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FENOFIBRATE 160MG FILM-COATED TABLETS

Active substance(s): FENOFIBRATE

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TEVA UK Ref:

Version:

231-30-87688-C LEA FENOFIBRATE 160mg FC TAB TUK

4

8 May 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine.
• 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.
• 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.
IN THIS LEAFLET:

Pharma code 433 (10110010)
First bar is 105mm from the top edge of the leaflet.

1. What Fenofibrate 160 mg Film-coated
Tablets is and what it is used for
2. What you need to know before you take
Fenofibrate 160 mg Film-coated Tablets
3. How to take Fenofibrate 160 mg
Film-coated Tablets
4. Possible side effects
5. How to store Fenofibrate 160 mg
Film-coated Tablets
6. Contents of the pack and other
information

1

WHAT FENOFIBRATE 160 mg
FILM-COATED TABLETS IS AND
WHAT IT IS USED FOR

Your doctor may order regular blood tests to
monitor your liver and kidney function.
Pancreatitis (inflammation of the pancreas
leading to abdominal pain) sometimes
occurs in patients taking fenofibrate: please
refer to 'Do NOT take Fenofibrate' above,
and '4. Possible side effects' below).
Children
Fenofibrate is not recommended for children
and adolescents under 18 years because
there is not enough clinical data.
Other medicines and fenofibrate
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Especially tell your doctor or pharmacist if
you are using any of the following:
• Anti-coagulants to thin your blood (e.g.
warfarin): the risk of bleeding could be
increased
• Ciclosporin, an immuno-suppressant:
your kidney function could be affected
• Statins or fibrates, which are other
lipid-modifying medicines: the risk of
muscle problems could be increased (see
‘Warnings and precautions' above).

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 non-medical
treatments such as exercise and weight loss,
to lower levels of fats in the blood.

Taking Fenofibrate with food and drink

Warnings and precautions

This medicine contains soya lecithin. If you
are allergic to peanut or soya, do not use
this medicinal product (see 'Do not take
Fenofibrate' above).

You should take Fenofibrate during a meal,
as it won't work as well if you take it on an
empty stomach.

A high cholesterol level in your blood
(hypercholesterolaemia) requires that you
take special care, even if the high
cholesterol level does not affect the way you
YOU NEED TO KNOW BEFORE feel. You should follow the dietary
2 WHAT
YOU TAKE FENOFIBRATE 160 mg
recommendations given by your doctor
FILM-COATED TABLETS
while taking this medicine.
Do NOT take Fenofibrate
Pregnancy and breast-feeding
• If you are allergic (hypersensitive) to
fenofibrate or any of the other ingredients If you are pregnant or breast-feeding, think
you might be pregnant or are planning to
of this medicine
have a baby, ask your doctor or pharmacist
• If you are allergic (hypersensitive) to
before taking this medicine.
peanut or soya or related products (see
'Important information about some of the As there is not enough experience with use
ingredients of Fenofibrate', below)
of Fenofibrate during pregnancy, you should
• If you have known photo-allergy (allergic use Fenofibrate only if your doctor
reaction caused by sunlight or exposure
considers it absolutely necessary.
to UV light) or phototoxic reactions
It is not known whether the fenofibrate
(damage to skin caused by exposure to
passes into breast-milk. Therefore, you
sunlight or UV light) during treatment
should not use Fenofibrate if you are
with fibrates (lipid-modifying medicines)
breast-feeding.
or ketoprofen (an anti-inflammatory
Driving and using machines
medicine)
• If you suffer from liver or kidney disease
Fenofibrate has no or negligible influence
or gallbladder disease
on the ability to drive and use machines.
• If you suffer from pancreatitis
Important information about some of the
(inflammation of the pancreas leading to
ingredients of Fenofibrate
abdominal pain).
Talk to your doctor or pharmacist:
• If you are over 70 years old
• If you or a blood relative have or have had
muscle disease
• If you have impaired kidney function
• If you have an underactive thyroid gland
(hypothyroidism)
• If you have a high alcohol intake
• If you are already taking another fibrate or
a statin (another type of lipid-modifying
medicine), or if you are taking oral
contraceptives ('the pill').
These factors may put you at increased risk
for muscle problems during treatment with

REG0065534

fenofibrate. You should contact your doctor
immediately if you experience unexplained
muscle pain, muscle tenderness or muscle
weakness. This is because in rare cases,
muscle problems due to fenofibrate can be
serious.

Version 2.4

This medicine contains a sugar called
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 160 mg
FILM-COATED TABLETS

Always take Fenofibrate exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.

Approved

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FENOFIBRATE 160 mg
FILM-COATED TABLETS

TEVA UK Ref:

Version:

231-30-87688-C LEA FENOFIBRATE 160mg FC TAB TUK

4

PAGE 2: REAR FACE (OUTSIDE OF REEL)

The usual dose is one tablet a day for
adults, including the elderly.
If you are currently taking one 200 mg
Fenofibrate Capsule, you can change to one
tablet of Fenofibrate 160 mg Film-coated
Tablets.
If you have impaired kidney function
Your doctor will prescribe a lower dose.
Other strengths and pharmaceutical forms
of fenofibrate are available for doses not
realisable/practicable with this medicinal
product.

