XADAGO

Safinamide 50mg, Oral tablet

Alcohol

· Severity: Moderate

· Notes for Consumers: You may suddenly feel drowsy when taking Safinamide with alcohol. The chance of experiencing a sudden onset of drowsiness is increased when taking these drugs together. Avoid driving or performing other tasks requiring mental alertness while drinking alcohol, and use care in such activities while you are taking Safinamide. Discuss any new or worsening side effects, like confusion, difficulty staying alert, sudden onset of drowsiness, or falls, with your health care provider. Drinking alcoholic beverages with high tyramine content (e.g., tap beers) may increase your risk for high blood pressure; ask your health care provider about alcoholic beverages that are best avoided.

· Notes for Professionals: Dopaminergic medications, including safinamide, may cause a sudden onset of somnolence which sometimes has resulted in motor vehicle accidents. Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event. Such events may increase when safinamide is combined with alcohol or other CNS depressants. Because of possible additive effects, advise patients about the potential for increased somnolence during concurrent use of alcohol. Ethanol ingestion of alcoholic beverages with high tyramine content (e.g., tap beers) also may place some patients at risk for hypertension. If a patient ingests beverages very rich in tyramine and does not feel well soon after, the patient should contact their healthcare provider.

Safinamide 50mg, Oral tablet

Tyramine-containing foods

· Severity: Major

· Notes for Consumers: Most foods do not interact with Safinamide. Certain foods that are rich in tyramine might increase the risk of side effects with Safinamide. Follow all the instructions of your health care provider for your diet. You should probably limit your intake of aged or smoked meats (like sausages or smoked or pickled fish), aged cheeses, yeast extracts, and certain alcoholic beverages like tap beers. Taking these foods along with Safinamide might increase the risk of high blood pressure or other side effects. Ask your dietician or health care professional for a complete listing of foods best avoided. If you eat foods very rich in tyramine and do not feel well soon after eating, contact your healthcare provider.

· Notes for Professionals: Safinamide is selective for MAO-B at recommended doses (50 to 100 mg/day) and can generally be used without dietary tyramine restriction. Patients should be informed not to exceed the recommended safinamide dose and to follow all dietary instructions. Certain foods may contain very high amounts (i.e., 150 mg or greater) of tyramine and could potentially cause a hypertensive reaction in individual patients with increased sensitivity to tyramine and are best avoided or limited. Food sources considered to be high in tyramine and that may interact with MAO inhibitors in general include Stilton aged cheese, concentrated yeast extracts (e.g., Marmite), aged meats, and sauerkraut. Ethanol ingestion of alcoholic beverages with high tyramine content (e.g., tap beers) also may place patients at risk. If a patient eats foods very rich in tyramine and does not feel well soon after eating, the patient should contact their healthcare provider. Patients should also be instructed to contact their healthcare provider if they experience severe headache, shortness of breath, palpitations, diaphoresis, chest pain or other symptoms suggestive of a significant hypertensive reaction or hypertensive crisis.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>