FENOFIBRATE 200MG CAPSULES

Active substance: FENOFIBRATE MICRONISED

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Fenofibrate 200mg
capsules
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.

In this leaflet
1 What Fenofibrate capsules are and what
they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Fenofibrate capsules are and what
they are 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 200mg capsules are 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 200mg capsules 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 Before you take

Do not take Fenofibrate capsules and tell your
doctor if you:

• are allergic (hypersensitive) to fenofibrate or any of the
other ingredients in the capsules (see section 6).
• have developed a sensitivity to sunlight or artificial light
(e.g. sunbeds) when taking fibrates (e.g. fenofibrate or
bezafibrate) or ketoprofen (used for muscle and bone
disorders, gout or period pain).
• have severely impaired liver function.
• have gallbladder or liver disease.
• have severe kidney problems.
• have problems with your pancreas.
• are giving Fenofibrate capsules to a child or adolescent.
Fenofibrate capsules must not be used in children and
adolescents under 18.
Continued top of next column
AAAE1773 50684341

Check with your doctor or pharmacist before
taking Fenofibrate capsules if you:

• have had impaired kidney function.
• have severely increased levels of a type
of fat (triglycerides) in the blood (severe
hypertriglyceridaemia) (seen in a blood test).
• have any of the following which may increase the risk of
you developing abnormal muscle breakdown:
- impaired kidney function
- an underactive thyroid
- a high alcohol intake
- are over 70 years old
- have had or have a family member with a history of
hereditary muscular disorders.
• have decreased levels of a certain protein in the blood
(hypoalbuminaemia) (seen in a blood test).
• are already taking a fibrate (e.g. bezafibrate) or a statin
(e.g. atorvastatin), especially if you have muscle disease.
• have poorly controlled diabetes mellitus (type II).
• have nephrotic syndrome characterised by large
amounts of protein in the urine, water retention and
increased levels of fats in the blood.
• have a condition which effects the amount of protein in
the blood (dysproteinemia).
• have obstructive liver disease.
• are taking medicines which may effect fat metabolism
(e.g. thiazides, beta blockers, corticosteroids or
antiretrovirals).

Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Especially:
• oral anti-coagulants e.g. warfarin (used to prevent blood
clotting).
• statins e.g. atorvastatin (used to lower cholesterol).
• ciclosporin (used to suppress the immune system).
• phenylbutazone (a non-steroidal anti-inflammatory
drug).
• other fibrates e.g. bezafibrate (used to lower cholesterol
and other fats (lipids) in the blood).
• oestrogen or medicines which contain oestrogen
(contraceptives).

Pregnancy and breast-feeding

Fenofibrate capsules should not be used if you are
pregnant or breast-feeding. Speak to your doctor before
taking any medicine.

Sugar intolerance

If you have been told you have an intolerance to some
sugars, contact your doctor before taking this medicine, as
it contains a type of sugar called lactose.
Continued over page





item no: AAAE1773 50684341

148x210 reel fed
4197
min pt size:

M.cort (BST Technical)

approved for print/date

Technical Approval
date sent:
supplier: Actavis UK

03/08/12

technically app. date:

03/08/12

Ingredient warning

Fenofibrate capsules contain ponceau 4R, cochineal red A
(E124) which may cause allergic reactions.

Tests

Your doctor may want to carry out tests to monitor the
levels of certain enzymes within your body.

3 How to take

Always take Fenofibrate capsules exactly as your doctor
has told you. If you are not sure, check with your doctor or
pharmacist.
Swallow the capsules whole with water during a meal.

Doses:
Adults (including the elderly)
One capsule a day. Your doctor will monitor your response
to the treatment.
Children and adolescents
Fenofibrate capsules must not be used in children and
adolescents under 18.

If you take more than you should

If you (or someone else) swallow a lot of capsules at the
same time, or you think a child may have swallowed any
contact your nearest hospital casualty department or tell
your doctor immediately.

If you forget to take the capsules

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and then take the next dose at the right time.

Rare (occurs in less than 1 in 1,000 users):
Disorder of the nerves causing weakness, tingling and
numbness (peripheral neuropathy), hair loss, increase
in blood levels of creatinine and urea, loss of sex drive,
decreased levels of haemoglobin and white blood cells.
If you notice increased bruising, nosebleeds, sore throats,
infections, excessive tiredness, breathlessness on exertion
or abnormal paleness of the skin, you should tell your
doctor who may want you to have a blood test.
Very rare (occurs in less than 1 in 10,000 users):
Lung disease (interstitial pneumopathies), inflammation
of the liver (hepatitis) causing yellowing of the skin or
whites of the eyes (jaundice) or tiredness, development of
gallstones, abnormal muscle breakdown which can lead to
kidney problems (rhabdomyolysis).
If you notice any side effects, they get worse, or if you
notice any not listed, please tell your doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children.
Do not store above 25°C.
Store in the original package.
Do not use Fenofibrate capsules after the expiry date
stated on the label/carton/bottle. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6 Further information

What Fenofibrate capsules contain

4 Possible side effects

Like all medicines, Fenofibrate capsules can cause side
effects, although not everybody gets them.

Stop taking Fenofibrate capsules and tell your doctor
immediately if you develop:
• Muscle poisoning: muscle pain, breakdown,
inflammation, cramps or weakness, increase in the levels
of a certain enzyme within the body (seen in a blood
test).
Contact your doctor immediately if you develop:
• An allergic reaction: swelling of the face, lips, tongue or
throat, itchy skin rash, narrowing of the airways causing
difficulty breathing or swallowing.
• Hepatitis: yellowing of the skin or whites of the eyes
(jaundice), itching.
Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users):
Headache, tiredness, spinning sensation, stomach or
intestine disorders such as feeling or being sick, stomach
pains, diarrhoea and wind. Skin rash, itching, a skin rash
with pale or red irregular raised patches with severe
itching, sensitivity to sunlight or artificial light (e.g. sun
beds) which may include reddening of the skin, blisters
or lumps.

• The active substance (the ingredient that makes the
capsules work) is micronised fenofibrate. Each capsule
contains 200mg of the active substance.
• The other ingredients are lactose monohydrate,
pregelatinised starch, sodium lauryl sulphate, povidone,
magnesium stearate, gelatin, titanium dioxide (E171),
yellow iron oxide (E172), ponceau 4R, cochineal red A
(E124).

What Fenofibrate capsules look like and
contents of the pack

Fenofibrate capsules are orange, hard, gelatine capsules.
Pack size is 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in August 2012.

If you would like a
leaflet with larger
text, please contact
01271 311257.

Uncommon (occurs in less than 1 in 100 users):
Increased levels of a certain enzyme within the body (seen
in a test), muscle toxicity (muscle pain, inflammation,
cramps and weakness), blood clotting, inflammation of
the pancreas causing stomach and back pain.
Continued top of next column
AAAE1773 50684341

Actavis, Barnstaple, EX32 8NS, UK





AAAE1773 50684341

148x210 reel fed
4197
min pt size:

M.cort (BST Technical)

Technical Approval
date sent:
supplier: Actavis UK

03/08/12

technically app. date:

03/08/12

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.

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