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FENOFIBRATE 160MG FILM-COATED TABLETS

Active substance(s): FENOFIBRATE / FENOFIBRATE / FENOFIBRATE

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TEVA UK Ref:

231-30-87688-E LEA FENOFIBRATE 160mg FC TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

6

Colours Used:

20 December 2016
PANTONE® GREEN C
BLACK
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

FENOFIBRATE 160 mg
FILM-COATED TABLETS

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.
What is 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

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.

2

What you need to know before
you take Fenofibrate 160 mg
Film-coated Tablets

Do NOT take Fenofibrate
• If you are allergic to fenofibrate or any of
the other ingredients of this medicine
(listed in section 6)
• If you are allergic to peanut or soya or
related products (see 'Important
information about some of the ingredients
of Fenofibrate', below)
• If you have known photo-allergy (allergic
reaction caused by sunlight or exposure to
UV light) or phototoxic reactions (damage
to skin caused by exposure to sunlight or
UV light) during treatment with fibrates
(lipid-modifying medicines) or ketoprofen
(an anti-inflammatory medicine)
• If you have severe kidney problems
• If you suffer from liver disease or
gallbladder disease
• If you suffer from pancreatitis
(inflammation of the pancreas leading to
abdominal pain).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Fenofibrate:
• If you are over 70 years old
• If you or a blood relative have or have had
muscle disease
• If you have kidney 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
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.
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 section 4 below).
Children and adolescents
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).
Taking Fenofibrate with food and drink
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 levels in your blood
(hypercholesterolaemia) requires that you
take special care, even if the high
cholesterol level does not affect the way you
feel. You should follow the dietary
recommendations given by your doctor
while taking this medicine.
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
before taking this medicine.
As there is not enough experience with use
of Fenofibrate during pregnancy, you should
use Fenofibrate only if your doctor
considers it absolutely necessary.
It is not known whether the fenofibrate
passes into breast-milk. Therefore, you should
not use Fenofibrate if you are breast-feeding.
Driving and using machines
Fenofibrate has no or negligible influence
on the ability to drive and use machines.
Important information about some of the
ingredients of Fenofibrate
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).
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 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.
The recommended 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.

Top of page cut-off to middle of registration mark: 44 mm.

Package leaflet:
Information for the patient

TEVA UK Ref:

231-30-87688-E LEA FENOFIBRATE 160mg FC TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

6

Colours Used:

PANTONE® GREEN C
BLACK
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.
Use in children
This medicinal product is not recommended
for use in children because there is not
enough clinical data.
Method of administration
Oral use.
Swallow the tablets whole with water. It is
important to take the tablets with food, as they
won’t work as well if your stomach is empty.
To treat your raised blood cholesterol levels,
you must follow the dietary
recommendations given to you by your
doctor while taking this medicine.
Duration of treatment
Do not forget that for fenofibrate to be
effective, it needs to be taken very regularly,
and for as long as your doctor has
recommended, even if this duration is a
very long time. Do not stop taking this
medicine unless your doctor has told you to.
If you take more Fenofibrate than you should
If you accidentally take too many tablets, or
you think that a child has swallowed any,
contact your nearest hospital casualty
department or tell your doctor immediately.
If you forget to take Fenofibrate
If you forget to take Fenofibrate, take it with
your next meal, unless it is nearly time to
take your next dose: do not take a double
dose to make up for a forgotten one.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

20 December 2016






Muscle breakdown
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
• 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 or sunbeds
• Drop in haemoglobin (that carries oxygen
in blood) and white blood cells - shown in
tests
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
• 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 160 mg
Film-coated Tablets

• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
Possible
side
effects
4
date which is stated on the carton and
blister after EXP. The expiry date refers to
Like all medicines, this medicine can cause
the last day of that month.
side effects, although not everybody gets them.
• Do not store above 25°C.
Stop taking Fenofibrate and see a doctor
• Store in the original package. Keep the
straight away, if you notice any of the
blisters in the outer carton.
following serious side effects - you may
• Do not throw away any medicines via
need urgent medical treatment:
wastewater or household waste. Ask your
Uncommon: may affect up to 1 in 100 people
pharmacist how to throw away medicines
• Stomach pain - this may be a sign that
you no longer use. These measures will
your pancreas is inflamed (pancreatitis)
help protect the environment.
• Chest pain and feeling breathless - these
of the pack and other
may be signs of a blood clot in the lung
6 Contents
information
(pulmonary embolism)
• Pain, redness or swelling in the legs What Fenofibrate 160 mg Film-coated
these may be signs of a blot clot in the leg Tablets contains
(deep vein thrombosis.
• The active substance is fenofibrate.
Rare: may affect up to 1 in 1,000 people
• The other ingredients are microcrystalline
• Allergic reaction - the signs may include
cellulose, povidone K-30, povidone K-25,
swelling of the face, lips, tongue or throat,
croscarmellose sodium, crospovidone,
which may cause difficulty in breathing
sodium starch glycolate (type A), sodium
• Yellowing of the skin and whites of the
laurilsulfate, lactose monohydrate,
eyes (jaundice), or an increase in liver
colloidal silica anhydrous, sodium stearyl
enzymes - these may be signs of an
fumarate, polyvinyl alcohol
inflamed liver (hepatitis)
part-hydrolyzed, titanium dioxide (E171),
talc, soya lecithin and xanthan gum.
not known: frequency cannot be estimated
from the available data
What Fenofibrate 160 mg Film-coated
• Cramps or painful, tender or weak
Tablets looks like and contents of the pack
muscles - these may be signs of muscle
• Film-coated Tablet: white to off-white,
inflammation or breakdown, which can
oval-shaped film-coated tablet, debossed
cause kidney damage or even death.
"93" on one side and "7331" on the other.
Stop taking Fenofibrate and see a doctor
• Fenofibrate 160 mg Film-coated Tablets
straight away, if you notice any of the side
are available in pack sizes of 1, 10, 14, 15,
effects above.
28, 30, 50, 56, 60, 84, 90 & 100 Film-coated
Tablets.
Other side effects include:
Not all pack sizes may be marketed.
Common: may affect up to 1 in 10 people
Marketing
Authorisation Holder and
• Diarrhoea
Manufacturer
• Wind (flatulence)
• Feeling sick (nausea)
TEVA UK Limited, Eastbourne, BN22 9AG.
• Being sick (vomiting)
This leaflet was last revised in December
• Raised levels of liver enzymes in the blood 2016.
- shown in tests
PL 00289/1161
Uncommon: may affect up to 1 in 100 people
• Headache
87688-E
• Gallstones
160 x 323

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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