BEZALIP RETARD 400MG TABLETS
Active substance: BEZAFIBRATE
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BEZALIP RETARD 400mg TABLETS BEZALIP MONO 400mg TABLETS (Bezafibrate) Patient Information Leaflet
27mm
This medicine is known as the above names but will be referred to as Bezalip Mono throughout this leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. Index 1. What Bezalip Mono is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 1. What Bezalip Mono is and what it is used for Bezalip Mono belongs to a group of medicines called lipid-regulating drugs, which lower high levels of cholesterol and other fats (lipids) in the blood (hyperlipidaemia). This reduces and prevents any long term effects associated with hyperlipidaemia. 2. Before you take Do not take Bezalip Mono and tell your doctor if you: are allergic (hypersensitive) to bezafibrate or any of the other ingredients in the tablets (see section 6). are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines. are taking statins (e.g. atorvastatin) and have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain): - impaired kidney function - an underactive thyroid (hypothyroidism) - severe infection - trauma - surgery - a change in the levels of hormones or chemicals in your body (seen in a blood test) - a high alcohol intake are having dialysis. have liver disease. have gall bladder disease. have nephrotic syndrome (a kidney disorder). have impaired kidney function. Check with your doctor or pharmacist before taking Bezalip Mono if you: have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain): - impaired kidney function - an underactive thyroid (hypothyroidism) - severe infection - trauma - surgery - a change in the levels of hormones or chemicals in your body (seen in a blood test) - a high alcohol intake - are elderly (over 65 years old) - have a family history of muscle disease.
CUSTOMER APPROVED:
DATE:
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
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. Especially: coumarin-type anti-coagulants e.g. warfarin (used to prevent blood clotting). antidiabetic medicines such as insulin (used in diabetes). ciclosporin (used to suppress the immune system). anion exchange resins such as cholestyramine (used to lower cholesterol). Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other. statins e.g. atorvastatin (used to lower cholesterol). monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in depression). oestrogen or medicines which contain oestrogen. Pregnancy and breast-feeding Speak to your doctor before taking Bezalip Mono during pregnancy or breast-feeding.
UK PIL DATED NOVEMBER 2011 MULTIPLE MANUFACTURERS
Driving and using machines Bezalip Mono may make you feel dizzy. Make sure you are not affected before you drive or operate machinery. Sugar intolerance If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose. Tests If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests. 3. How to take Always take Bezalip Mono exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Swallow the tablets whole with water, after food in the morning or evening. Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other.
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
Bezalip retard 400mg tabs
05/12/12
05-0440
DT
DATE:
CUSTOMER: Waymade
PRODUCT:
CODE:
6464/0299A
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.4 - waymade - 05/12/12
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
WARNING!
Doses: Adults: One tablet a day (400mg bezafibrate a day). Elderly: Your doctor may reduce the dose depending on how well your kidneys are working.
27mm
Children: Not recommended. Impaired kidney function: Do not take Bezalip Mono if you have impaired kidney function or are having dialysis.
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
If you take more than you should If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems (rhabdomyolysis). If you forget to take the tablets Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. 4. Possible side effects Like all medicine, Bezalip Mono can cause side effects, although not everybody gets them. Contact your doctor immediately if you notice signs of: an allergic reaction (hypersensitivity): swelling of the face, lips, tongue or throat, itchy skin rash or narrowing of the airways causing difficulty breathing or swallowing. gallstones: pain in the upper abdomen or yellowing of the skin or whites of the eyes (jaundice). abnormal muscle breakdown (rhabdomyolysis): muscle pain or weakness, swelling. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Common (occurs in less than 1 in 10 users): decreased appetite. Uncommon (occurs in less than 1 in 100 users): dizziness, headache, bloated feeling, feeling sick, diarrhoea, blocked bile flow (cholestasis), itching, pale or red irregular raised patches with severe itching (hives), rash, sensitivity to sunlight or artificial light (e.g. sun beds), hair loss (alopecia), muscle weakness, cramps or pain (myalgia), acute kidney failure, erection problems, changes in the levels of certain enzymes within the body (seen in a blood test), increased blood levels of creatinine.
