FENOFIBRATE 67MG CAPSULES
Active substance: FENOFIBRATE MICRONISED
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65mm
Fenofibrate 67mg capsules
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.
have or have had impaired kidney function. have severely increased levels of a type of fat (triglycerides) in the blood (severe hypertriglyceridaemia) (seen in a blood test). have any of the following which may increase the risk of you developing abnormal muscle breakdown: - impaired kidney function - an underactive thyroid - a high alcohol intake - are over 70 years old - have had or have a family member with a history of hereditary muscular disorders. have decreased levels of a certain protein in the blood (hypoalbuminaemia) (seen in a blood test). are already taking a fibrate (e.g. bezafibrate) or a statin (e.g. atorvastatin), especially if you have muscle disease. have poorly controlled diabetes mellitus (type II). have nephrotic syndrome characterised by large amounts of protein in the urine, water retention and increased levels of fats in the blood. have a condition which effects the amount of protein in the blood (dysproteinemia). have obstructive liver disease. are taking medicines which may effect fat metabolism (e.g. thiazides, beta blockers, corticosteroids or antiretrovirals).
Check with your doctor or pharmacist before taking Fenofibrate capsules if you:
In this leaflet 1 What Fenofibrate capsules are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information
Fenofibrate capsules belong 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. Fenofibrate capsules are 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. Fenofibrate capsules 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.
Taking other medicines
2 Before you take
Do not take Fenofibrate capsules and tell your doctor if you:
are allergic (hypersensitive) to fenofibrate or any of the other ingredients in the capsules (see section 6). have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking fibrates (e.g. fenofibrate or bezafibrate) or ketoprofen (used for muscle and bone disorders, gout or period pain). have severely impaired liver or kidney function. have problems with your pancreas. have gallbladder or liver disease.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: oral anti-coagulants e.g.warfarin (used to prevent blood clotting). statins e.g. atorvastatin (used to lower cholesterol). ciclosporin (used to suppress the immune system). phenylbutazone (a non-steroidal anti-inflammatory drug). other fibrates e.g. bezafibrate (used to lower cholesterol and other fats (lipids) in the blood). oestrogen or medicines which contain oestrogen (contraceptives).
Pregnancy and breast-feeding
Fenofibrate capsules should not be used if you are pregnant or breast-feeding. Speak to your doctor before taking any medicine.
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. Continued top of next column 50567507 Continued over page
210mm+/-0.5mmtocentrelineofnexteyemark
1 What Fenofibrate capsules are and what they are used for
83.6mm
C L
Pharmacode Position
Ingredient warning Tests
Fenofibrate capsules contain sunset yellow (E110) which may cause allergic reactions. Your doctor may want to carry out tests to monitor the levels of certain enzymes within your body.
Uncommon (occuring in less than 1 in 100 users): Increased levels of a certain enzyme within the body (seen in a test), muscle toxicity (muscle pain, inflammation, cramps and weakness), blood clotting, inflammation of the pancreas causing stomach and back pain. Rare (occuring in less than 1 in 1,000 users): Disorder of the nerves causing weakness, tingling and numbness (peripheral neuropathy), hair loss, increase in blood levels of creatinine and urea, loss of sex drive, decreased levels of haemoglobin and white 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. Very rare (occuring in less than 1 in 10,000 users): Lung disease (interstitial pneumopathies), inflammation of the liver (hepatitis) causing yellowing of the skin or whites of the eyes (jaundice) or tiredness, development of gallstones, abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis). If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
3 How to take
Always take Fenofibrate capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Swallow the capsules whole with water during a meal. Doses: Adults (including the elderly) Three capsules a day, taken in divided doses. Your doctor will monitor your response to the treatment. Children One capsule a day per 20kg of bodyweight. Impaired kidney function If you have impaired kidney function, your doctor may prescribe you a lower dose.
If you take more than you should
5 How to store
If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.
If you forget to take the capsules
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.
