Package leaflet: Information for the user

Fenofibrate 200 mg Capsules

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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.    Howto take Fenofibrate Capsules

4.    Possible side effects

5.    Howto store Fenofibrate Capsules

6.    Contents of the pack and other information

1. What Fenofibrate Capsules are and what they are used for

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 underthe age of 18.

People with kidney problems

If you have kidney problems, your doctor may tell you to take a lower dose. Ask your doctor or pharmacist aboutthis.

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 yourdoctor 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 nottake 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 doctortells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Fenofibrate belongs to a group of medicines, commonly known as fibrates. These medicines are used to lowerthe level of fats (lipids) in the blood. Forexample the fats known as triglycerides.

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 nottake 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 sufferfrom 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 yourdoctor or pharmacist before taking Fenofibrate:

•    if you have kidney problems (your doctor may need to start you on a lower dose)

•    if you sufferfrom 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 yourfamily have had muscle problems

•    if you are over70 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 afterstarting treatment.

The risk of muscle breakdown is greater in certain patients.

Tell yourdoctor if any of the following applies to you:

•    You have any kidney problems

•    Youhaveanunderactivethyroid

•    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 orfluvastatin) 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.

In particular please let yourdoctor know if you already take:

•    Anticoagulants to thin your blood (forexample, warfarin)

•    Otherdrugsto control lipid (fat) levels in the blood (forexample, 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 with food and drink

The capsules should betaken with or afterfood.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyourdoctororpharmacistforadvice before taking this medicine.

Driving and using machines

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

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.

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.

3. Howto take Fenofibrate Capsules

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 breakdown

•    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: mav affect more than 1 in 10 people

•    Stomach pain, being sick, feeling sick, diarrhoea and wind (flatulence)

Uncommon: mav 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 sexdrive

•    Slight increases in blood levels of substances normally excreted by the kidneys (creatinine)

Rare: mav 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 cells

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: www.mhra.gov.uk/yellowcard. 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 EXR The expiry date refers to the last day of that month.

Do not store above 25⁰C. 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 environment.

6. Contents of the pack and other information

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.

Swallow the capsule whole with a glass of water. It is importantto take the capsule with food, as it will not work as well if your stomach is empty.

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).

What Fenofibrate Capsules look like and the contents of the pack

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

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Ranbaxy (UK) Limited 5th floor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB34AZ United Kingdom

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87 2132 JH Hoofddorp The Netherlands

Alkaloida Chemical Company Zrt.

Kabay Janos u. 29.

Tiszavasvari 4440    ^

Hungary

CO

This leaflet was last revised in July 2016.    £

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