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Sinemet CR Sustained-Release Tablets

Generic Name: Carbidopa/Levodopa Sustained-Release Tablets (CAR-bih-doe-puh/LEE-voe-doe-puh)
Brand Name: Sinemet CR


Sinemet CR Sustained-Release Tablets is used for:
Treating symptoms associated with Parkinson disease and parkinsonism-like symptoms caused by other conditions. It may also be used to treat certain conditions as determined by your doctor.

Sinemet CR Sustained-Release Tablets is an antidyskinetic combination. Levodopa is transformed by the body and the brain into a substance which helps to decrease tremors and other symptoms of Parkinson disease. Carbidopa helps levodopa to reach the brain.

Do NOT use Sinemet CR Sustained-Release Tablets if:
you are allergic to any ingredient in Sinemet CR Sustained-Release Tablets
you have narrow-angle glaucoma, undiagnosed skin growths, skin cancer, or a history of skin cancer
you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.

Before using Sinemet CR Sustained-Release Tablets:
Some medical conditions may interact with Sinemet CR Sustained-Release Tablets. 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 an irregular heartbeat, heart disease, ulcer, mental/mood disorders, seizures, blood pressure problems, asthma, lung problems, liver or kidney problems, blood or hormone problems, stomach or intestinal bleeding, glaucoma, or history of heart attack
Some MEDICINES MAY INTERACT with Sinemet CR Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Butyrophenones, (eg, haloperidol), isoniazid, papaverine, phenothiazines (eg, phenergan), phenytoin, or risperidone because the effectiveness of Sinemet CR Sustained-Release Tablets may be decreased
MAO inhibitors (eg, phenelzine) because risk of severe high blood pressure may be increased
Tricyclic antidepressants (eg, amitriptyline) because risk of high blood pressure or unusual muscle movements may be increased
Metoclopramide because side effects may occur
Blood pressure medicines or selegiline because risk of severe dizziness on standing may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sinemet CR Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sinemet CR Sustained-Release Tablets:
Use Sinemet CR Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Sinemet CR Sustained-Release Tablets on an empty stomach at least 1 hour before or 2 hours after eating.
Carefully follow the dosing schedule given to you by your health care provider. It may take several weeks to a few months to notice benefit from use because the dose is carefully adjusted over time.
Swallow whole. Do not break, crush, or chew before swallowing.
If you are also taking iron salts (eg, ferrous sulfate), separate the administration of these medicines by at least 2 hours.
Take Sinemet CR Sustained-Release Tablets regularly to receive the most benefit from it. Taking Sinemet CR Sustained-Release Tablets at the same times each day will help you to remember to take it.
Continue taking Sinemet CR Sustained-Release Tablets even if you feel better. Do not miss any doses.
If you have been taking levodopa, do not start taking Sinemet CR Sustained-Release Tablets until at least 12 hours after your final dose of levodopa.
If you miss a dose of Sinemet CR Sustained-Release Tablets, 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 Sinemet CR Sustained-Release Tablets.

Important safety information:
Sinemet CR Sustained-Release Tablets may cause drowsiness, dizziness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sinemet CR Sustained-Release Tablets. Using Sinemet CR Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Sinemet CR Sustained-Release Tablets. Sinemet CR Sustained-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Sinemet CR Sustained-Release Tablets.
Diabetes patients - Sinemet CR Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. Sinemet CR Sustained-Release Tablets may interfere with urine tests for ketones and cause inaccurate test results. Check with your doctor before you adjust your dose of your diabetes medicine or change your diet.
Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Sinemet CR Sustained-Release Tablets. Symptoms may include: increased body heat; muscle rigidness; altered mental abilities, including lack of response to your surroundings; irregular or fast heartbeat; sweating. Contact your doctor at once if any of these symptoms occur.
Do not suddenly stop taking Sinemet CR Sustained-Release Tablets. Some conditions may become worse when Sinemet CR Sustained-Release Tablets is suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects.
Alcohol, hot weather, exercise, and fever may increase the risk for drowsiness, dizziness, and lightheadedness. To prevent these effects, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
Gradually increase physical activity as your symptoms improve.
A dark color (red, brown, or black) may appear in your saliva, urine, or sweat after taking Sinemet CR Sustained-Release Tablets. This is not harmful.
The effects of Sinemet CR Sustained-Release Tablets might start to wear off between doses. Talk with your doctor if Sinemet CR Sustained-Release Tablets stops working well or if your condition worsens.
Sinemet CR Sustained-Release Tablets may affect certain lab test results. Make sure laboratory personnel and your doctors know you use Sinemet CR Sustained-Release Tablets.
LAB TESTS, such as complete blood cell counts and liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Sinemet CR Sustained-Release Tablets with caution in ELDERLY patients because they may be more sensitive to its effects.
Sinemet CR Sustained-Release Tablets is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Sinemet CR Sustained-Release Tablets during pregnancy. It is unknown if Sinemet CR Sustained-Release Tablets is excreted in breast milk. If you are or will be breast-feeding while you are using Sinemet CR Sustained-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Sinemet CR Sustained-Release Tablets:
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:

Confusion; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; taste changes; trouble sleeping; upset stomach; urinary tract infection; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in vomit; chest pain; confusion; depression; fast or irregular heartbeat; fever; hallucinations; mental or mood changes; muscle pain or unusual stiffness; severe abdominal pain; severe lightheadedness or fainting; sore throat; thoughts of suicide; unexplained fever or sweating; unusual bruising or bleeding; unusual or painful movements or spasms of the face, eyelids, mouth, tongue, arms, hands, or legs; vision changes (blurred/double vision); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Sinemet CR Sustained-Release Tablets:
Store Sinemet CR Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sinemet CR Sustained-Release Tablets out of the reach of children and away from pets.

General information:
If you have any questions about Sinemet CR Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Sinemet CR Sustained-Release Tablets 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.
This information is a summary only. It does not contain all information about Sinemet CR Sustained-Release Tablets. 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.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.