• Blood clots in the veins (deep vein
thrombosis) or in the arteries of the lung
(pulmonary embolism)
• Gallstones.
Rare: may affect up to 1 in 1,000 people
• Reduced levels of haemoglobin
(oxygen-carrying pigment in blood) and
white blood cells
• Reduced sex drive
• Hair loss.

Very rare: may affect up to 1 in 10,000
people
• Chronic disease of the lung tissues
Children
(interstitial pneumopathy)
This medicinal product is not recommended
• Photosensitivity reactions (sensitivity to
for use in children because there is not
sunlight, sunlamps or sunbeds) with
enough clinical data.
redness, raised boils or solid swelling
Method of administration
• Inflammation of the liver (hepatitis), which
Oral use.
may produce jaundice (yellowing of the
Swallow the tablets whole with water. It is
skin and whites of the eyes), abdominal
important to take the tablets with food, as
pain and itching.
they won’t work as well if your stomach is
Reporting
of side effects
empty.
If you get any side effects, talk to your
To treat your raised blood cholesterol levels, doctor or pharmacist. This includes any
you must follow the dietary
possible side effects not listed in this leaflet.
recommendations given to you by your
You can also report side effects directly via
doctor while taking this medicine.
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Duration of treatment
By reporting side effects you can help
Do not forget that for fenofibrate to be
effective, it needs to be taken very regularly, provide more information on the safety of
this medicine.
and for as long as your doctor has
recommended, even if this duration is a
TO STORE FENOFIBRATE
5 HOW
very long time. Do not stop taking this
160 mg FILM-COATED TABLETS
medicine unless your doctor has told you to.
• Keep out of the reach and sight of children.
If you take more Fenofibrate than you
• Do not store above 25°C. Do not use
should
Fenofibrate after the expiry date which is
stated on the carton and blister after EXP.
If you accidentally take too many tablets, or
The expiry date refers to the last day of
you think that a child has swallowed any,
that month.
contact your nearest hospital casualty
department or tell your doctor immediately. • Store in the original packaging. Keep the
blisters in the outer carton.
If you forget to take Fenofibrate
• Medicines should not be disposed of via
If you forget to take Fenofibrate, take it with
wastewater or household waste. Ask your
your next meal, unless it is nearly time to
pharmacist how to dispose of medicines
take your next dose: do not take a double
no longer required. These measures will
dose to make up for a forgotten one.
help to protect the environment.
If you have any further questions on the use 6 CONTENTS OF THE PACK AND
OTHER INFORMATION
of this product, ask your doctor or
pharmacist.
What Fenofibrate 160 mg Film-coated

4

POSSIBLE SIDE EFFECTS

Tablets contains

Like all medicines, Fenofibrate can cause
side effects, although not everybody gets
them.
Contact your doctor immediately if you
experience unexplained muscle pain,
muscle tenderness or muscle cramps or
weakness. These side effects are rare
(occurring in fewer than 1 in 1,000 patients)
but they can sometimes be serious. Very
rarely (in fewer than 1 in 10,000 patients),
muscle breakdown may occur (see
‘Warnings and precautions', in section 2
above).
Common: may affect up to 1 in 10 people
• Digestive disorders such as abdominal
pain, nausea (feeling sick), vomiting
(being sick), diarrhoea, flatulence
• Alterations in blood test results of liver
function.
Uncommon: may affect up to 1 in 100
people
• Alterations in blood test results of kidney
function
• Pancreatitis (inflammation of the pancreas
leading to abdominal pain)
• Skin rashes, itching, hives,
photosensitivity reactions (sensitivity to
sunlight, sunlamps or sunbeds)

• The active substance is fenofibrate.
• The other ingredients are microcrystalline
cellulose, povidone K-30, povidone K-25,
croscarmellose sodium, crospovidone,
sodium starch glycolate (type A), sodium
laurilsulfate, lactose monohydrate,
colloidal silica anhydrous, sodium stearyl
fumarate, polyvinyl alcohol
part-hydrolyzed, titanium dioxide (E171),
talc, soya lecithin and xanthan gum.
What Fenofibrate 160 mg Film-coated
Tablets looks like and contents of the pack
• Film-coated Tablet: white to off-white,
oval-shaped film-coated tablet, debossed
"93" on one side and "7331" on the other.
• Fenofibrate 160 mg Film-coated Tablets
are available in pack sizes of 1, 10, 14, 15,
28, 30, 50, 56, 60, 84, 90 & 100 Film-coated
Tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in May 2015.
PL 00289/1161
87668-C

160 x 323

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Version 2.4

Approved

Page 2 of 3

8 May 2015

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-00289-1161-fenofibrate-160mg-film-coated-tablets

APPROVALS
Signed by
Michael Silvester

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Meaning of Signature
Regulatory Affairs Approval

Version 2.4

Approved

Server Date
08-May-2015 03:50:35 PM

Page 3 of 3

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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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