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FENOFIBRATE 160MG TABLETS

Active substance(s): FENOFIBRATE / FENOFIBRATE / FENOFIBRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SUPRALIP® 160MG TABLETS
(fenofibrate)

This leaflet is for Supralip 160mg Tablets which will be
referred to as Supralip throughout this leaflet.

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

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Supralip is and what it is used for
What you need to know before you take Supralip
How to take Supralip
Possible side effects
How to store Supralip
Contents of the pack and other information

1. What Supralip is and what it is used for
Supralip 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.
Supralip is used, alongside a low fat diet and other nonmedical treatments such as exercise and weight loss, to lower
levels of fats in the blood.
Supralip 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.

Your doctor may do a blood test to check your muscles before
and after starting treatment.
The risk of muscle breakdown is higher in some patients. In
particular, tell your doctor if:

you are over 70 years old

you have kidney problems

you have thyroid problems

you or a close family member has muscle problem which
runs in the family

you drink large amounts of alcohol

you are taking medicines called statins to lower
cholesterol (such as simvastatin, atorvastatin,
pravastatin, rosuvastatin or fluvastatin)

you have ever had muscle problems during treatment
with statins or fibrates (such as fenofibrate, bezafibrate
or gemfibrozil).









you are allergic to fenofibrate or any of the other
ingredients of this medicine (listed in Section 6:
Contents of the pack and other information)
you are allergic to peanut or arachis oil or soya lecithin
or related products
while taking other medicines (such as other fibrates or
an anti-inflammatory medicine called ‘Ketoprofen’), you
have had an allergic reaction or skin damage from
sunlight or UV light
you have severe liver, kidney or gallbladder problems
you have pancreatitis (an inflamed pancreas which
causes abdominal pain) which is not caused by high
levels of fat in the blood.

Do not take Supralip if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking
Supralip.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking
Supralip if:

you have any liver or kidney problems

you may have an inflamed liver (hepatitis) - signs
include yellowing of the skin and the whites of the eyes
(jaundice), an increase in liver enzymes (shown in blood
tests), stomach pain and itching

you have an under-active thyroid gland
(hypothyroidism).
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Supralip.

Supralip and effects on muscles

Stop taking Supralip and see a doctor straight away if you get

unexplained cramps

painful, tender or weak muscles.
This is because this medicine may cause muscle problems,
which may be serious. These problems are rare but include
muscle inflammation and breakdown. This can cause kidney
damage or even death.

If you have kidney problems, your doctor may tell you to take
a lower dose. Ask your doctor or pharmacist about this.

Use in children and adolescents

The use of Supralip is not recommended in children and
young people under 18 years of age.

If you take more Supralip than you should

If you take more Supralip than you should or if someone else
has taken your medicine, tell your doctor or contact your
nearest hospital.

If you forget to take Supralip

If any of the above apply to you (or you are not sure), talk to
your doctor before taking Supralip.

If you forget to take a dose, take the next dose with
your next meal

Then take the next dose at the usual time

Do not take a double dose to make up for a forgotten
dose.
If you are worried about this talk to your doctor.

Other medicines and Supralip

If you stop taking Supralip

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:

anti-coagulants to thin your blood (such as warfarin)

other medicines to control levels of fat in the blood
(such as, statins or fibrates). This is because
taking a statin or another fibrate in addition to Supralip
may increase the risk of muscle problems

a particular class of medicines to treat diabetes (such as
rosiglitazone or pioglitazone)

cyclosporin (an immunosuppressant).
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Supralip.

Pregnancy, breast-feeding and fertility




2. What you need to know before you take
Supralip
Do not take Supralip if:

People with kidney problems

Tell your doctor if you are pregnant, think you may be
pregnant or are planning to have a baby. This is because
it is not known how Supralip may affect your unborn
baby. You should only use Supralip if your doctor tells
you to
Do not use Supralip if you are breast-feeding or planning
to breast-feed your baby. This is because it is not known
whether Supralip passes into human milk.

Driving and using machines

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

Supralip contains lactose monohydrate and
soybean lecithin




Supralip contains sugar called lactose monohydrate.
If you have been told by your doctor that you cannot
tolerate or digest some sugars (have an intolerance),
talk to your doctor before taking this medicine
Supralip contains soybean lecithin. If you are allergic to
peanuts, arachis oil or soya, do not take this medicine.



