- eliglustat tartrate
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 can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: EU/1/14/974/001, EU/1/14/974/002, EU/1/14/974/003 .
Cerdelga 84 mg capsules, hard
Package leaflet: Information for the patient
Cerdelga 84 mg capsules, hard
▼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 Cerdelga is and what it is used for
2. What you need to know before you take Cerdelga
3. How to take Cerdelga
4. Possible side effects
5. How to store Cerdelga
6. Contents of the pack and other information
1. WHAT CERDELGA IS AND WHAT IT IS USED FOR
Cerdelga is a medicine used for the long term treatment of adult patients with Gaucher disease type 1.
Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is not effectively broken down by your body. As a result glucosylceramide builds up in your spleen, liver and bones. The build-up prevents these organs from working properly. Cerdelga contains the active substance eliglustat which decreases the production of glucosylceramide, thereby preventing its build-up. In turn this helps your affected organs to work better.
People differ in the speed that their body breaks down this medicine. As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond. Cerdelga is meant to be used in patients whose body breaks down this medicine at normal speed (known as intermediate metabolisers and extensive metabolisers) or slow speed (known as poor metabolisers). Your doctor will determine if Cerdelga is suitable for you before you start taking it, using a simple laboratory test.
Gaucher disease type 1 is a lifelong condition and you must continue to take this medicine as prescribed by your doctor to gain the maximum benefit from your medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CERDELGA
Do not take Cerdelga
Warnings and precautions
Talk to your doctor or pharmacist before taking Cerdelga, if you:
Children and adolescents
Cerdelga has not been tested in children and adolescents under 18 years of age. Do not give this medicine to children or adolescents.
Other medicines and Cerdelga
Please tell your doctor or pharmacist if you are using, or have recently used, or might use, any other medicines.
Medicines that must not be taken in combination with each other and Cerdelga
Cerdelga must not be used with certain type of medicines. These medicines can interfere with your body’s ability to break down Cerdelga and this can result in higher levels of Cerdelga in your blood. These medicines are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors. There are many medicines in these categories and depending on how your body breaks down Cerdelga the effects may differ from person to person. Please speak to your doctor regarding these medicines before you start taking Cerdelga. Your doctor will determine which medicines you can use based on how fast your body breaks down eliglustat.
Medicines that may increase the level of Cerdelga in the blood such as:
Medicines that may decrease the level of Cerdelga in the blood:
Cerdelga may increase the level of the following types of medicines in the blood:
Taking Cerdelga with food and drink
Avoid consumption of grapefruit or grapefruit juice since it may increase the level of Cerdelga in your blood.
Pregnancy, breast-feeding and fertility
If you are pregnant, think that you may be pregnant or are planning to have a baby, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
The active substance in this medicine has been shown to pass in trace amounts into breast milk in animals. Breast-feeding is not recommended during treatment with this medicine. Tell your doctor if you are breast-feeding.
There are no known effects on fertility at normal doses.
Driving and using machines
Cerdelga has negligible or no influence on the ability to drive and use machines.
Cerdelga contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE CERDELGA
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you are an intermediate metaboliser or extensive metaboliser:
Swallow one 84 mg capsule whole twice a day with water. It may be taken with or without food. Take one capsule in the morning and one capsule at night.
If you are a poor metaboliser:
Swallow one 84 mg capsule whole once a day with water. It may be taken with or without food. Take one capsule at the same time every day.
Do not open, crush, dissolve, or chew the capsule before swallowing it. If you cannot swallow the capsule whole, tell your doctor.
Continue taking Cerdelga every day for as long as your doctor tells you.
How to pull the blister/wallet from the sleeve
While pressing your thumb and finger together at one end of the sleeve (1) gently pull the blister/wallet out to open the sleeve (2).
If you take more Cerdelga than you should
If you take more capsules than you were told to, consult your doctor immediately. You may experience dizziness marked by loss of balance, slow heart rate, nausea, vomiting and light-headedness.
If you forget to take Cerdelga
Take the next capsule at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Cerdelga
Do not stop taking Cerdelga without talking to your doctor.
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. Most of the side effects are mild and will generally disappear over time.
Common (may affect up to 1 in 10 people):
In clinical studies, a small number of patients fainted. All of these patients had risk factors for fainting. Please tell your doctor immediately if you are feeling faint or you have fainted.
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 contact details below.
By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. HOW TO STORE CERDELGA
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 carton, sleeve and blister after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Cerdelga contains
What Cerdelga looks like and contents of the pack
Cerdelga capsules have a pearl blue-green opaque cap and a pearl white opaque body with “GZ02” printed in black on the capsule.
Pack sizes of 14 hard capsules in 1 blister wallet of 14 capsules, 56 hard capsules in 4 blister wallets of 14 capsules each or 196 hard capsules in 14 blister wallets of 14 capsules each
Not all packs may be marketed in your country.
Marketing Authorisation Holder
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in November 2018
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
There are also links to other websites about rare diseases and treatments.
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