VYDURA 75 mg ORAL LYOPHILIZED
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How to use VYDURA 75 mg ORAL LYOPHILIZED
Introduction
Package Leaflet: Information for the Patient
VYDURA 75 mg Oral Lyophilisate
rimegepant
This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is VYDURA and what is it used for
- What you need to know before you take VYDURA
- How to take VYDURA
- Possible side effects
- Storage of VYDURA
- Contents of the pack and further information
1. What is VYDURA and what is it used for
VYDURA contains the active substance rimegepant, which blocks the activity of a substance in the body called calcitonin gene-related peptide (CGRP). People with migraine may have high levels of CGRP. Rimegepant binds to the CGRP receptor, reducing the ability of CGRP to also bind to the receptor. This reduces the activity of CGRP and produces two effects:
- it can stop an active migraine attack, and
- it can reduce 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 apply 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. difficulty breathing or severe skin rash. These symptoms may occur several days after administration.
Children and adolescents
VYDURA should not be given to children and adolescents under 18 years of age, as it has not 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 the way 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 for treating HIV infections);
- bosentan (medicine used to treat high blood pressure);
- St. John's Wort (herbal remedy used to treat depression);
- phenobarbital (medicine used to treat epilepsy);
- rifampicin (medicine used to treat tuberculosis);
- modafinil (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 abnormal heart rhythm, chest pain [angina], or high blood pressure);
- cyclosporin (medicine used to prevent organ rejection after a transplant).
Pregnancy and breastfeeding
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 on pregnant women are unknown.
If you are breastfeeding or plan to breastfeed, ask your doctor or pharmacist for advice before taking this medicine. You and your doctor will decide whether to use VYDURA during breastfeeding.
Driving and using machines
VYDURA is not expected to affect your ability to drive or use machines.
3. How to take VYDURA
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.
How much to take
For the prevention of migraine, the recommended dose is one oral lyophilisate (75 mg of rimegepant) every two days.
For the treatment of a migraine attack once started, the recommended dose is one oral lyophilisate (75 mg of rimegepant) as needed, no more than once a day.
The maximum daily dose is one oral lyophilisate (75 mg of rimegepant) per day.
How to take this medicine
VYDURA is administered orally.
The oral lyophilisate can be taken with or without food or water.
Instructions:
|
If you take more VYDURA than you should
Talk to your doctor or pharmacist or go to the hospital immediately. 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 miss a dose, simply take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.
If you have any other questions about 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 immediately if you have signs of an allergic reactionsuch as severe skin rash or difficulty breathing. Allergic reactions with VYDURA are rare (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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 blister after EXP. The expiry date is the last day of the month stated.
Do not store above 30°C. Store in the original blister to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and further information
Composition of VYDURA
- The active substance is rimegepant. Each oral lyophilisate contains 75 mg of rimegepant (as sulfate).
- The other ingredients are: gelatin, mannitol, peppermint flavor, and sucralose.
Appearance and packaging of the product
The VYDURA 75 mg oral lyophilisates are white to off-white, circular, and have the symbol.
Package sizes:
- 2 single-dose oral lyophilisates in a perforated blister.
- 8 single-dose oral lyophilisates in perforated unit-dose blisters.
- 16 single-dose oral lyophilisates in perforated unit-dose blisters.
Not all pack sizes may be marketed.
Marketing authorisation holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
HiTech Health Limited
5-7 Main Street
Blackrock
Co. Dublin
A94 R5Y4
Ireland
Millmount Healthcare Limited
Block-7, City North Business Campus
Stamullen
Co. Meath
K32 YD60
Ireland
Pfizer Ireland Pharmaceuticals Unlimited Company
Little Connell
Newbridge
Co. Kildare
W12 HX57
Ireland
You can request more information about this medicine from the local representative of the marketing authorisation holder:
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11 | Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. +370 5 251 4000 |
???????? ??????? ?????????? ????, ???? ???????? ???: +359 2 970 4333 | Magyarország Pfizer Kft. Tel.: + 36 1 488 37 00 |
Ceská republika Pfizer, spol. s r.o. Tel: +420 283 004 111 | Malta Vivian Corporation Ltd. Tel.: +356 21344610 |
Danmark Pfizer ApS Tlf.: +45 44 20 11 00 | Nederland Pfizer bv Tel: +31 (0) 800 63 34 636 |
Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51000 | Norge Pfizer AS Tlf: +47 67 52 61 00 |
Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500 | Österreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0 |
Ελλ?δα Pfizer Ελλ?ς Α.Ε. Τηλ.: +30 210 6785800 | Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00 |
España Pfizer, S.L. Tel: +34 91 490 99 00 | Portugal Laboratórios Pfizer, Lda. Tel: +351 21 423 5500 |
France Pfizer Tél: +33 (0)1 58 07 34 40 | România Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 00 |
Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 777 | Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s podrocja farmacevtske dejavnosti, Ljubljana Tel.: +386 (0)1 52 11 400 |
Ireland Pfizer Healthcare Ireland Unlimited Company Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616161 | Slovenská republika Pfizer Luxembourg SARL, organizacná zložka Tel: + 421 2 3355 5500 |
Ísland Icepharma hf. Sími: +354 540 8000 | Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 |
Italia Pfizer S.r.l. Tel: +39 06 33 18 21 | Sverige Pfizer AB Tel: +46 (0)8 550 520 00 |
Κ?προς Pfizer Ελλ?ς Α.Ε. (Cyprus Branch) Τηλ.: +357 22817690 | |
Latvija Pfizer Luxembourg SARL filiale Latvija Tel: + 371 670 35 775 |
Date of last revision of this leaflet:04/2025.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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