UBRELVY contains the active substance ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. It is used for the acute treatment of migraine attacks with or without aura in adults.

UBRELVY is not used to prevent migraine headaches.

It is not known if UBRELVY is safe and effective in children.

Do not use Ubrelvy:

·        If you are allergic to ubrogepant or any of the other ingredients of this medicine (listed in section 6).

·        if you are taking medicines known as a strong CYP3A4 inhibitor, such as:

ketoconazole   clarithromycin itraconazole.

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines. If you or your doctor know that you have a bowel blockage (intestinal obstruction).

Take special care with Ubrelvy:

·       Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported with use of UBRELVY. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions occurred within hours after dosing and were not serious, and some reactions led to discontinuation. If a serious or severe hypersensitivity reaction occurs, discontinue UBRELVY and institute appropriate therapy.

Before you take UBRELVY:

Before you take UBRELVY, tell your doctor about your medical conditions, including if you:

·       have liver problems.

·       have kidney problems.

Children

It is not known if UBRELVY is safe and effective in children.

Other medicines and UBRELVY

Tell your doctor or pharmacist if you:

·     take any of the following, as your healthcare provider may need to change the dose of UBRELVY:

• verapamil        • cyclosporine • ciprofloxacin • fluconazole   • fluvoxamine

• phenytoin        • barbiturates  • rifampin       • St. John’s Wort    • quinidine

• carvedilol        • eltrombopag • curcumin        

These are not all of the medicines that could affect how UBRELVY works. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines.

Keep a list of medicines you take to show to your healthcare provider or pharmacist when you get a new medicine.

UBRELVY with food

You should not take a second tablet within 24 hours if you consume grapefruit or grapefruit juice.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, discuss this with your doctor before UBRELVY treatment.

Pregnancy:

It is not known if UBRELVY will harm your unborn baby.

Breast feeding:

It is not known if UBRELVY passes into your breast milk.

Driving and using machines

UBRELVY is not expected to have any effect on the ability to drive and use machines.

•  Take UBRELVY exactly as your healthcare provider tells you to take it.

•  Take UBRELVY with or without food.

•  Most patients can take a second tablet 2 hours after the first tablet, as needed.

•  It is not known if it is safe to take UBRELVY for more than 8 migraine headaches in 30 days.

•  You should write down when you have headaches and when you take UBRELVY so you can talk to your healthcare provider about how UBRELVY is working for you.

If you take more UBRELVY than you should

If you take too much UBRELVY, call your healthcare provider or go to the nearest hospital emergency room right away.

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Common: may affect up to 1 in 10 people

•        nausea

•        fatigue

•        sleepiness

•        dry mouth

Unknown Frequency:

Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus.

Reporting side effects

If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly via national reporting system listed in section 6.  By reporting side effects you can help provide more information on the safety of the 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 label and the carton after EXP:. The expiry date refers to the last day of that month.

Store below 30ºC.