SUPRALIP 160MG FILM-COATED TABLETS
Active substance: FENOFIBRATE
View full screen / Print PDF » Download PDF ⇩
Transcript
27mm
This product is known by the above name but will usually be referred to as Supralip in 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. 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. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Supralip is and what it is used for 2. Before you take Supralip 3. How to take Supralip 4. Possible side effects 5. How to store Supralip 6. Further information 1. What Supralip is and what it is used for Supralip belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides. Supralip is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood. Supralip can be used in addition to other medicines [statins] in some circumstances when levels of fats in the blood are not controlled with a statin alone. 2. Before you take Supralip Do not take Supralip: If you suffer from severe liver or kidney disease or gallbladder disease If you are allergic (hypersensitive) to fenofibrate or any of the other ingredients of Supralip If sunlight or UV light have caused an allergic reaction (photoallergy) or skin damage while you were taking fibrates or an anti-inflammatory drug called ketoprofen in the past If you suffer from acute or chronic pancreatitis (inflammation of the pancreas which causes abdominal pain) unless it is caused by high levels of a type of fat in the blood (hypertriglyceridemia) Take special care with Supralip Tell your doctor before you start to take this medicine: If you have any kidney or liver problems If you develop symptoms suggestive of hepatitis (inflammation of the liver) such as mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching If you suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) If you suffer from hypothyroidism (underactive thyroid gland) If you are pregnant or breast-feeding
CUSTOMER APPROVED:
Q.A. APPROVED:
DATE:
The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to you: kidney problems thyroid problems you are more than 70 years old you have ever had muscle problems during treatment with cholesterol lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin) or fibrates (such as fenofibrate, bezafibrate or gemfibrozil) you or close family members have a hereditary muscle disorder The risk of muscle problems can be greater if Supralip is taken with cholesterol lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, fluvastatin). Tell your doctor if you are taking any of these medicines. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular please let your doctor know if you already take: anti-coagulants to thin your blood (for example, warfarin) other drugs used to control lipid (fat) levels in the blood (for example, drugs known as statins or fibrates). Taking a statin (e.g. simvastatin, atorvastatin) at the same time as Supralip can increase the risk of muscle problems ciclosporin (an immunosuppressant)
UK PIL DATED JUNE 2012
CUSTOMER: Waymade
6464/2057D
Taking Supralip with food and drink Swallow the tablet with a glass of water. It is important to take the tablet with food, as it will not work as well if your stomach is empty. Pregnancy and breast-feeding Pregnancy Tell your doctor if you are, you think you might be or are planning to become pregnant. Supralip must not be taken if you are pregnant. Breast-feeding You must not use Supralip if you are breast-feeding or if you are planning to breast-feed your baby. Ask your doctor for advice before taking any medicine. Driving and using machines This medicine will not affect your ability to drive or use machines. Important information about some of the ingredients of Supralip If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. If you are allergic to soya lecithin, peanuts or arachis oil, do not take Supralip as it contains soya lecithin. 3. How to take Supralip Always take Supralip exactly as your doctor has told you. Also, please read the label on the packet. You should check with your doctor if you are not sure. Swallow the tablet with a glass of water. It is important to take the tablet with food, as it will not work as well as if your stomach is empty. The usual dose for adults is one tablet of Supralip a day. If you are currently taking one capsule of Lipantil Micro 200mg, you can change to one tablet of Supralip.
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.
Important advice regarding muscle effects: Contact your doctor quickly if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, there is a risk of muscle problems which may be serious, including muscle breakdown which can cause kidney damage. Your doctor may perform a blood test to check the condition of your muscles before and after starting treatment.
PRODUCT:
Supralip 160mg tabs
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
03/01/13
05-0269
DT
DATE:
CODE:
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.
000-0000D
SUPRALIP 160mg film-coated TABLETS (fenofibrate) Patient Information Leaflet
PROOF HISTORY: v.1 - waymade - 03/01/13
Leaflet Flat Size = 148 x 400
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
Use in children and adolescents The use of Supralip 160mg is not recommended in children and adolescents under 18 years of age. If you take more Supralip than you should If you accidentally take more Supralip than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately. If you forget to take Supralip Do not take a double dose to make up for a forgotten tablet. Take the next dose with your next meal and then carry on taking your tablets as usual. If you are worried about this talk to your doctor. If you stop taking Supralip Do not stop taking the medicine unless your doctor tells you to, or the tablets make you feel unwell. This is because raised cholesterol levels need treating for a long period of time. Remember you should also continue with a low-fat diet whilst taking Supralip. If your doctor stops your medicine, do not keep any left over tablets unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor.
