Skip to Content

UK Edition. Click here for US version.

FENOFIBRATE MICRO 267MG CAPSULES

Active substance(s): FENOFIBRATE MICRONISED

View full screen / Print PDF » Download PDF ⇩
Transcript
FENOFIBRATE MICRO
267 mg CAPSULES
PACKAGE LEAFLET:
INFORMATION FOR THE USER
The name of your medicine is Fenofibrate Micro 267 mg
Capsules, which will be called Fenofibrate Capsules
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.
• 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.
1. What Fenofibrate Capsules are and what they are used for
2. What you need to know before you take Fenofibrate
Capsules
3. How to take Fenofibrate Capsules
4. Possible side effects
5. How to store Fenofibrate Capsules
6. Contents of the pack and other information

1

What Fenofibrate Capsules are and what they
are used for

Fenofibrate is a type of drug known as a fibrate, and is used
to modify the lipid (fat) levels in the blood. If untreated, these
high levels of fat might cause problems later on leading to
heart disease or other illnesses.

Fenofibrate should only be used in patients who have not
been able to control their blood lipid levels with a low fat
diet, exercise and weight reduction.

2

What you need to know before you take
Fenofibrate Capsules

Do not take Fenofibrate Capsules:
• if you are allergic to Fenofibrate or to any of the
ingredients in the medicine (listed in section 6).
• if you have liver or kidney problems
• if you have gall bladder disease
• if you suffer from pancreatitis (inflammation of the
pancreas leading to abdominal pain)
• if you have had a side-effect of reacting to sunlight when
taking other fibrates (for example bezafibrate, ciprofibrate
or gemfibrozil) or ketoprofen
• if you are pregnant or there is a possibility that you may
become pregnant
• if you are breast feeding
• if you are under 18.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fenofibrate
Capsules if you:
• are over 70 years old
• have kidney disease or have a history of kidney disease
• have diabetes, especially Type 2 diabetes, that is not well
controlled
• have thyroid problems
• have alcohol problems (regularly drinking large amounts
of alcohol)
• have low levels of serum albumin (hypoalbuminaemia) a
component of the blood
• have a muscular disease.
• have liver problems.

Fenofibrate is used to reduce high fat (lipid) levels in the
blood. The types of fats in the blood which are lowered by
fenofibrate include triglycerides and cholesterol (known as
low density and very low density lipoproteins).

Taking other medicines
Please tell your doctor or pharmacist if you are taking any of
the following medicines:

Use in children and adolescents

Common (may affect up to 1 in 10 people):
• Stomach and bowel problems such as abdominal pain,
sickness, diarrhoea, and wind
• Alterations in blood test results that show how your liver
is working

Fenofibrate Capsules are not recommended for use in
children and adolescents younger than 18 years.
If you have been on a diet (as recommended by your doctor)
before starting to take Fenofibrate Capsules, you should
continue the same diet.
If you suffer from high blood pressure, your doctor may
advise you to start taking medication for this condition if you
are not already doing so.
Your doctor may also advise you to stop smoking if you are a
cigarette smoker.
If you take more Fenofibrate Capsules than you should:
It is important to stick to the dose on the label of your
medicine. If you or someone else takes too many Fenofibrate
Capsules all together, contact your doctor, pharmacist or
hospital emergency department immediately. Always take
any capsules left over with you and also the box, as this will
allow easier identification of the medicine.
If you forget to take your Fenofibrate Capsule:
If you forget to take a dose, take it as soon as you remember.
Do not take a double dose to make up for a forgotten dose if
it is almost time for your next dose.
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.
Tell your doctor straight away if you get any sudden
wheeziness, difficulty in breathing, swelling of the eyelids,
face or lips, rash or itching (especially affecting your whole
body).
Contact your doctor as soon as possible and stop taking
Fenofibrate if you develop any unexplained or persistent
muscle pain, tenderness, weakness or cramps, especially if
at the same time you feel unwell or have a high temperature.
In very rare cases this can progress to become a serious and
potentially life threatening condition, called rhabdomyolysis.

• anticoagulants (prevent clotting or thickening of the
blood, for example warfarin)
• other fibrates which lower levels of fats in the blood (for
example bezafibrate, ciprofibrate or gemfibrozil)

Uncommon side effects (may affect up to 1 in 100 people):
• Inflammation of the pancreas (pancreatitis)
• Skin rashes, itching, hives, photosensitivity reactions
(sensitivity to sunlight, sunlamps or sunbeds)
• Development of gallstones
• Formation of blood clots in veins (deep vein thrombosis)
and blockage of the lung arteries by blood clots
(pulmonary embolism).
Rare side effects (may affect up to 1 in 1,000 people):
• A loss of interest in sex or an inability to perform sexually
• Hair loss
• Headache, tiredness
• A feeling of dizziness or spinning (Vertigo)
• Muscle weakness or pain
• A slight decrease in the level of a component in red blood
cells (haemoglobin) in the blood
• A slight decrease in the number of leukocytes (a type of
white blood cells) in the blood
• A slight increase in the levels certain substances in the
blood (serum transaminases, serum creatinine and urea).
• Delayed or inhibited orgasm
Very rare side effects (may affect up to 1 in 10,000 people):
• Problems with the lungs known as interstitial
pneumopathy.
• Inflammation of the liver (hepatitis), which may produce
jaundice (yellowing of the skin and whites of the eyes),
abdominal pain and itching. Your doctor may need to
carry out tests to check this.
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.

• statins which reduce the level of fats in the blood (for
example atorvastatin, fluvastatin, pravastatin,or
simvastatin)
• ciclosporin (used after organ transplants)
• phenylbutazone, a non-steroidal anti-inflammatory drug
used to treat ankylosing spondylitis
• oestrogens which are in medicines including HRT
(hormone replacement therapy) and the Pill.
• drugs to control Type 2 diabetes (glitazones).
Taking Fenofibrate capsules may increase the levels of
certain enzymes in your blood (transaminases). Your doctor
may decide to monitor this with blood tests every 3 months
during the first year of treatment.
Please inform your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
You should not take Fenofibrate Capsules while pregnant or
breast-feeding unless your doctor tells you to.
Driving and using machines
Fenofibrate has no or negligible influence on the ability to
drive and use machines.
Fenofibrate Capsules contain 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 Capsules

Always take Fenofibrate Capsules exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Fenofibrate Capsules should always be taken with food and
swallowed whole with a little water.
Adults and elderly patients
The usual dose of Fenofibrate Capsules is one capsule taken
daily during a main meal.
This dose may be reduced (by your doctor) if you have kidney
problems.

5

How to store Fenofibrate Capsules

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store your capsules in the original
packaging.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last day of
that month.
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
protect the environment.

6

Contents of the pack and other information

What Fenofibrate Capsules contain:
The active ingredient is fenofibrate in a micronized form.
This form has very fine particles which can enter the blood
stream quickly.
Fenofibrate 267 mg Capsules also contain: lactose
monohydrate, pregelatinised starch, sodium lauryl sulphate,
crospovidone, magnesium stearate, anhydrous colloidal
silica, gelatin, brilliant blue (E133), titanium dioxide (E171).
What Fenofibrate Capsules look like and contents of the pack
Fenofibrate Capsules are blue capsules and are available in
blister packs of 28 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer
PSI supply nv, Axxes Business Park,
Guldensporenpark 22 – Block C, 9820 Merelbeke, Belgium.
This leaflet was last revised: November 2015
PL 00289/1485

83840-E

Expand view ⇕

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.

Hide