Fenofibrate 200mg Capsules
PATIENT INFORMATION LEAFLET
Fenofibrate 200mg Capsules (Micronised)
Please read all of this leaflet carefully before you start using this medicine.
■ Keep this leaflet. You may need to read it again.
■ If you have further questions, please ask your doctor or your pharmacist.
■ This medicine has been prescribed for you personally and you should not pass it on to other people.
It may harm them even if their symptoms are the same as yours.
■ If any of the side effects become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
Q What Fenofibrate is and what it is used for |4 Possible side effects
a Before you use Fenofibrate How to store Fenofibrate
3 How to use Fenofibrate^^^^^^^^^^^^^^ Further information
What Fenofibrate is and what it is used for
Fenofibrate Capsules belong to a group of medicines called Lipid-Lowering medicines or Fibrates. These work by helping to reduce cholesterol and triclygerides (fats) in the blood.
Fenofibrate is used to treat the following in adults when an appropriate diet and other non-drug therapeutic measures (e.g. weight reduction or increased physical activity) have proved to be insufficient:
■ hypercholesterolaemia (an abnormally large amount of cholesterol in the blood)
■ hypertriglyceridaemia (an abnormally large amount of triglycerides (fats) in the blood)
■ treatment of persistent secondary hyperlipoproteinemia's (disorders that occur if there are too many fatty substances in the blood) despite effective treatment of the underlying illness e.g. Dyslipidaemia (abnormal amount of lipids (cholesterol and/or fat) in the blood) in
Diabetes Mellitus
Before you use Fenofibrate
Do not use Fenofibrate if:
■ You are allergic (hypersensitive) to Fenofibrate, other lipid-lowering medicines or fibrates or any of the other ingredients in the capsules (these are listed in Section 6, Further information)
■ You suffer from severe liver problems. Generally, your doctor will monitor liver enzymes (transaminases) every 3 months for the first 12 months of treatment with this medicine
■ You suffer from kidney problems
■ You have developed a sensitivity to sunlight or to artificial light (e. g. sunbed) during treatment with Fenofibrate or similar medicines particularly Ketoprofen (an anti-inflammatory medicine)
■ In combination with another lipid-lowering medicine from the fibrate class or a HMG-CoA reductase inhibitor (see Taking other medicines)
■ Fenofibrate 200mg must not be used in children
Take special care with Fenofibrate
■ If you experience pain, tenderness, cramps, or weakness in your muscles while taking this medicine (see Section 4, Possible side effects)
■ If you have or have had impaired kidney function and/or decreased level of a certain protein in the blood (hypoalbuminuria)
■ If you are already taking another fibrate or a statin (type of medicine to lower the level of fats in the blood - see Taking other medicines)
Tell your doctor immediately if any of the following
apply to you:
■ If you suffer from signs of liver problems like unexplained nausea (feeling sick), stomach pain, fatigue (tiredness), loss of appetite, darkened urine, itching or yellowing of the eyes or skin (jaundice)
Taking other medicines
Please inform your doctor or pharmacist if you are
taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.
Medicines which may interact with Fenofibrate:
■ Medicines used to thin the blood e.g. warfarin (oral anti-coagulants) Fenofibrate increases the antiblood-clotting effects of oral anticoagulants, thus increasing the risk of bleeding. If you are taking anticoagulant medicines, the dosage should be reduced at the start of treatment and then adjusted, and frequently monitored during and 8 days after withdrawal of Fenofibrate treatment
■ Medicines used to lower cholesterol levels e.g. Gemfibrozil (fibrates) and Simvastatin (statins or HMG-CoA reductase inhibitors)
■ Ketoprofen (an anti-inflammatory medicine)
Taking Fenofibrate with food and drink
■ Take Fenofibrate with food
■ Take the capsules with a sufficient quantity of liquid (e.g. a glass of water)
■ Dietary measures initiated before treatment should be continued
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Pregnancy
Do not take Fenofibrate if you are pregnant, thinking of becoming pregnant or suspect you are pregnant. The safety of Fenofibrate during pregnancy has not been sufficiently established.
There is no indication for prescribing fibrates during pregnancy except in certain circumstances (major elevation of triglycerides (fats) where dietary measures have proved to be insufficient, which exposes the mother to the risk of inflammation of the pancreas).