Keep out of the reach and sight of children. Do not store above 25C. Store in the original package. Do not use Fenofibrate capsules after the expiry date stated on the label/carton/bottle. 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.
4 Possible side effects
Like all medicines, Fenofibrate capsules can cause side effects, although not everybody gets them. Stop taking Fenofibrate capsules and tell your doctor immediately if you develop: Muscle poisoning: muscle pain, breakdown, inflammation, cramps or weakness, increase in the levels of a certain enzyme within the body (seen in a blood test). Contact your doctor immediately if you develop: An allergic reaction: swelling of the face, lips, tongue or throat, itchy skin rash, narrowing of the airways causing difficulty breathing or swallowing. Hepatitis: yellowing of the skin or whites of the eyes (jaundice), itching. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Common (occuring in less than 1 in 10 users): Headache, tiredness, spinning sensation, stomach or intestine disorders such as feeling or being sick, stomach pains, diarrhoea and wind. Skin rash, itching, a skin rash with pale or red irregular raised patches with severe itching, sensitivity to sunlight or artificial light (e.g. sun beds) which may include reddening of the skin, blisters or lumps.
6 Further information
What Fenofibrate capsules contain
The active substance (the ingredient that makes the capsules work) is micronised fenofibrate. Each capsule contains 67mg of the active substance. The other ingredients are lactose monohydrate, pregelatinised starch, sodium lauryl sulphate, povidone, magnesium stearate, gelatin, titanium dioxide (E171), quinolone yellow (E104), sunset yellow (E110).
What Fenofibrate capsules look like and contents of the pack
Pack size is 90.
Fenofibrate capsules are yellow, hard, gelatine capsules. Marketing Authorisation Holder and Manufacturer Actavis, Barnstaple, EX32 8NS, UK. This leaflet was last revised in May 2011
Pharmacode Position
65mm
Ifyouwouldlikea leafletwithlarger text,pleasecontact 01271311257.
Continued top of next column 50567507
Actavis, Barnstaple, EX32 8NS, UK
Fenofibrate 67mg capsules
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.
have or have had impaired kidney function. have severely increased levels of a type of fat (triglycerides) in the blood (severe hypertriglyceridaemia) (seen in a blood test). have any of the following which may increase the risk of you developing abnormal muscle breakdown: - impaired kidney function - an underactive thyroid - a high alcohol intake - are over 70 years old - have had or have a family member with a history of hereditary muscular disorders. have decreased levels of a certain protein in the blood (hypoalbuminaemia) (seen in a blood test). are already taking a fibrate (e.g. bezafibrate) or a statin (e.g. atorvastatin), especially if you have muscle disease. have poorly controlled diabetes mellitus (type II). have nephrotic syndrome characterised by large amounts of protein in the urine, water retention and increased levels of fats in the blood. have a condition which effects the amount of protein in the blood (dysproteinemia). have obstructive liver disease. are taking medicines which may effect fat metabolism (e.g. thiazides, beta blockers, corticosteroids or antiretrovirals).
Check with your doctor or pharmacist before taking Fenofibrate capsules if you:
In this leaflet 1 What Fenofibrate capsules are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information
Fenofibrate capsules belong 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. Fenofibrate capsules are 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. Fenofibrate capsules 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.
Taking other medicines
2 Before you take
Do not take Fenofibrate capsules and tell your doctor if you:
are allergic (hypersensitive) to fenofibrate or any of the other ingredients in the capsules (see section 6). have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking fibrates (e.g. fenofibrate or bezafibrate) or ketoprofen (used for muscle and bone disorders, gout or period pain). have severely impaired liver or kidney function. have problems with your pancreas. have gallbladder or liver disease.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: oral anti-coagulants e.g.warfarin (used to prevent blood clotting). statins e.g. atorvastatin (used to lower cholesterol). ciclosporin (used to suppress the immune system). phenylbutazone (a non-steroidal anti-inflammatory drug). other fibrates e.g. bezafibrate (used to lower cholesterol and other fats (lipids) in the blood). oestrogen or medicines which contain oestrogen (contraceptives).
