Fenofibrate 267mg Capsules
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FENOFIBRATE 267MG 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.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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^ • 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.
^ In this leaflet:
— 1. What fenofibrate is and what it is used for
2. Before you take fenofibrate
3. How to take fenofibrate
4. Possible side effects
5. How to store fenofibrate
6. Further 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.
2. BEFORE YOU TAKE FENOFIBRATE
Do not take fenofibrate and tell your doctor if:
• You are allergic (hypersensitive) to fenofibrate or any of the other ingredients of this medicine (see Section 6: Further 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 are pregnant, might become pregnant or think you may be pregnant (see “Pregnancy and breast-feeding” section below)
• You are breast-feeding (see “Pregnancy and breast-feeding” section below)
• 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.
Take special care and check with your doctor 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 an under-active thyroid gland (hypothyroidism)
• You regularly drink large amounts of alcohol
• You have low albumin blood levels (hypoalbuminaemia).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking fenofibrate.
Taking fenofibrate with other medicines
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.
Tell your doctor if you are taking any of the following:
• 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
Taking fenofibrate with food and drink
• 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. This is because it can increase the risk of muscle problems
Pregnancy and breast-feeding
Do not use this medicine if:
• You are pregnant, might become pregnant, or think you may be pregnant.
• 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 fenofibrate 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 Children under 18 years old
• Fenofibrate is not recommended for use in children under 18 years old 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, fenofibrate 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 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 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 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. This only happens in a very small number of patients taking fenofibrate
• You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis
Other side effects include:
Common affecting upto 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 affecting fewer 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 affecting fewer then 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)
• Flair 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 data 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 ary 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 in a safe place where children cannot see or reach it.
• Do not use fenofibrate after the expiry date which is stated on the carton. 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 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 Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Manufacturer is:
Zentiva, One Onslow Street, Guildford , Surrey GU1 4YS, UK This leaflet was last revised in: July 2013 ‘Zentiva’ is a registered trademark© 2013 Zentiva.
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