Do not stop taking Supralip unless your doctor tells you to, or
the tablets make you feel unwell. This is because you require
long-term treatment.
If your doctor stops your medicine, do not keep any leftover
tablets unless your doctor tells you to.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Supralip and see a doctor straight away, if
you notice any of the following serious side effects –
you may need urgent medical treatment:

Uncommon: may affect up to 1 in 100 people






cramps or painful, tender or weak muscles - these may
be signs of muscle inflammation or breakdown, which
can cause kidney damage or even death
stomach pain - this may be a sign that your pancreas is
inflamed (pancreatitis)
chest pain and feeling breathless - these may be signs
of a blood clot in the lung (pulmonary embolism)
pain, redness or swelling in the legs - these may be
signs of a blood clot in the leg (deep vein thrombosis).

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




allergic reaction - the signs may include swelling of the
face, lips, tongue or throat, which may cause difficulty in
breathing
yellowing of the skin and whites of the eyes (jaundice),
or an increase in liver enzymes - these may be signs of
an inflamed liver (hepatitis).

Not known: it is not known how often these happen


severe skin rash which reddens, peels and swells and
looks like a severe burn
long-term lung problems.

3. How to take Supralip



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

Stop taking Supralip and see a doctor straight away, if you
notice any of the side effects above.

Your doctor will determine the appropriate strength for you,
depending on your condition, your current treatment and
your personal risk status.

Taking this medicine

Take the tablet with food – it will not work as well if your
stomach is empty.

Swallow the tablet with a glass of water

Do not crush or chew the tablet.

Other side effects include:
Common: may affect up to 1 in 10 people








Remember that as well as taking Supralip, it is also important
that you:

have a low fat diet

take regular exercise.

diarrhoea
stomach pain
wind (flatulence)
feeling sick (nausea)
being sick (vomiting)
raised levels of liver enzymes in the blood – shown in
tests
increase in homocysteine (too much of this amino acid
in the blood has been associated to a higher risk of
coronary heart disease, stroke and peripheral
vascular disease, although a causal link has not been
established).

Uncommon: may affect up to 1 in 100 people

How much to take

The recommended dose is one tablet a day.
If you are already taking one capsule of Lipantil Micro 200mg,
you can change to one tablet of Supralip 160mg. You will still
receive the same amount of medicine.

Page 1 of 2







headache
gallstones
reduced sex drive
rash, itching or red patches on the skin
increase in creatinine (produced by the kidneys) –
shown in tests.

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






hair loss
increase in urea (produced by the kidneys) – shown in
tests
skin is more sensitive to sunlight, sun lamps and
sunbeds
drop in haemoglobin (that carries oxygen in blood) and
white blood cells – shown in tests.

Not known: it is not known how often these happen





muscle breakdown
complications of gallbladder stones
feeling exhausted (fatigue).

Tell your doctor or pharmacist if you notice any of the
side effects listed above.

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.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name:
Supralip 160mg Tablets
Reference No: 08929/0284

By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Supralip










Do not store above 30°C. Store in the original package.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and the blister after EXP. The
expiry date refers to the last day of that month.
Take any tablets that are out of date, or which you no
longer need, back to your pharmacist. Only keep them if
your doctor tells you to.
If your tablets appear to be discoloured or show any
other signs of deterioration, please contact your
pharmacist who will advise you.
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 to protect the environment.

6. Contents of the pack and other
information
What Supralip contains

Each tablet contains 160mg of micronised fenofibrate.
This is the active ingredient.
Each tablet also contains the following inactive ingredients:
sodium laurilsulfate, lactose monohydrate, povidone,
crospovidone, microcrystalline cellulose,
colloidal anhydrous silica, sodium stearyl fumarate.
The tablet coating consists of polyvinyl alcohol,
titanium dioxide (E171), talc, soybean lecithin and
xanthan gum.

What Supralip looks like and contents of the pack

Supralip are white, oblong, film-coated tablets engraved
“160” on one side and “Fournier logo” on the reverse.
Supralip is available in packs of 30 tablets.

Manufacturer

Supralip are manufactured by:
Recipharm Fontaine, 21121 Fontaine les Dijon, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0284

POM

Leaflet revision & issue date (Ref): 26.06.17
Supralip® is a registered trademark of
BGP Products Operations GmbH.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

FENOFIBRATE 160MG TABLETS
This leaflet is for Fenofibrate 160mg Tablets which will be
referred to as Fenofibrate throughout this leaflet.