CUSTOMER APPROVED:
Rare (occurs in less than 1 in 1,000 users): damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis).
DATE:
Q.A. APPROVED:
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
05/12/12
DT
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
5. How to Store There are no special storage conditions for Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets. Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of that month. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist before taking them. 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 Your medicine is called Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets. Each modified release tablet contains 400mg of the active ingredient, bezafibrate.
UK PIL DATED NOVEMBER 2011 MULTIPLE MANUFACTURERS
CUSTOMER: Waymade PRODUCT: Bezalip retard 400mg tabs
The tablet is round, white, film-coated and marked BM on one side and D9' on the other side or the tablet is round, white, film-coated and marked D9 on one side and plain on the reverse. Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets also contain the following: lactose, povidone K25, polymethacrylic acid esters, macrogol 10000, hypromellose, talc, polysorbate 80, titanium dioxide (E171), sodium citrate dihydrate, colloidal silica anhydrous, sodium lauryl sulphate and magnesium stearate. Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets are available as blister packs of 30 tablets. POM PL No: 6464/0299
This product is manufactured by Patheon Italia S.p.A., Monza, Milan, Italy, and/or, Cenexi 52, Rue Marcel et Jaques Gaucher, 94120 Fontenay-Sous-Bois, France and procured from within the EU and repackaged by the Product Licence holder: Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR Leaflet revision and issue date (Ref.) 05.12.2012 BEZALIP is a registered trademark of HOFFMANN-LA-ROCHE AG
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Very rare (occurs in less than 1 in 10,000 users): inflammation in the lungs (interstitial lung disease), decreased levels of platelets in the blood causing a disorder characterised by blood spots, bruising and discolouring to the skin (thrombocytopenic purpura), decreased levels of the red blood pigment haemoglobin, increased levels of certain enzymes within the body (seen in a blood test), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Toxic epidermal necrolysis), changes in the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.
05-0440
DATE:
CODE:
6464/0299A
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.4 - waymade - 05/12/12
BEZALIP RETARD 400mg TABLETS BEZALIP MONO 400mg TABLETS (Bezafibrate) Patient Information Leaflet
27mm
This medicine is known as the above names but will be referred to as Bezalip Mono throughout this leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. Index 1. What Bezalip Mono is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 1. What Bezalip Mono is and what it is used for Bezalip Mono belongs to a group of medicines called lipid-regulating drugs, which lower high levels of cholesterol and other fats (lipids) in the blood (hyperlipidaemia). This reduces and prevents any long term effects associated with hyperlipidaemia. 2. Before you take Do not take Bezalip Mono and tell your doctor if you: are allergic (hypersensitive) to bezafibrate or any of the other ingredients in the tablets (see section 6). are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines. are taking statins (e.g. atorvastatin) and have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain): - impaired kidney function - an underactive thyroid (hypothyroidism) - severe infection - trauma - surgery - a change in the levels of hormones or chemicals in your body (seen in a blood test) - a high alcohol intake are having dialysis. have liver disease. have gall bladder disease. have nephrotic syndrome (a kidney disorder). have impaired kidney function. Check with your doctor or pharmacist before taking Bezalip Mono if you: have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain): - impaired kidney function - an underactive thyroid (hypothyroidism) - severe infection - trauma - surgery - a change in the levels of hormones or chemicals in your body (seen in a blood test) - a high alcohol intake - are elderly (over 65 years old) - have a family history of muscle disease.
CUSTOMER APPROVED:
DATE:
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
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. Especially: coumarin-type anti-coagulants e.g. warfarin (used to prevent blood clotting). antidiabetic medicines such as insulin (used in diabetes). ciclosporin (used to suppress the immune system). anion exchange resins such as cholestyramine (used to lower cholesterol). Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other. statins e.g. atorvastatin (used to lower cholesterol). monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in depression). oestrogen or medicines which contain oestrogen. Pregnancy and breast-feeding Speak to your doctor before taking Bezalip Mono during pregnancy or breast-feeding.
