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PACKAGE LEAFLET PHEZAM ® ATC code: N06BX00 PHARMACOTHERAPEUTIC GROUP Psychostimulants. Antivertigo preparations. Nootropic agents. COMPOSITION Piracetam 400 mg and Cinnarizine 25 mg in one capsule. ACTION Phezam is a combined preparation with pronounced antihypoxic effect. The effects of both components are mutually enhanced with respect to the antihypoxic and cerebrovascular resistance reducing effects. The preparation increases the cerebral blood flow. The toxicity of the combination does not excess that of the single components. Both components are thorough and rapidly absorbed in the gastrointestinal tract. cinnarizin achieves peak levels in blood, liver, kidneys, heart, lungs, spleen and brain within 1-4 h after the administration, and the respective time for piracetam is 2 - 6 h. Cinnarizin is completely metabolized, while piracetam is excreted unchanged in the urine within approx. 30 h. The latter binds to the plasma proteins to the extent of 91%. The distribution of piracetam is quick and includes all vital organs. It passes freely through the brain-blood barrier and concentrates predominantly in the cortex of encephalon and cerebellum and also in nucleus caudatus, hippocampus, corpus medianum, geniculus lateralis and plexus choroidalis. The elimination half-life of piracetam in the cerebrospinal fluid is longer than the plasma half-life, which proves 1 the tropism of the preparation to the cerebral tissue. INDICATIONS Psycho-organic syndrome of different origin – acute and chronic cerebrovascular diseases, brain injury, inflammatory and infectious CNS – diseases; labyrinthopathy – vertigo, dizziness, roaring in the ears, nystagmus, nausea and vomiting; prevention of kinesia; Meniere’s syndrom; cerebral infarct, chronic hypertonia with encephalopathy; vascular dementia, psychogenic disorders connected with memory, attention and concentration disturbances, emotional lability. CONTRAINDICATIONS Known hypersensitivity to the components. High-dose administration in severe renal insufficiency. ADVERSE REACTIONS/SIDE EFFECTS In very rare cases hypersensitivity may occur, including different skin reactions, photosensitivity. Adverse reactions, typical of the separate components of the preparation may also appear. DRUG AND NON-DRUG INTERACTIONS When used concomitantly, Phezam may enhance the sedative effects of CNS depressants, tricyclic antidepressants and alcohol; it also potentates the effects of nootropic and antihypertensive agents. The effect of the preparation is intensified by vasodilators and reduced by antihypotensive drugs. WARNINGS AND PRECAUTIONS The preparation should be administered cautiously in case of renal and/or liver impairment. Due to the content of Cinnarizin, the preparation may give rise to false positive results in the doping control tests for sportsmen. 2 Cinnarizin may compromise the radioactive iodine determination tests. PREGNANCY AND BREAST-FEEDING There are no contraindications for use, but it should be taken into account that during pregnancy and breast-feeding drugs are prescribed only for compelling reasons and after careful consideration of the risk/benefit ratio. EFFECT ON ACTIVE ATTENTION, ABILITY TO DRIVE AND USE MACHINES No reports are available on adverse influence on the active attention, motor activity and reflexes. DOSAGE AND MODE OF ADMINISTRATION 1-2 capsules 3 times daily in the course of 1-3 months depending on the severity of the disease. Children: 1-2 capsules 1-2 times daily. OVERDOSAGE No reports of overdosage have been received up to date. PACKAGE Capsules of 25 mg in packs of 60. STORAGE In a dry place, at temperature 15-25oC, protected from light. 3