Abiraterone Medical Valley

Package leaflet: Information for the user

Abiraterone Medical Valley 500 mg film-coated tablets

abiraterone acetate
Generic medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Abiraterone Medical Valley is and what it is used for
2. What you need to know before taking Abiraterone Medical Valley
3. How to take Abiraterone Medical Valley
4. Possible side effects
5. How to store Abiraterone Medical Valley
6. Contents of the pack and other information

1. What Abiraterone Medical Valley is and what it is used for

Abiraterone Medical Valley contains a medicine called abiraterone acetate. It is used in adult men to treat prostate cancer that has spread to other parts of the body. Abiraterone Medical Valley stops your body from producing testosterone; this may slow down the growth of prostate cancer.
When Abiraterone Medical Valley is prescribed in the early stage of the disease that still responds to hormone therapy, it is used together with a treatment that lowers testosterone levels (androgen deprivation therapy).
When 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 (too much fluid in the body), or low levels in the blood of a chemical substance known as potassium.

2. What you need to know before taking Abiraterone Medical Valley

Do not take Abiraterone Medical Valley

• if you are allergic to abiraterone acetate or to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if pregnant. Abiraterone Medical Valley is intended for use only in male patients.
• if you have severe liver damage.
• in combination with Ra-223 (used to treat prostate cancer).

Do not take this medicine if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Abiraterone Medical Valley:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low potassium levels in your blood (low potassium levels may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or rapid heartbeat
• if you experience shortness of breath
• if you gain weight rapidly
• if you have swelling in your feet, ankles, or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• regarding the need to take this medicine together with prednisone or prednisolone
• regarding possible effects on bones
• if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorders, including heart rhythm problems (arrhythmia), or if you are taking medicines for these conditions.

Inform your doctor if you develop yellowing of the skin or eyes, dark-colored urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, a liver function problem (called acute liver failure) may occur, which can lead to death.

Reduction in red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain may occur.

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

If you are considering taking Ra-223 after treatment with Abiraterone Medical Valley and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

Abiraterone Medical Valley may affect your liver, and you may not experience any symptoms. While taking this medicine, your doctor will periodically perform blood tests to monitor for any effects on the liver.

Children and adolescents

This medicine is not intended for use in children and adolescents. If Abiraterone Medical Valley is accidentally ingested by a child or adolescent, go immediately to the hospital and bring the package leaflet to show the emergency doctor.

Other medicines and Abiraterone Medical Valley

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Abiraterone Medical Valley may increase the effects of certain medicines, including heart medications, tranquilizers, certain diabetes medicines, herbal remedies (e.g. St. John’s wort), and others. Your doctor may decide to adjust the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone Medical Valley. This could lead to side effects or Abiraterone Medical Valley may not work as effectively as it should.

Androgen deprivation therapy may increase the risk of heart rhythm problems.

Inform your doctor if you are taking medicines

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of opioid dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform your doctor if you are taking any of the medicines listed above.

Abiraterone Medical Valley with food

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

Pregnancy and breastfeeding

Abiraterone Medical Valley is not intended for use in women.

• This medicine may harm the unborn baby if taken during pregnancy.
• Pregnant women or women who could be pregnant must wear gloves if they need to touch or handle Abiraterone Medical Valley.
• If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn baby.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate tools or machinery.

Abiraterone Medical Valley contains lactose and sodium

• Abiraterone Medical Valley contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
• This medicine contains 24 mg of sodium (a main component of table salt) per two-tablet dose. This corresponds to 1.2% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to take Abiraterone Medical Valley

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is 1,000 mg (two tablets) once daily.
How to take this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Medical Valley with food.
• Take Abiraterone Medical Valley at least one hour before or at least two hours after a meal (see section 2, “Abiraterone Medical Valley with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone Medical Valley is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You must take prednisone or prednisolone every day while you are taking Abiraterone Medical Valley.
• The dose of prednisone or prednisolone may need to be adjusted in case of a medical emergency. Your doctor will inform you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

Your doctor may also prescribe other medicines while you are taking Abiraterone Medical Valley and prednisone or prednisolone.
If you take more Abiraterone Medical Valley than you should
If you take more Abiraterone Medical Valley than you should, contact your doctor or go to hospital immediately.
If you forget to take 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, speak to your doctor immediately.

If you stop taking Abiraterone Medical Valley
Do not stop taking Abiraterone Medical Valley or prednisone or prednisolone unless your doctor tells you to.
If you have any 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 everyone experiences them.
Stop taking Abiraterone Medical Valley and contact a doctor immediately if you notice any of the following side effects:

• Muscle weakness, muscle cramps, or a sensation of pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:

Very common (may affect more than 1 in 10 people):
Fluid retention in the legs or feet, low blood potassium levels, increased liver function test values, high blood pressure, urinary tract infection, diarrhoea.

Common (may affect up to 1 in 10 people):
High levels of fats in the blood, chest pain, irregular heart rhythm (atrial fibrillation), heart failure, rapid heartbeat, severe infection called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

Uncommon (may affect up to 1 in 100 people):
Problems with the adrenal glands (related to salt and water imbalances), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

Rare (may affect up to 1 in 1,000 people):
Lung irritation (also known as allergic alveolitis). Liver function problems (also known as acute liver failure).

Not known (frequency cannot be estimated from the available data):
Heart attack, changes in the ECG (electrocardiogram) (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 tissue may occur in men being treated for prostate cancer. Abiraterone Medical Valley in combination with prednisone or prednisolone may increase bone tissue loss.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this 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 after Exp.. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Abiraterone Medical Valley contains

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are microcrystalline cellulose (silicified): composed of microcrystalline cellulose and colloidal silicon dioxide; croscarmellose sodium; hypromellose 2910; monohydrate lactose; magnesium stearate; colloidal silicon dioxide; sodium lauryl sulfate (see section 2, “Abiraterone Medical Valley contains lactose and sodium”). The coating contains black iron oxide (E 172); red iron oxide (E 172); yellow iron oxide (E 172); macrogol 3350; polyvinyl alcohol; talc; titanium dioxide (E 171).

Description of the appearance of Abiraterone Medical Valley and pack sizes

• Abiraterone Medical Valley tablets are red-beige, oval-shaped, film-coated tablets, marked with “500” on one side.
• Each 28-day pack contains 56 film-coated tablets. Each 30-day pack contains 60 film-coated tablets.

Marketing Authorization Holder
Medical Valley Invest AB
Brädgårdsvägen 28
23632 Höllviken
Sweden

Manufacturer
Laboratorios León Farma, S.A.
Poligono Industrial Navatejera
Calle La Vallina Sn 24193 - Villaquilambre, Leon.
Spain

Laboratorios Liconsa, S.A.
Avenida De Miralcampo 7,
Poligono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara,
Spain

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