Safinamide Oral Tablet (SAFINAMIDE - ORAL)

For Parkinson's disease.

Brand Name(s): Xadago

Generic Name: Safinamide

Instructions

This medicine may be taken with or without food.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

This medicine is usually combined with another medicine to treat your condition.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

It is very important to avoid some foods while on this medicine. Please ask your doctor or nurse to provide you with a list of foods you should avoid.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Foods containing tyramine can interact with this medicine to cause serious side effects, including a dangerous rise in blood pressure. Talk to your doctor, pharmacist or dietitian about foods to avoid.

If you need to stop this medicine, your doctor may wish to gradually reduce the dosage before stopping.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

If possible, avoid using with marijuana or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Do not take St. John's wort while on this medicine.

Avoid taking other medicines that may increase your risk for dangerously high blood pressure, including stimulants (such as amphetamines, ephedrine), cough and cold products (such as pseudoephedrine or phenylephrine), or herbal products (such as ephedra, Ma Huang).

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • dizziness or drowsiness

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • agitated feeling or trouble sleeping
  • loss of balance
  • chest pain
  • confusion
  • severe, watery or bloody diarrhea
  • fainting
  • fever
  • hallucinations (unusual thoughts, seeing or hearing things that are not real)
  • severe or persistent headache
  • fast, irregular, or slow heartbeat
  • high blood pressure
  • unusual strong urges - such as increased need to shop, gamble, or have sex
  • sensitivity to light
  • uncontrollable movement of face, tongue, arms or legs
  • muscle aches, spasms or abnormal movements
  • falling asleep suddenly during usual daily activities
  • sore or stiff neck
  • restlessness
  • excessive or unusual sweating
  • sudden change or loss of vision
  • severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.