Bicalutamide 50 Mg Film-Coated Tablets
50 mg film-coated tablets
bicalutamide
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Bicalutamide 50 mg film-coated tablets are and what they are used for
2. Before you take Bicalutamide 50 mg film-coated tablets
3. How to take Bicalutamide 50 mg film-coated tablets
4. Possible side effects
5. How to store Bicalutamide 50 mg film-coated tablets
6. Further information
1. WHAT BICALUTAMIDE 50 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Bicalutamide 50 mg film-coated tablets are used for the treatment of advanced prostate carcinoma. They are 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.
Bicalutamide 50 mg film-coated tablets are 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. BEFORE YOU TAKE BICALUTAMIDE 50 MG FILMCOATED TABLETS
Do not take Bicalutamide 50 mg film-coated tablets:
• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of Bicalutamide 50 mg film-coated tablets.
• if you take terfenadine (for hay fever or allergy], aslemizole (for hay fever or allergy) or cisapride (for stomach disorders).
Bicalutamide 50 mg film-coated tablets should not be given to women or to children and adolescents.
Take special care with Bicalutamide 50 mg film-coated tablets:
• 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 Bicalutamide 50 mg film-coated tablets should be discontinued.
• if your renal function 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.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Bicalutamide 50 mg film-coated tablets 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 Bicalutamide 50 mg film-coated tablets together with one of the following medicines, the effect of bicalutamide as well as the other medicine may be influenced. Please speak to your doctor before taking any of these medicines together with Bicalutamide 50 mg film-coated tablets:
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)
Taking Bicalutamide 50 mg film-coated tablets 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:
Ask your doctor or pharmacist for advice before taking any medicine. Bicalutamide 50 mg film-coated tablet is contra-indicated in females. Women shall not take Bicalutamide 50 mg film-coated tablets.
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.
Important information about some of the ingredients of Bicalutamide 50 mg film-coated tablets:
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 BICALUTAMIDE 50 MG FILM-GOATED TABLETS
Always take Bicalutamide 50 mg film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The doctor prescribes an appropriate dosage for you personally. The usual 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 at approximately the same time each day.
If you take more Bicalutamide 50 mg film-coated tablets 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 Bicalutamide 50 mg film-coated tablets:
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 Bicalutamide 50 mg film-coated tablets:
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bicalutamide 50 mg film-coated tablets 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 Bicalutamide 50 mg film-coated tablets 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):
• tender or enlarged breast tissue.
• reduced sexual desire, erection problems, impotence.
• hot flushes.
Common side effects (affecting less than 1 in 10 people):
• nausea (feeling sick).
• diarrhoea or constipation.
• dizziness.
• difficulty in sleeping.
• skin rash, itching, sweating, excessive body hair.
• feeling weak.
• weight gain.
• diabetes mellitus.
• oedema.
• general pain, pelvic pain.
• chills.
• 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):
• loss of appetite, weight loss.
• depression.
• high blood sugar.
• drowsiness.
• shortness of breath.
• dry mouth, indigestion, flatulence (wind).
• hair loss.
• needing to urinate during the night, blood in the urine.
• abdominal pain, chest pain, headache, back pain, neck pain.
Rare side effects (affecting less than 1 in 1000 people):
• vomiting.
• dry skin.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE BICALUTAMIDE 50 MG FILM-COATED TABLETS
Keep out of the reach and sight of children.
Do not use Bicalutamide 50 mg film-coated tablets 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 Bicalutamide 50 mg film-coated tablets if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Bicalutamide 50 mg film-coated tablets contain
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 (El71), Hypromellose).
What Bicalutamide 50 mg film-coated tablet 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<oated tablets in blister packs (PVC/PVDC /aluminium foil)
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Gedeon Richter Pic.
1103 Budapest Gyomroi ut 19-21 Hungary
Manufacturer:
Gedeon Richter Pic.
1103 Budapest Gyomroi ut 19-21 Hungary
Names and addresses of manufacturers responsible for batch release in the EEA:
Gedeon Richter Pic.
1103 Budapest Gyomroi ut 19-21 Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
Italy: BICALUTAMIDE DOC Generici 50 mg compresse rivestite United Kingdom: Bicalutamide 50 mg film-coated tablets