AZILECT

Do NOT use Azilect if:

• you are allergic to any ingredient in Azilect
• you are taking fluoxetine or have taken it within the past 5 weeks
• you are taking a norepinephrine reuptake inhibitor (eg, atomoxetine), a selective serotonin reuptake inhibitor (SSRI) (eg, paroxetine), a serotonin and norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine, duloxetine), selegiline or another MAOI (eg, phenelzine), or St. John’s wort, or if you have taken any of these medicines within the past 14 days
• you are taking an anorexiant (eg, amphetamine); bupropion; buspirone; cyclobenzaprine; dextromethorphan; meperidine; methadone; methylphenidate; propoxyphene; a sympathomimetic, including amphetamines, cold products, or certain diet pills or preparations (eg, pseudoephedrine, phenylephrine, phenylpropanolamine, ephedrine); a tetracyclic antidepressant (eg, mirtazapine); tramadol; or a tricyclic antidepressant (eg, amitriptyline)
• you will be receiving certain types of anesthesia or having elective surgery within the next 14 days
• you have moderate to severe liver problems
• you have certain adrenal gland problems (eg, pheochromocytoma)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Azilect:

Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of skin cancer or uncontrolled muscle movements (eg, twitching of the face and tongue and involuntary movements of the arms and legs)
• if you have a history of liver problems or low blood pressure

Some MEDICINES MAY INTERACT with Azilect. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anorexiants (eg, amphetamine), bupropion, cyclobenzaprine , dextromethorphan, MAOIs (eg, phenelzine), meperidine, methadone, narcotic analgesics (eg, fentanyl), norepinephrine reuptake inhibitors (eg, atomoxetine), propoxyphene, selegiline, SNRIs (eg, venlafaxine, duloxetine), SSRIs (eg, fluoxetine), St. John’s wort, sympathomimetics (eg, amphetamines, pseudoephedrine, phenylephrine, ephedrine ), tetracyclic antidepressants (eg, mirtazapine), tramadol, or tricyclic antidepressants (eg, amitriptyline) because serotonin syndrome (eg, fever, muscle stiffness or rigidity, vital sign changes, mental or mood changes, coma) may occur
• Buspirone because severe high blood pressure may occur
• Levodopa because the risk of uncontrolled muscle movements, hallucinations, or lightheadedness when you sit up or stand may be increased
• Ciprofloxacin because it may increase the risk of Azilect’s side effects
• Benzodiazepines (eg, midazolam) or methylphenidate because the risk of their side effects may be increased by Azilect

Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Azilect:

Use Azilect as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Azilect by mouth with or without food.
• If you miss a dose of Azilect, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Azilect.

Important safety information:

• Azilect may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Azilect with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol while you are using Azilect.
• Azilect may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Eating certain foods that contain very high amounts of tyramine (eg, aged cheeses) while you use Azilect may cause severe high blood pressure. Other foods that contain tyramine (eg, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) are NOT likely to cause such a reaction with recommended doses of Azilect. However, seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.
• Do NOT take more than the recommended dose of Azilect without checking with your doctor. Taking more than the recommended dose may increase your risk of severe high blood pressure if you eat foods high in tyramine. Discuss any questions with your doctor.
• Avoid medicines that contain dextromethorphan, pseudoephedrine, phenylephrine, or ephedrine while you are using Azilect.
• Tell your doctor or dentist that you take Azilect before you receive any medical or dental care, emergency care, or surgery. Azilect should be discontinued at least 14 days before elective surgery.
• If your doctor tells you to stop taking Azilect, you will need to wait at least 14 days before beginning to take certain other medicines (eg, medicines for depression, anxiety, pain, cough, congestion, weight loss, Parkinson disease; muscle relaxants). Ask your doctor if you are unsure when you should start to take your new medicines after you have stopped taking Azilect.
• Azilect may increase your risk of developing skin cancer. Ask your doctor if you should have skin examinations while you are taking Azilect. Contact your doctor if you notice any skin changes (eg, change in color or thickness).
• Lab tests, including skin examinations, may be performed while you use Azilect. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Azilect should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Azilect while you are pregnant. It is not known if Azilect is found in breast milk. If you are or will be breast-feeding while you use Azilect, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Azilect:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms; headache; joint pain; lightheadedness; sleeplessness; stomach upset; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; blood in the urine; blurred vision; changes in sexual ability or desire; chest pain; confusion; depression; enlarged pupils; fast or irregular heartbeat; fever; hallucinations; inability to sit still; numbness or tingling of the hands or feet; one-sided weakness; seizures; sensitivity to light; severe headache; skin changes; sore or stiff neck; tremor; trouble thinking or walking; unexplained nausea or vomiting; unusual sweating; vision or speech problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:

Contact your local Poison Control or emergency room immediately.Symptoms may include coma; cool, clammy skin; difficulty breathing; excessive sweating; fast or irregular heartbeat; fever; hallucinations; hyperactivity; seizures; severe dizziness, drowsiness, or headache.

Proper storage of Azilect:

Store Azilect at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Azilect out of the reach of children and away from pets.

General information:

• If you have any questions about Azilect, please talk with your doctor, pharmacist, or other health care provider.
• Azilect is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Azilect. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.