Bicalutamide 150mg Film-Coated Tablets
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PACKAGE
USER
Bicalutamide
Bicalutamide
LEAFLET: INFORMATION FOR THE
150 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.
What is in this leaflet:
1. What Bicalutamide 150 mg is and what it is used for
2. What you need to know before you take
Bicalutamide 150 mg
3. How to take Bicalutamide 150 mg
4. Possible side effects
5. How to store Bicalutamide 150 mg
6. Contents of the pack and other information
1. What Bicalutamide 150 mg is and what it is used for
Bicalutamide 150 mg can be used alone but can also be given as part of a combination treatment to patients that have had their prostate removed. Additionally in combination with radiation therapy for the treatment of prostate cancer, whereby the cancer has spread from the capsule of the prostate gland to the close surrounding tissue. These patients are at high risk for the cancer to spread.
The active ingredient of Bicalutamide 150 mg, bicalutamide, belongs to a group of medicines called non-steroidal anti-androgens. It blocks the undesired effect of a chemical made by a male sex gland (androgens) and inhibits cell growth in the prostate in this way.
2. What you need to know before you take Bicalutamide 150 mg
Do not take Bicalutamide 150 mg
- if you are allergic to bicalutamide or any of the other ingredients of this medicine(listed in section 6)
- if you are already taking terfenadine or astemizole (for hay fever or allergy), or cisapride (for stomach disorders).
Bicalutamide 150 mg should not be taken by women
or must not be given to children or 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 considered possible benefits and risks. If this is the case, your doctor will regularly perform tests of liver function. 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 your blood still shows high levels of a certain protein used to detect prostate cancer and the disease is still getting worse, bicalutamide treatment may need to be stopped.
- if you have diabetes and are already taking a “LHRH analogue”. These include goserelin, buserelin, leuprorelin and triptorelin.
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 Bluefish if you are already taking any of the following medicines:
- terfenadine or astemizole (for hay fever or allergy)
- cisapride (for stomach disorders)
If you take Bicalutamide 150 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 150 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 150 mg with food and drink
Bicalutamide 150 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 150 mg is contra-indicated in females and must not be given to pregnant or breast-feeding mothers.
Bicalutamide 150 mg may induce a period of subfertility or infertility in man.
Driving and using machines
Bicalutamide 150 mg is unlikely to adversely affect your ability to drive a car or to operate machinery. However, some people may occasionally feel dizzy or drowsy after taking Bicalutamide 150 mg. 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 150 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.
3. How to take Bicalutamide 150 mg
Always use Bicalutamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is one tablet once daily. Read the instruction label on the package.
It is better to take the tablet at the same time everyday. The film-coated tablet should be swallowed whole
with some water or another liquid without being
chewed and can be taken with or without food.
Use in children and adolescents:
This medicine is not recommended for patients under the age of 18 years.
If you take more Bicalutamide 150 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 150 mg
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 are worried, ask your doctor or pharmacist for advice.
If you stop taking Bicalutamide 150 mg
Do not stop using the drug even if you feel healthy unless so advised by your doctor.
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4. Possible side effects
350 mm
5. How to store Bicalutamide 150 mg
6. Contents of the pack and other information
This medicinal Member States names:
Austria
Czech Republic
Denmark
Finland
Germany
Hungary
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
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.
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:
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.
• Pain in your abdomen
• Blood in your urine
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)
• Skin rash
• Swelling and tenderness of your breasts
• Feeling weak
Common (affects less than 1 in 10 people)
• Hot flushes
• Feeling sick (nausea)
• 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
• Chills, general pain and pelvic pain
• Itching
• Dry skin
• Problems getting an erection (erectile dysfunction)
• Putting on weight
• Reduced sex drive and reduced fertility
• Hair loss
• Hair re-growth or growth of extra hair
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale
• Loss of appetite
• Depression
• Feeling sleepy
• Indigestion
• Dizziness
• Constipation
• Wind (flatulence)
• Chest pain
• Swelling
• 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)
• 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.
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 150 mg contains
- The active substance is bicalutamide. Each film-coated tablet contains 150 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 150 mg looks like and contents of the pack
Bicalutamide 150 mg is supplied as white, round, biconvex film-coated tablets with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal parts.
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
product is authorised in the of the EEA under the following
Bicalutamid Bluefish 150 mg Filmtabletten
Bicalutamid Bluefish 150 mg Potahovanych tablet Bicalutamid Bluefish 150 mg Filmovertrukne tabletter Bicalutamid Bluefish 150 mg Kalvopaallysteista tablettia Bicalutamid Bluefish 150 mg Filmtabletten
Bicalutamid Bluefish 150 mg Filmtabletta
Bicalutamide Bluefish 150 mg Compresse rivestite con film Bicalutamide Bluefish 150 mg Filmomhulde tabletten Bicalutamid Bluefish 150 mg Filmdrasjerte tabletter Bicalutamida Bluefish 150 mg Comprimidos recubiertos con pelicula EFG
Bicalutamid Bluefish 150 mg Filmdragerade tabletter Bicalutamide 150 mg film-coated tablets
This leaflet was last revised in {1/2015}.
Occasionally, Bicalutamide 150 mg may be associated with changes in your blood, which may require your doctor to do certain blood tests.
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