Bicalutamide 50mg Film-Coated Tablets.
PACKAGE
USER
Bicalutamide
Bicalutamide
LEAFLET: INFORMATION FOR THE
50 mg film-coated tablets
PHARMACEUTICALS
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.
1. What Bicalutamide 50 mg is and what it is used for
2. What you need to know before you take Bicalutamide 50 mg
3. How to take Bicalutamide 50 mg
4. Possible side effects
5. How to store Bicalutamide 50 mg
6. Contents of the pack and other information
Bicalutamide is used for the treatment of advanced prostate carcinoma. It is taken together with a drug known as a luteinising hormone-releasing hormone (LHRH) analogue which reduces the levels of androgens (male sex hormones) within the body, or with accompanying surgical removal of the testicles.
Bicalutamide 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.
Do not take Bicalutamide 50 mg
- 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), astemizole (for hay fever or allergy) or cisapride (for stomach disorders).
Bicalutamide should not be taken by women or must not be given to children and adolescents.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide
if your liver function is moderately or severely impaired. The drug should then only be taken after your doctor has carefully cons idered pos sible 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 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 are already taking a “LHRH analogue”. These include goserelin, buserelin, leuprorelin and triptorelin.
If you take Bicalutamide 50 mg 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.
- warfarin or any similar medicine to prevent blood clots,
- cyclosporin (used to suppress your immune system to prevent and treat rejection of a transplanted organ or bone marrow),
- calcium channel blockers (used to treat high blood pressure or some heart conditions)
- cimetidine (used to treat stomach ulcers),
- ketoconazole (used to treat fungal infections of the skin and nails).”
- midazolam (used e.g. for preoperative sedation)
Bicalutamide 50 mg with with food and drink
Bicalutamide 50 mg can be taken before, during or after a meal, but also you can take them without food. The film coated tablet should be swallowed with some water or another liquid.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Bicalutamide 50 mg is contra-indicated in females and must not be given to pregnant or breast-feeding mothers.
Driving and using machines
Bicalutamide 50 mg is unlikely to affect your ability to drive or to operate machinery.
However, some people may occasionally feel drowsy when taking Bicalutamide 50 mg. If this happens to you, you should exercise caution when carrying out such tasks. If you suffer from dizziness or drowsiness you would be best advised not to carry out such tasks. However if you still drive a car or use machines you should exercise extra caution.
Bicalutamide 50 mg contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor immediately.
Always use Bicalutamide 50 mg 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 onefilm-coated 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.
Use in children and adolescents:
This medicine is not recommended for patients under the age of 18 years.
If you take more Bicalutamide 50 mg 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
If you forget to take your daily dose, skip it when you remember it and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you are worried, ask your doctor or pharmacist for advice.
Other medicines and Bicalutamide
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Do not take Bicalutamide if you are already taking any of the following medicines:
- terfenadine or astemizole (for hay fever or allergy)
- cisapride (for stomach disorders)
If you stop taking Bicalutamide 50 mg
Do not stop taking your film-coated tablets 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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5. How to store Bicalutamide 50 mg
6. Contents of the pack and other information
Denmark
Finland
Germany
Hungary
Italy
Netherlands
Norway
Spain
Sweden
Serious side effects:
You should contact your doctor straight away if you notice any of the following serious side effects:
Uncommon (affect less than 1 in 100 people):
• Rash, itching or hives on the skin.
• Swelling of the face, lips, tongue, throat or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
If this happens to you, see a doctor straight away. Also tell your doctor straight away if you notice any of the following:
Very common (affects more than 1 in 10 people):
• Pain in your abdomen.
• Blood in your urine.
Common (affects less than 1 in 10 people):
• Yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver problems or in rare cases (affects less than 1 in 1,000 people) liver failure.
Uncommon (affects less than 1 in 100 people):
• Serious shortness of breath or shortness of breath which suddenly gets worse. This may be with a cough or high temperature (fever). These may be signs of an inflammation of the lungs called ‘interstitial lung disease’.
Other possible side effects:
Very common (affects more than 1 in 10 people)
• Dizziness
• Constipation
• Feeling sick (nausea)
• Tender or enlarged breast tissue.
• Feeling week
• Swelling
• Hot flushes.
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
Common (affects less than 1 in 10 people)
• Loss of appetite
• Sleeplessness
• Diarrhoea
• Having frequent loose or liquid bowel movements disturbances in the function of the liver (elevated levels of liver enzymes due to interruption in the excretion of bile [choestasis]), enlarged liver.
• Sweating
• Reduced sex drive and reduced fertility
• Chills, general pain and pelvic pain
• Depression
• Feeling sleepy
• Indigestion
• Wind (flatulence)
• Hair loss
• Hair re-growth or growth of extra hair
• Dry skin
• Itching
• Skin rash
• Problems getting an erection (erectile dysfunction)
• Weight gain
• Chest pain
• Reduced heart function
• Heart attack
• Diabetes mellitus
Uncommon (affects less than 1 in 100 people)
• Hyperglycaemia (high blood sugar levels)
• Shortness of breath (dyspnoea)
• Dry mouth
• Needing to urinate during the night
• Back pain
• Neck pain
• Headache
• Weight loss
Rare (affects less than 1 in 1000 people)
• Increased skin sensitivity to sunlight.
• Vomiting
Very rare (affects 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.
Occasionally, Bicalutamide 50 mg may be associated with changes in your blood, which may require your doctor to do certain blood tests.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of
children. This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
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.
What Bicalutamide 50 mg contains
- The active substance is bicalutamide. Each film-coated tablet contains 50 mg bicalutamide.
Tablet core:
The other ingredients are: Lactose monohydrate, Povidone K- 25, Sodium starch glycolate (Type A), Magnesium Stearate.
Film coating
Opadry OY-S-9622 which contains Hypromellose 5cp (E464), Titanium dioxide (E171) and Propylene Glycol.
What Bicalutamide 50 mg looks like and contents of the pack
Bicalutamide 50 mg is supplied as white, round, biconvex film-coated tablets. The tablets are packed in blister packs containing 14, 28, 30, 90,
98, 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
Torsgatan 11, SE-111 23 Stockholm, Sweden
Manufacturer
Genepharm S.A.
18th klm Marathonos Avenue 153 51 Pallini Attikis Greece
Medical information
For UK residents only: if you have any questions or would like more information, call our Medical Information Department on 0808 178 9241.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Bicalutamid Bluefish 50 mg
Filmtabletten
Czech Republic Bicalutamid Bluefish 50 mg Potahovanych tablet Bicalutamid Bluefish 50 mg Filmovertrukne tabletter Bicalutamid Bluefish 50 mg Kalvopaallysteista tablettia Bicalutamid Bluefish 50 mg Filmtabletten
Bicalutamid Bluefish 50 mg Filmtabletta
Bicalutamide Bluefish 50 mg Compresse rivestite con film Bicalutamide Bluefish 50 mg Filmomhulde tabletten Bicalutamid Bluefish 50 mg Filmdrasjerte tabletter Bicalutamida Bluefish 50 mg Comprimidos recubiertos con pehcula EFG
Bicalutamid Bluefish 50 mg Filmdragerade tabletter United Kingdom Bicalutamide 50 mg film-coated tablets
This leaflet was last revised in {1/2015}.
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