VYDURA 75 mg ORAL LYOPHILIZED

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:

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.