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 they may decrease Sinemet CR Sustained-Release Tablets's effectiveness
• 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 by mouth 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), do not take them within 2 hours before or 2 hours after taking Sinemet CR Sustained-Release Tablets. Check with your doctor if you have questions.
• Take Sinemet CR Sustained-Release Tablets on a regular schedule to get 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. These effects may be worse if you take it with alcohol or certain medicines. Use Sinemet CR Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Sinemet CR Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Tell your doctor or dentist that you take Sinemet CR Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients -- Sinemet CR Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Diabetes patients - Sinemet CR Sustained-Release Tablets may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Sinemet CR Sustained-Release Tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• 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.
• Sinemet CR Sustained-Release Tablets 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.
• 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 interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Sinemet CR Sustained-Release Tablets.
• Lab tests, including complete blood cell counts and liver function tests, may be performed while you use Sinemet CR Sustained-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sinemet CR Sustained-Release Tablets with caution in ELDERLY; they may be more sensitive to its effects.
• Sinemet CR Sustained-Release Tablets should not be used in CHILDREN; safety and effectiveness in 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 Sinemet CR Sustained-Release Tablets while pregnant. It is not known if Sinemet CR Sustained-Release Tablets is found in breast milk. If you are or will be breast-feeding while you are using Sinemet CR Sustained-Release Tablets, check with your doctor. Discuss any possible 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; itching; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), 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.

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