Fenofibrate 200mg Capsules
Read all of this leaflet carefully before you start taking this medicine 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet "T What Fenofibrate capsules are and what they are used for 1^1 What you need to know before you take Fenofibrate capsules 3| How to take Fenofibrate capsules "4 Possible side effects T| How to store Fenofibrate capsules Contents of the pack and other information
T| What Fenofibrate capsules are and what they are used for
Fenofibrate 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.
Fenofibrate 200mg 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 200mg 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.
What you need to know before you take Fenofibrate capsules
Do not take Fenofibrate capsules and tell your doctor if you:
• are allergic 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 function.
• have gallbladder or liver disease.
• have severe kidney problems.
• have problems with your pancreas.
• are giving Fenofibrate capsules to a child or adolescent.
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Fenofibrate capsules must not be used in children and adolescents under 18.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Fenofibrate capsules if you:
• 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).
Other medicines and Fenofibrate capsules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Fenofibrate capsules contain lactose
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.
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Ingredient warning
Fenofibrate capsules contain ponceau 4R, cochineal red A (E124) which may cause allergic reactions.
Tests
Your doctor may want to carry out tests to monitor the levels of certain enzymes within your body.
How to take Fenofibrate capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow the capsules whole with water during a meal.
Doses:
Adults (including older people)
One capsule a day. Your doctor will monitor your response to the treatment.
Children and adolescents
Fenofibrate capsules must not be used in children and adolescents under 18.
Impaired kidney function
If you have impaired kidney function, your doctor may prescribe you a lower dose.
If you take more than you should
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.
"4 Possible side effects
Like all medicines, this medicine 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 (may affect up to 1 in 10 people)
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.
Uncommon (may affect up to 1 in 100 people)
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 (may affect up to 1 in 1,000 people)
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 (may affect up to 1 in 10,000 people)
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).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. you can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine
How to store Fenofibrate capsules
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Fenofibrate capsules contain
• The active substance (the ingredient that makes the capsules work) is micronised fenofibrate. Each capsule contains 200mg of the active substance.
• The other ingredients are lactose monohydrate, pregelatinised starch, sodium lauryl sulfate, povidone, magnesium stearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), ponceau 4R, cochineal red A (E124).
What Fenofibrate capsules look like and contents of the pack
Fenofibrate capsules are orange, hard, gelatine capsules.
Pack size is 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in October 2015.
If you would like a leaflet with larger text, please contact 01271 385257.
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Actavis, Barnstaple, EX32 8NS, UK
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