12.5 mg/50 mg, 25 mg/100 mg tablet
carbidopa/levodopa
What Sinemet is and what it is used for
Sinemet contains a combination of levodopa and carbidopa for the treatment of Parkinson’s disease. Levodopa is almost identical to dopamine, a substance found in the brain and spinal cord where it helps in the transmission of impulses between nerve cells. Too little dopamine can cause symptoms that are the same as in Parkinson’s disease, such as tremors, muscle stiffness, slow movements, and difficulty keeping balance. Treatment with levodopa increases the amount of dopamine, thereby reducing these symptoms.
Carbidopa is a so-called decarboxylase inhibitor, which is added to improve the effect of levodopa.
Your doctor may have prescribed the medicine for a different area of use and/or with a different dosage than stated in the package insert. Always follow the doctor’s prescription and the instructions on the medicine package.
What you need to know before taking Sinemet
Do not take Sinemet:
- if you are allergic to levodopa, carbidopa, or any of the other ingredients of this medicine (listed in section 6)
- if you have increased pressure in the eye ( glaucoma, glaucoma where the angle between the cornea and the iris is small, so-called narrow-angle glaucoma )
- if you have been treated for depression with a so-called MAO inhibitor in the last two weeks
- if you suffer from severe cardiovascular disease, severe liver or kidney disease, psychosis, hormonal problems (overproduction of adrenal cortex or thyroid hormone), attacks of high blood pressure caused by a tumor in the adrenal medulla ( pheochromocytoma ).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sinemet. It is important that, before starting Sinemet, you tell your doctor about any medical problems you have or have had, especially if you have or have had
- myocardial infarction
- severe lung problems or asthmatic bronchitis
- hormonal disorders
- depression or mental disorder
- gastric ulcer
- previous seizures
- suspected skin changes or previously had skin cancer ( melanoma ).
Tell your doctor if you or your family/caregiver notices that you develop addiction-like symptoms that lead to a craving for larger doses of Sinemet and other medicines used to treat Parkinson’s disease.
Tell your doctor if you or your family/carer notice that you develop a strong urge or desire to behave in ways that are unusual for you, or if you cannot resist the impulse, urge, or temptation to do certain activities that could harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to re-evaluate your treatment.
Children and young people
Sinemet should not be given to children or adolescents under the age of 18 (experience is lacking).
Other medicines and Sinemet
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
The effect of the treatment can be affected if Sinemet is taken at the same time as certain other medicines. Tell your doctor if you have previously been treated with levodopa or if you use or intend to use other medicines (also applies to over-the-counter medicines). The doctor needs to know if you are already being treated with iron tablets or certain medications used to treat depression (so -selective MAO inhibitors ), schizophrenia ( risperidone ), tuberculosis ( isoniazid ) as well as drugs for high blood pressure, muscle twitching, seizures in epilepsy or other diseases that cause involuntary movements.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
There is limited experience with the use of Sinemet during pregnancy.
It is unknown whether Sinemet passes into breast milk.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Sinemet can cause somnolence (severe drowsiness) and/or sudden sleep attacks. You should therefore refrain from driving and other activities where reduced attention could put yourself or others at risk of serious injury or death (eg operating machinery) until the attacks or drowsiness have stopped.
How to take Sinemet
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
The dose is determined by the doctor, who adjusts it individually for you. Do not change the dosage or stop the treatment without consulting your doctor. Sudden interruptions can cause side effects.
If you need to divide the tablet to swallow it, you must make sure that you take all parts of the tablet (one whole dose ). If the tablet breaks when you take it out of the blister pack, make sure you have all the parts (full dose one). If you do not have all the parts, discard the parts and take a new tablet from the package.
Taking only a few parts of a tablet (too low a dose ) can lead to worsening of symptoms.
If you have taken too much Sinemet
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Sinemet
If you forget to take a dose, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and then follow your dosing schedule.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 users): Sudden and unexpected movements, temporary slowing of movements, disturbance in muscle tone ( dystonia ), dizziness and lightheadedness when standing up quickly, loss of appetite ( anorexia ), nausea, vomiting, bitter taste in the mouth, palpitations, irregular heartbeat, mental changes of various degrees of severity, eg anxiety, confusion, memory impairment, abnormal excitement, paranoid ideas, hallucinations, insomnia, depression with or without suicidal tendencies.
Uncommon (may affect up to 1 in 100 users): Dry mouth (careful oral hygiene is therefore important), increased amount of saliva, difficulty swallowing, diarrhea, constipation, dark-colored urine, flatulence, stomach pain, discomfort, increased blood pressure, edema (fluid retention ), fainting, fainting, flushing, weight gain or loss, muscle spasms and twitching, hoarseness, changed breathing pattern, feeling tired/weak, headache, agitation and changed dream pattern with nightmares.
Rare (may affect up to 1 in 1,000 people): Teeth grinding (especially during sleep), disorientation, hiccups, acid reflux, dark saliva, burning sensation in the tongue, ulceration, and bleeding from the gastrointestinal mucosa, inflammation of a superficial blood vessel (vein ), hives, skin rash, itching and other hypersensitivity reactions of varying severity, e.g. redness, hair loss, activation of pigment tumor ( melanoma ). Eye side effects of various kinds, including blurred vision and double vision, pupil dilation, eyelid twitching, drooping eyelids, and small pupils (activation of latent Horner’s syndrome). Anemia and other effects on blood count, numbness, tingling, epileptic seizures, and a cluster of symptoms including high fever, stiff muscles, and mood changes. Cramps in the masticatory muscles with difficulty opening the mouth, urinary retention, urine leakage, increased sex drive, prolonged and painful erection, shortness of breath, chest pain, increased and/or discolored sweating, angioedema (swelling of the face, lips, tongue and/or throat), somnolence (severe drowsiness), sudden sleep attacks.
Frequency not known (cannot be estimated from available data):
You may experience the following side effects:
- Ask for a higher dose of Sinemet than is needed to control motor systems, known as dopaminergic dysregulation syndrome. Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings, or other side effects after taking larger doses of Sinemet.
- Inability to resist an impulse to perform an action that may be harmful such as:
- A strong impulse to excessive gambling despite serious consequences for you personally or your family
- Changed or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sex drive
- Uncontrollable and excessive need to buy things and spend money
- Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce symptoms.
Certain blood test results can be affected when using Sinemet, such as an increase in certain liver function tests and the blood sugar level. Bacteria and blood have also been found in the urine. Sinemet can cause a false positive reaction for ketone bodies and white blood cells in urine.
How Sinemet should be stored
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Use before the expiry date stated on the carton and label/blister after “Exp.”. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are
- Sinemet 12.5 mg/50 mg: carbidopa 12.5 mg, levodopa 50 mg.
- Sinemet 25 mg/100 mg: carbidopa 25 mg, levodopa 100 mg.
- Other ingredients are
- Microcrystalline cellulose, pregelatinized starch, corn starch, magnesium stearate, and quinoline yellow (E104).
Appearance and package sizes of the medicine
Sinemet 12.5 mg/50 mg: yellow, oval tablet, marked with “520” on one side and plain on the other side.
Tablet size: 9.5mm x 5mm.
Packaging: 100 tablets in plastic/aluminum blister packaging.
Sinemet 25 mg/100 mg: yellow, oval tablet, marked with “650” on one side and plain on the other side.
Tablet size: 12.7mm x 7.1mm.
Packaging: 100 tablets in a plastic jar.
Marketing Authorisation Holder
NV Organon
Kloosterstraat 6
5349 AB Us
Netherlands
Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands