Fenofibrate Micro 267mg Capsules
Out of date information, search anotherThe name of your medicine is Fenofibrate Micro 267 mg Capsules, which will be called Fenofibrate Capsules throughout this leaflet.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 anyfurtherquestions, askyour doctor or pharmacist.
• This medicine has been prescribed foryou 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.
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 mightcause problems later on leading to heart disease or other illnesses.
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).
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.
OWhat you need to know before you take Fenofibrate Capsules
Do not take Fenofibrate Capsules:
• if you are allergic to Fenofibrate orto any of the ingredients in the medicine (listed in section 6).
• if you have severe liver or kidney problems • if you have gall bladder disease • if you sufferfrom pancreatitis (inflammation of the pancreas leading to abdominal pain)
• if you have had a side-effect of reacting to sunlightwhen taking other fibrates (for example bezafibrate, ciprofibrate or gemfibrozil) or ketoprofen
• if you are pregnant orthere is a possibility that you may become pregnant • if you are breastfeeding • if you are under 18.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fenofibrate Capsules if you:
• areover70yearsold
• have kidney disease or have a history of kidney disease • have diabetes, especially Type 2 diabetes, that is notwell 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.
Taking other medicines
Please tell yourdoctor 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)
• statins which reducethe 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). Yourdoctor maydecideto monitor this with blood tests every 3 months during the first year of treatment.
Please inform yourdoctor or pharmacist if you are taking or have recentlytaken any other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
Youshould nottake Fenofibrate Capsuleswhile pregnantor breast-feeding unless your doctor tells you to.
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 byyour doctorthatyou havean intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take Fenofibrate Capsules
Alwaystake Fenofibrate Capsules exactly asyour doctor or pharmacist has told you. Checkwith your doctor or pharmacist if you are not sure.
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 dosemaybe reduced (byyour doctor) if you have kidney problems.
Use in children and adolescents
Fenofibrate Capsules are not recommended for use in children and adolescentsyoungerthan 18years.
If you have been on a diet (as recommended byyour doctor) before starting to take Fenofibrate Capsules, you should continue the same diet.
If you sufferfrom high blood pressure,your doctor may advise you to start taking medication forthis condition if you are not already doing so.
Yourdoctor may also advise you to stop smoking if you are a cigarette smoker.
If you take more Fenofibrate Capsules than you should:
It is importantto stick to the dose on the label ofyour medicine. If you orsomeone else takestoo many Fenofibrate Capsules all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any capsules left overwith youand 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 asyou remember. Donottakeadouble dose tomakeupfora forgotten dose if it is almost time for your next dose.
If you have anyfurtherquestions onthe use of this medicine, askyourdoctoror pharmacist.
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 howyour 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
• Aslight decrease inthe level of a component in red blood cells (haemoglobin) in the blood
• Aslightdecreaseinthenumber of leukocytes (a type of white blood cells) in the blood
• Aslight increase in the levels certain substances in the blood (serum transaminases, serum creatinine and urea).
• Delayed or inhibited orgasm
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Do notstore above 250C. 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 notthrow away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Fenofibrate Capsules contain:
The active ingredient is fenofibrate in a micronized form. Thisform hasveryfine particles which can enterthe 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).
Like all medicines, this medicine can cause side effects, although not everybody getsthem.
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).
Contactyour doctor assoon as possible and stoptaking 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 casesthis can progressto becomea serious and potentially life threatening condition, called rhabdomyolysis.
Very rare side effects (may affect up to 1 in 10,000 people):
• Problemswiththe lungs known as interstitial pneumopathy.
• Inflammation of the liver (hepatitis), which mayproduce jaundice (yellowing of the skin and whites of the eyes), abdominal pain and itching. Your doctor may need to carry outtests to check this.
Reporting of side effects
If you get any side effects, talkto yourdoctoror 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 effectsyou can help provide more information on the safety of this medicine.
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: January 2015
PL 00289/1485 83840-D
TEVA UK LIMITED