UK PIL DATED NOVEMBER 2011 MULTIPLE MANUFACTURERS
Driving and using machines Bezalip Mono may make you feel dizzy. Make sure you are not affected before you drive or operate machinery. Sugar intolerance If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose. Tests If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests. 3. How to take Always take Bezalip Mono exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Swallow the tablets whole with water, after food in the morning or evening. Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other.
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
Bezalip retard 400mg tabs
05/12/12
05-0440
DT
DATE:
CUSTOMER: Waymade
PRODUCT:
CODE:
6464/0299A
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.4 - waymade - 05/12/12
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
WARNING!
Doses: Adults: One tablet a day (400mg bezafibrate a day). Elderly: Your doctor may reduce the dose depending on how well your kidneys are working.
27mm
Children: Not recommended. Impaired kidney function: Do not take Bezalip Mono if you have impaired kidney function or are having dialysis.
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
If you take more than you should If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems (rhabdomyolysis). If you forget to take the tablets Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. 4. Possible side effects Like all medicine, Bezalip Mono can cause side effects, although not everybody gets them. Contact your doctor immediately if you notice signs of: an allergic reaction (hypersensitivity): swelling of the face, lips, tongue or throat, itchy skin rash or narrowing of the airways causing difficulty breathing or swallowing. gallstones: pain in the upper abdomen or yellowing of the skin or whites of the eyes (jaundice). abnormal muscle breakdown (rhabdomyolysis): muscle pain or weakness, swelling. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Common (occurs in less than 1 in 10 users): decreased appetite. Uncommon (occurs in less than 1 in 100 users): dizziness, headache, bloated feeling, feeling sick, diarrhoea, blocked bile flow (cholestasis), itching, pale or red irregular raised patches with severe itching (hives), rash, sensitivity to sunlight or artificial light (e.g. sun beds), hair loss (alopecia), muscle weakness, cramps or pain (myalgia), acute kidney failure, erection problems, changes in the levels of certain enzymes within the body (seen in a blood test), increased blood levels of creatinine.
CUSTOMER APPROVED:
Rare (occurs in less than 1 in 1,000 users): damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis).
DATE:
Q.A. APPROVED:
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
05/12/12
DT
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
5. How to Store There are no special storage conditions for Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets. Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of that month. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist before taking them. 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 Your medicine is called Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets. Each modified release tablet contains 400mg of the active ingredient, bezafibrate.
UK PIL DATED NOVEMBER 2011 MULTIPLE MANUFACTURERS
CUSTOMER: Waymade PRODUCT: Bezalip retard 400mg tabs
The tablet is round, white, film-coated and marked BM on one side and D9' on the other side or the tablet is round, white, film-coated and marked D9 on one side and plain on the reverse. Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets also contain the following: lactose, povidone K25, polymethacrylic acid esters, macrogol 10000, hypromellose, talc, polysorbate 80, titanium dioxide (E171), sodium citrate dihydrate, colloidal silica anhydrous, sodium lauryl sulphate and magnesium stearate. Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets are available as blister packs of 30 tablets. POM PL No: 6464/0299
This product is manufactured by Patheon Italia S.p.A., Monza, Milan, Italy, and/or, Cenexi 52, Rue Marcel et Jaques Gaucher, 94120 Fontenay-Sous-Bois, France and procured from within the EU and repackaged by the Product Licence holder: Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR Leaflet revision and issue date (Ref.) 05.12.2012 BEZALIP is a registered trademark of HOFFMANN-LA-ROCHE AG
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Very rare (occurs in less than 1 in 10,000 users): inflammation in the lungs (interstitial lung disease), decreased levels of platelets in the blood causing a disorder characterised by blood spots, bruising and discolouring to the skin (thrombocytopenic purpura), decreased levels of the red blood pigment haemoglobin, increased levels of certain enzymes within the body (seen in a blood test), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Toxic epidermal necrolysis), changes in the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.
05-0440
DATE:
CODE:
6464/0299A
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.4 - waymade - 05/12/12
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
