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FENOFIBRATE 160 MG FILM-COATED TABLETS

Active substance(s): FENOFIBRATE / FENOFIBRATE

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Package leaflet: Information for the user
Fenofibrate 160 mg Film-coated Tablets
Fenofibrate
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.

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. Take this leaflet or some film-coated tablets with you so your doctor will know what
you have taken.
If you forget to take Fenofibrate
− If you forget a dose, take the next dose with your next meal.
− Then take your next film-coated tablet at the normal time.
− Do not take a double dose to make up for a forgotten dose.
If you are worried about this talk to your doctor.
If you stop taking Fenofibrate
Do not stop taking fenofibrate unless your doctor tells you to, or the film-coated tablets make you feel unwell. This
is because abnormal levels of fats in the blood need treating for a long period of time.

What is in this leaflet
1. What Fenofibrate is and what it is used for
2. What you need to know before you take Fenofibrate
3. How to take Fenofibrate
4. Possible side effects
5. How to store Fenofibrate
6. Contents of the pack and other information

Remember that as well as taking fenofibrate it is also important that you:
− have a low fat diet
− take regular exercise.

1. What Fenofibrate is and what it is used for

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

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.

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:

Fenofibrate 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.
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.
2. What you need to know before you take Fenofibrate
Do not take Fenofibrate:
− if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6).
− while taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light
(these medicines include other fibrates and an anti-inflammatory medicine called ‘ketoprofen’)
− 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 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 before taking fenofibrate if:
− you have any liver 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 (hypo-thyroidism).
− you have kidney disease.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking fenofibrate.
Effects on muscles
Stop taking fenofibrate and see a doctor straight away if you get unexplained cramps or painful, tender or weak
muscles while taking this medicine.
− 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.
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. 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 problems 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.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking fenofibrate.
Other medicines and Fenofibrate
Tell your doctor or pharmacist if you are using, have recently used or might use 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 fat levels in the blood (such as, statins or fibrates). Taking a statin at the same
time as fenofibrate may increase the risk of muscle problems.
− a particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)
− ciclosporin (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 and 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.
As there is not enough experience with the use of fenofibrate during pregnancy, you should use fenofibrate only,
if your doctor considers it absolutely necessary.
It is not known, whether the active substance in fenofibrate passes into breast milk. Therefore, you should not use
fenofibrate if you are breastfeeding or planning to breast-feed your baby.
Driving and using machines
This medicine will not affect you being able to drive or use tools or machines.
Fenofibrate contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product
3. How to take Fenofibrate

If your doctor stops your medicine, do not keep any left over film-coated 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

− allergic reaction - the signs may include swelling of the face, lips, tongue or throat, which may cause
difficulty in breathing.
− 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).
− 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).
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.
Uncommon (may affect up to 1 in 100 people):
− headache
− gallstones
− reduced sex drive
− urticaria (hives) and rash
− increase in creatinine (produced by the kidneys) – shown in tests
− pancreatitis (inflammation of the pancreas leading to abdominal pain)
− thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and breathlessness),
deep vein thrombosis (blood clot in the leg causing pain, redness or swelling)
− muscle pain, muscle inflammation, muscle cramps and weakness.
Rare (may affect up to 1 in 1,000 people):
− hair loss
− feeling dizzy (vertigo)
− feeling exhausted (fatigue)
− increase in urea (produced by the kidneys) – shown in tests
− increased sensitivity of your skin to sunlight, sun lamps and sunbeds
− drop in haemoglobin (that carries oxygen in blood) and white blood cells – shown in tests
− hepatitis (inflammation of the liver), symptoms of which may be mild jaundice (yellowing of the skin and
whites of the eyes), stomach pain and itching
− hypersensitivity (allergic reaction).
Not known (frequency cannot be estimated from the available data):
− severe form of skin rash with reddening, peeling and swelling of the skin that resembles severe burns
− long-term lung problems
− muscle breakdown
− complications of gallbladder stones.
− If you get any unusual breathing discomfort, tell your doctor straight away.
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fenofibrate
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fenofibrate contains
The active substance is fenofibrate (micronised). Each film-coated tablet contains 160 mg fenofibrate.
The other ingredients are lactose monohydrate, crospovidone (type B), sodium laurilsulfate, povidone K 30,
croscarmellose sodium, silicified microcrystalline cellulose (comprising cellulose microcrystalline and silica,
colloidal anhydrous), sodium stearyl fumarate, polyvinyl alcohol, macrogol 4000, talc, titanium dioxide
(E 171).
What Fenofibrate looks like and contents of the pack
Fenofibrate 160 mg Film-coated Tablets are white to off-white, oval shaped, biconvex, film-coated tablets,
debossed with “160” on one side and plain on the other side. They are about 18.50 mm in length and about 8.90
mm in width.

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.

Fenofibrate 160 mg Film-coated Tablets are supplied in blisters packed in cartons containing 10, 20, 28, 30, 50,
84, 90, 98 and 100 film-coated tablets.

Taking this medicine
Swallow the film-coated tablet with
− a glass of water.
− Do not crush or chew the film-coated tablet.
− Take the film-coated tablet with food - it will not work as well if your stomach is empty.

Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way,
Crawley, West Sussex
RH11 7XA
United Kingdom
And
Manufacturer
Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Germany

Patients with kidney problems
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 fenofibrate is not recommended in children and adolescents under 18 years of age.

This leaflet was last revised in 04/2017.

8063915-7803

How much to take
The recommended dose is one film-coated tablet a day.
If you are currently taking one capsule of 200 mg fenofibrate, you can change to one film-coated tablet of
fenofibrate.

Not all pack sizes may be marketed.

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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