Sinemet CR

• Merck Sharp & Dohme Corp.

Serious side effects have been reported with Sinemet CR.

• unusual or uncontrolled movements of the mouth, tongue, face, head, neck, arms, and legs
• fast, irregular, or pounding heartbeat
• depression
• thoughts of death or suicide
• hallucinations
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty swallowing or breathing
• hives
• black, tarry stools
• red blood in stools
• blood in vomit
• vomit that looks like coffee grounds

Sinemet CR can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how Sinemet CR affects you.

Do not take Sinemet CR if you:

• are allergic to Sinemet CR or any of its ingredients
• are taking or have recently stopped taking a monoamine oxidase inhibitor (MAOI)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sinemet CR, there are no specific foods that you must exclude from your diet when receiving this medication.

However, tell your doctor if you plan on changing your diet to include foods that are high in protein, such as meat, poultry, and dairy products, since these foods can affect the way your body uses the medication.

Carbidopa and levodopa is a combination medicine used to treat symptoms of Parkinson's disease, such as muscle stiffness, tremors, spasms, and poor muscle control. Parkinson's disease may be caused by low levels of a chemical called dopamine (DOE pa meen) in the brain.

Levodopa is converted to dopamine in the brain. Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect.

Carbidopa and levodopa is also used to treat Parkinson symptoms caused by carbon monoxide poisoning or manganese intoxication.

Carbidopa and levodopa may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

In the U.S.

• Parcopa
• Rytary
• Sinemet 10-100
• Sinemet 25-100
• Sinemet 25-250
• Sinemet CR

In Canada

• Sinemet 100/10
• Sinemet 100/25
• Sinemet 250/25
• Sinemet CR 100/25
• Sinemet CR 200/50

Available Dosage Forms:

• Tablet, Extended Release
• Capsule, Extended Release
• Tablet
• Tablet, Disintegrating

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Decarboxylase Inhibitor

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Change in the way you act.
• Hallucinations (seeing or hearing things that are not there).
• Feeling confused.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• A skin lump or growth.
• Change in color or size of a mole.
• Trouble controlling body movements that is new or worse.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.
• Belly pain.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Fever or chills.
• Sore throat.
• Any unexplained bruising or bleeding.
• Very bad dizziness or passing out.
• Very bad headache.
• Dark urine or yellow skin or eyes.
• Change in eyesight, eye pain, or very bad eye irritation.
• Shortness of breath.
• Feeling very tired or weak.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bad dreams.
• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Headache.
• Not able to sleep.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Sinemet CR. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Sinemet CR. Sinemet CR may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see PRECAUTIONS, Drug Interactions).

Sinemet CR is contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.