Bicalutamide 50mg Film-Coated Tablets.
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ArtwsTK Creative Dee inns |
Artwork No. |
121108/11 |
Colours Used | |||
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Customer |
Relon Chem |
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Balck | |||
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Description |
Bicalutamide 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. |
8 | ||||
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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 50 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. Do not pass it on to others. It may harm them, even if tneir 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 is and what it is used for
2. Before you take Bicalutamide 50 mg
3. Howto take Bicalutamide 50 mg
4. Possible side effects
5. Howto store Bicalutamide 50 mg
6. Further information
1. WHAT BICALUTAMIDE 50 MG IS AND WHAT IT IS USED FOR
Bicalutamide 50 mg is used for the treatment of advanced prostate cancer. It is taken together with a drug known as an luteinising hormonereleasing hormone (LHRH) analogue which reduces the levels of androgens (male sex hormones) within the body, or with accompanying surgical removal of the testicles. The active ingredient of Bicalutamide 50 mg, bicalutamide, belongs to a group of medicines called non-steroidal anti-androgens. It 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 50MG
Do not take Bicalutamide 50 mg
• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of Bicalutamide 50 mg
• if you are already taking terfenadine or astemizole (for hay fever or allergy), or cisapride (for stomach disorders).
Bicalutamide 50 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 50 mg 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.
• If you have diabetes and are already taking an "LHRH analogue". These include goserelin, buserelin, leuprorelin and triptorelin.
• Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide.
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Taking other medicines
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.
Ifyou 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.
Bicalutamide might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs(e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
• 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 50 mg with food and drink
Bicalutamide 50 mg can betaken 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
Bicalutamide 50 mg is contra-indicated in females and must not be given to pregnant or breastfeeding mothers.
Driving and using machines
Bicalutamide 50 mg is unlikely to adversely affect your ability to drive a car or to operate machinery. However, some people may occasionally feel dizzy ordrowsyafter 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.
Important information about some of the ingredients of Bicalutamide 50 mg
Bicalutamide 50 mg contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, sucn as lactose, contactyour doctor immediately.
3. HOWTO TAKE BICALUTAMIDE 50MG
Always take Bicalutamide 50 mg exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure. The usual dose is one film coated' tablet daily. It is better to take the film coated 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 50 mg than vou 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 50 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 50 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:
Uncommon serious side effects (may affect up to I in 100 people):
Serious allergic reaction which causes:
• 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 straightaway.
Also tell your doctor straightaway ifyou notice any of the following side effects:
Very common side effects (may affect more than I in 10 people):
• Pain in your abdomen
• Blood in your urine
Common side effects (may affect up to I in 10
people):
• Yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver problems or in rare cases (may affect up to I in 1,000 people) liver failure.
Uncommon side effects (may affect up to I in 10
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 lungdisease"
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):
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
• Dizziness
• Constipation, feeling sick (nausea)
• Hot flushes
• Fellingweak, swelling
• Swelling and tenderness of your breasts.
Common side effects (may effect up to I in 10
people):
• Weight gain
• Feeling sleepy
• Indigestion, wind (flatulence)
• Hair loss, hair re-growth or growth of extra hair
• Skin rash, dry skin, itching
• Decreased appetite
• Chest pain
• Being unable to get an erection
• Reduced sex drive
• Depression
• Heart attack, reduced heart function
• Changes in liver enzymes
Rare (may affect up to I in 1,000 people)
• Increase skin sensitivity to sunlight
Your doctor may do blood tests to check for any changes to your blood.
Do not be concerned by this list of possible side effects. You may not get any of them.
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: "http://www.mhra.gov.u k/yel lowcard11 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 50MG
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Bicalutamide 50 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. FURTHER INFORMATION
What Bicalutamide 50 mg contains
• The active substance is bicalutamide. Each film-coated tablet contains 50mg bicalutamide.
The other ingredients are:
Tablet core:
Lactose monohydrate, Povidone K- 25, Sodium starch glycolate Type A, Magnesium Stearate.
Film coating:
Opadry OV-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 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 WA8 0RP
Manufacturer
Genepharm S.A
18th 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 50mgfilm-coated tablets LT: Bicalgen 50mg plevele dengtos tabletes.
This leaflet was last revised in October 2016.