TUPRAT 250 mg Film-Coated Tablets

Зміст інструкції

1. TUPRAT 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is TUPRAT and what it is used for
   2. What you need to know before you take TUPRAT
   3. How to take TUPRAT
   4. Possible side effects
   5. How to store TUPRAT
   6. Package Contents and Other Information

TUPRAT 250 mg film-coated tablets, 500 mg film-coated tablets

Abiraterone acetate
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is TUPRAT and what it is used for

TUPRAT contains a medicine called abiraterone acetate. It is used for the treatment of prostate cancer in adult men that has spread to other parts of the body. TUPRAT stops the production of testosterone by the body; this may slow the growth of prostate cancer.
When TUPRAT is prescribed in the early stages of the disease, which still responds to hormonal therapy, it is used with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe you another medicine called prednisone or prednisolone. This medicine is used to reduce the possibility of having high blood pressure, too much water in the body (fluid retention), or reduced levels in the blood of a chemical substance known as potassium.

2. What you need to know before you take TUPRAT

Do not take TUPRAT

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6);
• if you are a woman, especially if you are pregnant. The use of abiraterone is only indicated in men.
• if you have severe liver damage.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above conditions apply to you. If you have any doubts, ask your
doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told that you have high blood pressure or heart failure or low potassium levels in your blood (a low potassium level can increase the risk of heart rhythm problems)
• if you have had other problems with your heart or blood vessels
• if you have an irregular or fast heartbeat
• if you are short of breath
• if you have rapidly gained weight
• if you have swelling of your feet, ankles or legs
• if you have taken a medicine called ketoconazole in the past for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about the possible effects on bones
• if you have high blood sugar levels.

Tell your doctor if you have been told that you have any heart or blood vessel problems, including problems with your
heart rhythm (arrhythmia) or if you are being treated for these conditions.
Tell your doctor if you have yellowing of the skin or eyes, dark-colored urine, or severe nausea or vomiting
as these could be signs or symptoms of liver problems. Rarely, a
liver function problem (called acute liver failure) can occur, which can lead to death.
A decrease in red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain may occur.
Abiraterone should not be given in combination with Ra-223 due to a possible increased risk of
fractures or death.
If you think you are going to take Ra-223 after treatment with abiraterone and prednisone/prednisolone, you should wait 5
days before starting treatment with Ra-223.
If you are unsure whether any of the above points apply to you, ask your doctor or
pharmacist before taking this medicine.

Blood monitoring
Abiraterone can have effects on the liver and you may not experience any symptoms. When you take this
medicine, your doctor will periodically perform blood tests to check for any effects of
abiraterone on your liver.

Children and adolescents
The use of this medicine is not indicated in children and adolescents. If abiraterone is accidentally
ingested by a child or adolescent, go to the hospital immediately and bring the package
leaflet with you to show to the emergency room doctor.

Other medicines and TUPRAT
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is important because abiraterone can increase the effects of some medicines including
medicines for the heart, tranquillizers, some medicines for diabetes, herbal medicines (e.g. St John's wort) and others. Your doctor may decide to change the dose of these medicines. Also, some
medicines can increase or decrease the effects of abiraterone. This can lead to unwanted effects,
or abiraterone may not work as well as it should.
Androgen deprivation therapy can increase the risk of heart rhythm problems. Tell 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 part of detoxification from drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

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

TUPRAT with food

• This medicine should not be taken with food (see section 3 “How to take this medicine”).
• Taking TUPRAT with food can cause unwanted effects.

Pregnancy and breastfeeding
The use of TUPRAT is not indicated in women.

• This medicine can cause harm to the unborn child if taken by a pregnant woman.
• If you have sexual intercourse with a woman of childbearing potential, you must use a condom and anothereffective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom to protect the fetus.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate tools or machines.

TUPRAT contains lactose and sodium

• TUPRAT contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’

3. How to take TUPRAT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.

How much to take
The recommended dose is 1,000 mg (four tablets/two tablets) once a day.

Taking this medicine
Take this medicine by mouth.

• Do not take TUPRAT with food.
• Take TUPRAT at least one hour before or at least two hours after a meal(see paragraph 2 “TUPRAT with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• TUPRAT is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone following exactly the instructions of your doctor.
• You must take prednisone or prednisolone every day while taking TUPRAT.
• It may be necessary to change the amount of prednisone or prednisolone, in emergency cases. Your doctor will inform you if you need to change the amount of prednisone or prednisolone you are taking. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

The doctor may also prescribe you other medicines while you take TUPRAT and prednisone or prednisolone.

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

If you forget to take TUPRAT

• If you forget to take TUPRAT or prednisone or prednisolone, take the usual dose the next day.
• If you forget to take TUPRAT or prednisone or prednisolone for more than one day, talk to your doctor without waiting too long.

If you stop taking TUPRAT
Do not stop taking TUPRAT or prednisone or prednisolone unless your doctor tells you to.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Stop taking TUPRAT and contact your doctor immediately if you experience any of the following
side effects:

• Muscle weakness, muscle spasms or a feeling of a 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 in the legs or feet, low potassium levels in the blood, increased values in liver function tests,
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 heartbeat (atrial fibrillation), heart failure,
fast heartbeat, a serious infection called sepsis, bone fractures, indigestion, blood in the urine, rash.

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

Rare(may affect up to 1 in 1,000)
Lung irritation (also called allergic alveolitis).
Problems with liver function (also called acute liver failure).

Not known(frequency cannot be estimated from available data):
Heart attack, changes in the ECG - electrocardiogram (prolongation of the QT interval) and severe
allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or an itchy
rash.
Bone loss may occur in men treated for prostate cancer. TUPRAT in combination
with prednisone or prednisolone may increase bone loss.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 TUPRAT

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the pack 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 in waste water 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 TUPRAT contains

• The active ingredient is abiraterone acetate. Each tablet contains 250 mg or 500 mg of abiraterone acetate.
• The other ingredients are: Tablet: Croscarmellose sodium, Sodium lauryl sulfate, Povidone (E1201), Microcrystalline cellulose (E460), Lactose monohydrate, Anhydrous colloidal silica (E551), Magnesium stearate (E470b) (see section 2 “TUPRAT contains lactose and sodium”). Coating: Polyvinyl alcohol (E1203), Titanium dioxide (E171), Macrogol (E1521), Talc (E553b), Only for 500 mg:Red iron oxide (E172), Black iron oxide (E172)

Description of the appearance of TUPRAT and package contents

• TUPRAT tablets are film-coated tablets, oval in shape, from white to off-white in color, with “250” imprinted on one side.
• TUPRAT tablets are film-coated tablets, oval in shape, purple in color, with “500” imprinted on one side.
• The tablets are supplied in
• 250 mg:
• blisters made of aluminum-OPA/Alu/PVC or aluminum-PVC/PE/PVDC containing 120 film-coated tablets.
• 500 mg: blisters made of aluminum-OPA/Alu/PVC or aluminum-PVC/PE/PVDC containing 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Nextad Pharma S.r.l.
Via Giuseppe Gioachino Belli 86
00193 Roma

Manufacturer
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate
3056 Limassol, Cyprus

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Italy TUPRAT