Safinamide oral tablets

What is this medicine?

SAFINAMIDE (sa FINE a mide) is a monoamine oxidase inhibitor (MAOI). It is used to treat Parkinson's disease.

How should I use this medicine?

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.

What side effects may I notice from receiving this medicine?

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 emotions or moods

• changes in vision

• falling asleep during normal activities like driving

• hallucinations

• high blood pressure

• new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges

• 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

• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

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

What may interact with this medicine?

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

What if I miss a dose?

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.

Where should I keep my medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• mental illness

• narcolepsy

• sleep apnea

• an unusual or allergic reaction to safinamide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.

You may get drowsy or dizzy. Do not drive, use machinery, 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 can interfere with the effect of this medicine. Talk to your doctor before drinking alcoholic beverages while taking this medicine.

When taking this medicine, you may fall asleep without notice. You may be doing activities like driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your health care provider right away if this happens to you.

There have been reports of increased sexual urges or other strong urges such as gambling while taking this medicine. If you experience any of these while 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.