Syndopa Tablets (Generic Carbidopa and Levodopa Tablets)

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

2. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) is used in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism (such as shakiness, stiffness, difficulty moving) that may follow carbon monoxide intoxication or manganese intoxication. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement. Carbidopa prevents the breakdown of levodopa in the bloodstream so more levodopa can enter the brain. Carbidopa can also reduce some of levodopa's side effects such as nausea and vomiting. © The Swiss Pharmacy

3. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Syndopa Tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strengths of 110mg , 125mg and 275mg. © The Swiss Pharmacy

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

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

6. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) The active ingredients contained in Syndopa tablets are Levodopa and Carbidopa. Each Syndopa tablet contains Levodopa 100mg & Carbidopa 10mg or Levodopa 100mg & Carbidopa 25mg or Levodopa 250mg & Carbidopa 25mg © The Swiss Pharmacy

7. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Uses of Syndopa 110mg , 125mg and 275mg Tablets: Syndopa Tablets (Carbidopa and Levodopa combination) is used to treat Parkinson's disease, sometimes called shaking palsy or paralysis agitans. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord). Levodopa and Carbidopa combination is also used to treat parkinsonism caused by encephalitis, or parkinsonism caused by carbon monoxide or manganese poisoning. 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. © The Swiss Pharmacy

8. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Recommended Adult Dosage For most patients, the starting dose of Syndopa tablets (Generic Carbidopa and Levodopa Tablets) is one tablet of Syndopa 25/100 three times a day.This dosage schedule provided 75 mg of Carbidopa per day. Dosage may be increased by one tablet every day or every other day (given at intervals of 3 to 4 hours), as necessary, until a dosage equivalent of eight tablets of Syndopa 25/100 a day is reached. Syndopa tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

9. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Contraindications ➔Syndopa 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 (Generic Levodopa and Carbidopa Tablets). These inhibitors must be discontinued at least two weeks prior to initiating therapy with Syndopa. 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 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

10. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Contraindications ➔As with Levodopa, Syndopa should 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 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

11. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Storage Instructions Syndopa Tablets (Generic Carbidopa and Levodopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

12. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Warnings Patients receiving treatment with Syndopa tablets (Generic Carbidopa and Levodopa 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, 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, Levodopa must be discontinued for at least 12 hours or more before Syndopa is started. Syndopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

13. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Warnings Periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy with Syndopa (Generic Levodopa and Carbidopa Tablets). Patients who improve while on therapy with Syndopa 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 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 should be administered cautiously to patients with a history of peptic ulcer disease due to the possibility of upper gastrointestinal hemorrhage. © The Swiss Pharmacy

14. Syndopa Tablets (Generic Carbidopa and Levodopa 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 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 tablets. © The Swiss Pharmacy

15. Syndopa Tablets (Generic Carbidopa and Levodopa 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. If general anesthesia is required, therapy with Syndopa (Generic Levodopa and Carbidopa Tablets) may be continued as long as the patient is permitted to take fluids and medication by mouth. If 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

16. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Warnings Patients 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

17. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Possible Side Effects Most common Syndopa (Carbidopa and Levodopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

18. Syndopa Tablets (Generic Carbidopa and Levodopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

19. Syndopa Tablets (Generic Carbidopa and Levodopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

20. Syndopa Tablets (Generic Carbidopa and Levodopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

21. Syndopa Tablets (Generic Carbidopa and Levodopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

22. Syndopa Tablets (Generic Carbidopa and Levodopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

23. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Overdosage Management of acute overdosage with Levodopa and Carbidopa Tablets (Syndopa) 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 drugs as well as Levodopa and Carbidopa tablets should be taken into consideration. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

24. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Syndopa Tablets During Pregnancy Levodopa and Carbidopa Tablets (Syndopa 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

25. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Syndopa Tablets During Pregnancy There are no adequate or well-controlled studies of Levodopa and Carbidopa tablets (Syndopa) 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 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=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy

26. Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) Syndopa Tablets Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) are manufactured by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html © The Swiss Pharmacy