Safinamide oral tablets

What is this medication?

SAFINAMIDE (sa FINE a mide) is a monoamine oxidase inhibitor (MAOI). It is used to treat Parkinson's disease.

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

COMMON BRAND NAME(S): Xadago

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• eye disease, vision problems
• high or low blood pressure
• history of stroke
• if you drink alcohol
• liver disease
• mental illness
• narcolepsy
• sleep apnea
• an unusual or allergic reaction to safinamide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your medicine at regular intervals and at the same time each day. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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.

What if I miss a dose?

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.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• atomoxetine
• certain medicines for depression
• cyclobenzaprine
• dextromethorphan
• linezolid
• MAOIs like Azilect, Carbex, Eldepryl, Marplan, Nardil, and Parnate
• meperidine
• methadone
• methylene blue
• propoxyphene
• stimulant medicines for attention disorders, weight loss, or to stay awake
• St. John's Wort
• tramadol
• tryptophan
• viloxazine

This medicine may also interact with the following medications:

• alcohol
• antihistamines for allergy, cough and cold
• certain medicines for sleep
• decongestants, including nasal sprays or eye drops
• furazolidone
• imatinib
• irinotecan
• isoniazid
• lapatinib
• medicines for anxiety or psychotic disturbances
• medicines for sleep during surgery
• methotrexate
• metoclopramide
• mitoxantrone
• narcotic medicines for pain
• procarbazine
• rosuvastatin
• sulfasalazine
• topotecan
• yohimbine

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.

What should I watch for while using this medication?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can interfere with the effect of this medicine. Talk to your doctor before drinking alcoholic beverages while taking this medicine.

When taking this medicine, you may fall asleep without notice. You may be doing activities like driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your health care provider 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 medicine. If you experience any of these while taking this medicine, you should report this to your health care provider 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 medicine. The combination may cause a dangerous rise in blood pressure. Ask your doctor or health care professional, pharmacist, or nutritionist 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 health care provider.

Some medicines may interact with this medicine and could cause adverse effects. Talk to your doctor if you are taking or planning to take any over-the-counter drugs, especially cough remedies or decongestants, including nasal sprays or eye drops. This medicine may also interact with antidepressants and certain medicines for pain. Contact your health care provider before taking new medications including antidepressants, pain medicines, or prescription or over-the-counter medicines for congestion, cough, colds, or allergies.

If you are scheduled for any medical or dental procedure, tell your healthcare provider that you are taking this medicine. This medicine can interact with other medicines used during surgery.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in emotions or moods
• changes in vision
• falling asleep during normal activities like driving
• hallucinations
• high blood pressure
• new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges
• signs and symptoms of hypertensive crisis like severe headache with confusion and blurred vision, severe chest pain, shortness of breath, nausea and vomiting, seizures
• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• nausea
• trouble sleeping
• upset stomach

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.

Where should I keep my medication?

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 medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.