Sinemet CR Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||GTP-CH Deficiency, Neuroleptic Malignant Syndrome, Parkinson's Disease|
|Class:||Dopaminergic antiparkinsonism agents|
|Ingredients:||levodopa, carbidopa, hydroxypropylcellulose, hypromellose, magnesium stearate|
levodopa and carbidopa controlled release tablets
About this Medication
SINEMET CR is the brand name for the substance - levodopa and carbidopa, available only on prescription from your physician.
What the Medication is Used For
Your physician has prescribed SINEMET CR to treat the symptoms of Parkinson's disease.
Parkinson's disease is a chronic disorder characterized by slow and unsteady movement, muscular stiffness, and tremor. If untreated, Parkinson's disease can cause difficulty in performing normal daily activities.
What it Does
SINEMET CR is a combination of levodopa, the metabolic precursor of dopamine, and carbidopa, an aromatic amino acid decarboxylase inhibitor, in a controlled-release tablet. It treats the symptoms of Parkinson's disease.
SINEMET CR tablets are formulated to slowly release the two active ingredients, levodopa and carbidopa.
It is believed that the symptoms of Parkinson's disease are caused by a lack of dopamine, a naturally occuring chemical produced by certain brain cells. Dopamine has the role of relaying messages in certain regions of the brain that control muscle movement. Difficulty in movement results when too little dopamine is produced.
Levodopa acts to replenish dopamine in the brain, while carbidopa ensures that enough levodopa gets to the brain where it is needed. In many patients, this reduces the symptoms of Parkinson's disease. The controlled release formula keeps the amount of levodopa in your body as even as possible.
When it Should not Be Used
Do not take SINEMET CR, if you:
- are allergic to any of its ingredients
- have any suspicious skin lesions (moles) which have not been examined by your doctor or if you have ever had skin cancer
- are being treated with certain MAO inhibitor drugs, such as for depression, within the last 2 weeks
- have narrow-angle glaucoma
- have untreated heart, liver, kidney, lung, blood or hormonal disease
- have been told that you should not take sympathomimetic drugs such as isoproterenol, amphetamines, epinephrine or cough and cold medications containing drugs related to epinephrine
What the Medicinal Ingredient Is
Levodopa and carbidopa
What the Non-medicinal Ingredients Are
Hydroxypropylcellulose, hypromellose and magnesium stearate.
SINEMET CR 100/25 and SINEMET CR 200/50 tablets contain FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake.
What Dosage Forms it Comes In
Controlled release tablets (levodopa/carbidopa): 100 mg/25 mg (dappled purple) and 200/50 (dappled purple).
Warnings and Precautions
Some people feel sleepy, drowsy, or, rarely, may suddenly fall asleep without warning (i.e. without feeling sleepy or drowsy) when taking SINEMET CR. During treatment with SINEMET CR take special care when you drive or operate a machine. If you experience excessive drowsiness or a sudden sleep onset episode, refrain from driving and operating machines, and contact your physician.
Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the drugs used to treat Parkinson's disease. Therefore, patients treated with SINEMET CR should have periodic skin examinations.
Before taking SINEMET CR, tell your physician or pharmacist if you:
- have or have had any medical conditions including: allergies; depression or mental disturbances; lung, kidney, liver, heart or hormonal problems; skin cancer or suspicious skin lesions; ulcer in your gut (called "duodenal" or "peptic ulcer"); convulsions/seizures; or glaucoma
- have previously been treated with levodopa
- are pregnant or plan to become pregnant
- are breastfeeding or wish to breastfeed
- are going to have an operation that requires general anesthesia
- drive or operate machinery
Tell your doctor if you or your family member/caregiver notices you are developing urges to gamble, increased sexual urges, excessive eating or spending, and/or other intense urges that could harm yourself or others. These behaviors are called impulse control disorders. Your doctor may need to review your treatments.
It is not recommended to use SINEMET CR while you are pregnant or breast-feeding.
It is not known what effect SINEMET CR may have on human pregnancy. Levodopa, one of the components of SINEMET CR, is passed into human milk. If you are pregnant, may become pregnant or intend to breast-feed, tell your physician, who will help you weigh the benefits of the drug for you against possible risks to your baby.
As you improve on SINEMET CR, you may increase your physical activity gradually and with caution related to any other medical conditions you may have.
SINEMET CR should not be given to children under 18 years of age.
Interactions with this Medication
Although SINEMET CR can generally be given with other medicines, there are exceptions. Tell your physician about all medicines you are taking or plan to take, including those obtained without a prescription.
