TEVA UK Ref: 231-30-87791-D LEA FENOFIBRATE 67mg MICRO CAP TAB    Version: 4    08 May 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

FENOFIBRATE 67 mg CAPSULES

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

•    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.

IN THIS LEAFLET:

First bar is 105mm from the top edge of the leaflet.

1.    What Fenofibrate 67 mg Capsules is and what it is used for

2.    What you need to know before you take Fenofibrate 67 mg Capsules

3.    How to take Fenofibrate 67 mg Capsules

4.    Possible side effects

5.    How to store Fenofibrate 67 mg Capsules

6.    Contents of the pack and other information

Ol WHAT FENOFIBRATE 67 mg CAPSULES 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.

Ol WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENOFIBRATE 67 mg CAPSULES

Do NOT take Fenofibrate

• If you are allergic (hypersensitive) to fenofibrate or any of the other ingredients of this medicine

• If you have known photo-allergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine)

• If you suffer from liver, kidney or gallbladder disease • If you suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain).

Warnings and precautions

Talk to your doctor or pharmacist:

• If you are over 70 years old • If you or a blood relative have or have had muscle disease

• If you have impaired kidney function • If you have an underactive thyroid gland (hypothyroidism)

• If you have a high alcohol intake • If you are already taking another fibrate or a statin (another type of lipid-modifying medicine), or if you are taking oral contraceptives ('the pill').

These factors may put you at increased risk for muscle problems during treatment with fenofibrate. You should contact your doctor immediately if you experience unexplained muscle pain, muscle tenderness or muscle weakness. This is because in rare cases, muscle problems due to fenofibrate can be serious.

Your doctor may order regular blood tests to monitor your liver and kidney function.

Pancreatitis (inflammation of the pancreas leading to abdominal pain) sometimes occurs in patients taking fenofibrate: please refer to 'Do NOT take Fenofibrate' above, and '4. Possible side effects' below).

In children, fenofibrate should only be used after specialist advice and genetic and laboratory tests to treat severe hereditary disease.

Other medicines and fenofibrate

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

Especially, tell your doctor or pharmacist if you are taking any of the following:

•    Anti-coagulants to thin your blood (e.g. warfarin): the risk of bleeding could be increased

•    Ciclosporin, an immunosuppressant: your kidney function could be affected

•    Statins or fibrates, which are other lipid-modifying medicines: the risk of muscle problems could be increased (see ''warnings and precautions' ' above).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Fenofibrate with food and drink

You should take Fenofibrate during a meal, as it won't work as well if you take it on an empty stomach.

A high cholesterol level in your blood (hypercholesterolaemia) requires that you take special care, even if the high cholesterol level does not affect the way you feel. You should follow the dietary recommendations given by your doctor while taking this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

As there is not enough experience with use of Fenofibrate during pregnancy, you should use Fenofibrate only if your doctor considers it absolutely necessary.

It is not known whether the fenofibrate passes into breast-milk. Therefore, you should not use Fenofibrate if you are breast-feeding.

Driving and using machines

Fenofibrate has no or negligible influence on the ability to drive and use machines.

©I HOW TO TAKE FENOFIBRATE 67 mg CAPSULES

Always take Fenofibrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual initial dose is one capsule three times a day for adults, including the elderly. Your doctor may reduce your dose to two capsules a day or increase to four capsules a day depending on how you respond to treatment.

If you have impaired kidney function

Your doctor will prescribe a lower dose. Other strengths and pharmaceutical forms of fenofibrate are available for doses not realisable/practicable with this medicinal product.

Children

The dose for children is lower than the adult dose. Your doctor will work out the correct

Top of page cut-off to middle of registration mark: 44 mm.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

dose depending on the child's body weight. Ask your doctor or pharmacist if you would like more details. Other strengths and pharmaceutical forms of fenofibrate are available for doses not realisable/practicable with this medicinal product.

Method of administration

Oral use.

Swallow the capsules whole with water. It is important to take the capsules with food, as they won't work as well if your stomach is empty.

To treat your raised blood cholesterol levels, you must follow the dietary recommendations given to you by your doctor while taking this medicine.

Duration of treatment

Do not forget that for fenofibrate to be effective, it needs to be taken very regularly, and for as long as your doctor has recommended, even if this duration is a very long time. Do not stop taking this medicine unless your doctor has told you to.

If you take more Fenofibrate than you should

If you accidentally take too many capsules, or you think that a child has swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Fenofibrate

If you forget to take Fenofibrate, take it with your next meal, unless it is time to take your next dose: do not take a double dose to make up for a forgotten one.

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

*4 POSSIBLE SIDE EFFECTS

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

The following side effects are important and will require immediate action if you

experience them. You should stop taking Fenofibrate and see your doctor immediately if the following symptoms occur:

Very rare side effects (may affect up to 1 in 10 000 people):

•    Muscle wasting or inflammation and tenderness that may progress to become a serious, potentially life-threatening condition (called 'rhabdomyolysis').

Rare side effects (may affect up to 1 in 1 000 people):

•    Muscle weakness or pain.

The following side effects have also been reported.

Common (may affect up to 1 in 10 people):

•    Digestive disorders such as abdominal pain, nausea (feeling sick), vomiting (being sick), diarrhoea, flatulence

•    Alterations in blood test results that show how your liver is working.

Uncommon (may affect up to 1 in 100 people):

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

•    Skin rashes, itching, hives, photosensitivity reactions (sensitivity to sunlight, sunlamps or sunbeds)

•    Blood clots in the veins (deep vein thrombosis) or in the arteries of the lung (pulmonary embolism)

•    Gallstones.

Rare (may affect up to 1 in 1 000 people):

•    Alterations in blood test results that show how your kidneys are working

•    Reduced levels of haemoglobin (oxygen-carrying pigment in blood) and white blood cells

•    Headache, dizziness, reduced sex drive, tiredness

•    Hair loss.

Very rare (may affect up to 1 in 10 000 people):

•    Chronic lung disease causing breathlessness (interstitial pneumopathy)

•    Inflammation of the liver (hepatitis), which may produce jaundice (yellowing of the skin and whites of the eyes), abdominal pain and itching.

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.

HOW TO STORE FENOFIBRATE 67 mg CAPSULES

•    Keep out of the reach and sight of children.

•    Do not use Fenofibrate 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.

•    Store in the original package in order to protect from light. Keep the blister in the outer carton.

•    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.

©I CONTENTS OF THE PACK AND OTHER INFORMATION

What Fenofibrate 67 mg Capsules contain

• The active substance is fenofibrate. One hard-gelatin capsule contains 67 mg fenofibrate.

• The other ingredients are sodium laurilsulfate, povidone, pregelatinised maize starch, crospovidone, croscarmellose sodium, sodium starch glycolate (potato origin), colloidal silica anhydrous and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide (E171), quinoline yellow and iron oxide yellow (E172) and edible printing ink containing shellac, iron oxide black, polypropylene glycol.

What Fenofibrate 67 mg Capsules look like and contents of the pack

• Hard-gelatin capsule:

Hard-gelatin capsule with opaque yellow cap and body, filled with white to off-white powder, with small agglomerates, imprinted FM67 on both cap and body • Pack sizes of 1, 28, 30, 50, 60, 84, 90 or 100 hard-gelatin capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Teva UK Limited, Eastbourne, BN22 9AG This leaflet was last revised in May 2015.

PL 00289/1158

TTWTI    87791-C

TEVA UK LIMITED    160 x 323

This is a representation of an electronic record that was signed electronically and this

PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE