Patient leaflet - FENOFIBRATE 200 MG CAPSULES
accord
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
- ______________ Keep this leaflet. You may need to read it again.
- J Ifyou have anyfurtherquestions,askyourdoctoror 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.
' ifyou get any side effects, talktoyourdoctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.
What is in this leaflet
H 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
16 Contents of the pack and other information
H What Fenofibrate capsules are and what they are used for Fenofibrate belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level offats (lipids) in the blood, for example the fats known as triglycerides.
Fenofibrate 200mg capsules are used, alongside a low fat diet and other nonmedical treatments such as exercise and weight loss, to lower levels offats in the blood.
Fenofibrate 200mg capsules can be used in addition to other medicines (called statins) in some circumstances when levels of fats in the blood are not controlled with a statin alone.
|2 What you need to know before you take Fenofibrate capsules
Do not take Fenofibrate capsules if:
- you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
- while taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an antiinflammatory medicine called ‘ketoprofen’)
- you have severe liver, kidney or gallbladder problems
- you have pancreatitis (an inflamed pancreas which causes abdominal pain), which is not caused by high levels of fat in the blood.
Do not take Fenofibrate capsules if any of the above apply to you. Ifyou are not sure, talk to your doctor or pharmacist before taking Fenofibrate capsules.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fenofibrate capsules if you:
- have any liver or kidiey problems
- may have an inflamed liver (hepatitis) – signs include yellowing ofthe skin and whites of the eyes (jaundice) and an increase in liver enzymes (shown in blood tests)
- have an under-active thyroid gland (hypo-thyroidism)
Package leaflet: Information for the patient Fenofibrate 200mg capsules
- have diabetes, especiallyType 2 diabetes, that is not well controlled
- have problems with certain proteins in your blood
- have an alcohol problem
- are taking other medicines
- or your family have had muscle problems
- are over 70 years of age.
(Some ofthe above conditions can lead to high levels of lipids in your blood and need to be corrected before you start therapy with fenofibrate).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Fenofibrate capsules.
Your doctor might want to test your blood or urine to check if Fenofibrate capsules are working properly and also ifyour kidneys, muscles and liver are working properly.
Effects on muscles
- Stop taking Fenofibrate capsules and see a doctor straight away if you get unexplained cramps or painful, tender or weak muscles while taking this medicine. This is because this medicine may cause muscle problems, which may be serious These problems are rare but include muscle inflammation and breakdown. This can cause kidney damage or even death.
Your doctor may do a blood test to check your muscles before and after starting treatment.
The risk of muscle breakdown is higher in some patients. Tell your doctor if you:
- are over 70 years old
- have kidney problems
- have thyroid problems
- or a close family member has a musde problem which runs in the family
- drink large amounts ofalcohol
- are taking medicines called statins to lower cholesterol – such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
- have ever had muscle problems during treatment with statins or fibrates -such as fenofibrate, bezafibrate or gemfibrozil.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Fenofibrate capsules.
Other medicines and Fenofibrate capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
- Anti-coagulants to thin your blood (such as warfarin)
- Other medicines to control fat levels in the blood (such as statins or fibrates). Taking a statin at the same time as Fenofibrate capsules may increase the risk of muscle problems
- A particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)
- Ciclosporin – used to suppress your immune system.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Fenofibrate capsules.
Fenofibrate capsules with food, drink and alcohol
It is important to take the capsule with food – it will not work as well if your stomach is empty.
Pregnancy, breast-feeding and fertility
- Do not take Fenofibrate capsules and tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby
- Do not take Fenofibrate capsules if you are breast-feeding or planning to breast-feed your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine will not affect you being able to drive or use tools or 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.
Fenofibrate capsules contain Ponceau 4R, cochineal red A (E124)
May cause allergic reactions.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’
3 how to take fenofibrate capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status.
Taking this medicine
- Swallow the capsule whole with a glass of water
- Do not open or chew the capsule
- Take the capsule with food – it will not work as well if your stomach is empty.
