium levels in the blood, increased liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may affect up to 1 in 10 people):
High levels of fats in the blood, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat, severe infection – sepsis, bone fractures, indigestion, blood in the urine, rash.
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 1,000 people):
Lung inflammation (also known as allergic alveolitis).
Liver failure (also known as acute liver failure).
Frequency not known (frequency cannot be estimated from the available data):
Heart attack, changes in ECG (QT interval prolongation), and severe allergic reactions with 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 Medical Valley in combination with prednisone and prednisolone may worsen this effect.

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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 to provide more information on the safety of the medicine.

5. How to store Abiraterone Medical Valley

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. The expiry date refers to the last day of the specified month.
There are no special storage instructions 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 help protect the environment.

6. Contents of the pack and other information

What Abiraterone Medical Valley contains

The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate, equivalent to 446 mg of abiraterone.
The other ingredients are: sodium croscarmellose, monohydrate lactose, sodium lauryl sulphate, hypromellose 2910, microcrystalline cellulose (silicated), anhydrous colloidal silicon dioxide, magnesium stearate (see section 2 "Abiraterone Medical Valley contains lactose and sodium"). The tablet coating contains polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Abiraterone Medical Valley looks like and contents of the pack

Abiraterone Medical Valley tablets are oval, red-beige, film-coated tablets with the imprint "500" on one side.
Each 30-day cardboard box contains 60 film-coated tablets.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Email: [email protected]

Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
C/ La Vallina s/n
24193 - Villaquilambre, León
Spain

Laboratorios Liconsa, S.A.
Av. Miralcampo 7
19200 Azuqueca de Henares, Guadalajara
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Abirateron Medical Valley
Finland Abirateron Medical Valley 500 mg film-coated tablets
Iceland Abirateron Medical Valley 500 mg film-coated tablets
Netherlands Abirateron Xiromed 500 mg film-coated tablets
Germany Abirateron AXiromed 500 mg film-coated tablets
Norway Abirateron Medical Valley
Poland Abiraterone Medical Valley
Sweden Abirateron Medical Valley 500 mg film-coated tablets
Italy Abiraterone Medical Valley 500 mg film-coated tablets