Bicalutamide 150 Mg Film-Coated Tablets
PACKAGE LEAFLET
Package leaflet: Information for the user
/.../ 150 mg film-coated tablets
bicalutamide
Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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:
1. What /.../ is and what it is used for
2. What you need to know before you take /.../
3. How to take /.../
4. Possible side effects
5. How to store /.../
6. Contents of the pack and other information
1. What /.../ is and what it is used for
/.../ is indicated either alone or in combination with surgical removal of the prostate gland or radiotherapy in patients with locally advanced prostate cancer at high risk of disease progression.
Bicalutamide is a substance with antiandrogenic effects, which binds to the androgen receptors and thus interferes with some of the actions of the male sex hormones.
2. What you need to know before you take /.../
Do not take /.../
- if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
- if you are taking terfenadine (for hay fever or allergy), astemizole (for hay fever or allergy) or cisapride (for stomach disorders)
Women or children shall not take /.../.
Warnings and precautions
Talk to your doctor or pharmacist before taking /.../:
- if your liver function is moderately or severely impaired. The drug should then only be taken after your doctor has carefully considered possible benefits and risks. If this is the case, your doctor will regularly perform tests of liver function (bilirubin, transaminases, alkaline phosphatase). If severe disturbances to liver function develop, treatment with /.../ should be discontinued.
- if your renal functions is severely impaired. The drug should then only be taken after your doctor has carefully considered possible benefits and risks.
- if you suffer from heart disease. If this is the case, your doctor should regularly monitor your heart function.
Please tell your doctor if you have any of the following:
Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using /.../.
Other medicines and /.../
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
/.../ may not be used together with any of the following medicines:
- terfenadine or astemizole (for hay fever or allergy)
- cisapride (for stomach disorders)
If you take /.../ together with one of the following medicines, the effect of bicalutamid as well as the other medicine may be influenced. Please speak to your doctor before taking any of these medicines together with /.../:
- warfarin or any similar medicine to prevent blood clots
- ciclosporin (used to supress the immune system to prevent and treat rejection of a transplanted organ or bone marrow)
- cimetidine (to treat stomach ulcers)
- ketoconazole (used to treat fungal infections of the skin and nails)
- Ca-channel-blockers (to treat high blood pressure)
/.../ might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs(e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
/.../ with food and drink
Take one tablet of bicalutamide, preferably at the same time of the day with or without food.
Pregnancy and breast-feeding
/.../ is contra-indicated in females.
Women shall not take /.../.
Driving and using machines
There is a possibility that these tablets could make you feel dizzy or drowsy. If you are affected in this way, you should not drive or operate machinery.
/.../ contains lactose
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take /.../
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The doctor prescribes an appropriate dosage for you personally. The recommended dose is one tablet once daily. Read the instruction label on the package.
Tablets are swallowed whole with some liquid. Try to take the medicinal product approximately at the same time each day.
If you take more /.../ than you should
If you have taken too many tablets contact your doctor or the nearest hospital as soon as possible. Take with you the remaining tablets or the pack so the doctor can identify what you have taken.
If you forget to take /.../
If you forget to take your daily dose, skip it when you remember it and wait until the next administration time. Do not take a double dose to make up for a forgotten dose.
If you stop taking /.../
Do not stop using the drug even if you feel healthy unless so advised by your doctor.
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.
You should contact your doctor straight away if you notice any of the following serious side effects:
Uncommon serious side effects (affecting less than 1 in 100 people):
- Serious allergic reaction which causes swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing or breathing or severe itching of the skin with raised lumps.
- Serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever. Some patients taking /.../ get an inflammation of the lungs called interstitial lung disease.
Rare serious side effects (affecting less than 1 out of 1,000 people):
- Yellowing of the skin or whites of the eyes caused by liver problems (including liver failure). Other side effects:
Tell your doctor if any of the following side effects bother you:
Very common side effects (affecting more than 1 in 10 people):
- skin rash
- tender or enlarged breast tissue
- impotence
- feeling weak
Common side effects (affecting less than 1 in 10 people):
- nausea (feeling sick)
- diarrhoea or constipation
- indigestion, flatulence (wind)
- abdominal pain
- dizziness
- drowsiness
- difficulty in sleeping
- hot flushes
- hair loss
- dry skin
- itching
- sweating
- excessive body hair
- blood in the urine
- reduced sexual desire
- erection problems
- loss of appetite
- weight gain
- diabetes mellitus
- swelling (oedema)
- chest pain, general pain, pelvic pain
- chills
- depression
- liver problems (symptoms include feeling/being sick, abdominal pain, loss of appetite, diarrhoea, feeling tired/weak)
- blood tests which show changes in the way the liver is working
- reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
Uncommon side effects (affecting less than 1 in 100 people):
- weight loss
- high blood sugar
- shortness of breath
- dry mouth,
- needing to urinate during the night
- headache, back pain, neck pain.
Rare side effects (affecting less than 1 in 1000 people):
- vomiting
- liver failure (which may be fatal)
Very rare side effects (affecting less than 1 in 10,000 people):
- chest pain and heart failure (which may be associated with breathlessness, especially on exertion, a fast heart beat, swelling in the limbs and mottling of the skin), irregular heart beat, abnormal ECG heart tracing
- reduction in blood platelets which increases risk of bleeding or bruising.
Not known (frequency cannot be estimated from the available data):
- Changes in ECG (QT prolongation)
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store /.../
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 container. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
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 protect the environment.
6. Content of the pack and other information
What /.../ contains
- The active substance is bicalutamide.
- The other ingredients are
Tablet core: Lactose monohydrate, Sodium starch glycolate (type A), Povidone-K30, Silica, colloidal anhydrous, Magnesium stearate
Film-coating: Opadry II. White 33G28523 (Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Macrogol 3350, Triacetin
What /.../ looks like and contents of the pack
White, or almost white, round, biconvex film-coated tablet, with engraved sign “XL” on one side and “RG” on the other side.
Packaging: 10, 14, 20, 28; 30; 40; 50; 56, 80, 84; 90; 100; 140, 200, 280 film-coated tablets in blister packs (PVC/PVDC/aluminium foil).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
<{To be completed nationally}>
Manufacturer:
Gedeon Richter Plc.
1103 Budapest Gyomroi ut 19-21 Hungary
Names and addresses of manufacturers responsible for batch release in the EEA:
Gedeon Richter Plc.
1103 Budapest Gyomroi ut 19-21 Hungary
Juta Pharma GmbH,
Gutenbergstrasse 13;
24941 Flensburg - Germany
This leaflet was last revised in MM/YYYY.
<{To be completed nationally}>