XADAGO

Safinamide 50mg, Oral tablet

Cannabis

· Severity: Major

· Notes for Consumers: Discuss cannabis use with your care team. The effects of your medication may be altered if used with cannabis. Call emergency services right away if you experience slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, or trouble staying awake.

· Notes for Professionals: Advise patients to avoid cannabis use while taking CNS depressants due to the risk for additive CNS depression and potential for other cognitive adverse reactions.

Safinamide 50mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol while taking this medication. Drinking alcohol may alter the effects of your medication. Serious side effects may occur. Contact your care team if you experience new or worsening side effects.

· Notes for Professionals: Advise patients to avoid alcohol consumption while taking safinamide. Alcohol consumption may increase the risk for somnolence and hypertension. 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. Ingestion of alcohol-containing beverages with high tyramine content (i.e., more than 150 mg of tyramine) may also place some patients at risk for hypertension.

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>