Breast-feeding
It is not recommended to breast-feed while you are taking Fenofibrate due to lack of information concerning passage into milk.
Driving or using machinery
Fenofibrate may affect the ability to drive and use machinery. If this is experienced, it is necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.
Important information about some of the ingredients of Fenofibrate
Fenofibrate contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Fenofibrate
Always take Fenofibrate as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
In combination with diet, this medication constitutes a long-term symptomatic treatment, the efficacy of which should be monitored periodically.
■ Take Fenofibrate with food
■ Take the capsules with a sufficient quantity of liquid (e.g. a glass of water)
■ Dietary measures initiated before treatment should be continued.
Adults (including the elderly)
The usual dose is 200mg one capsule daily.
Once the cholesterol level has been normalised, it is recommended to reduce the dosage.
Response to treatment should be monitored by determination of serum lipid values. Rapid reduction of serum lipid levels usually follows 200mg Fenofibrate, but if an adequate response has not been achieved after several months (e.g. 3 months) different therapeutic measures should be considered.
continued....
In impaired kidney function:
In case of impaired kidney function the dose may need to be reduced.
Children
Fenofibrate is not recommended for children.
Do not change your dose unless your doctor tells you to do so.
If you taken more Fenofibrate than you should
If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.
If you forget to take Fenofibrate
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten capsule.
If you stop taking/using Fenofibrate
It is important that you keep on taking Fenofibrate until the prescribed dose has finished. Do not stop taking the capsules even though you may feel better. Do not stop or change your treatment before talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Fenofibrate can cause side effects, although not everybody gets them.
Stop using Fenofibrate and contact your doctor or go to your nearest Accident and Emergency Department immediately if you develop the following:
■ Muscle pain, inflammation, muscular cramps and weakness, particularly, if at the same time, you feel unwell or have a high temperature. This may be signs of a serious, potentially life-threatening muscle breakdown called Rhabdomyolysis. These effects are usually reversible when the medicine is withdrawn.
Tell your doctor immediately if any of the following apply to you:
■ If you suffer from signs of liver problems like unexplained nausea (feeling sick), stomach pain, fatigue (tiredness), loss of appetite, darkened urine, itching or yellowing of the eyes or skin (jaundice)
Common side effects (affects less than 1 in 10 patients)
■ Abdominal pain
■ Feeling or being sick (nausea/vomiting)
■ Diarrhoea
■ Wind (Flatulence)
■ Moderately elevated levels of certain liver enzymes (serum transaminases)
Uncommon side effects (affects less than 1 in 100 patients)
■ Skin rash, itching (pruritus), nettle rash (urticaria) Rare side effects (affects less than 1 in 1000 patients)
■ Development of gallstones
■ Headache
■ Dizziness
■ Disorders of sexual function
Very rare side effects (affects less than 1 in 10,000 patients)
■ Muscle breakdown (rhabdomyolysis). These effects are usually reversible when the medicine is withdrawn
■ Inflammation of the pancreas (pancreatitis)
■ Sensitivity to sunlight or to artificial light (e.g. sunbed) with reddening of the skin, rash, small fluid-filled blister or lesions. (This can occur even after many months of uncomplicated use)
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.
How to store Fenofibrate
Keep out of the reach and sight of children.
Do not use Fenofibrate after the expiry date which is stated on the carton/blister after "EXP". 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.
Further information
The active ingredient in each capsule is 200mg of Fenofibrate.
Other ingredients are:
Sucrose, Maize Starch, Hypromellose, Sodium Laurilsulfate, Dimeticone (35% emulsion), Simeticone (30% emulsion), Talc. The capsule is made of Gelatin, Titanium Dioxide (E171) and Yellow Iron Oxide (E172)
What Fenofibrate look like and contents of the pack:
Fenofibrate are opaque yellow caps and transparent bodies, containing white spherical microgranules.
Fenofibrate are available in packs of: 20, 28, 30, 50, 90 or 100
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Tillomed Laboratories Ltd 3 Howard Road Eaton Socon, St Neots Cambridgeshire PE198ET United Kingdom
Manufacturer:
Salutas Pharma GmbH Otto-Von-Guericke-Allee 1 39179 Barleben Germany
Product Licence Number:
Fenofibrate 200mg Capsules: PL 11311/0184
The leaflet was last revised in March 2011.
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