Azilect 1mg Tablets - 30 Count Bottle

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

RASAGILINE - ORAL

(ra-SA-ji-leen)

COMMON BRAND NAME(S): Azilect

USES: This medication is used alone or with other medications (e.g., levodopa, carbidopa) to treat movement disorders caused by Parkinson's disease. It does not cure Parkinson's disease, but it may improve shakiness (tremor), muscle stiffness, and sudden switching between normal movement and stiffness ("on-off" problems). It may improve your range of motion and ability to walk, dress, and exercise. Rasagiline is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin).

HOW TO USE: Take this medication by mouth, usually once daily with or without food or as directed by your doctor. Dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more often than directed. It may take a few weeks for the full benefits of the drug to be noticed. Do not stop taking this drug without first consulting your doctor. Talk with your doctor if the medication stops working well or if your condition worsens.

SIDE EFFECTS: Dizziness, joint pain, heartburn, nausea, fever, muscle pain, dry mouth, and stomach/abdominal pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. If you are also taking levodopa, you may experience more side effects from the levodopa when taking rasagiline. Tell your doctor immediately if any of these side effects occur: nausea, shakiness, muscle stiffness, mental/mood changes such as hallucinations/abnormal dreams. Your doctor may need to change your medication or dose. Do not stop or change the dose of your levodopa without talking with your doctor first. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, loss of balance, mental/mood changes (e.g., agitation, confusion, depression, hallucinations), worsening muscle stiffness/twitching, changes in sexual ability/interest, increased shaking (tremor), swollen ankles/legs, change in amount of urine, unusual weight gain/loss. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds. This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk. (See also Drug Interactions section.) Seek immediate medical attention if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, vision changes (e.g., double/blurred vision), sudden sensitivity to light (photophobia). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rasagiline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: cerebrovascular disease (e.g., stroke), heart disease (e.g., coronary artery disease, heart attack, history of chest pain, congestive heart failure), personal/family history of high blood pressure, history of severe/frequent headaches, liver disease, sore in the stomach/intestine/esophagus (peptic ulcer), bleeding problems, diabetes, personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), overactive thyroid (hyperthyroidism), a certain kind of adrenal gland tumor (pheochromocytoma). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. To minimize dizziness and the risk of fainting, get up slowly when rising from a sitting or lying position. This is especially important if you are also taking levodopa and when you first start taking rasagiline. Before having surgery, tell your doctor or dentist you are taking this medication. You may need to stop taking this drug beforehand. Follow your doctor's instructions carefully. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with rasagiline include: antidepressants (including amitriptyline, bupropion, fluoxetine, SNRIs such as duloxetine/venlafaxine), other MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), appetite suppressants (such as diethylpropion, sibutramine), drugs for attention deficit disorder (such as atomoxetine, methylphenidate), buspirone, cyclobenzaprine, dextromethorphan, certain herbal products (such as ephedra/ma huang, St. John's wort), cold medications/nasal decongestants (such as phenylephrine, phenylpropanolamine, pseudoephedrine), certain narcotic medications (meperidine, methadone, propoxyphene), street drugs (such as MDMA/"ecstasy", LSD, mescaline), stimulants (such as amphetamines, ephedrine), supplements (such as tryptophan, tyramine), tramadol. Tell your doctor or pharmacist if you are using any of these medications before, during, or within 2 weeks after treatment with rasagiline. Tell your doctor or pharmacist if you have taken fluoxetine at least 5 weeks before starting rasagiline. Discuss with your doctor how much time to wait between starting or stopping any of these drugs and taking rasagiline. Check the labels on all your medicines (such as allergy, cough-and-cold products, diet pills) because they may contain dextromethorphan, decongestants, or stimulants. Ask your pharmacist about the safe use of those products. Other medications can affect the removal of rasagiline from your body, which may affect how rasagiline works. Examples include cimetidine, fluvoxamine, rifampin, quinolone antibiotics (such as ciprofloxacin), anticonvulsants (such as carbamazepine, oxcarbazepine), among others. A very serious high blood pressure reaction may rarely occur if you eat a large amount of tyramine while taking this medication and for 2 weeks after you stop the medication. Avoid foods and beverages that are high in tyramine, including: aged cheeses (such as Stilton, cheddar), dried/aged/fermented meats and sausages (such as salami, liverwurst), preserved fish (such as pickled herring), fermented foods (such as sauerkraut, kim chee), most soybean products (such as soy sauce, tofu), broad/fava beans, tap beers, vermouth. Consult your doctor or dietician for more details and a complete list of other tyramine-containing foods you should avoid. Seek immediate medical attention if you notice symptoms of very high blood pressure such as unusually fast/slow heartbeat, vomiting, unexplained sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, difficulty thinking, slurred speech.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may not appear for up to 12 hours and may include: excitement, irritability, restlessness, dizziness, weakness, drowsiness, flushing, sweating, fast heartbeat, headache, confusion, seizures.

NOTES: Do not share this medication with others. People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.