FIBRAZATE- XL 400MG MODIFIED RELEASE TABLETS
Active substance: BEZAFIBRATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
(Bezafibrate)
Fibrazate XL 400 mg Modified Release Tablets
SZ00000LT000
In this leaflet: 1. What Fibrazate XL is and what it is used for 2. Before you take Fibrazate XL 3. How to take Fibrazate XL 4. Possible side effects 5. How to store Fibrazate XL 6. Further Information
Read all of this leaflet carefully 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Fibrazate XL 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. Fibrazate XL 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.
1 2
What Fibrazate XL is and what it is used for
Before you take Fibrazate XL
Do not take Fibrazate XL and tell your doctor if you: are allergic (hypersensitive) to bezafibrate or any of the other ingredients in these tablets (see section 6). are allergic (hypersensitive) to fibrates or you have developed a sensitivity to sunlight or artifical light (e.g. sunbeds) while 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.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Especially: coumarins or anticoagulants e.g. warfarin or low dose aspirin (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 colestipol or cholestyramine (used to lower cholesterol). Fibrazate XL 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.
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. are diabetic. -
Pregnancy and breast-feeding Fibrazate XL 400 mg Tablets should not be taken if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Fibrazate XL may make you feel dizzy. Make sure you are not affected before you drive or operate machines. Tests If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests.
Take special care with Fibrazate XL Check with your doctor or pharmacist before taking Fibrazate XL 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)
Always take Fibrazate XL exactly as your doctor has told you. If you are not sure, check with your doctor or Continued on the next page >> pharmacist.
3
How to take Fibrazate XL
Swallow the tablets whole with a glass of water, after food in the morning or evening. Fibrazate XL and an anion exchange resin should not be taken within 2 hours of each other. Doses: Adults: One tablet a day (400 mg bezafibrate a day).
raised patches with severe itching (hives), rash, sensitive to sunlight or artificial light (e.g. sunbeds), hair loss (alopecia), muscle weakness, cramp or pain (myalgia), acute kidney failure, erection problems, changes in the levels of certain enzymes within the blood (seen in a blood test), increased blood levels of creatinine.
Your doctor may prescribe a different dose depending on your condition. You should always follow your doctors instructions on taking your medicine. Your pharmacist may also help if you are not sure. Elderly patients: Your doctor may reduce the dose depending on how well your kidneys are working. Children: Not recommended.
Rare: (occurs in less than 1 in 1,000 users): damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis).
Impaired kidney function: Do not take Fibrazate XL if you have impaired kidney function or are having dialysis. If you take more Fibrazate XL 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 Fibrazate XL 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. If you stop taking Fibrazate XL Do not stop taking your medicine without consulting your doctor. While taking Fibrazate XL 400 mg Tablets, it is important that you continue to follow any special diet you may have been given. Your doctor may want to monitor your response to treatment and you should make sure that you keep any follow-up appointments. If you have not had a significant response to the treatment after 3 or 4 months, your doctor may decide to stop your medicine.
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 discolouration of the skin (thrombocytopenia purpura), decreased levels of the red blood pigment haemoglobin, increased levels of certain enzymes within the body (seen in blood tests), 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 resemble severe burns (Toxic epidermal necrolysis), changes in the number 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. If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Like all medicines, Fibrazate XL can cause side effects, although not everyone gets them.
4
Possible side effects
Do not take Fibrazate XL Tablets after the expiry date shown on the label. Do not store these tablets above 30C. If you notice any visible signs of deterioration in your medicine such as broken or chipped tablets, take it to your pharmacist for advice. Keep all medicines out of the reach of children. Your medicines can harm them.
5 6
How to store Fibrazate XL
Stop taking Fibrazate XL and 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 eyes or skin (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.
Further information
What Fibrazate XL contains: The name of your medicine is Fibrazate XL 400 mg Modified Release Tablets. The active ingredient in it is bezafibrate. The other ingredients include: polyethylene oxide, magnesium stearate, purified siliceous earth, talc, hypromellose, macrogol 4000 and titanium dioxide (E171).
Uncommon: (occurs in less than 1 in 100 users): dizziness, headache, feeling bloated, feeling sick, diarrhoea, blocked bile flow (cholestasis), itching, pale or red irregular
Marketing Authorisation Holder and Manufacturer Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. This leaflet was last approved in 07/2012.
What Fibrazate XL look like and contents of the pack: Each modified release tablet is a white round film coated tablet marked 400 on one face, which contains 400 mg bezafibrate. Fibrazate XL is supplied in packs of 30 tablets.
