Patient leaflet - Vydura 75 mg oral Lyophilisate
1. What VYDURA is and what it is used for
VYDURA contains the active ingredient rimegepant, that stops the activity of a substance in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased levels of CGRP. Rimegepant attaches to the receptor for CGRP, reducing the ability of CGRP to also attach to the receptor. This reduces the activity of
CGRP and has two effects:
- 1) it can stop an active migraine attack, and
- 2) it can decrease the number of migraine attacks that occur when taken preventively.
VYDURA is used to treat and prevent migraine attacks in adults.
2. What you need to know before you take VYDURA
Do not take VYDURA
- if you are allergic to rimegepant or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking VYDURA, if any of the following applies to you:
- if you have severe liver problems
- if you have reduced kidney function or are on kidney dialysis
During treatment with VYDURA, stop taking this medicine and tell your doctor immediately:
- if you experience any symptoms of an allergic reaction, e.g., trouble breathing or severe rash. These symptoms can occur several days after administration.
Children and adolescents
VYDURA should not be given to children and adolescents under 18 years of age because it has not yet been studied in this age group.
Other medicines and VYDURA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some medicines may affect the way VYDURA works or VYDURA may affect how other medicines work.
The following is a list of examples of medicines that should be avoided when taking VYDURA:
- itraconazole and clarithromycin (medicines used to treat fungal or bacterial infections).
- ritonavir and efavirenz (medicines to treat HIV infections).
- bosentan (a medicine used to treat high blood pressure).
- St. John’s wort (a herbal remedy used to treat depression).
- phenobarbital (a medicine used to treat epilepsy).
- rifampicin (a medicine used to treat tuberculosis).
- modafinil (a medicine used to treat narcolepsy).
Do not take VYDURA more than once every 48 hours with:
- fluconazole and erythromycin (medicines used to treat fungal or bacterial infections).
- diltiazem, quinidine, and verapamil (medicines used to treat an abnormal heart rhythm, chest pain (angina) or high blood pressure).
- cyclosporin (a medicine used to prevent organ rejection after an organ transplant).
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is preferable to avoid the use of VYDURA during pregnancy as the effects of this medicine in pregnant women are not known.
If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use VYDURA while breast-feeding.
Driving and using machines
VYDURA is not expected to affect your ability to drive or use machines.
3. How to take VYDURA
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
For prevention of migraine, the recommended dose is one oral lyophilisate (75 mg rimegepant) every other day.
For treatment of a migraine attack once it has started, the recommended dose is one oral lyophilisate (75 mg rimegepant) as needed, not more than once daily.
The maximum daily dose is one oral lyophilisate (75 mg rimegepant) per day.
How to take this medicine
VYDURA is for oral use.
The oral lyophilisate can be taken with or without food or water.
Instructions:
Use dry hands when opening. Peel back the foil covering of one blister and gently remove the oral lyophilisate. Do not push the oral lyophilisate through the foil.
As soon as the blister is opened, remove the oral lyophilisate and place it on or under the tongue, where it will dissolve. No drink or water is needed.
Do not store the oral lyophilisate outside the blister for future use.
If you take more VYDURA than you should
Talk to your doctor or pharmacist or go to a hospital straight away. Take the medicine pack and this leaflet with you.
If you forget to take VYDURA
If you take VYDURA for the prevention of migraine and you miss a dose, just take the next dose at the usual time. Do not take a double dose to
make up for a forgotten dose.
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 using VYDURA and contact your doctor straight away if you have signs of an allergic reaction such as severe rash or shortness of breath. Allergic reactions with VYDURA are uncommon (may affect up to 1 in 100 people).
A common side effect (may affect up to 1 in 10 people) is nausea.
Reporting of side effects
If you 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:
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 VYDURA
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 and the blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C. Store in the original blister in order to protect from moisture.
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.
If the medicine becomes discolored or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What VYDURA contains
- The active substance is rimegepant. Each oral lyophilisate contains 75 mg rimegepant (as sulfate).
- The other ingredients are: gelatin, mannitol, mint flavour, and sucralose.
What VYDURA looks like and contents of the pack
VYDURA 75 mg oral lyophilisates are white to off-white, circular, and debossed with the symbol .
Pack sizes:
- 2 x 1 oral lyophilisate perforated unit dose blisters.
Not all pack sizes may be marketed.
Manufacturer: Millmount Healthcare Limited Block-7, City North Business Campus Stamullen
Co. Meath K32 YD60
Ireland Procured from within the EU and repackaged for the PL Holder: Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom PL: 45763/1455
POM
Vydura® is a registered trademark of Pfizer Ireland Pharmaceuticals For any information about this medicine, please contact the local representative of the Product Licence Holder: Abacus Medicine Ltd. tel: tel: +44(0)2036301244 email: MedInfo@abacusmedicine.co.uk or drugsafetyuk@abacusmedicine.co.uk This leaflet was last revised on 06.03.2025.
Blind or partially sighted? Is this leaflet hard to see or read? Call 02036301310 or write to info@abacusmedicine.com to obtain the leaflet in a format suitable for you. |
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