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Leaflet Flat Size = 148 x 400
4. Possible side effects Like all medicines, Supralip can cause side effects, although not everybody gets them. Some patients have experienced the following side effects whilst taking fenofibrate: Common side effects (experienced by between 1 in 10 and 1 in 100 patients): Stomach pain, nausea, vomiting, diarrhoea and flatulence Raised levels of various liver enzymes in the blood Uncommon side effects (experienced by between 1 in 100 and 1 in 1,000 patients): Pancreatitis (inflammation of the pancreas leading to abdominal pain) Thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and breathlessness), deep vein thrombosis (blood clot in the leg causing pain, redness or swelling) Reactions such as rashes, itching, red patches on the skin Slight increase in creatinine (substance excreted by the kidneys) Gallstones Muscle pain, muscle inflammation, muscle cramps and weakness Headache Reduced sex drive Rare side effects (experienced by between 1 in 1,000 and 1 in 10,000 patients): Hepatitis (inflammation of the liver), symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching Hypersensitivity (allergic reaction) Hair loss Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood cells Increased sensitivity to sunlight, sun lamps and sunbeds Slight increase in urea (substance excreted by the kidneys) During post marketing experience, some patients have also experienced (the frequency of these side effects is not known): Chronic disease of the lung tissues, muscle breakdown. If you develop any unusual discomfort, tell your doctor as soon as possible.
CUSTOMER APPROVED:
DATE:
DATE:
02/02/12
05-0269
5. How to store Supralip Do not use after the expiry date printed on the carton label or blister label EXP. The expiry date refers to the last day of that month. Supralip 160mg film-coated tablets should not be stored above 30C. Store in the original package. Keep all medicines out of the sight and reach of children. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist before taking them. Supralip 160 mg film-coated tablets 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.
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
6. Further information Your medicine is called Supralip 160mg film-coated tablets. Each white, oval, film-coated tablet marked 160 on one side and a logo on the other side, contains 160mg of the active ingredient fenofibrate, in a modified release, micronised formulation. Supralip 160mg film-coated tablets also contain the following: lactose monohydrate, sodium laurilsulfate, povidone, microcrystalline cellulose, anhydrous colloidal silica, crospovidone, sodium stearyl fumarate, and Opadry OYB 28920 (which contains polyvinyl alcohol, titanium dioxide (E171), talc, soya lecithin and xanthan gum). Supralip 160mg film-coated tablets are available as blister packs of 30 tablets.
UK PIL DATED JUNE 2012 6464/2057D
CUSTOMER: Waymade
POM
PL No: 6464/2057
PRODUCT:
This product is manufactured by Recipharm Fontaine, Rue des Prts Potets, 21121 Fontaine-les-Dijon, France and is 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.) 03.01.2013 Supralip is a registered trademark of FOURNIER INDUSTRIE
Black
000-0000D
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Supralip 160mg tabs
DT
Q.A. APPROVED:
CODE:
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.1 - waymade - 03/01/13
Notes:
WARNING!
This product is known by the above name but will usually be referred to as Supralip in 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. 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. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Supralip is and what it is used for 2. Before you take Supralip 3. How to take Supralip 4. Possible side effects 5. How to store Supralip 6. Further information 1. What Supralip is and what it is used for Supralip belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides. Supralip is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood. Supralip can be used in addition to other medicines [statins] in some circumstances when levels of fats in the blood are not controlled with a statin alone. 2. Before you take Supralip Do not take Supralip: If you suffer from severe liver or kidney disease or gallbladder disease If you are allergic (hypersensitive) to fenofibrate or any of the other ingredients of Supralip If sunlight or UV light have caused an allergic reaction (photoallergy) or skin damage while you were taking fibrates or an anti-inflammatory drug called ketoprofen in the past If you suffer from acute or chronic pancreatitis (inflammation of the pancreas which causes abdominal pain) unless it is caused by high levels of a type of fat in the blood (hypertriglyceridemia) Take special care with Supralip Tell your doctor before you start to take this medicine: If you have any kidney or liver problems If you develop symptoms suggestive of hepatitis (inflammation of the liver) such as mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching If you suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) If you suffer from hypothyroidism (underactive thyroid gland) If you are pregnant or breast-feeding
CUSTOMER APPROVED:
Q.A. APPROVED:
DATE:
The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to you: kidney problems thyroid problems you are more than 70 years old you have ever had muscle problems during treatment with cholesterol lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin) or fibrates (such as fenofibrate, bezafibrate or gemfibrozil) you or close family members have a hereditary muscle disorder The risk of muscle problems can be greater if Supralip is taken with cholesterol lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, fluvastatin). Tell your doctor if you are taking any of these medicines. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular please let your doctor know if you already take: anti-coagulants to thin your blood (for example, warfarin) other drugs used to control lipid (fat) levels in the blood (for example, drugs known as statins or fibrates). Taking a statin (e.g. simvastatin, atorvastatin) at the same time as Supralip can increase the risk of muscle problems ciclosporin (an immunosuppressant)
UK PIL DATED JUNE 2012
CUSTOMER: Waymade
6464/2057D
Taking Supralip with food and drink Swallow the tablet with a glass of water. It is important to take the tablet with food, as it will not work as well if your stomach is empty. Pregnancy and breast-feeding Pregnancy Tell your doctor if you are, you think you might be or are planning to become pregnant. Supralip must not be taken if you are pregnant. Breast-feeding You must not use Supralip if you are breast-feeding or if you are planning to breast-feed your baby. Ask your doctor for advice before taking any medicine. Driving and using machines This medicine will not affect your ability to drive or use machines. Important information about some of the ingredients of Supralip If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. If you are allergic to soya lecithin, peanuts or arachis oil, do not take Supralip as it contains soya lecithin. 3. How to take Supralip Always take Supralip exactly as your doctor has told you. Also, please read the label on the packet. You should check with your doctor if you are not sure. Swallow the tablet with a glass of water. It is important to take the tablet with food, as it will not work as well as if your stomach is empty. The usual dose for adults is one tablet of Supralip a day. If you are currently taking one capsule of Lipantil Micro 200mg, you can change to one tablet of Supralip.
