Active ingredient
- bempedoic acid
- ezetimibe
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.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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: PLGB 08265/0039.
Nustendi 180mg/10mg film-coated tablets
Package leaflet: Information for the patient
Nustendi 180 mg/10 mg film-coated tablet
bempedoic acid/ezetimibe
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 Nustendi is and what it is used for
2. What you need to know before you take Nustendi
3. How to take Nustendi
4. Possible side effects
5. How to store Nustendi
6. Contents of the pack and other information
1. What Nustendi is and what it is used for
What Nustendi is and how it works
Nustendi is a medicine that lowers levels of ‘bad’ cholesterol (also called “LDL-cholesterol”), a type of fat, in the blood.
Nustendi contains two active substances, which reduce your cholesterol in two ways:
What Nustendi is used for
Nustendi is given to adults with primary hypercholesterolaemia or mixed dyslipidaemia, which are conditions that cause a high cholesterol level in the blood. It is given in addition to a cholesterol-lowering diet.
Nustendi is given:
2. What you need to know before you take Nustendi
Do not take Nustendi:
Warnings and precautions
Talk to your doctor or pharmacist before taking Nustendi:
Your doctor should do a blood test before you start taking Nustendi with a statin. This is to check how well your liver is working.
Children and adolescents
Do not give Nustendi to children and adolescents under 18 years of age. The use of Nustendi has not been studied in this age group.
Other medicines and Nustendi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking medicine(s) with any of the following active substances:
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, trying to get pregnant, or think you may be pregnant, as there is a possibility that it could harm an unborn baby. If you get pregnant while taking this medicine, call your doctor immediately and stop taking Nustendi.
Driving and using machines
Nustendi has minor influence on the ability to drive and use machines.
However, some people may get dizzy after taking Nustendi. Avoid driving or using machines if you think your ability to react is reduced.
Nustendi contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Nustendi
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet once daily.
If you are taking colestyramine, take Nustendi either at least 2 hours before or at least 4 hours after taking colestyramine.
Swallow the tablet whole with food or between meals.
If you take more Nustendi than you should
Contact your doctor or pharmacist immediately.
If you forget to take Nustendi
If you notice that you forgot:
If you stop taking Nustendi
Do not stop taking Nustendi without your doctor’s permission as your cholesterol may rise again.
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.
Contact your doctor immediately if you have any of the following serious side effects (frequencies are unknown):
Other side effects can occur with the following frequencies:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from available data)
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 Website: 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 Nustendi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and carton. The expiry date refers to the last day of the month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not throw away any medicine 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 Nustendi contains
What Nustendi looks like and contents of the pack
Film-coated tablets are blue, oval, debossed with “818” on one side and “ESP” on the other side. Tablet dimensions: 15 mm × 7 mm × 5 mm.
The following pack sizes are registered: 10, 14, 28, 30, 84, 90, 98, or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets.
The following pack sizes are currently marketed: 28 film-coated tablets.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact:
This leaflet was last revised in May 2021.
Problems reading this leaflet?
To listen to or request a copy of this leaflet in Braille, large print or audio, please call, free of charge 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Nustendi 180mg/10mg Film-Coated Tablets
Reference number: PLGB 08265/0039
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