It is particularly important to tell your physician if you are taking:
- antihypertensive drugs (used to treat elevated blood pressure)
- some medications used to treat psychiatric conditions or mental depression (including phenothiazines, butyrophenones, risperidone, selegiline, tricyclic antidepressants and monoamine oxidase inhibitors)
- tetrabenazine (medications used to treat conditions related to involuntary movements such as Huntingtons Disease)
- phenytoin (anti-epileptic medication)
- papaverine (medication for intestinal spasms)
- isoniazid (medication to treat tuberculosis)
- metoclopramide (for nausea and vomiting)
- iron salts (such as multivitamins) which may reduce the amount of carbidopa and/or levodopa available to the body
A change in diet to foods that are high in protein (such as meat, fish, dairy products, seeds and nuts) may delay the absorption of levodopa and SINEMET CR may not work as well as it should.
Proper Use of this Medication
The dosage of SINEMET CR is variable and your physician will adjust it according to the severity of your disease and your response to treatment.
SINEMET CR is a sustained-release formulation of levodopa-carbidopa which releases these ingredients over a 4- to 6- hour period.
The effect of the first morning dose of SINEMET CR may be delayed for up to 1 hour compared with the response usually obtained from the first morning dose of SINEMET (levodopa-carbidopa). Consult your physician if such delayed responses pose a problem in treatment.
SINEMET CR should only be administered as whole tablets. In order to maintain the slow-release properties of SINEMET CR, do not chew or crush the tablets.
For best results take SINEMET CR every day. It is important to carefully follow your physician's advice on how much SINEMET CR to take and how often to take it. Promptly inform your physician of any change in your condition such as nausea or abnormal movements, as this may require an adjustment in your prescription.
Do not change the dose regimen prescribed by your physician and do not add any additional antiparkinson medications, including other levodopa-carbidopa preparations, without first consulting your physician.
Do not stop taking this medicine abruptly or lower the dosage without checking with your physician. If you suddenly stop or reduce your dosage you may experience the following symptoms: stiff muscles, high temperature (fever) and mental changes.
In case of an overdose, contact your physician immediately so that medical attention may be given promptly.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
Try to take SINEMET CR as prescribed. However, if you have missed a dose, take it as soon as you remember. If it is almost time to take your next tablet, do not take the missed tablet, but resume your normal schedule.
Side Effects and what to Do About Them
SINEMET CR is generally well tolerated. Like any other medicine, however, SINEMET CR may have unintended or undesirable effects, so called side effects.
Very rare but serious side effects that have been reported include sudden sleep onset episodes (see WARNINGS AND PRECAUTIONS).
Certain side effects that have been reported with SINEMET CR may affect some patients' ability to drive or operate machinery.
SINEMET CR can cause somnolence (excessive drowsiness) and sudden sleep onset episodes. Therefore you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see WARNINGS AND PRECAUTIONS).
The most frequent side effects are: abnormal movements (which may or may not resemble your Parkinson's symptoms), nausea, hallucinations, confusion, dizziness, and dry mouth.
Other possible side effects include: abnormal dreams or difficulty sleeping, mental changes, depression, weakness, vomiting, and loss of appetite, flushing, and hair loss (see WARNINGS AND PRECAUTIONS). Occasionally, dark color (red, brown or black) may appear in your saliva, urine, sweat after you take SINEMET CR.
Serious Side effects how often they Happen and what to Do About Them
|Symptoms / Effects||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Most Common||Abnormal involuntary movements, such as spasms or twitching||✓|
|Common||Hallucinations (seeing or hearing things that are not there)||✓|
|Feeling of lightheadedness when standing quickly; fainting||✓|
|Rare||Allergic reactions [red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing or swallowing]||✓|
|Falling asleep without warning||✓|
|Impulse control symptoms (inability to resist the impulse to perform an action that could be harmful) such as compulsive gambling, increased sexual urges and/or behaviours, uncontrollable excessive shopping or spending, binge/compulsive eating, and/or other urges||✓|
|Changed patches of pigmented skin, including irritated or irregular moles, or moles in which you have noticed changes (melanoma)||✓|
|Uneven (irregular) heart beat or palpitations||✓|
This is not a complete list of side effects. For any unexpected effects while taking SINEMET CR, contact your doctor or pharmacist.
How to Store It
Store your tablets at room temperature (15 °C and 30 °C). Store in tightly closed container, protected from light and moisture.
Keep all medicines out of the reach of children.
Do not use outdated medicine.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect
or at Merck Canada Inc. by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-800-369-3090, or
- Mail to: Merck Canada Inc.
P.O. Box 1005
Pointe-Claire–Dorval, QC H9R 4P8
NOTE:NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program or Merck do not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.merck.ca or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594