VYDURA 75 mg oral lyophilisate

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

VYDURA 75 mg oral lyophilisate

rimegepant

This medicinal product is subject to additional monitoring, which will allow rapid identification of new information on its safety. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What VYDURA is and what it is used for
2. What you need to know before taking VYDURA
3. How to take VYDURA
4. Possible adverse reactions
5. How to store VYDURA
6. Contents of the pack and other information

1. What VYDURA is and what it is used for

VYDURA contains the active substance rimegepant, which inhibits the activity of a substance in the body called calcitonin gene-related peptide (CGRP). People with migraine 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 results in two effects:

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

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

2. What you need to know before taking VYDURA

Do not take VYDURA

• if you are allergic to rimegepant or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult 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 undergoing renal dialysis.

During treatment with VYDURA, stop taking this medicine and contact your doctor immediately:

• if you experience any symptoms of an allergic reaction (e.g., difficulty breathing, severe rash, swelling of the tongue, mouth, or face, difficulty swallowing, throat tightness, or hoarseness). These symptoms may occur several days after administration.

Children and adolescents

VYDURA must not be given to children and adolescents under 18 years of age, as 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 need to take any other medicines. This is because some medicines may affect how VYDURA works, or VYDURA may affect how other medicines work.

Below 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 used 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 abnormal heart rhythm, chest pain [angina], or high blood pressure);
• cyclosporine (a medicine used to prevent organ rejection after transplant).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is preferable to avoid using VYDURA during pregnancy, as the effects of this medicine in pregnant women are unknown.

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using this medicine. You and your doctor should decide whether you will 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 instructions for use of this medicine given 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 other day.

For the treatment of an acute migraine attack once it has started, the recommended dose is one oral lyophilisate (75 mg of rimegepant) as needed, no more than once per 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

Consult your doctor or pharmacist or go immediately to a hospital. Take the medicine pack and this leaflet with you.

If you forget to take VYDURA

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Stop using VYDURA and contact your doctor immediately if you have signs of an allergic reaction (such as severe skin rash or difficulty breathing) or signs of a serious allergic reaction known as "anaphylaxis" (such as swelling of the tongue, mouth or face, difficulty swallowing or breathing, throat tightness or hoarseness). Allergic reactions with VYDURA, including anaphylaxis, are uncommon (may affect up to 1 in 100 people).

A common adverse effect (may affect up to 1 in 10 people) is nausea.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VYDURA

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of VYDURA

• The active substance is rimegepant. Each oral lyophilisate contains 75 mg of rimegepant (as sulfate).
• The other components are: gelatin, mannitol, peppermint flavour, and sucralose.

Appearance of the product and contents of the pack

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

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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