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Active substance(s): FENOFIBRATE

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Package leaflet: Information for the user

Fenofibrate 200 mg Capsules
Fenofibrate 267 mg Capsules

Swallow the capsule whole with a glass of water. It is important to take the capsule with food,
as it will not work as well if your stomach is empty.
The recommended dose for adults is one capsule of Fenofibrate 200mg Capsule a day, taken at
mealtimes. However your doctor may want you to take one capsule of Fenofibrate 267mg a
day (higher dose).
Use in children and adolescents
Fenofibrate is not recommended for use in children under the age of 18.

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 you doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Fenofibrate Capsules are and what they are used for
2. What you need to know before you take Fenofibrate Capsules
3. How to take Fenofibrate Capsules
4. Possible side effects
5. How to store Fenofibrate Capsules
6. Contents of the pack and other information
1. 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
Fenofibrate 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.
Fenofibrate 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.
Fenofibrate can often also increase the amount of a “good” type of cholesterol, called HDL or
high density lipoprotein cholesterol.
It is always essential to continue a low-fat diet during treatment with Fenofibrate.
2. What you need to know before you take Fenofibrate Capsules
Do not take Fenofibrate Capsules if:
• You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients listed in
section 6 (an allergic reaction can include rashes, hives, itching, swelling of
face/lips/hands/feet or breathing difficulties)
• You suffer from liver or kidney disease or gallbladder disease
• 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
• You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain)
unless it is caused by high levels of fat in the blood (hypertriglyceridemia)
Warnings and precautions
Tell your doctor or pharmacist before taking Fenofibrate:
• if you have kidney problems (your doctor may need to start you on a lower dose)
• if you suffer from an under active thyroid gland (hypothyroidism)
• if you have diabetes, especially Type 2 diabetes, that is not well controlled
• if you have liver problems
• if you have problems with certain proteins in your blood
• if you have an alcohol problem
• you are taking other medicines
• if you or your family have had muscle problems
• if you are over 70 years of age
(Some of the above conditions can lead to high levels of lipids in your blood and need to be
corrected before you start therapy with fenofibrate).
Your doctor might want to test your blood or urine to check if Fenofibrate is working properly
and also if your kidneys, muscles and liver are working properly.
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.
The risk of muscle breakdown is greater in certain patients.
Tell your doctor if any of the following applies to you:
• You have any kidney problems
• You have an under active thyroid
• You often drink large amounts of alcohol
• 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 Fenofibrate 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.
Other medicines and Fenofibrate Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.

People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose. Ask your doctor or
pharmacist about this.
If you take more Fenofibrate Capsules than you should
If you have taken more Fenofibrate Capsules than you should, consult your doctor or go to the
nearest hospital casualty department immediately. Take this leaflet or some capsules with you
so your doctor will know what you have taken.
If you forget to take Fenofibrate Capsules
If you miss a dose, take the next dose with your next meal and then carry on taking your
capsules as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Fenofibrate Capsules
Do not stop taking the medicine unless your doctor tells you to, or your medicine makes 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 Fenofibrate. If your doctor
stops your medicine, do not keep any left over capsules unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor immediately or go to the casualty department at your nearest hospital if
you experience any of the following:

Reactions such as rashes, itching or red patches on the skin
Pancreatitis (inflammation of the pancreas leading to stomach pain)
Gallstones (cholelithiasis)
Muscle pain, muscle inflammation, muscle cramps, spasms or weakness, muscle
• 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
Other side effects
Common: may affect more than 1 in 10 people
• Stomach pain, being sick, feeling sick, diarrhoea and wind (flatulence)
Uncommon: may affect up to 1 in 100 people
• Blood clot in the lung causing chest pain and breathlessness (pulmonary embolism); blood
clot in the leg causing pain, redness or swelling (deep vein thrombosis)
• Headache
• Reduced sex drive
• Slight increases in blood levels of substances normally excreted by the kidneys (creatinine)
Rare: may affect up to 1 in 10,000 people
• Slight increases in substances excreted by the kidneys (urea)
• Hair loss
• Increased sensitivity to light
• Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood
Not known: frequency cannot be estimated from the available data
• Chronic disease of the lung tissues
• Fatigue
• Vertigo
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
5. How to store Fenofibrate Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Do not store above 25ºC. Store in the original package.
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
6. Contents of the pack and other information
What Fenofibrate Capsules contain
- Each capsule contains 200 mg or 267 mg of the active substance micronised Fenofibrate.
- The other ingredients are sodium lauryl sulphate, lactose, pregelatinised starch,
crospovidone, talc, colloidal anhydrous silica, magnesium stearate, gelatin and titanium
dioxide (E171).
- The black printing ink contains shellac glaze, iron oxide black and propylene glycol.
- The 200 mg capsules also contains sunset yellow FCF (E110).
- The 267 mg capsules also contain FD & C blue No. 2 (E132) and yellow iron oxide (E172).

In particular please let your doctor know if you already take:
• Anticoagulants to thin your blood (for example, warfarin)
• Other drugs 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 Fenofibrate
can increase the risk of muscle problems.
• Ciclosporin (an immunosuppressant)
• Drugs to control Type 2 diabetes (glitazones)

Fenofibrate capsules are available in pack sizes of 10, 14, 20, 28, 30, 56, 60 and 90 capsules.
Not all pack sizes may be marketed.

Fenofibrate Capsules with food and drink
The capsules should be taken with or after food.

Fenofibrate 200 mg Capsules are orange cap/orange body imprinted with 'FB200' on cap and
body containing white to off-white granular powder.

You should avoid drinking alcohol with Fenofibrate as this increases the risk of muscle

Fenofibrate 267 mg Capsules are ivory yellow cap/green body imprinted with 'FB267' on cap
and body containing white to off-white granular powder.

Pregnancy and 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.

Marketing Authorisation Holder and Manufacturer

Fenofibrate Capsules contain sunset yellow (E110)
This medicine also contains sunset yellow (E110) which is found in the 200 mg capsules. This
is a colouring agent and can cause an allergic reaction.

Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co-Tipperary
Republic of Ireland

3. How to take Fenofibrate Capsules

This leaflet was last revised in June 2016.

Font Size : 8 pt.

Fenofibrate Capsules contain lactose
This medicine contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

Marketing Authorisation Holder
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom


Driving and using machines
This medicine should not affect your ability to drive or use machines.

What Fenofibrate Capsules look like and the contents of the pack

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not sure.

[ 5128309 ] - LIT. FENOFIBRATE CAP (FLAT), MARKET - UK-R, SIZE: 122 x 420 mm (Single Folded), SPIL-DWS : 07.06.16vs/V1, 27.04.16US,
16.04.16US, (REFERENCE CODE : 5117758), ITF CODE: 05128309

Reflex Blue U


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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.