FENOFIBRATE VIATRIS
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
FENOFIBRATE VIATRIS contains the active ingredient fenofibrate. FENOFIBRATE VIATRIS
is used to help regulate cholesterol and triglycerides which are fat-like substances
in the blood.
For more information, see Section 1. Why am I using FENOFIBRATE VIATRIS? in the full CMI.
For more information, see Section 1. Why am I using FENOFIBRATE VIATRIS? in the full CMI.
Do not use if you have ever had an allergic reaction to fenofibrate or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use FENOFIBRATE VIATRIS? in the full CMI.
For more information, see Section 2. What should I know before I use FENOFIBRATE VIATRIS? in the full CMI.
Some medicines may interfere with FENOFIBRATE VIATRIS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
The initial recommended dose is 145 mg daily, taken as 1 x 145 mg tablet, your doctor
may prescribe a lower dose if you have kidney problems.
More instructions can be found in Section 4. How do I use FENOFIBRATE VIATRIS? in the full CMI.
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Things you should do
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Remind any doctor, surgery, dentist or pharmacist you visit that you are using this
medicine.
Tell you doctor if you have these medical conditions: kidney problems, muscular aching,
tenderness or weakness not caused by exercise.
Tell your doctor if you become pregnant.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not take this medicine if you have an allergy to any fibrates (such as gemfibrozil)
and ketoprofen.
Do not take this medicine if you are pregnant or breastfeeding.
Do not take this medicine if you have liver disease, severe kidney disease, disease
of the gallbladder or pancreas, experienced muscle pain, tenderness or weakness from
other medicines used to treat high cholesterol or triglycerides.
Do not take this medicine if you are taking another fibrate.
Do not take this medicine if you are allergic to peanuts, peanut oil, soy lecithin
or related products.
Do not give FENOFIBRATE VIATRIS to anyone under the age of 18 years.
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Driving or using machines
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Be careful driving or operating machinery until you know how FENOFIBRATE VIATRIS affects
you.
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Drinking alcohol
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Avoid drinking large quantities of alcohol while you are taking this medicine.
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Looking after your medicine
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Keep the medicine in a cool, dry place where the temperature stays below 30°C.
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For more information, see Section 5. What should I know while using FENOFIBRATE VIATRIS? in the full CMI.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
FENOFIBRATE VIATRIS
Active ingredient(s):
fenofibrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using FENOFIBRATE VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using FENOFIBRATE VIATRIS.
Where to find information in this leaflet:
FENOFIBRATE VIATRIS contains the active ingredient fenofibrate. FENOFIBRATE VIATRIS belongs to a group of medicines known as fibric acid derivatives.
FENOFIBRATE VIATRIS works through the activation of a cell nuclear receptor called
PPARα, which reduces the amount of triglycerides and bad cholesterol made in the body
and increases the good cholesterol.
Cholesterol is present in many foods and is also made in your body by the liver. If
your body does not balance the amount of cholesterol it needs with the amount of cholesterol
eaten, then your cholesterol becomes too high.
High cholesterol is more likely to occur with certain diseases or if you have a family
history of high cholesterol.
When you have high levels of cholesterol it may 'stick' to the inside of your blood
vessels instead of being carried to the parts of the body where it is needed.
Over time, this can form hard areas (called plaque) on the walls of your blood vessels,
making it more difficult for the blood to flow. This blocking of your blood vessels
can lead to heart disease (such as heart attack and angina), and stroke.
Cholesterol is carried through the body by different proteins, LDL and HDL. LDL cholesterol
is the 'bad' cholesterol that can block your blood vessels. HDL cholesterol is the
'good' cholesterol that is thought to remove the 'bad' cholesterol from the blood
vessels.
In most patients, FENOFIBRATE VIATRIS reduces the bad cholesterol and can actually
raise the good cholesterol.
Patients with type 2 diabetes may have some level of diabetic retinopathy, a complication
of diabetes that may lead to vision loss or impairment. FENOFIBRATE VIATRIS has been
shown to slow the progression of diabetic retinopathy in patients diagnosed with this
condition.
FENOFIBRATE VIATRIS does not reduce the cholesterol that comes from fat in food.
Therefore, when you are taking FENOFIBRATE VIATRIS, you also need to follow a low
fat diet and other measures, such as exercise and weight control.
FENOFIBRATE VIATRIS is used to help regulate cholesterol and triglycerides which are
fat-like substances in the blood.
Do not use FENOFIBRATE VIATRIS if:
you are allergic to fenofibrate, any fibrates (such as gemfibrozil) or any of the
ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath
or swelling of the face, lips or tongue, which may cause difficulty in swallowing
or breathing.
Always check the ingredients to make sure you can use this medicine.
you are taking another fibrate.
you are allergic to peanuts, peanut oil, soy lecithin or related products.
it after the expiry date printed on the pack or if the packaging is damaged or shows
signs of tampering.
