What is the most important information I should know about safinamide?
You should not use safinamide if you have severe liver disease.
TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. Some medicines can cause unwanted or dangerous effects (including death) when used within 14 days of when you take safinamide.
What is safinamide?
Safinamide is monoamine oxidase inhibitor type B (MAO-B). This medicine works by allowing a chemical called dopamine (DOE pa meen) to work for longer periods of time in the brain. Low levels of dopamine in the brain are associated with Parkinson's disease.
Safinamide is given with levodopa and carbidopa to treat "wearing-off" episodes (muscle stiffness, loss of muscle control) in people with Parkinson's disease.
Safinamide may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking safinamide?
You should not use safinamide if you are allergic to it, or if you have:
- severe liver disease.
Some medicines can cause unwanted or dangerous effects (including death) when used with safinamide. You should not use any of the following medicines within 14 days before or 14 days after you take safinamide:
- amphetamines (Adderall, Dexedrine, and others);
- cough medicine that contains dextromethorphan;
- methylphenidate (Concerta, Ritalin, Daytrana, and others);
- St. John's wort;
- another MAO inhibitor --isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others;
- certain antidepressants such as amitriptyline (Elavil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), maprotiline (Ludiomil) , milnacipran (Savella), trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and many others; or
- opioid (narcotic) medicine such as meperidine (Demerol), methadone, propoxyphene (Darvon), tramadol (Ultram, Ultracet), and others.
To make sure safinamide is safe for you, tell your doctor if you have ever had:
- liver disease;
- high or low blood pressure;
- bipolar disorder, schizophrenia, or psychosis;
- unusual urges or impulses;
- abnormal muscle movements;
- problems with retina of your eye; or
- narcolepsy or other sleep disorder (or if you take medicine to help you sleep).
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether safinamide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take safinamide?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Safinamide must be given in combination with levodopa and carbidopa and it should not be used alone.
Safinamide is usually taken once per day at the same time each day.
You may take safinamide with or without food.
Your blood pressure will need to be checked often.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking safinamide?
While taking safinamide and for 14 days after you stop, avoid eating foods that are high in tyramine, including: pickled food (such as eggs or herring), and meats that are aged, cured, smoked, or fermented.
Eating tyramine while you are taking safinamide can raise your blood pressure to dangerous levels which could cause life-threatening side effects. You should become very familiar with the list of foods to avoid while you are taking safinamide.
Some people taking this medicine have fallen asleep during normal daytime activities such as working, driving, or other physical activity. Avoid driving or operating machinery until you know how this medicine will affect you.
What are the possible side effects of safinamide?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- vision changes;
- twitching or uncontrolled muscle movements;
- confusion, agitation, unusual thoughts or behavior;
- hallucinations (seeing or hearing things that are not real);
- a seizure;
- fever, sweating, fast heart rate, overactive reflexes;
- nausea, vomiting, diarrhea; or
- increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.
Common side effects may include:
- involuntary muscle movements;
- nausea; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect safinamide?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- sulfasalazine; or
This list is not complete. Other drugs may interact with safinamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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