Patient leaflet - ABIRATERONE FRESENIUS KABI 250 MG TABLETS
Abiraterone Fresenius Kabi 250 mg tablets Abiraterone Fresenius Kabi 500 mg film-coated tablets
abiraterone acetate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Abiraterone Fresenius Kabi is and what it is used for
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2. What you need to know before you take Abiraterone Fresenius Kabi
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3. How to take Abiraterone Fresenius Kabi
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4. Possible side effects
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5. How to store Abiraterone Fresenius Kabi
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6. Contents of the pack and other information
1. what abiraterone fresenius kabi is and what it is used for
Abiraterone Fresenius Kabi contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. Abiraterone Fresenius Kabi stops your body from making testosterone; this can slow the growth of prostate cancer.
When Abiraterone Fresenius Kabi is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy).
When you take this medicine your doctor will also prescribe another medicine called prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood.
2. what you need to know before you take abiraterone fresenius kabi
Do not take Abiraterone Fresenius Kabi:
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– if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
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– if you are a woman, especially if pregnant. Abiraterone Fresenius Kabi is for use in male patients only.
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– if you have severe liver damage.
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– in combination with Ra-223 (which is used to treat prostate cancer).
effects of a number of medicines including heart medicines, tranquilisers, some medicines for diabetes, herbal medicines (e.g., St John’s wort) and others. Your doctor may want to change the dose of these medicines. Also, some medicines may increase or decrease the effects of Abiraterone Fresenius Kabi. This may lead to side effects or to Abiraterone Fresenius Kabi not working as well as it should.
Androgen deprivation treatment may increase the risk of heart rhythm problems. Tell your doctor if you are receiving medicine
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– used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);
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– known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].
Tell your doctor if you are taking any of the medicines listed above.
Abiraterone Fresenius Kabi with food
This medicine must not be taken with food (see section 3, “Taking this medicine”).
Taking Abiraterone Fresenius Kabi with food may cause side effects.
Pregnancy and breast-feeding
Abiraterone Fresenius Kabi is not for use in women.
Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle Abiraterone Fresenius Kabi.
This medicine may cause harm to the unborn child if it is taken by women who are pregnant.
If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method.
If you are having sex with a pregnant woman, use a condom to protect the unborn child.
Driving and using machines
This medicine is not likely to affect your being able to drive and use any tools or machines.
Abiraterone Fresenius Kabi contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Abiraterone Fresenius Kabi 250 mg tablets
This medicine contains less than 1 mmol sodium (23 mg) per dose of four 250 mg tablets, that is to say essentially ‘sodium-free’.
Abiraterone Fresenius Kabi 500 mg film-coated tablets
This medicine contains 24 mg of sodium (main component of cooking/table salt) in each dose of two 500 mg tablets. This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.
3. how to take abiraterone fresenius kabi
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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Do not take this medicine if any of the above apply to you.
If you are not sure, talk to 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
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– if you have been told you have high blood pressure or heart failure or low blood potassium (low blood potassium may increase the risk of heart rhythm problems)
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– if you have had other heart or blood vessel problems
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– if you have an irregular or rapid heart rate
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– if you have shortness of breath
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– if you have gained weight rapidly
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– if you have swelling in the feet, ankles, or legs
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– if you have taken a medicine known as ketoconazole in the past for prostate cancer
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– about the need to take this medicine with prednisolone
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– about possible effects on your bones – if you have high blood sugar.
Tell your doctor if you have been told you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
Tell your doctor if you have yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.
Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
Abiraterone Fresenius Kabi must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.
If you plan to take Ra-223 following treatment with Abiraterone Fresenius Kabi and prednisolone, you must wait 5 days before starting treatment with Ra-223.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Blood monitoring
Abiraterone Fresenius Kabi may affect your liver, and you may not have any symptoms. When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver.
Children and adolescents
This medicine is not for use in children and adolescents. If Abiraterone Fresenius Kabi is accidentally ingested by a child or adolescent, go to the hospital immediately and take the package leaflet with you to show to the emergency doctor.
Other medicines and Abiraterone Fresenius Kabi
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 Fresenius Kabi may increase the
How much to take
The recommended dose is 1,000 mg (four tablets of 250 mg or two tablets of 500 mg) once a day.
Taking this medicine
Take this medicine by mouth.
Do not take Abiraterone Fresenius Kabi with food.
Take Abiraterone Fresenius Kabi at least one hour before or at least two hours after eating (see section 2, “Abiraterone Fresenius Kabi with food”).
