rimegepant: package leaflet

VYDURA contains the active ingredient rimegepant, that stops the activity of a substance in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased levels of CGRP. Rimegepant attaches to the receptor for CGRP, reducing the ability of CGRP to also attach to the receptor. This reduces the activity of CGRP and has two effects:
1) it can stop an active migraine attack, and
2) it can decrease the number of migraine attacks that occur when taken preventively.

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

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 applies 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., trouble breathing, severe rash, swelling of tongue, mouth or face, trouble swallowing, throat tightness, or hoarseness). These symptoms can occur several days after administration.

Children and adolescents
VYDURA should not be given to children and adolescents under 18 years of age because 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 take any other medicines. This is because some medicines may affect the way VYDURA works or VYDURA may affect how 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 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 an abnormal heart rhythm, chest pain (angina) or high blood pressure).
- cyclosporin (a medicine used to prevent organ rejection after an organ transplant).

Pregnancy and breast-feeding
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 in pregnant women are not known.

If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use VYDURA while breast-feeding.

Driving and using machines
VYDURA is not expected to affect your ability to drive or use machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take
For prevention of migraine, take one oral lyophilisate (75 mg rimegepant) every other day or every day, as directed by your healthcare provider.

For treatment of a migraine attack once it has started, the recommended dose is one oral lyophilisate (75 mg rimegepant) as needed, not more than once daily.

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

How to take this medicine
VYDURA is for oral use.
The oral lyophilisate can be taken with or without food or water.

Instructions:

Use dry hands when opening. Peel back the foil covering of one blister and gently remove the oral lyophilisate. Do not push the oral lyophilisate through the foil.

As soon as the blister is opened, remove the oral lyophilisate and place it on or under the tongue, where it will dissolve. No drink or water is needed.
Do not store the oral lyophilisate outside the blister for future use.

If you take more VYDURA than you should
Talk to your doctor or pharmacist or go to a hospital straight away. 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 you miss a dose, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using VYDURA and contact your doctor straight away if you have signs of an allergic reaction (such as severe rash or shortness of breath) or signs of a severe allergic reaction known as ‘anaphylaxis’ (such as swelling of tongue, mouth or face, trouble swallowing or breathing, throat tightness, or hoarseness). Allergic reactions, including anaphylaxis, with VYDURA are uncommon (may affect up to 1 in 100 people).

For treatment of migraine a common side effect (may affect up to 1 in 10 people) is nausea.

For prevention of migraine common side effects (may affect up to 1 in 10 people) are constipation and nausea.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 the blister after EXP.
The expiry date refers to the last day of that month.

Do not store above 30 °C. Store in the original blister in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What VYDURA contains
- The active substance is rimegepant. Each oral lyophilisate contains 75 mg rimegepant (as sulfate).
- The other ingredients are: gelatin, mannitol, mint flavour, and sucralose.

What VYDURA looks like and contents of the pack
VYDURA 75 mg oral lyophilisates are white to off-white, circular, and debossed with the symbol .

Pack sizes:
- 2 x 1 oral lyophilisate perforated unit dose blisters.
- 8 x 1 oral lyophilisate perforated unit dose blisters.
- 16 x 1 oral lyophilisate perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation 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

For any information about this medicine, please contact 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

България
Пфайзер Люксембург САРЛ, Клон България
Тел: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: + 36 1 488 37 00

Česká 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
Ελλάδα
Pfizer Ελλάς 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 področja 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, organizačná 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

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ.: +357 22817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

This leaflet was last revised in .

Other sources of information

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