Bicalutamide 50 Mg Film-Coated Tablets
PACKAGE LEAFLET
/.../ 50 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 is it used for
/.../ is used for the treatment of advanced prostate carcinoma. It is taken together with a drug known as a luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormone treatment - or with accompanying surgical removal of the testicles.
/.../ is one of a group of medicines known as the non-steroidal antiandrogens. The active substance bicalutamide blocks the undesired effect of the male sex hormones (androgens) and inhibits cell growth in the prostate in this way.
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 take terfenadine (for hay fever or allergy), astemizol (for hay fever or allergy) or cisaprid (for stomach disorders).
/.../ should not be given to women or to children and adolescents.
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.
- if you have diabetes and you are also receiving additional homone treatment for your prostate cancer: your doctor may wish to check your blood glucose levels.
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 take 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):
- reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
- dizziness
- tender or enlarged breast tissue.
- impotence.
- hot flushes
- abdominal pain
- constipation
- nausea (feeling sick)
- blood in the urine
- feeling weak
- swelling (oedema).
Common side effects (affecting less than 1 in 10 people):
- diarrhoea.
- dyspepsia (indigestion)
- flatulence (wind)
- difficulty in sleeping (insomnia)
- drowsiness (somnolence)
- skin rash
- dry skin
- itching (pruritus)
- sweating
- excessive body hair.
- weight gain.
- diabetes mellitus.
- general pain, chest pain, pelvic pain.
- chills.
- blood tests which show changes in the way the liver is working.
- hair loss
- erection problems
- loss of appetite
- reduced sexual desire
- depression
- heart failure or heart attack (which may be fatal).
- liver problems (symptoms include feeling/being sick, abdominal pain, loss of appetite, diarrhoea, feeling tired/weak)
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
- nettle rash (hives)
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 (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. Contents of the pack and other information What /.../ contains
- The active substance is bicalutamide. Each tablet contains 50 mg bicalutamide.
- The other ingredients are:
Tablet core: Silica, colloidal anhydrous, Magnesium stearate, Povidone-K30, Sodium starch glycolate (Type A), Lactose monohydrate.
Tablet coating: Opadry II 33G28523 White (Triacetin, Macrogol 3350, Lactose monohydrate, Titanium dioxide (E171), Hypromellose).
What /.../ looks like and contents of the pack
White or almost white, round, biconvex film-coated tablet, with engraved sign „L” on one side, and „RG” on the other side.
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 medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Bica-Q 50 mg Filmtabletten
United Kingdom: Bicalutamide 50 mg Tablets
This leaflet was last revised in MM/YYYY.
<{To be completed nationally}>
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