Bicalutamide 150mg Film-Coated Tablets
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ArtwsTK Creative Dee inns |
Artwork No. |
121108/12 |
Colours Used | |||
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Customer |
Relon Chem |
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Balck | |||
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Description |
Bicalutamide 1 50mg Tablets Leaflet |
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Keyline (not to print) | |||
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Market |
UK | |||||
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_c |
Language |
English | ||||
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Size |
140 x 280 mm | |||||
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■jP |
Min. Font Size |
9 pt | ||||
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Page No. |
1 of 1 | |||||
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r e-mail : prasad.pdp@gmail.com Ph : +91-9845609386 |
Version No. |
11 | ||||
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Date |
11-10-16 | |||||
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Softwa re |
Illustrator 1 0 | |||||
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Packaging Development |
Quality Assurance (QA) |
Quality Control (QC) |
Production | |||
Bicalutamide 150 mg film-coated tablets.
Bicalutamide
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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 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.
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. Howto store Bicalutamide 150 mg
6. Contents of the pack and other information
1. WHAT BICALUTAMIDE I50MG 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 tne 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 I50MG
Do not take Bicalutamide 150 mg
• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of Bicalutamide 150 mg
• 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
• 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.
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Other medicines and Bicalutamide I50mg tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines, This is because Bicalutamide can affect the way other medicines work. Also some other medicines can affect the way Bicalutamide works.
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,
• terfenadine or astemizole (for hay fever or allergy),
• Cisapride (for stomach disorders),
• Ciclosporin (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).
Taking Bicalutamide 150 mg with food and drink
Bicalutamide 150 mg can be taken before, during or after a meal, but alsoyou can take them without food. The film coated tablet should be swallowed with some water or another liquid.
Pregnancy, breast-feeding and fertility
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.
Sun light or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV-light while you are taking Bicalutamide.
Bicalutamide contains lactose
Ifyou have been told by your doctor that you have an intolerance to some sugars, such as lactose, contactyour doctor immediately.
3. HOWTO TAKE BICALUTAMIDE 150 mg
Always take Bicalutamide 150 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose is one film coated tablet daily. It is better to take the tablet at the same time every day. The film coated tablet should be swallowed with some water or another liquid without being chewed and can be taken with or without food.
Children and adolescents
This medicine is not recommended for patients underthe age of I8years.
If you take more Bicalutamide 150 mg than you should
If you take more than your normal dose, contact your doctor. In the case of an overdose, contact the nearest hospital immediately. If possible, take your film-coated tablets or the box with you to show the doctor what you have taken.
Ifyou forget to take Bicalutamide 150 mg
Ifyou forget to take your medicine, take your dose when you remember 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.
Ifyou stop taking Bicalutamide 150 mg
Do not stop taking your film coated tablets, even if you are feeling well, unless your doctor tells you.
Ifyou have any further questions on the use of this product, askyour 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-you may need urgent medical treatment.
Allergic reactions (uncommon, may affect up to I in 100 people)
The symptoms can include sudden onset of:
• 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.
Also tell your doctor straight away if you notice any of the following
Common (may affect up to I in 10 people):
• Blood in urine
• Abdominal pain
• Yellowing of the skin or whites of your eyes (jaundice). These may be symptoms of liver impairment.
Uncommon (may affect up to I 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 get an inflammation of the lungs called interstitial lung disease with possible fatal outcome
Not known (frequency cannot be estimated from the available data)
• Changes in ECG (QT prolongation)
Other possible side effects:
Very common side effects (may affect more than I in 10 people):
• Rash
• Feeling weak
• Tender or enlarged breasts
Common side effects (may affect up to I in 10 people):
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale
• Decreased appetite
• Sleepiness, dizziness.
• Hot flushes.
• Nausea (feeling sick), constipation (difficulty on passing stools), indigestion, flatulence (wind).
• Itching, dryskin, lossof hairorhairre-growth.
• Weight gain
• Depression
• Chest pain, swelling
• Problems getting an erection (erectile dysfunction)
• Changes in liver enzymes
• Reduced sex drive, and reduced fertility
Rare side effects (may affect up tolin 1000 people):
• Hepatic failure
• Increased skin sensitivity to sunlight
Occasionally bicalutamide 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 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.
5. HOW TO STORE BICALUTAMIDE 150
mg
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Bicalutamide 150 mg after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
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.
6. CONTENTS OF THE PACKAND OTHER INFORMATION
What Bicalutamide 150 mg contains
The active substance is bicalutamide. Each film-coated tablet contains I50mg bicalutamide.
The other ingredients are:
Tablet core:
Lactose monohydrate, Povidone K- 25, Sodium starch glycolate Type A, Magnesium Stearate.
Film coating:
Opadry O'Y-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 film coated tablets are packed in blister packs containing 28 tablets contained in a carton.
Marketing Authorisation Holder
Relonchem Limited Cheshire House,
Gorsey lane
Widnes
WA80RP
Manufacturer
Genepharm S.A
18' klm Marathonos Avenue,
15351 Pallini Attikis Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Bicalutamide I50mgfilm-coated tablets This leaflet was last revised in October 2016.