Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vydura

Document Subject

Generated Narrative: MedicinalProductDefinition mp443c755443342bac5ae9c42b145300e0

identifier: http://ema.europa.eu/identifier/EU/1/22/1645/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VYDURA 75 mg oral lyophilisate

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-443c755443342bac5ae9c42b145300e0

identifier: http://ema.europa.eu/identifier/EU/1/22/1645/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vydura

Attesters

What is in this leaflet

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

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 or severe rash. 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, the recommended dose is one oral lyophilisate (75 mg rimegepant) every other day.

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. Allergic reactions with VYDURA are uncommon (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 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 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 YDIreland

Pfizer Ireland Pharmaceuticals Little Connell Newbridge Co. Kildare W12 HXIreland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. +370 5 251 4
,
: +359 2 970 4Magyarorsz g Pfizer Kft.
Tel.: + 36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel.: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0) 800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer . . .: +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer
T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel.: +386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520
Pfizer . . (Cyprus Branch) .: +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel: + 371 670 35 This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: