FIBRAZATE- XL 400MG MODIFIED RELEASE TABLETS

Active substance: BEZAFIBRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Fibrazate® XL 400 mg Modified Release Tablets

SZ00000LT000

(Bezafibrate)

Read all of this leaflet carefully 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. Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.

In this leaflet:
1. What Fibrazate XL is and what it is used for
2. Before you take Fibrazate XL
3. How to take Fibrazate XL
4. Possible side effects
5. How to store Fibrazate XL
6. Further 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

Before you take Fibrazate XL

Do not take Fibrazate® XL and tell your doctor if you:
• are allergic (hypersensitive) to bezafibrate or any of the
other ingredients in these tablets (see section 6).
• are allergic (hypersensitive) 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.

Take special care with Fibrazate XL
Check with 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)

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.
-

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

Pregnancy and breast-feeding
Fibrazate XL 400 mg Tablets should not be taken if you are
pregnant or breast feeding. Ask your doctor or pharmacist for
advice before taking any 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.

3

How to take Fibrazate XL

Always take Fibrazate® XL exactly as your doctor has told
you. If you are not sure, check with your doctor or
Continued on the next page >>
pharmacist.

Swallow the tablets whole with a glass of water, after food
in the morning or evening.
Fibrazate XL and an anion exchange resin should not be
taken within 2 hours of each other.
Doses:
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 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).

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.
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

Possible side effects

Like all medicines, Fibrazate® XL 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.
Tell your doctor if you notice any of the following side
effects or notice any other effects not listed.
Common: (occurs in less than 1 in 10 users):
decreased appetite.

Uncommon: (occurs in less than 1 in 100 users):
dizziness, headache, feeling bloated, feeling sick, diarrhoea,
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 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).

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.
If any side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5

How to store Fibrazate XL

Do not take Fibrazate® XL Tablets after the expiry date
shown on the label.
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.
Keep all medicines out of the reach of children. Your
medicines can harm them.

6

Further information

What Fibrazate XL contains:
The name of your medicine is Fibrazate® XL 400 mg
Modified Release Tablets. The active ingredient in it is
bezafibrate.
The other ingredients include: polyethylene oxide,
magnesium stearate, purified siliceous earth, 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
tablet marked ʻ400ʼ on one face, which contains 400 mg
bezafibrate. Fibrazate® XL is supplied in packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
This leaflet was last approved in 07/2012.

SZ00000LT000

Expand view ⇕

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.

Hide
(web2)