Check with your doctor if you:
have any other medical conditions:
liver disease
severe kidney disease
disease of the gallbladder or pancreas
experienced muscle pain, tenderness or weakness from other medicines used to treat
high cholesterol or triglycerides.
take any medicines for any other condition.
have any allergies to any other medicines, foods, preservatives or dyes.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
It may affect your developing baby if you take it during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in FENOFIBRATE VIATRIS passes into breast milk and there is
a possibility your baby may be affected.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with FENOFIBRATE VIATRIS and affect how it works.
oral anti-coagulants (medicines used to prevent blood clots)
other cholesterol regulating medicines including fibrates
ciclosporin (a medicine which suppresses the immune system)
glitazones (medicines to reduce sugar levels)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FENOFIBRATE VIATRIS.
How much to take
The initial recommended dose is 145 mg daily, taken as 1 x 145 mg tablet, your doctor
may prescribe a lower dose if you have kidney problems.
Swallow the tablet(s) whole with a full glass of water.
Follow the instructions provided and use FENOFIBRATE VIATRIS until your doctor tells
you to stop.
When to take FENOFIBRATE VIATRIS
FENOFIBRATE VIATRIS can be taken at any time of the day, with or without food. Any
dietary measures started before treatment with FENOFIBRATE VIATRIS should be continued.
If you forget to use FENOFIBRATE VIATRIS
FENOFIBRATE VIATRIS should be used regularly at the same time each day. If you miss
your dose at the usual time, take it as soon as you remember, and then go back to
taking your medicine as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of getting an unwanted side effect.
If you use too much FENOFIBRATE VIATRIS
If you think that you have used too much FENOFIBRATE VIATRIS, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) or advice, or
(Australia telephone 13 11 26) or advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
Symptoms of an overdose may include:
diarrhoea
nausea
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Have your blood fats checked when requested by your doctor to make sure FENOFIBRATE
VIATRIS is working.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking FENOFIBRATE VIATRIS.
Call your doctor straight away if you:
become pregnant while you are taking this medicine.
Remind any doctor, surgery, dentist or pharmacist you visit that you are using FENOFIBRATE
VIATRIS.
Things you should not do
Do not stop using this medicine suddenly.
Do not use this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not give FENOFIBRATE VIATRIS to anyone under the age of 18 years.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FENOFIBRATE
VIATRIS affects you.
FENOFIBRATE VIATRIS may cause dizziness in some people
Drinking alcohol
Tell your doctor if you drink alcohol.
Drinking large quantities of alcohol may increase your chance of FENOFIBRATE VIATRIS
causing liver problems.
Things that may help you reduce the chance of coronary heart disease
Lowering high cholesterol can help reduce your chances of having Coronary Heart Disease
(CHD). However, your chances of having CHD may be increased by several other factors
including high blood pressure, cigarette smoking, diabetes, excess weight, family
history of CHD, being a male and being a woman who has reached menopause.
Some self-help measures suggested below may help your condition and help reduce your
chances of having CHD. Talk to your doctor, pharmacist, or dietician about these measures
and for more information.
Diet - continue the healthy diet recommended by your doctor, dietician or pharmacist.
Weight - your doctor may advise you to lose weight if you are overweight.
Exercise - make exercise a part of your routine - walking is good. Ask your doctor
for advice before starting exercise.
Smoking - your doctor will advise you to stop smoking.
Looking after your medicine
Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the box or the blister pack they may not keep well.
Keep the medicine in a cool, dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine (as relevant)
If your doctor or pharmacist tells you to stop taking this medicine, or the medicine
has passed its expiry date, ask your pharmacist what to do with any that are left
over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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stomach pain or discomfort
back pain
headache
muscular pain or spasms
unusual tiredness or weakness
diarrhoea or constipation
nausea
skin reactions, photosensitivity reactions
sexual dysfunction
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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difficulty in breathing
severe abdominal pain
chest pain
temporary paralysis of the muscles
yellowing of the skin and eyes and dark coloured urine
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What FENOFIBRATE VIATRIS contains
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Active ingredient
(main ingredient)
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fenofibrate
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Other ingredients
(inactive ingredients)
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sucrose
hypromellose
sodium lauryl sulfate
lactose monohydrate
crospovidone
microcrystalline cellulose
colloidal anhydrous silica
docusate sodium
magnesium stearate
polyvinyl alcohol
titanium dioxide
purified talc
lecithin
xanthan gum
In addition to the ingredients listed above the 48 mg tablet also contains:
indigo carmine aluminium lake
quinoline yellow aluminium lake
sunset yellow FCF aluminium lake
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Potential allergens
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contains soya bean products, sulfites and sugars as lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What FENOFIBRATE VIATRIS looks like
FENOFIBRATE VIATRIS 48 mg (AUST R 230444) - yellow, oval, film-coated tablet engraved
with "FI" on one side.
Available in boxes of 60 tablets.
FENOFIBRATE VIATRIS 145 mg (AUST R 230443) - white, oval, film-coated tablet engraved
"145" on one side and "Fournier logo" on the reverse.
Available in boxes of 30 tablets.
