Rytary 48.75-195mg Capsule

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.

CARBIDOPA/LEVODOPA EXTENDED-RELEASE CAPSULE - ORAL

(KAR-bi-DOE-pa/LEE-voe-DOE-pa)

COMMON BRAND NAME(S): Rytary

USES: This medication is used to treat the symptoms of Parkinson\'s disease (such as shakiness, stiffness, difficulty moving) or Parkinson-like conditions. Parkinson\'s disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement. Carbidopa prevents the breakdown of levodopa in the bloodstream so more levodopa can enter the brain. Carbidopa can also reduce some of levodopa\'s side effects such as nausea and vomiting.

HOW TO USE: Take this medication by mouth as directed by your doctor, usually 3 times a day. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. If you have trouble swallowing the capsule, you may open up the capsule and sprinkle the entire contents onto a small amount (1 to 2 tablespoons or 15 to 30 grams) of applesauce. Swallow all of the mixture right away without chewing it. Do not prepare the mixture ahead of time for later use. This medication may be taken with or without food. However, avoid high-protein diets because they may reduce how much of the medication you can absorb. Also avoid taking this medication with a high-fat, high-calorie meal since this can slow down the time it begins to work by about 2 hours. The manufacturer says you should take your first dose of the day about 1 to 2 hours before eating. Ask your doctor or pharmacist how best to take this medication. Separate your dose of this medication as many hours as possible from any iron supplements or products containing iron (such as multivitamins with minerals) you may take. Iron can reduce the amount of carbidopa/levodopa that is absorbed by your body. Do not take other forms of carbidopa or levodopa without consulting your doctor first. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. The dosage is based on your medical condition and response to treatment. Some people may experience a \"wearing-off\" effect of this medication just before the next dose is due or an \"on-off\" effect at other times. If these effects occur and bother you, tell your doctor. Do not change your dose of this or any other medication without checking with your doctor first. Do not suddenly decrease the dose or suddenly stop taking this medication because doing either may lead to a serious condition. If you must stop this medication, slowly reduce the dose as directed by your doctor. See also Side Effects section. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Dizziness, nausea, vomiting, dry mouth, trouble sleeping, unusual dreams, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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. This medication may cause urine, sweat, or saliva to turn red, brown, or black. This effect is harmless, but your clothes may become stained. Some people taking this medication have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with this medication even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section. Tell your doctor right away if you have any serious side effects, including: fainting, mental/mood changes (such as agitation, confusion, depression, hallucinations, thoughts of suicide), unusual strong urges (such as increased gambling, increased sexual urges), new/worsening movements you can\'t control/spasms, greatly increased eye blinking/twitching, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), unusual tiredness, tingling of the hands/feet, vision changes (such as blurred/double/decreased vision), eye pain, severe stomach/abdominal pain, vomit that looks like coffee grounds, black/tarry stools, problems with urination. Get medical help right away if you have any very serious side effects, including: chest pain. Suddenly stopping or reducing the dose of this medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, unusual muscle stiffness, severe confusion, sweating, fast/irregular heartbeat, rapid breathing. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 or at www.fda.gov/medwatch. 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 this medication, tell your doctor or pharmacist if you are allergic to carbidopa or levodopa; 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: blood disorders, breathing problems (such as asthma, emphysema), glaucoma, heart or blood vessel problems (such as irregular heartbeat, heart attack, angina), kidney disease, liver disease, mental/mood disorders (such as depression, schizophrenia), ulcers of the stomach/intestines, seizures, sleep disorder. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. See also Side Effects section. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Levodopa passes into breast milk in small amounts and may affect how much milk you make. It is unknown if carbidopa passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. 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 this drug include: antipsychotic drugs (such as chlorpromazine, haloperidol, thioridazine), certain drugs to treat high blood pressure (such as methyldopa). Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. However, certain MAO inhibitors (rasagiline, safinamide, selegiline) may be used with careful monitoring by your doctor. Ask your doctor when to start or stop taking this medication. This medication may interfere with certain laboratory tests (including urine catecholamine/glucose/ketone tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: irregular heartbeat, mental/mood changes, worsening of movements you can\'t control/spasms.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as blood count, heart/kidney/liver function) may be performed periodically to monitor your progress or check for side effects. People with Parkinson\'s disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you have a mole that gets bigger or looks different, or if you have 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. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature away from high heat, moisture, and light. 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.

Information last revised June 2018. Copyright(c) 2018 First Databank, Inc.