FIBRAZATE XL 400 MG MODIFIED RELEASE TABLETS

Active substance: BEZAFIBRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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 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.

2



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 elderly (over 65 years old)
- have a family history of muscle disease.
are diabetic.

Other medicines and Fibrazate XL
Tell your doctor or pharmacist 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). Fibrazate XL
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.

What you need to know before you take
Fibrazate XL

Do not take Fibrazate XL and tell your doctor if you:
• are allergic to active substance 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.

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.

test), increased blood levels of creatinine.
Rare (occurs in less than 1 in 1,000 users):
Damage to nerve endings causing tingling, pins and needles,
inflammation of the pancreas (pancreatitis), depression, difficulty
sleeping.

Fibrazate XL 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).

Very rare (occurs in less than 1 in 10,000 users):
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.

Your doctor may prescribe a different dose depending on your
condition. You should always follow your doctorʼs instructions on
taking your medicine. Your pharmacist may also help if you are
not sure.
Elderly patients: Your doctor may reduce the dose depending on
how well your kidneys are working.
Children: Not recommended.
Impaired kidney function: Do not take Fibrazate XL 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).

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.

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.

5

If you stop taking Fibrazate XL
Do not stop taking your medicine without consulting your doctor.
While taking Fibrazate XL 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.

4

How to store Fibrazate XL

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the label.
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.

Possible side effects

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 everyone gets them.
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.

6

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, purified siliceous earth, talc, hypromellose,
macrogol 4000 and titanium dioxide (E171).

Common (occurs in less than 1 in 10 users):
Decreased appetite, stomach disorders.

What Fibrazate XL look like and contents of the pack
Each modified release tablet is a white round film coated tablet
marked ʻ400ʼ on one face, which contains 400mg bezafibrate.
Fibrazate XL is supplied in packs of 30 tablets.

Uncommon (occurs in less than 1 in 100 users):
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
in the levels of certain enzymes within the blood (seen in a blood

Marketing authorisation holder and manufacturer
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, UK.
This leaflet was last revised in 08/2014.

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SZ00000LT000

Artwork Proof Box

Ref: N033: Brand alignment + QRD template update
Proof no.
007.0

Date prepared:
26/08/2014

Colours:
Black
Dimensions: 148 x 210 mm

Font size:
6pt
Fonts:
Helvetica

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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.

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