Xadago (Safinamide)

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 -narcolepsy or other sleep disorder -schizophrenia -taken an MAOI like Azilect, Carbex, Eldepryl, Marplan, Nardil, or Parnate in the last 14 days -an unusual or allergic reaction to safinamide, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

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.

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.

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

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Visit your doctor or health care professional for regular checks on your progress. Do not stop this medicine suddenly. Ask your doctor or health care professional for advice about gradually reducing your dose. You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, work in high places, 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 may increase dizziness or drowsiness. Talk to your doctor before drinking alcoholic beverages while taking this medicine. It is possible to suddenly fall asleep or suddenly feel like falling asleep during usual activities of daily living (e.g., cooking, driving a car, talking on the phone, eating, working) while you are taking this medicine. This may result in having accidents, which can be severe. Your chances of falling asleep while doing normal activities and taking this medicine are greater if you take other medicines that cause drowsiness. If you find that you suddenly fall asleep or suddenly feel like falling asleep during usual daily activities, you should not drive or participate in potentially dangerous activities and you should contact your doctor right away. You should not drive, operate machinery, or work at heights during treatment with this medicine if you have ever experienced severe drowsiness and/or have fallen asleep without warning before using this medicine. While taking this medicine, you may feel increased sexual urges, or other strong urges to gamble, spend money, or binge eat, and be unable to control these urges. If you or your family notice these or other strong urges while you are 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.

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 vision -falls -hallucination, loss of contact with reality -high blood pressure -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 -signs and symptoms of serotonin syndrome like confusion, heavy sweating, fever, involuntary muscle jerking, tremor, rigid muscles, unstable blood pressure, diarrhea -suddenly falling asleep or sudden feelings of wanting to fall asleep during usual activities like driving or eating -uncontrolled, sudden body movements (dyskinesia) -unusual or obvious changes in behavior such as agitation, confusion, disorganized thinking 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.

Keep out of the reach of children. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

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.