Prospect: information for the patient

VYDURA 75 mg lyophilized oral

rimegepant

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is VYDURA and what it is used for

2.What you need to know before starting to take VYDURA

3.How to take VYDURA

4.Possible adverse effects

5.Storage of VYDURA

6.Contents of the package and additional information

VYDURA contains the active ingredient rimegepant, which inhibits the activity of a substance in the body called calcitonin gene-related peptide (CGRP). People with migraines may have elevated levels of CGRP. Rimegepant binds to the CGRP receptor, reducing the ability of CGRP to bind to the receptor as well. This reduces CGRP activity and produces two effects:

1. it may halt an active migraine episode, and
2. it may decrease the number of migraine episodes that occur when taken preventatively.

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

Do not take VYDURA

-if you are allergic to rimegepant or any of the other components of this medication

(listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take VYDURA if any of the following apply to you:

-if you have severe liver problems;

-if you have reduced kidney function or are on dialysis.

Stop taking VYDURA and inform your doctor immediately if you experience any of the following during treatment:

-any symptoms of an allergic reaction, such as difficulty breathing or intense skin rash. These symptoms may appear several days after administration.

Children and adolescents

VYDURA should not be administered to children and adolescents under 18 years of age, as it has not yet been studied in this age group.

Other medications and VYDURA

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because some medications may affect the functioning of VYDURA or VYDURA may affect the functioning of other medications.

The following is a list of examples of medications that should be avoided when taking VYDURA:

-itraconazole and clarithromycin (medications used to treat fungal or bacterial infections);

-ritonavir and efavirenz (medications for treating HIV infections);

-bosentan (medication used to treat high blood pressure);

-St. John's Wort (herbal remedy used to treat depression);

-phenobarbital (medication used to treat epilepsy);

-rifampicin (medication used to treat tuberculosis);

-modafinil (medication used to treat narcolepsy).

Do not take VYDURA more than once every 48 hours with:

-fluconazole and erythromycin (medications used to treat fungal or bacterial infections);

-diltiazem, quinidine, and verapamil (medications used to treat abnormal heart rhythm, chest pain [angina], or high blood pressure);

-ciclosporin (medication used to prevent organ rejection after a transplant).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. It is recommended to avoid using VYDURA during pregnancy, as its effects on pregnant women are unknown.

If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using this medication. You and your doctor should decide whether to use VYDURA during breastfeeding.

Driving and operating machinery

VYDURA is not expected to affect your ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult 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 it has started, the recommended dose is one oral lyophilisate (75 mg of rimegepant) as needed, not more than once a day.

The maximum daily dose is one oral lyophilisate (75 mg of rimegepant) per day.

How to take this medication

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

Consult your doctor or pharmacist or go immediately to a hospital. Bring with you the packaging of the medication and this leaflet.

If you forget to take VYDURA

If you take VYDURA for the prevention of migraine and forget to take a dose, simply take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Stop using VYDURA and contact your doctor immediately if you experience 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 frequent adverse effect (may affect up to 1 in 10 people) are nausea.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 86 °F. Store in the original blister pack to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of VYDURA

-The active ingredient is rimegepant. Each lyophilized oral contains 75 mg of rimegepant (as sulfate).

-The other components are: gelatin, mannitol, peppermint aroma, and sucralose.

Appearance of the product and contents of the container

VYDURA 75 mg oral lyophilisates are white to off-white, circular, and have the symbol.

Container sizes:

• 2unit doses of oral lyophilisate in perforated blister pack.
• 8oral lyophilisates in perforated single-dose blister pack.
• 16oral lyophilisates in perforated single-dose blister pack.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

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

Little Connell

Newbridge

Co. Kildare

W12 HX57

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Phone: +34 91 490 99 00

Last review date of this leaflet:01/2024.

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.