Active ingredient
- fenofibrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0137.
Fenofibrate 267mg Capsules
PATIENT INFORMATION LEAFLET
FENOFIBRATE 267MG CAPSULES
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What fenofibrate is and what it is used for
2. What you need to know before you take fenofibrate
3. How to take fenofibrate
4. Possible side effects
5. How to store fenofibrate
6. Contents of the pack and other 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.
It is always essential to continue a low-fat diet during treatment with fenofibrate and it is important to exercise.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENOFIBRATE
Do not take Fenofibrate if:
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face throat or tongue
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.
Warnings and Precautions
Talk to your doctor or pharmacist before taking fenofibrate if:
(Some of the 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. Your doctor might want to test your blood or urine to check if fenofibrate is working properly and also if your kidneys, muscles and liver are working properly.
Effects on muscles
Stop taking fenofibrate and see a doctor straight away if you get unexplained cramps or painful, tender or weak muscles while taking this medicine.
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:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking fenofibrate.
Other medicines and fenofibrate
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.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Fenofibrate with food, drink and alcohol
Pregnancy, breast-feeding and fertility
Do not use this medicine if:
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 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
How much to take
Adults
Use in children and adolescents
People with kidney problems
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 with your next meal, then go on as before. Do not take a double dose to make up for a forgotten capsule.
If you are worried about this talk to your doctor.
Blood tests
If you stop taking fenofibrate
Do not stop taking fenofibrate unless your doctor tell you to, or the capsules make you feel unwell. This is because abnormal levels of fate in the blood need treating for a long period of time.
Remember that as well as taking fenofibrate it is also important that you:
If you have any further questions on the use of this product, 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 and see a doctor or got to a hospital straight away, if you notice any of the following serious side effects — you may need urgent medical treatment:
Uncommon (affects less than 1 in 100 people):
Rare (affects less than 1 in 1000 people):
Not known (frequency cannot be estimated from the available data):
Other side effects include:
Common (affects less than 1 in 10 people):
Uncommon (affects less than 1 in 100 people):
Rare (affects less than 1 in 1000 people):
This side effect can also happen after using a sun lamp (UV)
Not known (frequency cannot be estimated from the available data):
If you get any unusual breathing discomfort, tell your doctor straight away.
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 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 of this medicine.
5. HOW TO STORE FENOFIBRATE
6. CONTENTS OF THE PACK AND OTHER 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.
The Marketing Authorisation Holder is:
The Manufacturer is:
This leaflet was last revised in: September 2019
'Zentiva' is a registered trademark © 2019
Zentiva
1065016789
12 New Fetter Lane, LONDON, EC4A 1JP, UK
+44 (0)800 090 2408
+44 (0)844 8793 188