Swallow the tablets whole with water.
Do not break the tablets.
Abiraterone Fresenius Kabi is taken with a medicine called prednisolone. Take the prednisolone exactly as your doctor has told you.
You need to take prednisolone every day while you are taking Abiraterone Fresenius Kabi.
The amount of prednisolone you take may need to change if you have a medical emergency. Your doctor will tell you if you need to change the amount of prednisolone you take. Do not stop taking prednisolone unless your doctor tells you to.
Your doctor may also prescribe other medicines while you are taking Abiraterone Fresenius Kabi prednisolone.
If you take more Abiraterone Fresenius Kabi than you should
If you take more than you should, talk to your doctor or go to a hospital immediately.
If you forget to take Abiraterone Fresenius Kabi
If you forget to take Abiraterone Fresenius Kabi or prednisolone, take your usual dose the following day.
If you forget to take Abiraterone Fresenius Kabi or prednisolone for more than one day, talk to your doctor without delay.
If you stop taking Abiraterone Fresenius Kabi
Do not stop taking Abiraterone Fresenius Kabi or prednisolone unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Abiraterone Fresenius Kabi and see a doctor immediately if you notice any of the following:
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– Muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may be signs that the level of potassium in your blood is low.
Other side effects include:
Very common (may affect more than 1 in 10 people):
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– Fluid in your legs or feet
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– Low blood potassium
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– Liver function test increases
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– High blood pressure
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– Urinary tract infection
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– Diarrhoea
Common (may affect up to 1 in 10 people):
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– High fat levels in your blood
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– Chest pain, irregular heart beat (atrial fibrillation), heart failure, rapid heart rate
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– Severe infections called sepsis
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– Bone fractures
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– Indigestion
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– Blood in urine
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– Rash
Uncommon (may affect up to 1 in 100 people):
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– Adrenal gland problems (related to salt and water problems)
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– Abnormal heart rhythm (arrhythmia)
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– Muscle weakness and/or muscle pain
Rare (may affect up to 1 in 1,000 people):
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– Lung irritation (also called allergic alveolitis)
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– Failure of the liver to function (also called acute liver failure)
Not known (frequency cannot be estimated from the available data):
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– Heart attack, changes in ECG – electrocardiogram (QT prolongation)
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– Serious allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue or throat, or an itchy rash
Bone loss may occur in men treated for prostate cancer. Abiraterone Fresenius Kabi in combination with prednisolone may increase bone loss.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.
Website: or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help to provide more information on the safety of this medicine.
5. how to store abiraterone fresenius kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and/or HDPE bottle and/or the blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. contents of the pack and other information
What Abiraterone Fresenius Kabi contains
Abiraterone Fresenius Kabi 250 mg tablets
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– The active substance is abiraterone acetate.
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– Each tablet contains 250 mg abiraterone acetate.
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– The other ingredients are lactose monohydrate, Cellulose, microcrystalline, croscarmellose sodium, povidone, sodium laurilsulfate, silica, colloidal anhydrous and magnesium stearate.
Abiraterone Fresenius Kabi 500 mg film-coated tablets
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– The active substance is abiraterone acetate.
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– Each film-coated tablet contains 500 mg abiraterone acetate.
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– The other ingredients are lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose, sodium laurilsulfate, silica, colloidal anhydrous and magnesium stearate (tablet core); polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide red (E 172) and iron oxide black (E 172) (tablet coating).
What Abiraterone Fresenius Kabi looks like and contents of the pack
Abiraterone Fresenius Kabi 250 mg tablets
Abiraterone Fresenius Kabi 250 mg are white to off-white oval tablets, approximately 16 mm long by 9.5 mm wide and debossed with “ATN” on one side and “250” on the other side.
Each bottle pack contains one bottle with 120 tablets.
Abiraterone Fresenius Kabi 500 mg film-coated tablets Abiraterone Fresenius Kabi 500 mg are oval-shaped purple film-coated tablets, approximately 19 mm long by 11 mm wide and debossed with “A7TN” on one side and “500” on the other side.
Each blister pack contains 56, 56×1, 60 or 60×1 film-coated tablets.
Each bottle pack contains one bottle with 60 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Fresenius Kabi Deutschland GmbH
Else-Kroner-Strape 1
61352 Bad Homburg v.d.Hohe
Germany
Manufacturer
Synthon BV, The Netherlands
Microweg 22, 6545 CM Nijmegen
This leaflet was last revised in March 2021
Uk FRESENIUS I KABI
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