XADAGO

SAFINAMIDE (sa FINE a mide) treats the symptoms of Parkinson disease in people who are taking Carbidopa; Levodopa. It works by increasing the amount of dopamine in your brain, a substance which helps manage body movements and coordination. This reduces the symptoms of Parkinson, such as body stiffness and tremors. It belongs to a group of medications called MAOIs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.
Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Do not take this medication with any of the following:
-Certain medications for depression, anxiety, or other mental health conditions
-Cyclobenzaprine
-Dextromethorphan
-Linezolid
-Other MAOIs, such as Marplan, Nardil, and Parnate
-Methylene blue
-Opioids
-Stimulant medications for ADHD, weight loss, or staying awake
-Supplements, such as St. John's wort or tryptophan
This medication may also interact with the following:
-Alcohol
-Antihistamines for allergy, cough, and cold
-Decongestants, including nasal sprays or eye drops
-Isoniazid
-Medications that help you fall asleep
-Metoclopramide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects.
This medication may affect your coordination, reaction time, or judgement. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.
While taking this medication, you may fall asleep without notice. You may be doing activities, such as driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your care team right away if this happens to you.
There have been reports of increased sexual urges or other strong urges, such as gambling while taking this medication. If you experience any of these while taking this medication, you should report this to your care team as soon as possible.
Foods that contain very high amounts of tyramine, such as aged, fermented, cured, smoked and pickled foods, should be avoided while taking this medication. The combination may cause a dangerous rise in blood pressure. Ask your care team for a complete listing of foods and beverages that are high in tyramine. If you consume a food or beverage very rich in tyramine and do not feel well soon after eating, contact your care team.
Some medications may interact with this medication and could cause adverse effects. Talk to your care team if you are taking or planning to take any over-the-counter medications, especially cough remedies or decongestants, including nasal sprays or eye drops. This medication may also interact with antidepressants and certain medications for pain. Contact your care team before taking new medications including antidepressants, pain medications, or prescription or over-the-counter medications for congestion, cough, colds, or allergies.
If you are scheduled for any medical or dental procedure, tell your care team that you are taking this medication. This medication can interact with other medications used during surgery.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Side effects that you should report to your care team as soon as possible:
-Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
-Change in vision
-Falling asleep during daily activities
-Increase in blood pressure
-Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
-Mood and behavior changes—anxiety, nervousness, irritability and restlessness, confusion, hallucinations, feeling distrust or suspicion of others
-New or worsening uncontrolled and repetitive movements of the face, mouth, or upper body
-Urges to engage in impulsive behaviors such as gambling, binge eating, sexual activity, or shopping in ways that are unusual for you
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
-Nausea
-Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children and pets.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.
To get rid of medications that are no longer needed or have expired:
-Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
-If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.