Package leaflet: information for the user

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Fenofibrate 200 mg Capsules

Fenofibrate

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

1.    What Fenofibrate is and what it is used for

2.    What you need to know before you take Fenofibrate

3.    How to take Fenofibrate

4.    Possible side effects

5.    Howto store Fenofibrate

6.    Content of the pack and other information

A SANDOZ

What Fenofibrate is and what it is 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 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.

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.

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.

What you need to know before you take Fenofibrate

Do not take Fenofibrate

•    if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6).

•    if you suffer from liver or kidney disease or gallbladder disease.

•    if 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.

•    if 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).

Warning and precautions

Talk to your doctor before taking this medicine

•    if you have any kidney problems.

•    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.

•    if 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).

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

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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).

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.

Pregnancy

Fenofibrate must not be taken if you are pregnant. Breast-feeding

You must not use Fenofibrate if you are breast-feeding or if you are planning to breast-feed your baby.

Driving and using machines

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

Fenofibrate contain contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3 How to take Fenofibrate

Always take this medicine exactly as your doctor has told you. Also, please read the label on the packet. Check with your doctor if you are not sure.

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 usual dose for adults is one capsule of Fenofibrate 200 mg a day, taken at mealtimes.

Use in children and adolescents

Fenofibrate is not recommended for use in children under the 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 about this.

If you take more Fenofibrate than you should

If you accidentally take more Fenofibrate than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Fenofibrate

Do not take a double dose to make up for a forgotten capsule. Take the next dose with your next meal and then carry on taking your capsules as usual. If you are worried about this talk to your doctor.

If you stop taking Fenofibrate

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 product, ask your doctor.

•    Headache

•    Muscle pain, muscle inflammation, muscle cramps, spasms or weakness

•    Reduced sex drive

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

Rare (may affect up to 1 in 1,000 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

•    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.

In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of Fenofibrate. A precise frequency cannot be estimated from the available data and is therefore classified as “not known”:

•    Muscle breakdown

•    Chronic disease of the lung tissues

•    Fatigue

•    Vertigo.

If you develop any unusual discomfort, tell your doctor as soon as possible.

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 (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

4 Possible side effects

Keep out of the reach and sight of children.

This medicinal product does not require any special storage condition.

Do not use these capsules after the expiry date which is stated on the carton. 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking the capsules and seek medical help immediately if you have any of the following allergic reactions:

•    difficulty breathing or swallowing, swelling of the face, lips, tongue or throat.

•    severe itching of the skin, with a red rash or raised lumps.

•    blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin.

If you experience muscular pain, painful muscular sensitivity or muscular weakness, contact your doctor immediately, as muscular problems can be serious in rare cases.

Other side effects whilst taking fenofibrate:

Common (may affect more than 1 in 10 people)

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

•    Raised levels of various liver enzymes in the blood.

Uncommon (may affect up to 1 in 10 people)

•    Pancreatitis (inflammation of the pancreas leading to stomach pain)

•    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)

•    Gallstones (cholelithiasis)

Content of the pack and other information

What Fenofibrate contains

•    The active substance is fenofibrate (micronised); each capsule contains 200 mg.

•    The other ingredients are sucrose, maize starch, hypromellose, sodium laurilsulfate, dimeticone, polyethylene glycol sorbitan monolaurate, (t-octylphenoxy) polyethoxyethanol, sorbic acid, sodium benzoate, propylene glycol, propyl p-hydroxybenzoate, methyl p-hydroxybenzoate, simeticone, polyethylene glycol stearate, polyethylene glycol sorbitan tristearate, glycerides, xanthan gum, methyl cellulose, sorbic acid, benzoic acid, sulfuric acid and talc. The capsule shell is made of gelatin, titanium dioxide (E171) and yellow iron oxide (E172) (see end of Section 2 for further information on sucrose).

What Fenofibrate looks like and contents of the pack

Fenofibrate capsules are hard capsules with opaque

yellow caps and transparent bodies, containing white

spherical microgranules.

The capsules are supplied in packs of 28.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 11/2013.

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