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FENOFIBRATE 267MG CAPSULES

Active substance(s): FENOFIBRATE / FENOFIBRATE / FENOFIBRATE

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PATIENT INFORMATION LEAFLET

FENOFIBRATE 267MG CAPSULES

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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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
• Your doctor may have given you this medicine before from another company. It may have
looked slightly different. However, either brand will have the same effect.
What is in this leaflet:
1. What fenofibrate is and what it is used for
2. What you need to know before you take fenofibrate
3. How to take fenofibrate
4. Possible side effects
5. How to store fenofibrate
6. Contents of the pack and other information
1. WHAT FENOFIBRATE IS AND WHAT IT IS USED FOR
The name of your medicine is Fenofibrate 267mg Capsules (called fenofibrate throughout this leaflet).
This 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.
It is always essential to continue a low-fat diet during treatment with fenofibrate and it is important
to exercise.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENOFIBRATE
Do not take fenofibrate if:
• You are allergic (hypersensitive) to fenofibrate or any of the other ingredients of this medicine
(see Section 6: Contents of the pack and other information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue
• You have ever had a skin reaction due to sunlight or artificial UV light (such as on a ‘sun bed’)
while taking another fibrate or ketoprofen (an anti-inflammatory medicine)
• You have severe kidney problems
• You have severe liver problems including cirrhosis
• You have gallbladder problems
• You have problems with your pancreas (pancreatitis)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking fenofibrate.
Warnings and Precautions
Talk to your doctor or pharmacist before taking fenofibrate if:
• You or any members of your family suffer from hereditary muscle problems
• You have ever had problems with your muscles as a result of the use of statins or fibrates
(medicines used to reduce cholesterol levels)
• You have liver or kidney problems
• You have diabetes, especially Type 2 diabetes, that is not well controlled
• You have problems with certain proteins in your blood
• You have an under-active thyroid gland (hypothyroidism)
• You regularly drink large amounts of alcohol
• You have low albumin blood levels (hypoalbuminaemia).
• You are over 70 years of age
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking fenofibrate.
Other medicines and fenofibrate
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This
includes medicines you buy without a prescription, including herbal medicines. This is because fenofibrate
can affect the way some other medicines work. Also some medicines can affect the way fenofibrate works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Any other medicines for high blood fat levels called ‘fibrates’, such as clofibrate, bezafibrate,
or gemfibrozil
• Medicines for thinning the blood (such as warfarin)
• Medicines containing oestrogen such as the contraceptive pill or hormone replacement therapy (HRT)
• Ciclosporin - used following transplant surgery and to treat rheumatoid arthritis.
• Pioglitazone- used to treat diabetes
Fenofibrate with food, drink and alcohol
• Fenofibrate should always be taken with food.
• Remember to keep to your low fat diet while you are taking fenofibrate
• Do not drink large amounts of alcohol while taking fenofibrate, as this can increase the risk of
muscle problems
Pregnancy, breast-feeding and fertility
Do not use this medicine if:
• You are pregnant, think you might bepregnant or are planning to have a baby
• You are breast-feeding or planning to breast-feed. This is because small amounts of fenofibrate
may pass into the mother’s milk
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel dizzy, drowsy or tired while taking fenofibrate. If this happens do not drive or use any
tools or machines.
3. HOW TO TAKE FENOFIBRATE
Always take this medicine exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Taking this medicine
• Swallow this capsule whole with a glass of water
• Always take this medicine with food
How much to take
Adults
• The usual dose is one capsule each day
Use in children and adolescents
• Fenofibrate is not recommended for use in children under 18 years old
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4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking fenofibrate and see a doctor or go to a hospital straight away, if you notice any of
the following serious side effects – you may need urgent medical treatment:
Uncommon (affects less than 1 in 100 people):
• You suddenly get pain in your head, chest or legs, or begin to have breathing difficulties. These
could be signs of a blood clot.
• You get severe stomach pain which may reach through to your back. This could be a sign of
pancreatitis
Rare (affects less than 1 in 1000 people):
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in
swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash
(urticaria)
This may mean you are having an allergic reaction to fenofibrate
• You get unexplained pain, tenderness or weakness in the muscles or pain in your joints. You
may also have a high temperature or tiredness. This could be a rare, but possibly life-threatening
illness called rhabdomolysis
• You get symptoms such as yellowing of the skin or eyes, tiredness or fever. This may be due to
changes in the way your liver is working.
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
Other side effects include:
Common (affects less than 1 in 10 people):
• Feeling sick (nausea) or being sick (vomiting), diarrhoea, wind, indigestion or stomach pains
• Fenofibrate can change the levels of liver enzymes shown up in blood tests. This can mean that
your liver is not working properly.
Uncommon (affects less than 1 in 100 people):
• Headache
• Skin rash (which may be itchy or lumpy)
• Muscle pain, muscle inflammation, muscle cramps and weakness
• Problems with your sex drive
• A blood test may show changes in the way your kidneys are working
• Pain below your ribs on the right side or in your right shoulder, feeling sick or being sick,
(particularly after eating following a fatty meal). This may mean you have gallstones
Rare (affects less than 1 in 1000 people):
• Being more sensitive to the sun than usual. In some cases this may cause lumps or boils to
appear on your skin. This side effect can also happen after using a sun lamp (UV)
• Hair loss (alopecia)
• Feeling tired, faint or dizzy, shortness of breath, pale skin. This could be signs of anaemia
• You get infections or bruise more easily than usual. This could be because of a blood problem
(such as agranulocytosis, neutropenia or thrombocytopenia)
Not known (frequency cannot be estimated from the available data):
• Balance problems, feeling dizzy, possibly with a feeling of spinning (vertigo)
• Feeling short of breath, especially during or after exercise, and a dry cough
• Tiredness
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 internet 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
• Keep this medicine out of the sight and reach of children
• 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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fenofibrate 267mg Capsules contain
Each capsule contains 267mg of fenofibrate as the active substance.
The other ingredients are, lauroyl macrogoglycerides, macrogol, hydroxypropylcellulose, and
sodium starch glycolate, gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide
(E172), titanium dioxide (E171) and indigo carmine (E132).
What fenofibrate looks like and contents of the pack
Fenofibrate capsules are green and caramel hard gelatin capsules. They are supplied in blister
packs of 28 capsules.
Marketing Authorisation Holder and Manufacturer:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
This leaflet was last revised in: August 2016. ‘Zentiva’ is a registered trademark
© 2016 Zentiva
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People with kidney problems
• If you have kidney problems your doctor may prescribe you a lower dose or tell you to wait
longer in between doses.
If you take more fenofibrate than you should
If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital
casualty department straight away. Take the pack and any remaining capsules with you. This is so
the doctors know what you have taken.
If you forget to take fenofibrate
If you forget to take a dose at the right time, take it as soon as you remember, then go on as before.
Do not take a double dose to make up for a forgotten capsule.
Blood Tests
• During treatment with fenofibrate your doctor may do blood tests to check how your liver and
kidneys are working or check whether you might be particularly at risk of getting muscle
problems.
• If you are going to have any other blood tests, it is important to tell the person doing the test that
you are taking fenofibrate. This is because fenofibrate can affect the result of some blood tests.
If you stop taking fenofibrate
Do not stop taking fenofibrate unless your doctor tells you to, or the capsules make you feel unwell.
This is because abnormal levels of fat in the blood need treating for a long period of time.
Remember that as well as taking fenofibrate it is also important that you:
• Have a low fat diet
• Take regular exercise
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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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