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.
Important advice regarding muscle effects: Contact your doctor quickly if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, there is a risk of muscle problems which may be serious, including muscle breakdown which can cause kidney damage. Your doctor may perform a blood test to check the condition of your muscles before and after starting treatment.
PRODUCT:
Supralip 160mg tabs
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
03/01/13
05-0269
DT
DATE:
CODE:
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.
000-0000D
SUPRALIP 160mg film-coated TABLETS (fenofibrate) Patient Information Leaflet
PROOF HISTORY: v.1 - waymade - 03/01/13
Leaflet Flat Size = 148 x 400
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
Use in children and adolescents The use of Supralip 160mg is not recommended in children and adolescents under 18 years of age. If you take more Supralip than you should If you accidentally take more Supralip than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately. If you forget to take Supralip Do not take a double dose to make up for a forgotten tablet. Take the next dose with your next meal and then carry on taking your tablets as usual. If you are worried about this talk to your doctor. If you stop taking Supralip Do not stop taking the medicine unless your doctor tells you to, or the tablets make you feel unwell. This is because raised cholesterol levels need treating for a long period of time. Remember you should also continue with a low-fat diet whilst taking Supralip. If your doctor stops your medicine, do not keep any left over tablets unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor.
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Leaflet Flat Size = 148 x 400
4. Possible side effects Like all medicines, Supralip can cause side effects, although not everybody gets them. Some patients have experienced the following side effects whilst taking fenofibrate: Common side effects (experienced by between 1 in 10 and 1 in 100 patients): Stomach pain, nausea, vomiting, diarrhoea and flatulence Raised levels of various liver enzymes in the blood Uncommon side effects (experienced by between 1 in 100 and 1 in 1,000 patients): Pancreatitis (inflammation of the pancreas leading to abdominal pain) Thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and breathlessness), deep vein thrombosis (blood clot in the leg causing pain, redness or swelling) Reactions such as rashes, itching, red patches on the skin Slight increase in creatinine (substance excreted by the kidneys) Gallstones Muscle pain, muscle inflammation, muscle cramps and weakness Headache Reduced sex drive Rare side effects (experienced by between 1 in 1,000 and 1 in 10,000 patients): Hepatitis (inflammation of the liver), symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching Hypersensitivity (allergic reaction) Hair loss Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood cells Increased sensitivity to sunlight, sun lamps and sunbeds Slight increase in urea (substance excreted by the kidneys) During post marketing experience, some patients have also experienced (the frequency of these side effects is not known): Chronic disease of the lung tissues, muscle breakdown. If you develop any unusual discomfort, tell your doctor as soon as possible.
CUSTOMER APPROVED:
DATE:
DATE:
02/02/12
05-0269
5. How to store Supralip Do not use after the expiry date printed on the carton label or blister label EXP. The expiry date refers to the last day of that month. Supralip 160mg film-coated tablets should not be stored above 30C. Store in the original package. Keep all medicines out of the sight and reach of children. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist before taking them. Supralip 160 mg film-coated tablets 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.
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
6. Further information Your medicine is called Supralip 160mg film-coated tablets. Each white, oval, film-coated tablet marked 160 on one side and a logo on the other side, contains 160mg of the active ingredient fenofibrate, in a modified release, micronised formulation. Supralip 160mg film-coated tablets also contain the following: lactose monohydrate, sodium laurilsulfate, povidone, microcrystalline cellulose, anhydrous colloidal silica, crospovidone, sodium stearyl fumarate, and Opadry OYB 28920 (which contains polyvinyl alcohol, titanium dioxide (E171), talc, soya lecithin and xanthan gum). Supralip 160mg film-coated tablets are available as blister packs of 30 tablets.
UK PIL DATED JUNE 2012 6464/2057D
CUSTOMER: Waymade
POM
PL No: 6464/2057
PRODUCT:
This product is manufactured by Recipharm Fontaine, Rue des Prts Potets, 21121 Fontaine-les-Dijon, France and is 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.) 03.01.2013 Supralip is a registered trademark of FOURNIER INDUSTRIE
Black
000-0000D
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Supralip 160mg tabs
DT
Q.A. APPROVED:
CODE:
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.1 - waymade - 03/01/13
Notes:
WARNING!
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.
