Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)

1. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) © The Swiss Pharmacy

2. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) is used in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord). © The Swiss Pharmacy

3. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Syndopa CR Tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strengths of Levodopa 100mg and Carbidopa 25mg as well as Levodopa 200mg and Carbidopa 50mg. © The Swiss Pharmacy

4. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Chemical Structure - Levodopa © The Swiss Pharmacy

5. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Chemical Structure - Carbidopa © The Swiss Pharmacy

6. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) The active ingredients contained in Syndopa CR tablets are Levodopa and Carbidopa. Each uncoated prolonged release Syndopa CR tablet contains Levodopa 100mg & Carbidopa 25mg or Levodopa 200mg & Carbidopa 50mg. © The Swiss Pharmacy

7. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Uses of Syndopa CR 125 mg and 250 mg tablets: Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) is used for the treatment of Parkinson's disease (sometimes called shaking palsy or paralysis agitans) and syndrome. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord). It is useful in relieving many of the symptoms of Parkinsonism, particularly rigidity and bradykinesia. Syndopa frequently is helpful in the management of tremor, dysphagia, sialorrhoea, and postural instability associated with Parkinson's disease and syndrome. Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) is used to treat Idiopathic Parkinson's disease, Postencephalitic Parkinsonism, Symptomatic Parkinsonism (carbon monoxide or manganese intoxication) and patients with Parkinson's disease or Parkinsonism who are taking vitamin preparations that contain Pyridoxine. © The Swiss Pharmacy

8. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Uses of Syndopa CR 125 mg and 250 mg tablets: This medicine is also used to reduce "off" time in patients previously treated with Levodopa/Decarboxylase inhibitor preparations, or with Levodopa alone, who have had motor fluctuations characterised by end-of-dose deterioration ("wearing-off" phenomenon), peak dose dyskinesias, akinesia, or similar evidence of short-duration motor disturbances. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of Levodopa. Some patients who responded poorly to Levodopa have improved on Carbidopa and Levodopa. This is most likely due to decreased peripheral decarboxylation of Levodopa caused by administration of Carbidopa rather than by a primary effect of Carbidopa on the nervous system. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

9. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Uses of Syndopa CR 125 mg and 250 mg tablets: Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of Dopamine in the brain, Levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

10. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Recommended Adult Dosage The dose of Syndopa CR Tablets Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) is given below: Patients Who Have Not Received Prior Levodopa Therapy: In early stage patients who have not had prior Levodopa therapy, the initial recommended dose is one tablet of Syndopa CR 50/200 once daily. When appropriate, the dosage may be increased to 1 tablet of Syndopa CR 50/200 two or three times daily. Initial dosages should not exceed 600 mg per day of Levodopa or be given at intervals of less than 6 hours. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

11. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Recommended Adult Dosage Patients Currently Treated With Conventional Levodopa/ Decarboxylase Inhibitor Combinations: For such patients the dosage with Syndopa CR 50/200 should be substituted at an amount that provides approximately 10% more Levodopa per day, although this may need to be increased to a dosage that provides up to 30% more Levodopa per day depending on the clinical response. The interval between doses of Syndopa CR 50/200 should be 4 to 8 hours during the waking day. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

12. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Contraindications ➔Syndopa CR tablets are contraindicated in patients with a known hypersensitivity to Levodopa, Carbidopa or any component of the tablet. ➔Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Syndopa CR (Generic Levodopa and Carbidopa CR Tablets). These inhibitors must be discontinued at least two weeks prior to initiating therapy with Syndopa CR. Carbidopa and Levodopa may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl). ➔Syndopa CR should not be administered to patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease; or to patients with narrow angle glaucoma. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

13. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Contraindications ➔As with Levodopa, Syndopa CR must not be given when administration of a sympathomimetic amine is contraindicated (e.g., Epinephrine, Norepinephrine or Isoproterenol). ➔Because Levodopa may activate a malignant melanoma, Levodopa and Carbidopa CR tablets should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

14. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Storage Instructions Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

15. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Warnings Patients undergoing therapy with Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including the driving of a car, which has sometimes resulted in accidents. Although some of the patients reported somnolence while on Syndopa CR, others perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. When patients already receiving Levodopa are switched to Syndopa CR, Levodopa must be discontinued for at least 12 hours or more before Syndopa CR is started. Syndopa CR should be substituted at a dosage that will provide approximately 20% of the previous Levodopa dosage. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

16. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Warnings Periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy with Syndopa CR (Generic Levodopa and Carbidopa CR Tablets). Patients who improve while on therapy with Syndopa CR should increase physical activities gradually, with caution, consistent with other medical considerations such as the presence of osteoporosis or phlebothrombosis. Care should be exercised in administering Syndopa CR to patients with a history of myocardial infarction or who have atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment in a facility with provisions for intensive cardiac care. Syndopa CR should be administered cautiously to patients with a history of peptic ulcer disease due to the possibility of upper gastrointestinal hemorrhage. © The Swiss Pharmacy

17. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Warnings The Levodopa induced involuntary movements and ‘on and off’ phenomenon may appear earlier with combination therapy. A symptom complex resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, altered consciousness, mental changes, autonomic instability and increased serum creatine phosphokinase has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy. Certain side effects that have been reported with Syndopa CR may affect some patients’ ability to drive or operate machinery. Given the reported cases of somnolence and sudden onset of sleep (not necessarily preceded by somnolence), physicians should caution patients about the risk of operating hazardous machinery, including driving motor vehicles, while taking Syndopa CR tablets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

18. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Warnings Pupillary dilatation and activation of latent Horner’s syndrome have been reported during Levodopa treatment. Patients with chronic wide angle glaucoma should therefore be treated cautiously with Syndopa CR . If general anesthesia is required, therapy with Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) may be continued as long as the patient is permitted to take fluids and medication by mouth. If Syndopa CR therapy is interrupted temporarily, the usual daily dosage may be administered as soon as the patient is able to take oral medication. Patients should be monitored carefully for the development of depression with suicidal tendencies. Patients with past or current psychoses should be treated with caution. Patients and caregivers should be advised to adhere to dosage instructions given by the physician. https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

19. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Warnings Patients undergoing treatment with this medicine should be regularly monitored for the development of impulse control disorders. Patients and caregivers should be made aware that behavioral symptoms of impulse control disorders. Hallucinations and confusion are known side effects of treatment with dopaminergic agents, including Levodopa. Patients should be aware of the fact that hallucinations (mostly visual) can occur. Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

20. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Possible Side Effects Most common Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) side effects have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

21. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Possible Side Effects The following other side effects have been reported with Levodopa and Carbidopa: 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

22. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Possible Side Effects The following other side effects have been reported with Levodopa and Carbidopa tablets: 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 carbidopa and levodopa 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

23. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Possible Side Effects Other side effects that have been reported with Levodopa alone and with various Carbidopa Levodopa formulations, and may occur with this combination product 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

24. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Possible Side Effects Other side effects that have been reported with Levodopa alone and with various Carbidopa Levodopa formulations, and may occur with this combination product are: Respiratory: pharyngeal pain, cough. Skin: malignant melanoma, 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

25. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Syndopa CR Tablets Overdosage Management of acute overdosage with Levodopa and Carbidopa CR Tablets (Syndopa CR) is the same as management of acute overdosage with Levodopa. Pyridoxine is not effective in reversing the actions of this product. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered judiciously and an adequate airway maintained. Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other medicines as well as Levodopa and Carbidopa tablets should be taken into consideration. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

26. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Syndopa CR Tablets During Pregnancy Levodopa and Carbidopa CR Tablets (Syndopa CR Tablets) has been classified by the US FDA as Pregnancy Category C. No teratogenic effects were observed in a study in mice receiving up to 20 times the maximum recommended human dose of Levodopa and Carbidopa Tablets. There was a decrease in the number of live pups delivered by rats receiving approximately two times the maximum recommended human dose of Carbidopa and approximately five times the maximum recommended human dose of Levodopa. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

27. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Syndopa CR Tablets During Pregnancy There are no adequate or well-controlled studies of Levodopa and Carbidopa CR tablets (Syndopa CR) in pregnant women. It has been reported from individual cases that Levodopa crosses the human placental barrier, enters the fetus, and is metabolized. Carbidopa concentrations in fetal tissue appeared to be minimal. Use of Syndopa CR in women of childbearing potential requires that the anticipated benefits of the medicine be weighed against possible hazards to mother and child. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy

28. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) Syndopa CR Tablets Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets) are manufactured by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html © The Swiss Pharmacy