Fenofibrate Micro 267mg 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.
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.
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.
• 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.
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
OWhat 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.
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.
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.
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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 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:
• 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)
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.
Use in children and adolescents
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.
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.
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
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.
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.
F^V 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
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