Download PACKAGE LEAFLET PHEZAM ATC code: N06BX00

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
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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.
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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.
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