Product Overview
【Drug Name】
Generic Name: Piribedil Sustained-Release Tablets
Brand Name: Tasmuda
English Name: Piribedil Sustained-Release Tablets
Pinyin: Bi Bei Di Er Huan Shi Pian
【Ingredients】
The main ingredient of this product is piribedil. Chemical Name: Piribedil, [(methylenedioxy-3,4-benzyl)-4-piperazinyl-1]-2-pyrimidine
【Appearance】
This product is a red sustained-release coated tablet.
【Indications】
For the adjunctive symptomatic treatment of chronic pathological cognitive and sensory neurological disorders in elderly patients (excluding Alzheimer's disease and other types of dementia). For the adjunctive treatment of intermittent claudication caused by chronic obstructive arterial disease of the lower extremities (stage 2). Note: This indication is determined based on the improvement in walking distance. Recommended for the treatment of ischemic symptoms in ophthalmology. For the treatment of Parkinson's disease: 1. As a monotherapy (for types with pronounced tremor) 2. Or initially or later in combination with dopamine therapy, especially for types accompanied by tremor.
【Dosage and Administration】
Oral administration.
For all indications except Parkinson's disease: Take one tablet daily at the end of a meal, or for more severe cases, take two tablets daily at the end of two separate meals.
The tablet should be swallowed with half a glass of water at the end of a meal; do not chew.
Treatment of Parkinson's disease:
1. As a monotherapy: 150mg to 250mg, i.e., 3 to 5 tablets daily, divided into 3 to 5 doses.
2. As a supplement to levodopa therapy: 1 to 3 tablets daily (approximately 50mg of piribedil is needed for every 250mg of levodopa).
The tablet should be swallowed with half a glass of water at the end of a meal; do not chew.
The dosage must be increased gradually, one tablet every three days.
Or as directed by your doctor.
【Adverse Reactions】
The following symptoms may occur: 1. Mild gastrointestinal discomfort (nausea, vomiting, bloating), which may disappear after individualized dosage adjustments. 2. Drowsiness has been reported with piribedil; in very rare cases, excessive daytime drowsiness and sudden onset of sleep have occurred.
3. Mental disturbances such as cloudiness or agitation may also occur, although these are rare. These symptoms usually disappear upon discontinuation of the drug.
4. Blood pressure disturbances (orthostatic hypotension) or unstable blood pressure are very rare.
5. Due to the presence of carmine, allergic reactions may occur. If any adverse events and/or adverse reactions occur after taking this medication, other than those described in this package insert, please contact your doctor.
【Contraindications】
This drug is contraindicated in the following situations:
1. Hypersensitivity to any component of this product.
2. Cardiovascular shock.
3. Acute phase of myocardial infarction.
4. Concomitant use: antiemetic benzodiazepines (see [Drug Interactions]); benzodiazepines (excluding clozapine) (except for Parkinson's patients) (see [Drug Interactions]).
【Precautions】
1. Drowsiness and sudden onset of sleep have been observed in patients treated with piribedil, especially Parkinson's patients. Sudden onset of sleep during daily activities without warning is rarely reported. Patients should be informed of this potential side effect and exercise caution if driving or operating machinery during treatment. Patients with a history of drowsiness or sudden sleep should not drive or operate machinery. Dosage reduction and discontinuation of treatment should be considered.
2. Due to the presence of sucrose, this product is not suitable for patients with fructose intolerance, poor glucose or galactose absorption, or insufficient sucrase-isomaltose enzyme.
3. Patients treated with piribedil may experience drowsiness and/or sudden sleep onset. They should be advised not to drive or engage in activities that could lead to serious accidents or death for themselves or others due to altered alertness (e.g., operating machinery) until such symptoms completely disappear.
【Special Populations】
Precautions for Children: The safety and efficacy of this medication in children have not been established.
Pregnancy and Lactation Precautions: This medication is strictly limited to use in elderly patients and those at risk of pregnancy. In the absence of relevant data, use in pregnant and lactating women is not recommended.
Precautions for the elderly: See other sections or as directed by your doctor.
【Drug Interactions】
Contraindicated combined use: 1. Steroids (excluding clozapine) (in non-Parkinson's patients): There is an antagonistic effect between dopamine agonists and steroids. Patients experiencing extrapyramidal symptoms while taking steroids should not use dopamine agonists but should instead use anticholinergic drugs. 2. Antiemetics: There is an antagonistic effect between dopamine agonists and steroids. Antiemetics without extrapyramidal effects should be used. Inappropriate combined use: Steroids (excluding clozapine) (in Parkinson's patients): There is an antagonistic effect between dopamine agonists and steroids. Dopamine agonists can cause or worsen mental disturbances. If a Parkinson's patient currently being treated with dopamine agonists must use steroids, the dopamine agonist dosage must be gradually reduced until complete discontinuation. (Sudden discontinuation of dopaminergic drugs may lead to malignant benzodiazepine syndrome.)
【Pharmacological Action】
In humans, clinical pharmacological studies have clarified its mechanism of action: 1. Stimulates dopaminergic cortical electrical activity in both awake and sleep states. 2. Different clinical functions under dopamine control have been demonstrated through behavioral or psychometric scale tests. Furthermore, piribedil increases femoral artery blood flow (the presence of dopaminergic receptors in the femoral vascular bed explains the effect of piribedil on peripheral circulation).
【Storage】
Store protected from light and in a tightly closed container.
【Specifications】
50mg
【Packaging】
Aluminum-plastic blister pack, 30 tablets/box.
【Shelf Life】
36 months
【Approval Number】
National Drug Approval Number HJ20140104
【Manufacturer】
Les Laboratoires Servier Division Oril
