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FENOFIBRATE 67MG CAPSULES

Active substance: FENOFIBRATE MICRONISED

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Fenofibrate 67mg 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 capsules belong 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 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
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 or kidney function.
• have problems with your pancreas.
• have gallbladder or liver disease.

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

• have or 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

Continued top of next column

148x210 Leaflet Reel Fed Profile (BST)

Fenofibrate 67mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAH7453

dimensions:

print proof no:

4

148 x 210

pharmacode:

origination date: 09.03.15

min pt size:

JDE No.:

50814563

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 2544

3.

7

6.

originated by:
approved for print/date

2.

Fenofibrate Capsules
67mg x 90’s (UK)

jh

revision date:

29.04.15

Technical Approval

revised by:

jh

date sent:

supplier:

UK

technically app. date: N/A

N/A

Non Printing Colours
1.
2.
3.

Date Sent:
02/07/28
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Ingredient warning

Fenofibrate capsules contain sunset yellow (E110) 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)
Three capsules a day, taken in divided doses. Your doctor will monitor
your response to the treatment.
Children
One capsule a day per 20kg of bodyweight.
Impaired kidney function
If you have impaired kidney function, your doctor may prescribe you
a lower dose.

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.

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.

Rare (occuring 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 (occuring 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).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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

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

• The active substance (the ingredient that makes the capsules work)
is micronised fenofibrate. Each capsule contains 67mg of the active
substance.
• The other ingredients are lactose monohydrate,
pregelatinised starch, sodium lauryl sulphate,
povidone, magnesium stearate, gelatin, titanium
dioxide (E171), quinolone yellow (E104), sunset yellow
(E110).

What Fenofibrate capsules look like and
contents of the pack

Fenofibrate capsules are yellow, hard, gelatine capsules.
Pack size is 90.

Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:

Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.

Common (occuring 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.

This leaflet was last revised in April 2015

Uncommon (occuring 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.

If you would like a
leaflet with larger
text, please contact
01271 385257.

Continued top of next column
50814563 AAAH7453

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Fenofibrate 67mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAH7453

dimensions:

print proof no:

4

148 x 210

pharmacode:

origination date: 09.03.15

min pt size:

JDE No.:

50814563

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 2544

3.

7

6.

originated by:
approved for print/date

2.

Fenofibrate Capsules
67mg x 90’s (UK)

jh

revision date:

29.04.15

Technical Approval

revised by:

jh

date sent:

supplier:

UK

technically app. date: N/A

N/A

Non Printing Colours
1.
2.
3.

Date Sent:
02/07/28
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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