Bicalutamide 150mg Film-Coated Tablets
PAGE 1: FRONT FACE (INSIDE OF REEL)
TEVA UK Ref: 231-30-86217-Y LEA BICALUTAMIDE 150mg TAB TUK
Version: 1 23 June 2014
PAGE 2: REAR FACE (OUTSIDE OF REEL)
Pharma code 0996
(Main)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 is and what it is used for
2. What you need to know before you take Bicalutamide
3. How to take Bicalutamide
4. Possible side effects
5. How to store Bicalutamide
6. Contents of the pack and other information
OWHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR
Bicalutamide belongs to the group of anti-androgens. Anti-androgens act against the effects of androgens (male sex hormones). Bicalutamide is used in adult men for the treatment of prostate cancer without metastases, when castration or other types of treatment are not indicated or unacceptable.
It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE
Do not take Bicalutamide
• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6)
• if you are taking any medications containing terfenadine, astemizole or cisapride (see 'Other medicines and bicalutamide', below)
• if you are a woman or a child.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide:
• if you have moderately or severely impaired liver function.
Before you start taking this product, please inform your doctor if you have any disease or disorder affecting your liver function.
Other medicines and Bicalutamide
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. It is especially important to mention:
• terfenadine or astemizole (for hay fever or allergy) (see 2. 'Before you take Bicalutamide', 'Do NOT take Bicalutamide' above)
• cisapride (for stomach disorders) (see 2. 'Before you take Bicalutamide', 'Do NOT take Bicalutamide' above)
• warfarin or any similar medicine to prevent blood clots
• ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow)
• calcium channel blockers such as nifedipine or verapamil (to treat high blood pressure or some heart conditions)
• cimetidine (to treat stomach ulcers)
• ketoconazole (used to treat fungal infections of the skin and nails).
Pregnancy and breast-feeding
Women must not take Bicalutamide.
Driving and using machines
Bicalutamide is unlikely to affect your ability to drive or operate machinery. However, some people may occasionally feel drowsy or dizzy when taking it. If this happens to you, you should exercise caution when carrying out such tasks. Bicalutamide contains lactose Bicalutamide tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you take this medicinal product.
^ HOW TO TAKE BICALUTAMIDE
Always take Bicalutamide exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Unless your doctor tells you otherwise, the recommended dose is one tablet once daily. It is important that you take the tablet at the same time each day.
The tablet should be swallowed whole with some water.
Children and teenagers under 18 years of age
Children and teenagers under the age of 18 years must not take Bicalutamide.
If you take more Bicalutamide than you should:
If you take an overdose of tablets or a child swallows tablet(s) accidentally, consult your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so that the doctor will know what you have taken.
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If you forget to take Bicalutamide:
If you forget to take a tablet at the usual time, skip this dose and do not take a tablet later; wait until the correct time for the next dose and then carry on taking the medication regularly as before, according to the original dosage schedule.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Bicalutamide
Do not stop taking the medicine even if you feel absolutely healthy, unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor or seek medical help immediately if you experience any of the following:
• Serious breathlessness or sudden worsening of breathlessness, possibly with a cough or fever. You may have an inflammation of the lung called 'interstitial lung disease', which occurs in less than one in every 100 patients treated with bicalutamide.
• Severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing. You may have a serious allergic reaction to bicalutamide, which occurs in less than one in every 100 patients treated.
The following side effects may also occur:
Very common (may affect more than 1 in 10 people)
• Rash
• Breast tenderness or enlargement
• Feeling weak.
Common (may affect up to 1 in 10 people)
• Anaemia (decreased levels of red blood cells, which may be associated with tiredness, a fast heart beat and breathing rate, paleness)
• Loss of appetite or weight increased
• Haemeturia (blood in urine)
• Decreased sexual desire or problems with erection
• Depression
• Dizziness, feeling sleepy
• Hot flushes
• Abdominal pain, constipation, feeling sick (nausea), indigestion, flatulence (wind)
• Liver problems, including jaundice (yellowing of the skin or eyes) and elevated levels of liver enzymes
• Itching, dry skin, hair loss (alopecia), excessive hair growth (hirsutism)
• Chest pain, swelling.
Uncommon (may affect up to 1 in 100 people)
• Serious allergic reactions, including severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing
• Inflammation of the lungs called "interstitial lung disease"
Rare (may affect up to 1 in 1,000 people)
• Liver failure.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
^ HOW TO STORE BICALUTAMIDE
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use Bicalutamide after the expiry date which is stated on the blister and outer packaging. 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.
©CONTENTS OF PACK AND OTHER INFORMATION
What Bicalutamide contains
• The active substance is bicalutamide.
Each film-coated tablet contains 150 mg bicalutamide.
• The other ingredients are:
Core: Microcrystalline cellulose, povidone, croscarmellose sodium, sodium lauryl sulfate, lactose monohydrate, anhydrous colloidal silica, magnesium stearate Coating: Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), macrogol 4000.
What Bicalutamide looks like and contents of the pack
Bicalutamide 150 mg Film-Coated Tablets are white to off-white biconvex film-coated tablets, debossed with "BCL' on one side and plain on the other. Package sizes: 20, 28, 30, 40, 56, 60, 84, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in 06/2014
PL 00289/0981
86217-Y