Isometheptene, Caffeine, and Acetaminophen Tablets and Reyvow

• Generic Name: acetaminophen / caffeine / isometheptene mucate
• Dosage Forms: tablet
• Other Brand Names: Prodrin, MigraTen

• It is used to treat headaches.

• Generic Name: lasmiditan
• Dosage Forms: n.a.
• Other Brand Names:

Reyvow is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults.

Reyvow is not used as a preventive treatment of migraine. It is not known if this medicine is safe and effective in children. [There is a pending DEA decision for control of lasmiditan under the Controlled Substances Act. A statement for patients about abuse and dependence risks cannot be completed at this time.]

Before you take Reyvow, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems have high blood pressure have a low heart rate are allergic to lasmiditan are pregnant or plan to become pregnant. It is not known if Reyvow will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Reyvow passes into your breastmilk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider will decide if you can take Reyvow with your other medicines.

Especially, tell your healthcare provider if you take:

propranolol or other medicines that can lower your heart rate any medicines that can increase your blood pressure any medicines that make you sleepy anti-depressant medicines called: selective serotonin reuptake inhibitors (SSRIs) serotonin norepinephrine reuptake inhibitors (SNRIs) tricyclic anti-depressants (TCAs) monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.

Take Reyvow exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider. Take Reyvow tablets by mouth with or without food. Do not take more than one dose in a 24-hour period. If you take Reyvow 50 mg, 100 mg, or 200 mg, and your headache goes away but comes back, you should not take a second dose within 24 hours. Some people who take too many Reyvow tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Reyvow. You should write down when you have headaches and when you take Reyvow so you can talk to your healthcare provider about how the medicine is working for you. Do not drive or operate machinery for at least 8 hours after taking Reyvow. You should not drink alcohol or take other medicines that make you drowsy.

Reyvow can cause serious side effects including:

See Important information serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using Reyvow, especially if this medicine is used with antidepressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma fast heartbeat changes in blood pressure high body temperature tight muscles trouble walking nausea, vomiting, or diarrhea medication overuse headache. Some people who take medicines like Reyvow for the acute treatment of migraine attacks for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Reyvow.

The most common side effects include:

dizziness sleepiness numbness feeling tired tingling

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Lilly at 1-800-LillyRx (1-800-545-5979).