Sinemet

Serious side effects have been reported with Sinemet.

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

Do not take Sinemet if you:

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

Tell your doctor if you are breastfeeding or plan to breastfeed.

Levodopa, one of the components of Sinemet, has been detected in human breast milk. Caution should be exercised when Sinemet is given to a nursing woman.

Take Sinemet exactly as prescribed.

This combination medication comes in regular (immediate-release) tablet form to be taken by mouth. It is usually taken 3 to 4 times a day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Sinemet at the same time.

You should not use carbidopa and levodopa if you have narrow-angle glaucoma.

Do not use carbidopa and levodopa if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• worsening of tremors (uncontrolled shaking);

• severe or ongoing vomiting or diarrhea;

• confusion, hallucinations, unusual changes in mood or behavior;

• depression or suicidal thoughts; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Some people taking carbidopa and levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Common side effects may include:

• jerky or twisting muscle movements;

• muscle contractions; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with carbidopa and levodopa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.

The most common adverse reactions reported with Sinemet have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea.

The following other adverse reactions have been reported with Sinemet:

Body as a Whole

Chest pain, asthenia.

Cardiovascular

Cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation.

Gastrointestinal

Dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations.

Hematologic

Agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia.

Hypersensitivity

Angioedema, urticaria, pruritus, Henoch-Schönlein purpura, bullous lesions (including pemphigus-like reactions).

Musculoskeletal

Back pain, shoulder pain, muscle cramps.

Nervous System/Psychiatric

Psychotic episodes including delusions, hallucinations, and paranoid ideation, bradykinetic episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal relationship with Sinemet has not been established.

Respiratory

Dyspnea, upper respiratory infection.

Skin

Rash, increased sweating, alopecia, dark sweat.

Urogenital

Urinary tract infection, urinary frequency, dark urine.

Laboratory Tests

Decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), LDH, bilirubin, BUN, Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine.

Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations, and may occur with Sinemet are:

Body as a Whole

Abdominal pain and distress, fatigue.

Cardiovascular

Myocardial infarction.

Gastrointestinal

Gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups.

Metabolic

Edema, weight gain, weight loss.

Musculoskeletal

Leg pain.

Nervous System/Psychiatric

Ataxia, extrapyramidal disorder, falling, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Horner's syndrome, peripheral neuropathy.

Respiratory

Pharyngeal pain, cough.

Skin

Malignant melanoma (see also CONTRAINDICATIONS), flushing.

Special Senses

Oculogyric crises, diplopia, blurred vision, dilated pupils.

Urogenital

Urinary retention, urinary incontinence, priapism.

Miscellaneous

Bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation.

Laboratory Tests

Decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; protein and glucose in urine.

No. 3916A  Sinemet 25-100 Tablets are yellow, round, uncoated tablets, that are coded "650" on one side and plain on the other. They are supplied as follows:

          NDC 0006-3916-68 bottles of 100.

No. 3915  Sinemet 10-100 Tablets are light dapple-blue, round, uncoated tablets, that are coded "647" on one side and plain on the other. They are supplied as follows:

          NDC 0006-3915-68 bottles of 100.

No. 3917  Sinemet 25-250 Tablets are light dapple-blue, round, uncoated tablets, that are coded "654" on one side and plain on the other. They are supplied as follows:

          NDC 0006-3917-68 bottles of 100.

Storage and Handling

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.

Dispense in a tightly closed, light-resistant container.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
Mylan Pharmaceuticals, Inc.
Morgantown, WV 26505, USA

Copyright © 1996-2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 07/2014

uspi-mk0295b-t-1407r003

Rx Only

Sinemet®
(carbidopa-levodopa) Tablets

25 mg/250 mg

Rx only

100 Tablets

NDC 0006-3917-68

Each tablet contains 25 mg carbidopa (anhydrous equivalent) and 250 mg levodopa.

USUAL ADULT DOSAGE: See Package Insert.

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.

Dispense in a tightly closed, light-resistant container. This is a bulk package and not intended for dispensing. Package not child resistant.

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

By: Mylan Pharmaceuticals, Inc.
Morgantown, WV 26505, USA

7001127401
100 | No. 3917