SZ00000LT000
(Bezafibrate)
Fibrazate XL 400 mg Modified Release Tablets
SZ00000LT000
In this leaflet: 1. What Fibrazate XL is and what it is used for 2. Before you take Fibrazate XL 3. How to take Fibrazate XL 4. Possible side effects 5. How to store Fibrazate XL 6. Further Information
Read all of this leaflet carefully 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Fibrazate XL 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. Fibrazate XL 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.
1 2
What Fibrazate XL is and what it is used for
Before you take Fibrazate XL
Do not take Fibrazate XL and tell your doctor if you: are allergic (hypersensitive) to bezafibrate or any of the other ingredients in these tablets (see section 6). are allergic (hypersensitive) to fibrates or you have developed a sensitivity to sunlight or artifical light (e.g. sunbeds) while 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.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Especially: coumarins or anticoagulants e.g. warfarin or low dose aspirin (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 colestipol or cholestyramine (used to lower cholesterol). Fibrazate XL 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.
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. are diabetic. -
Pregnancy and breast-feeding Fibrazate XL 400 mg Tablets should not be taken if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Fibrazate XL may make you feel dizzy. Make sure you are not affected before you drive or operate machines. Tests If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests.
Take special care with Fibrazate XL Check with your doctor or pharmacist before taking Fibrazate XL 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)
Always take Fibrazate XL exactly as your doctor has told you. If you are not sure, check with your doctor or Continued on the next page >> pharmacist.
3
How to take Fibrazate XL
Swallow the tablets whole with a glass of water, after food in the morning or evening. Fibrazate XL and an anion exchange resin should not be taken within 2 hours of each other. Doses: Adults: One tablet a day (400 mg bezafibrate a day).
raised patches with severe itching (hives), rash, sensitive to sunlight or artificial light (e.g. sunbeds), hair loss (alopecia), muscle weakness, cramp or pain (myalgia), acute kidney failure, erection problems, changes in the levels of certain enzymes within the blood (seen in a blood test), increased blood levels of creatinine.
Your doctor may prescribe a different dose depending on your condition. You should always follow your doctors instructions on taking your medicine. Your pharmacist may also help if you are not sure. Elderly patients: Your doctor may reduce the dose depending on how well your kidneys are working. Children: Not recommended.
Rare: (occurs in less than 1 in 1,000 users): damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis).
Impaired kidney function: Do not take Fibrazate XL if you have impaired kidney function or are having dialysis. If you take more Fibrazate XL 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 Fibrazate XL 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. If you stop taking Fibrazate XL Do not stop taking your medicine without consulting your doctor. While taking Fibrazate XL 400 mg Tablets, it is important that you continue to follow any special diet you may have been given. Your doctor may want to monitor your response to treatment and you should make sure that you keep any follow-up appointments. If you have not had a significant response to the treatment after 3 or 4 months, your doctor may decide to stop your medicine.
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 discolouration of the skin (thrombocytopenia purpura), decreased levels of the red blood pigment haemoglobin, increased levels of certain enzymes within the body (seen in blood tests), 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 resemble severe burns (Toxic epidermal necrolysis), changes in the number 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. If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Like all medicines, Fibrazate XL can cause side effects, although not everyone gets them.
4
Possible side effects
Do not take Fibrazate XL Tablets after the expiry date shown on the label. Do not store these tablets above 30C. If you notice any visible signs of deterioration in your medicine such as broken or chipped tablets, take it to your pharmacist for advice. Keep all medicines out of the reach of children. Your medicines can harm them.
5 6
How to store Fibrazate XL
Stop taking Fibrazate XL and 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 eyes or skin (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.
Further information
What Fibrazate XL contains: The name of your medicine is Fibrazate XL 400 mg Modified Release Tablets. The active ingredient in it is bezafibrate. The other ingredients include: polyethylene oxide, magnesium stearate, purified siliceous earth, talc, hypromellose, macrogol 4000 and titanium dioxide (E171).
Uncommon: (occurs in less than 1 in 100 users): dizziness, headache, feeling bloated, feeling sick, diarrhoea, blocked bile flow (cholestasis), itching, pale or red irregular
Marketing Authorisation Holder and Manufacturer Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. This leaflet was last approved in 07/2012.
What Fibrazate XL look like and contents of the pack: Each modified release tablet is a white round film coated tablet marked 400 on one face, which contains 400 mg bezafibrate. Fibrazate XL is supplied in packs of 30 tablets.
SZ00000LT000
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.
