Safinamide (sa-FIN-a-mide)

Treats Parkinson's disease in patients who are having "off" episodes.

Brand Name(s):

Xadago

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine at the same time each day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you missed a dose, take the next dose at the same time the next day.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take safinamide if you are also using amphetamine, cyclobenzaprine, dextromethorphan, methylphenidate, St John's wort, other MAO inhibitors (including linezolid), narcotic pain medicines (including meperidine, methadone, propoxyphene, tramadol), or medicine to treat depression (including amitriptyline, desvenlafaxine, duloxetine, milnacipran, nortriptyline, venlafaxine).
• Some foods and medicines can affect how safinamide works. Tell your doctor if you are using any of the following:
  • Imatinib, irinotecan, isoniazid, lapatinib, methotrexate, metoclopramide, mitoxantrone, rosuvastatin, sulfasalazine, or topotecan
  • Medicines for colds, cough, hay fever, or sinus problems
• Avoid foods and drinks that are high in tyramine, because your blood pressure could get dangerously high. Your doctor should give you a complete list. In general, do not eat anything aged or fermented, such as most cheese, most alcohol, cured meat (such as salami), sauerkraut, and soy sauce. Check the expiration dates on packages. Tyramine levels get higher as food gets older or if it has not been refrigerated properly.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver problems, dyskinesia, high blood pressure, or a history of eye or vision problems or mental health problems.
• This medicine may cause the following problems:
  • High blood pressure
  • Serotonin syndrome (when used with other medicines)
  • Dyskinesia (trouble controlling movements)
  • Unusual changes in behavior, compulsive behavior, hallucinations
• This medicine may make you drowsy. It may even cause you to fall asleep without warning while you are driving or doing other activities. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand up slowly if you feel dizzy or lightheaded.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, sweating, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blurred vision, change in vision
• Chest pain, fast, slow, or uneven heartbeat, severe headache
• Confusion, unusual changes in mood or behavior, behaviors you cannot control
• Lightheadedness, dizziness, fainting
• Muscle spasms, twitching, uncontrolled movements (especially of the face, neck, or back)
• Unusual drowsiness or sleepiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088