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VYDURA 75 mg ORAL LYOPHILIZED

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About the medicine

How to use VYDURA 75 mg ORAL LYOPHILIZED

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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

  1. What is VYDURA and what is it used for
  2. What you need to know before you take VYDURA
  3. How to take VYDURA
  4. Possible side effects
  5. Storage of VYDURA
  6. 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:

  1. it can stop an active migraine attack, and
  2. it can reduce the number of migraine attacks that occur when taken preventively.

VYDURA is used to treat and prevent migraine attacks in adults.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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:

Open with dry hands, remove protective film, and extract oral lyophilisate, do not push through film, instruction step 1

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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.

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Discuss questions about VYDURA 75 mg ORAL LYOPHILIZED, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

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Frequently Asked Questions

Is a prescription required for VYDURA 75 mg ORAL LYOPHILIZED?
VYDURA 75 mg ORAL LYOPHILIZED requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in VYDURA 75 mg ORAL LYOPHILIZED?
The active ingredient in VYDURA 75 mg ORAL LYOPHILIZED is rimegepant. This information helps identify medicines with the same composition but different brand names.
Who manufactures VYDURA 75 mg ORAL LYOPHILIZED?
VYDURA 75 mg ORAL LYOPHILIZED is manufactured by Pfizer Europe Ma Eeig. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of VYDURA 75 mg ORAL LYOPHILIZED online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether VYDURA 75 mg ORAL LYOPHILIZED is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to VYDURA 75 mg ORAL LYOPHILIZED?
Other medicines with the same active substance (rimegepant) include AIMOVIG 140 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, AIMOVIG 70 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, AJOVY 225 mg PRE-FILLED SYRINGE SOLUTION FOR INJECTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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