How much to take
The recommended dose for adults is one capsule a day, taken at mealtimes.
Use in children and adolescents
The use of Fenofibrate 200mg capsules is not recommended in children under the age of 18
People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose. Ask your doctor or pharmacist about this.
If you take more Fenofibrate capsules than you should
Ifyou take more Fenofibrate capsules than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately.
If you forget to take Fenofibrate capsules
- Ifyou forget a dose, take the next dose with your next meal
- Then take the next capsule at the normal time
- Do not take a double dose to make up for a forgotten dose
- Ifyou are worried about this, talk to your doctor.
If you stop taking Fenofibrate capsules
Do not stop taking Fenofibrate capsules unless your doctor tells you to, or the capsules make you feel unwell. This is because abnormal levels offats in the blood need treating for a long period oftime.
Remember that as well as taking Fenofibrate capsules it is important that you:
- Have a lowfat diet
- Take regular exercise.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Fenofibrate capsules and see a doctor immediately , ifyou notice any of the following serious side effects – you may need urgent medical treatment: Uncommon (may affect up to 1 in 100 people):
- Chest pain and feeling breathless – these may be signs of a blood clot in the lung (pulmonary embolism)
- Pain, redness or swelling in the legs – these may be signs of a blood clot in the leg (deep vein thrombosis)
- Stomach pain – this may be a sign that your pancreas is inflamed (pancreatitis).
Rare (may affect up to 1 in 1,000 people):
- Allergic reaction – the signs may include swelling ofthe face, lips, tongue or throat, which may cause difficulty in breathing
- Yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes – these may be signs ofan inflamed liver (hepatitis).
Continued top of next column
Not known (frequency cannot be estimated from the available data):
- Severe form of skin rash with reddening, peeling and swelling ofthe skin that resembles severe burns – these may be signs of severe skin reactions (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Cramps or painful, tender or weak muscles – these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death.
Other side effects include:
Common (may affect up to 1 in 10 people):
Diarrhoea; stomach pain; wind (flatulence); feeling sick (nausea); being sick (vomiting); raised levels of liver enzymes in the blood – shown in tests; increase in homocysteine (too much ofthis amino acid in the blood has been associated to a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal link has not been established).
Uncommon (may affect up to 1 in 100 people):
Headache; gallstones; reduced sex drive; rash; itching or red patches on the skin; increase in creatinine’ produced by the kidneys – shown in tests; muscle pain; muscle inflammation; muscle cramps and weakness.
Rare (may affect up to 1 in 1,000 people):
Hair loss; increase in ‘urea' produced by the kidneys – shown in tests; increased sensitivity of your skin to sunlight, sun lamps and sunbeds; drop in haemoglobin (that carries oxygen in the blood) and white blood cells – shown in tests; stomach pain and itching.
Not known (frequency cannot be estimated from the available data):
Long-term lung problems; complications of gallbladder stones; feeling dizzy (vertigo); feeling exhausted (fatigue).
Reporting of side effects
Ifyou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety ofthis medicine.
^1 How to store Fenofibrate capsules
Keep this medicine out of the sight and reach of children.
Do not store above 25° C.
Store in the original package.
Do not take this medicine after the expiry date which is stated on the label/carton/bottle. 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.
"6 Contents of the pack and other information
What Fenofibrate capsules contain
- The active substance (the ingredient that makes the capsules work is micronised fenofibrate. Each capsule contains 200mg ofthe active substance.
- The other ingredients are lactose monohydrate, pregelatinised starch, sodium lauryl sulfate, povidone, magnesium stearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), ponceau 4R, cochineal red A (E124).
What Fenofibrate capsules look like and contents of the pack
Fenofibrate capsules are orange, hard, gelatine capsules.Pack size is 28.
Marketing Authorisation Holder and Manufacturer Accord, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in April 2021.
Ifyou would like a leaflet with larger text, please contact 01271 385257.
50999182 BBBB1132