Vydura
Italy
Table of Contents
Package leaflet: Information for the patient
VYDURA 75 mg oral lyophilisate
rimegepant
Medicinal product subject to additional monitoring. This will allow for the rapid identification of
new safety information. You can help by reporting any adverse reactions you experience while
taking this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet
- What VYDURA is and what it is used for
- What you need to know before taking VYDURA
- How to take VYDURA
- Possible side effects
- How to store VYDURA
- Contents of the pack and other information
1. What VYDURA is and what it is used for
VYDURA contains the active substance rimegepant, which blocks the activity of a substance in the body called calcitonin gene-related peptide (CGRP). People who suffer from migraine may have higher levels of CGRP. Rimegepant binds to the CGRP receptor, reducing CGRP's ability to bind to the receptor. By this mechanism, it reduces CGRP activity and has two effects:
- it is able to stop an ongoing migraine attack, and
- it is able to reduce the number of migraine attacks that occur, when taken preventively.
VYDURA is used to treat and prevent migraine attacks in adults.
2. What you should 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
Talk to your doctor or pharmacist before taking VYDURA if any of the following conditions apply to you:
- If you have severe liver problems
- If you have reduced kidney function or are on dialysis.
During treatment with VYDURA, stop taking the medicine and contact your doctor immediately:
- if you experience any symptoms of an allergic reaction, such as difficulty breathing or severe skin rash. These symptoms may occur several days after administration.
Children and adolescents
VYDURA is not recommended for children and adolescents under 18 years of age, as it has not yet been studied in this age group.
Other medicines and VYDURA
Inform 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.
Below are some 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 in the lungs)
- 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 together 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)
- ciclosporin (a medicine used to prevent organ transplant rejection).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking 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, talk to your doctor or pharmacist before taking this medicine. You and your doctor will decide whether or not to use VYDURA during breastfeeding.
Driving and using machines
VYDURA is not expected to affect your ability to drive vehicles or operate machinery.
3. How to take VYDURA
Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How much medicine 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 ongoing migraine attack, 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 for oral use.
You may take the oral lyophilisate with or without food or water.
Instructions:
Open with dry hands. Lift the foil covering the blister and
gently remove the oral lyophilisate. Do not push the oral lyophilisate
through the foil.
Immediately after opening the blister, remove the oral lyophilisate and place it on or
under the tongue, where it will dissolve. No drinks or water are needed.
Do not store the oral lyophilisate outside the blister for future use.
If you take more VYDURA than you should
Contact your doctor or pharmacist immediately or go to the nearest hospital. Take the
medicine pack and this patient information leaflet with you.
If you forget to take VYDURA
If you are taking VYDURA for migraine prevention and have missed a dose, simply take the
next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking VYDURA and contact your doctor immediately if you experience signs of an allergic
reaction, such as rash or severe shortness of breath. Allergic reactions with VYDURA are not common
(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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store VYDURA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30 °C. Keep in the original blister to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What VYDURA contains
- The active substance is rimegepant. Each oral lyophilisate contains 75 mg of rimegepant (as sulfate).
- The other components are: gelatin, mannitol, mint flavour, and sucralose.
Description of the appearance of VYDURA and package contents
VYDURA 75 mg oral lyophilisates are white to off-white, circular, and bear the imprint
symbol.
Pack sizes:
- 2 x 1 oral lyophilisates in perforated, divisible blister packs for single dose
- 8 x 1 oral lyophilisates in perforated, divisible blister packs for single dose
- 16 x 1 oral lyophilisates in perforated, divisible blister packs for single dose
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
Little Connell
Newbridge
Co. Kildare
W12 HX57
Ireland
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel. +370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11
България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел: +359 2 970 4333 Tel.: + 36 1 488 37 00
Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420 283 004 111 Tel.: +356 21344610
Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0) 800 63 34 636
Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0
Ελλάδα Polska
Pfizer Ελλάς Α.Ε. Pfizer Polska Sp. z o.o.
Τηλ.: +30 210 6785800 Tel.: +48 22 335 61 00
España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500
France România
Pfizer Pfizer Romania S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00
Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0)1 52 11 400
Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: +1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: +44 (0)1304 616161
Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358 (0)9 430 040
Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00
Κύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited
Τηλ.: +357 22817690 Tel: +44 (0) 1304 616161
Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.