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

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Fenofibrate is and what it is used for
What you need to know before you take Fenofibrate
How to take Fenofibrate
Possible side effects
How to store Fenofibrate
Contents of the pack and other information

1. 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 nonmedical treatments such as exercise and weight loss, to lower
levels of fats in the blood.

Your doctor may do a blood test to check your muscles before
and after starting treatment.
The risk of muscle breakdown is higher in some patients. In
particular, tell your doctor if:

you are over 70 years old

you have kidney problems

you have thyroid problems

you or a close family member has muscle problem which
runs in the family

you drink large amounts of alcohol

you are taking medicines called statins to lower
cholesterol (such as simvastatin, atorvastatin,
pravastatin, rosuvastatin or fluvastatin)

you have ever had muscle problems during treatment
with statins or fibrates (such as fenofibrate, bezafibrate
or gemfibrozil).

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:

anti-coagulants to thin your blood (such as warfarin)

other medicines to control levels of fat in the blood
(such as, statins or fibrates). This is because
taking a statin or another fibrate in addition to
Fenofibrate may increase the risk of muscle problems

a particular class of medicines to treat diabetes (such as
rosiglitazone or pioglitazone)

cyclosporin (an immunosuppressant).
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Fenofibrate.

Pregnancy, breast-feeding and fertility


Tell your doctor if you are pregnant, think you may be
pregnant or are planning to have a baby. This is because
it is not known how Fenofibrate may affect your unborn
baby. You should only use Fenofibrate if your doctor tells
you to
Do not use Fenofibrate if you are breast-feeding or
planning to breast-feed your baby. This is because it is
not known whether Fenofibrate passes into human milk.

Driving and using machines




Do not take Fenofibrate if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Fenofibrate.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking
Fenofibrate if:

you have any liver or kidney problems

you may have an inflamed liver (hepatitis) - signs
include yellowing of the skin and the whites of the eyes
(jaundice), an increase in liver enzymes (shown in blood
tests), stomach pain and itching

you have an under-active thyroid gland
(hypothyroidism).
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Fenofibrate.

Fenofibrate and effects on muscles

Stop taking Fenofibrate and see a doctor straight away if
you get

unexplained cramps

painful, tender or weak muscles.
This is because this medicine may cause muscle problems,
which may be serious. These problems are rare but include
muscle inflammation and breakdown. This can cause kidney
damage or even death.

If you take more Fenofibrate than you should

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

If you forget to take Fenofibrate

If you stop taking Fenofibrate

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

Do not take Fenofibrate if:



The use of Fenofibrate is not recommended in children and
young people under 18 years of age.

Other medicines and Fenofibrate





Use in children and adolescents

If any of the above apply to you (or you are not sure), talk to
your doctor before taking Fenofibrate.

2. What you need to know before you take
Fenofibrate
you are allergic to fenofibrate or any of the other
ingredients of this medicine (listed in Section 6:
Contents of the pack and other information)
you are allergic to peanut or arachis oil or soya lecithin
or related products
while taking other medicines (such as other fibrates or
an anti-inflammatory medicine called ‘Ketoprofen’), you
have had an allergic reaction or skin damage from
sunlight or UV light
you have severe liver, kidney or gallbladder problems
you have pancreatitis (an inflamed pancreas which
causes abdominal pain) which is not caused by high
levels of fat in the blood.

If you have kidney problems, your doctor may tell you to take
a lower dose. Ask your doctor or pharmacist about this.

If you forget to take a dose, take the next dose with
your next meal

Then take the next dose at the usual time

Do not take a double dose to make up for a forgotten
dose.
If you are worried about this talk to your doctor.

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.



People with kidney problems

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

Fenofibrate contains lactose monohydrate and
soybean lecithin




Fenofibrate contains sugar called lactose monohydrate.
If you have been told by your doctor that you cannot
tolerate or digest some sugars (have an intolerance),
talk to your doctor before taking this medicine
Fenofibrate contains soybean lecithin. If you are allergic
to peanuts, arachis oil or soya, do not take this
medicine.

3. How to take Fenofibrate
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will determine the appropriate strength for you,
depending on your condition, your current treatment and
your personal risk status.

Taking this medicine

Take the tablet with food – it will not work as well if your
stomach is empty.

Swallow the tablet with a glass of water

Do not crush or chew the tablet.
Remember that as well as taking Fenofibrate, it is also
important that you:

have a low fat diet

take regular exercise.

How much to take

The recommended dose is one tablet a day.
If you are already taking one capsule of Lipantil Micro 200mg,
you can change to one tablet of Fenofibrate 160mg. You will
still receive the same amount of medicine.

Page 1 of 2



Do not stop taking Fenofibrate unless your doctor tells you to,
or the tablets make you feel unwell. This is because you
require long-term treatment.
If your doctor stops your medicine, do not keep any leftover
tablets unless your doctor tells you to.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Fenofibrate and see a doctor straight away,
if you notice any of the following serious side effects –
you may need urgent medical treatment:

Uncommon: may affect up to 1 in 100 people






cramps or painful, tender or weak muscles - these may
be signs of muscle inflammation or breakdown, which
can cause kidney damage or even death
stomach pain - this may be a sign that your pancreas is
inflamed (pancreatitis)
chest pain and feeling breathless - these may be signs
of a blood clot in the lung (pulmonary embolism)
pain, redness or swelling in the legs - these may be
signs of a blood clot in the leg (deep vein thrombosis).

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




allergic reaction - the signs may include swelling of the
face, lips, tongue or throat, which may cause difficulty in
breathing
yellowing of the skin and whites of the eyes (jaundice),
or an increase in liver enzymes - these may be signs of
an inflamed liver (hepatitis).

Not known: it is not known how often these happen



severe skin rash which reddens, peels and swells and
looks like a severe burn
long-term lung problems.

Stop taking Fenofibrate and see a doctor straight away, if you
notice any of the side effects above.

Other side effects include:
Common: may affect up to 1 in 10 people








diarrhoea
stomach pain
wind (flatulence)
feeling sick (nausea)
being sick (vomiting)
raised levels of liver enzymes in the blood – shown in
tests
increase in homocysteine (too much of this amino acid
in the blood has been associated to a higher risk of
coronary heart disease, stroke and peripheral
vascular disease, although a causal link has not been
established).

Uncommon: may affect up to 1 in 100 people






headache
gallstones
reduced sex drive
rash, itching or red patches on the skin
increase in creatinine (produced by the kidneys) –
shown in tests.

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






hair loss
increase in urea (produced by the kidneys) – shown in
tests
skin is more sensitive to sunlight, sun lamps and
sunbeds
drop in haemoglobin (that carries oxygen in blood) and
white blood cells – shown in tests.

Not known: it is not known how often these happen





muscle breakdown
complications of gallbladder stones
feeling exhausted (fatigue).

Tell your doctor or pharmacist if you notice any of the
side effects listed above.

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.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name:
Fenofibrate 160mg Tablets
Reference No: 08929/0284

By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Fenofibrate










Do not store above 30°C. Store in the original package.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and the blister after EXP. The
expiry date refers to the last day of that month.
Take any tablets that are out of date, or which you no
longer need, back to your pharmacist. Only keep them if
your doctor tells you to.
If your tablets appear to be discoloured or show any
other signs of deterioration, please contact your
pharmacist who will advise you.
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 to protect the environment.

6. Contents of the pack and other
information
What Fenofibrate contains

Each tablet contains 160mg of micronised fenofibrate.
This is the active ingredient.
Each tablet also contains the following inactive ingredients:
sodium laurilsulfate, lactose monohydrate, povidone,
crospovidone, microcrystalline cellulose,
colloidal anhydrous silica, sodium stearyl fumarate.
The tablet coating consists of polyvinyl alcohol,
titanium dioxide (E171), talc, soybean lecithin and xanthan
gum.

What Fenofibrate looks like and contents of the
pack

Fenofibrate are white, oblong, film-coated tablets engraved
“160” on one side and “Fournier logo” on the reverse.
Fenofibrate is available in packs of 30 tablets.

Manufacturer

Fenofibrate are manufactured by:
Recipharm Fontaine, 21121 Fontaine les Dijon, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0284

POM

Leaflet revision & issue date (Ref): 26.06.17

Page 2 of 2

Expand Transcript

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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