PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Fibrazate® XL 400 mg Modified Release Tablets

(Bezafibrate)

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, pharmacist or nurse.

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Fibrazate XL is and what it is used for

2.    What you need to know before you take Fibrazate XL

3.    How to take Fibrazate XL

4.    Possible side effects

5.    How to store Fibrazate XL

6.    Contents of the pack and other information

1

What Fibrazate XL is and what it is used for

Fibrazate XL 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. Fibrazate XL 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.

What you need to know before you take Fibrazate XL

Do not take Fibrazate XL and tell your doctor if you:

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

•    are allergic to fibrates or you have developed a sensitivity to sunlight or artifical light (e.g. sunbeds) while taking these medicines.

•    are taking statins (e.g. atorvastatin) and have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):

-    impaired kidney function

-    an underactive thyroid (hypothyroidism)

-    severe infection

-    trauma

-    surgery

-    a change in the levels of hormones or chemicals in your body (seen in a blood test)

-    a high alcohol intake.

•    are having dialysis.

•    have liver disease.

•    have gall bladder disease.

•    have nephrotic syndrome (a kidney disorder).

•    have impaired kidney function.

-    severe infection

-    trauma

-    surgery

-    a change in the levels of hormones or chemicals in your body (seen in a blood test)

-    a high alcohol intake.

-    are older people (over 65 years old)

-    have a family history of muscle disease.

• are diabetic.

Other medicines and Fibrazate XL

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

•    coumarins or anticoagulants e.g. warfarin or low dose aspirin (used to prevent blood clotting)

•    antidiabetic medicines such as insulin (used in diabetes)

•    ciclosporin (used to suppress the immune system)

•    anion exchange resins such as colestipol or cholestyramine (used to lower cholesterol). FibrazateXL and an anion exchange resin should not be taken within 2 hours of each other

•    statins e.g. atorvastatin (used to lower cholesterol)

•    monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in depression)

•    oestrogen or medicines which contain oestrogen.

Pregnancy and breast-feeding

Fibrazate XL 400mg Tablets should not be taken 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.

Driving and using machines

Fibrazate XL may make you feel dizzy. Make sure you are not affected before you drive or operate machines.

Tests

If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fibrazate XL if you:

• have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):

-    impaired kidney function

-    an underactive thyroid (hypothyroidism)

3

How to take Fibrazate XL

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

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Swallow the tablets whole with a glass of water, after food in the morning or evening.

in the levels of certain enzymes within the blood (seen in a blood test), increased blood levels of creatinine.

FibrazateXL and an anion exchange resin should not be taken within 2 hours of each other.

The recommended dose is:

Adults: One tablet a day (400 mg bezafibrate a day).

Your doctor may prescribe a different dose depending on your condition. You should always follow your doctor’s instructions on taking your medicine. Your pharmacist may also help if you are not sure.

Older people: Your doctor may reduce the dose depending on how well your kidneys are working.

Children and adolescents: Not recommended.

Impaired kidney function: Do not take FibrazateXL if you have impaired kidney function or are having dialysis.

If you take more Fibrazate XL than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

Signs of an overdose include abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems (rhabdomyolysis).

If you forget to take Fibrazate XL

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. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fibrazate XL

Do not stop taking your medicine without consulting your doctor. While taking FibrazateXL 400 mg Tablets, it is important that you continue to follow any special diet you may have been given. Your doctor may want to monitor your response to treatment and you should make sure that you keep any follow-up appointments. If you have not had a significant response to the treatment after 3 or 4 months, your doctor may decide to stop your medicine.

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

Damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis), depression, difficulty sleeping.

Very rare (may affect up to1 in 10,000 people):

Inflammation in the lungs (interstitial lung disease), decreased levels of platelets in the blood causing a disorder characterised by blood spots bruising and discolouration of the skin (thrombocytopenia purpura), decreased levels of the red blood pigment haemoglobin, increased levels of certain enzymes within the body (seen in blood tests), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome), severe rash involving reddening, peeling and swelling of the skin that resemble severe burns (Toxic epidermal necrolysis), changes in the number and types of your 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.

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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

How to store Fibrazate XL

4 Possible side effects

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

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store these tablets above 30°C.

If you notice any visible signs of deterioration in your medicine such as broken or chipped tablets, take it to your pharmacist for advice.

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.

Stop taking Fibrazate® XL and contact your doctor immediately if you notice signs of:

•    an allergic reaction (hypersensitivity):

swelling of the face, lips, tongue or throat, itchy skin rash or narrowing of the airways causing difficulty breathing or swallowing.

•    gallstones: pain in the upper abdomen, or yellowing of the eyes or skin (jaundice).

•    abnormal muscle breakdown (rhabdomyolysis):

muscle pain or weakness, swelling.

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

Decreased appetite, stomach disorders.

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

Dizziness, headache, feeling bloated, feeling sick, diarrhoea, stomach pain, constipation, indigestion, blocked bile flow (cholestasis), itching, pale or red irregular raised patches with severe itching (hives), rash, sensitive to sunlight or artificial light (e.g. sunbeds), hair loss (alopecia), muscle weakness, cramp or pain (myalgia), acute kidney failure, erection problems, changes

Contents of the pack and other information

What Fibrazate XL contains

•    The active substance is bezafibrate. Each tablet contains 400mg of the active substance.

•    The other ingredients are polyethylene oxide, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol 4000 and titanium dioxide (E171).

What Fibrazate XL look like and contents of the pack

Each modified release tablet is a white round film coated, biconvex tablet marked ‘400’ on one face, which contains 400mg bezafibrate. Fibrazate XL is supplied in packs of 28 and 30 tablets.

Marketing authorisation holder and manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 09/2015.    SZ00000LT000