Vydura 75 mg Freeze Dried Rimegepant Tablet
What Vydura Is And What It Is Used For
Vydura contains the active substance rimegepant, which prevents the activity of a substance in the body called calcitonin gene-related peptide (CGRP). People with migraines may have elevated levels of CGRP.
Vydura rimegepant binds to the receptor for CGRP, thereby reducing the ability of CGRP to also bind to the receptor. This reduces CGRP activity and has two effects:
- It can interrupt an ongoing migraine attack.
- It can reduce the number of migraine attacks if taken preventively.
Vydura is used to treat and prevent migraine attacks in adults.
What You Need To Know Before You Take Vydura
Do Not Take Vydura
- If you are allergic to vydura 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 apply to you:
- You have severe liver problems.
- Your kidney function is impaired, or you are on dialysis.
When you are treated with Vydura, you must stop taking this medicine and inform the doctor immediately.
- If you get symptoms of an allergic reaction, e.g. breathing problems or severe skin rash. These symptoms may appear several days after you take medicine.
Children And Young People
Vydura should not be given to children and adolescents under 18 years of age as it has not 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. The reason is that some medicines can affect how Vydura works, and Vydura can affect how other medicines work.
The following are examples of drugs to avoid when being treated with Vydura:
- Itraconazole and clarithromycin (used against fungal or bacterial infections)
- Ritonavir and efavirenz (used against HIV infection )
- Bosentan (used for high blood pressure )
- St. John’s wort ((traditional) herbal remedy for mild depression and mild anxiety)
- Phenobarbital (used for epilepsy )
- Rifampicin (used for tuberculosis )
- Modafinil (used for narcolepsy ).
Do not take Vydura more often than once every other day (every 48 hours) if you also take
- Fluconazole or erythromycin (used against fungal or bacterial infections)
- Diltiazem, quinidine, or verapamil (used for abnormal heart rhythm, chest pain (angina), or high blood pressure )
- Ciclosporin (used to prevent organ rejection after transplantation).
Pregnancy, Breastfeeding, And Fertility
If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine. The use of Vydura during pregnancy should be avoided as the effects of the medicine on pregnant women are unknown.
If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using this medicine. You and your doctor should decide if you should use Vydura while breastfeeding.
Driving Ability And Use Of Machinery
Vydura Pfizer is not expected to affect your ability to drive or use machines.
How To Use Vydura
Vydura uses:
- Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- How much to take
- To prevent migraines, the recommended dose is one freeze-dried tablet (75 mg rimegepant) every other day.
- For the treatment of a migraine attack that has already started, the recommended dose is one freeze-dried tablet (75 mg rimegepant) as needed, but not more than once daily.
- The highest daily dose is one freeze-dried tablet (75 mg rimegepant) per day.
How To Take This Medicine
- Vydura is intended for oral use.
- The freeze-dried tablet can be taken with or without food or water.
- Instructions:
If You Have Taken Too Much Vydura
Talk to a doctor or pharmacist or go to the hospital immediately. Take the medicine package and this leaflet with you.
If You Forget To Take Vydura
- If you are taking Vydura to prevent migraines and miss a dose, take the next dose at the usual time.
- Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible Vydura Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Stop using Vydura and contact your doctor immediately if you develop signs of an allergic reaction, eg. severe skin rash or shortness of breath. Allergic reactions to VYDURA are uncommon (may affect up to 1 in 100 users).
A common Vyduraside effect (which may affect up to 1 in 10 users) is nausea.
How Vydura Should Be Stored
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the carton and blister card after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 30 °C. Store in the original blister. Moisture sensitive.
- Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substance is rimegepant. Each freeze-dried tablet contains 75 mg rimegepant (as sulfate).
- Other ingredients are gelatin, mannitol, mint flavor, and sucralose.
Appearance And Package Sizes Of The Medicine
Vydura 75 mg lyophilized tablets are white to off-white, round, and embossed with the symbol
Package sizes:
- 2 x 1 freeze-dried tablet in perforated single-dose blisters in wallet packaging.
- 8 x 1 freeze-dried tablet in perforated single-dose blisters.
- 16 x 1 freeze-dried tablet in perforated single-dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Biohaven Pharmaceutical Ireland DAC
6th Floor, South Bank House
Barrow Street
Dublin D04 TR29
Ireland
Manufacturer
HiTech Health Limited
5-7 Main Street
Black Rock
Co. Dublin
A94 R5Y4
Ireland
Millmount Healthcare Limited
Block-7, City North Business Campus
The stem
Co. Meath
K32 YD60
Ireland
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienLuxembourg/LuxembourgPfizer NV/SATel/Tel: +32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +370 5 251 4000 |
| BulgariaPfizer Luxembourg САРЛ, Клон БулгарияPhone: +359 2 970 4333 | MagyarországPfizer Kft.Tel.: + 36 1 488 37 00 |
| Czech RepublicPfizer, coil. s iPhone: +420 283 004 111 | MaltaVivian Corporation Ltd.Tel.: +356 21344610 |
| DenmarkPfizer ApSPhone: +45 44 20 11 00 | The NetherlandsPfizer by phone: +31 (0) 800 63 34 636 |
| DeutschlandPFIZER PHARMA GmbHPhone: +49 (0)30 550055-51000 | NorwayPfizer iPhone: +47 67 52 61 00 |
| EstoniaPfizer Luxembourg SARL Eesti branch phone: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: +43 (0)1 521 15-0 |
| GreecePfizer Ελλάς Α.Ε.Tel.: +30 210 6785800 | PolishPfizer Polska Sp. z o. oTel.: +48 22 335 61 00 |
| SpainPfizer, SLPhone: +34 91 490 99 00 | PortugalLaboratórios Pfizer, Lda.Phone: +351 21 423 5500 |
| FrancePfizerTel: +33 (0)1 58 07 34 40 | RomaniaPfizer Romania SRLPhone: +40 (0) 21 207 28 00 |
| HrvatskaPfizer Croatia dooPhone: +385 1 3908 777 | SlovenijaPfizer Luxembourg SARLPfizer, a branch of marketing, LjubljanaTel.: +386 (0)1 52 11 400 |
| IrelandPfizer Healthcare IrelandTel: +1800 633 363 (toll-free)Phone: +44 (0)1304 616161 | Slovenian RepublicPfizer Luxembourg SARL, organizačná zložkaPhone: + 421 2 3355 5500 |
| IcelandIcepharma hf.Telephone: +354 540 8000 | Finland/FinlandPfizer OyPhone/Tel: +358 (0)9 430 040 |
| ItalyPfizer SrlPhone: +39 06 33 18 21 | SwedenPfizer ABPhone: +46 (0)8 550 520 00 |
| CyprusPfizer Ελλάς Α.Ε. (Cyprus Branch)Tel.: +357 22817690 | United Kingdom (Northern Ireland)Pfizer LimitedPhone: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL branch in LatviaPhone: + 371 670 35 775 |