Pregnancy and breast-feeding
Fenofibrate capsules should not be used if you are pregnant or breast-feeding. Speak to your doctor before taking any medicine.
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. Continued top of next column 50567507 Continued over page
210mm+/-0.5mmtocentrelineofnexteyemark
1 What Fenofibrate capsules are and what they are used for
83.6mm
C L
Pharmacode Position
Ingredient warning Tests
Fenofibrate capsules contain sunset yellow (E110) which may cause allergic reactions. Your doctor may want to carry out tests to monitor the levels of certain enzymes within your body.
Uncommon (occuring in less than 1 in 100 users): Increased levels of a certain enzyme within the body (seen in a test), muscle toxicity (muscle pain, inflammation, cramps and weakness), blood clotting, inflammation of the pancreas causing stomach and back pain. Rare (occuring in less than 1 in 1,000 users): Disorder of the nerves causing weakness, tingling and numbness (peripheral neuropathy), hair loss, increase in blood levels of creatinine and urea, loss of sex drive, decreased levels of haemoglobin and white 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. Very rare (occuring in less than 1 in 10,000 users): Lung disease (interstitial pneumopathies), inflammation of the liver (hepatitis) causing yellowing of the skin or whites of the eyes (jaundice) or tiredness, development of gallstones, abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis). If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
3 How to take
Always take Fenofibrate capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Swallow the capsules whole with water during a meal. Doses: Adults (including the elderly) Three capsules a day, taken in divided doses. Your doctor will monitor your response to the treatment. Children One capsule a day per 20kg of bodyweight. Impaired kidney function If you have impaired kidney function, your doctor may prescribe you a lower dose.
If you take more than you should
5 How to store
If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.
If you forget to take the capsules
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.
Keep out of the reach and sight of children. Do not store above 25C. Store in the original package. Do not use Fenofibrate capsules after the expiry date stated on the label/carton/bottle. 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.
4 Possible side effects
Like all medicines, Fenofibrate capsules can cause side effects, although not everybody gets them. Stop taking Fenofibrate capsules and tell your doctor immediately if you develop: Muscle poisoning: muscle pain, breakdown, inflammation, cramps or weakness, increase in the levels of a certain enzyme within the body (seen in a blood test). Contact your doctor immediately if you develop: An allergic reaction: swelling of the face, lips, tongue or throat, itchy skin rash, narrowing of the airways causing difficulty breathing or swallowing. Hepatitis: yellowing of the skin or whites of the eyes (jaundice), itching. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Common (occuring in less than 1 in 10 users): Headache, tiredness, spinning sensation, stomach or intestine disorders such as feeling or being sick, stomach pains, diarrhoea and wind. Skin rash, itching, a skin rash with pale or red irregular raised patches with severe itching, sensitivity to sunlight or artificial light (e.g. sun beds) which may include reddening of the skin, blisters or lumps.
6 Further information
What Fenofibrate capsules contain
The active substance (the ingredient that makes the capsules work) is micronised fenofibrate. Each capsule contains 67mg of the active substance. The other ingredients are lactose monohydrate, pregelatinised starch, sodium lauryl sulphate, povidone, magnesium stearate, gelatin, titanium dioxide (E171), quinolone yellow (E104), sunset yellow (E110).
What Fenofibrate capsules look like and contents of the pack
Pack size is 90.
Fenofibrate capsules are yellow, hard, gelatine capsules. Marketing Authorisation Holder and Manufacturer Actavis, Barnstaple, EX32 8NS, UK. This leaflet was last revised in May 2011
Pharmacode Position
65mm
Ifyouwouldlikea leafletwithlarger text,pleasecontact 01271311257.
Continued top of next column 50567507
Actavis, Barnstaple, EX32 8NS, UK
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.
