The instruction for medical use
of FEZAM medicine
the Trade name
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Structure One Capsule Capsule contains
active agents: piracetam of 400 mg, cinnarizine of 25 mg,
excipients: lactoses monohydrate, silicon dioxide colloidal, magnesium stearate,
structure of a cover of the capsule: titan dioxide (E 171), gelatin.
Solid gelatin, cylindrical capsules No. 0, with a lid and the body of white color.
Contents of capsules powdery mix white till faintly cream color, are allowed presence of agglomerates.
The pharmacotherapeutic group
Other psychostimulants and nootropa
the Code of automatic telephone exchange N06BX
Pharmacokinetics Absorption Quickly properties is also completely absorbed from digestive tract. The maximum concentration of cinnarizine in plasma note in 1-4 hour, piracetam in 2-6 hours.
High concentration of cinnarizine in 1-4 hours is noted in a liver, kidneys, heart, lungs, a spleen and a brain. Cinnarizine contacts for 91% proteins of plasma. Piracetam is quickly distributed in all vitals. It gets through a blood-brain barrier and concentrates mainly in gray matter of a cerebral cortex and cerebellum, and also in nucleus caudatus (kernel having a tail), hippocampus (hippocampus), corpus medianum, geniculus lateralis and plexus choroidalis (horoidalny texture).
Piracetam is removed with urine in an invariable look approximately in 30 hours. 60% of cinnarizine in an invariable look are removed with a stake, the rest with urine in the form of metabolites approximately in 5 hours.
the Combined drug improving cerebral circulation and brain metabolism.
Piracetam nootropic means. Has positive impact on exchange processes and blood circulation of a brain. Increases glucose utilization, improves a course of metabolic processes, improves microcirculation in ischemic zones, inhibits aggregation of the activated thrombocytes. Has protective action at the injuries of a brain caused by a hypoxia.
Cinnarizine a blocker of calcium channels with the significant influence on brain vessels, reduces receipt in cells of Sa2 + and reduces its keeping in depot of a plasmolemma, reduces a tone of smooth muscles of arterioles, reduces their reaction to biogenous vasoconstrictive substances. Has vasodilating effect, without having significant effect on the ABP. Improves cerebral circulation, increases resistance of fabrics to a hypoxia. Reduces excitability of a vestibular mechanism.
Both components mutually exponentiate action of each other. Concerning impact of drug on the central nervous system the sedation of cinnarizine prevails. The toxicity of a combination does not exceed toxicity of separate components. The therapeutic effect is shown in 1-6 hours.
– disturbances of cerebral circulation: in atherosclerosis of vessels of a brain,
the recovery period after ischemic and hemorrhagic strokes,
after craniocereberal injuries
– a psychoorganic syndrome with prevalence of disturbance of memory and other
cognitive functions or disturbances of the emotional and strong-willed sphere
– encephalopathies of various genesis
– a labyrinthopathy of various genesis (dizziness, sonitus, nausea,
vomiting, a nystagmus)
– Menyer’s syndrome
– prevention of kinetoz and migraine
– for improvement of training and memory of children with lag of intellectual
The route of administration and doses
the Adult appoint drug on 1-2 capsules three times a day within 1-3 months depending on disease severity.
To children from 6 years appoint 1-2 capsules 1-2 times a day.
It is impossible to take the drug more than 3 months!
It is desirable not to miss Fezam’s reception, especially, if it is appointed once. If it occurred, it is necessary to accept the capsule immediately, however if time of the following reception approached, the passed dose should not be accepted.
the General frequency of the undesirable phenomena is comparable to that for placebo.
Frequency of emergence of side reactions is estimated thus: very often – & gt, 1/10, is frequent from & gt, 1/100 to & lt, 1/10, sometimes from & gt, 1/1000 to & lt, 1/100, is rare from & gt, 1/10000 to & lt, 1/1000, is very rare – & lt, 1/10000.
rash, an itching, photosensitivity
pains in epigastriums, dyspepsia, nausea, vomiting
a headache, dryness in a mouth, irritability
a tremor of extremities, the raised muscle tone.
– hypersensitivity to drug components
– a heavy renal and/or liver failure
– the lactation period
– children up to 6 years
– a hemorrhagic stroke
At a concomitant use with Fezam strengthening of effect of somnolent and sedative drugs, tricyclic antidepressants, nootropic and antihypertensives and also ethanol is possible. Combined use with vasodilating drugs strengthens its action, and presence of cinnarizine leads to reduction of activity of hypertensive means.
Drug enhances activity of hormones of a thyroid gland and can cause a tremor and concern. Can strengthen effect of oral anticoagulants also.
With care should be applied at the states connected with increase in intraocular pressure or at patients with Parkinson’s disease. Persons should appoint drug with care with diseases of a liver and/or kidneys. In cases of a slight and moderate renal failure (especially if clearance of creatinine less than 60 ml/min.) it is necessary to lower a therapeutic dose or to increase intervals between receptions.
At persons with an abnormal liver function the control of content of liver enzymes is necessary.
It is necessary to avoid alcohol intake during treatment.
Drug can become the reason of false positive reaction at control of doping means at athletes.
There Is no feature of influence on ability to run the vehicle or potentially dangerous mechanisms data on influence of drug on ability to drive and work with the equipment.
Symptoms – an abdominal pain. At children excitement reactions prevail: insomnia, irritability, tremor, in rare instances, nightmares, hallucinations, spasms.
Treatment is symptomatic.
Fezam is very well had by patients, in case of overdose the serious side effects demanding drug withdrawal are not observed.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On the 2 or 6 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a cardboard box.
To Store storage conditions in the dry, protected from light place, at
a temperature not higher than 25 S. Hranit out of children’s reach!
A period of storage
it is impossible to use Drug after the expiration date specified on packing.
According to the prescription
the Producer Balkanpharma-Dupnitsa of the ABP
of 2600 Dupnits,
Bulgaria Samokovskoye St. шоссе№ 3
ph.: +359/701 58 196, fax: +359/701 58 555
The owner of the registration certificate
Balkanpharma-Dupnitsa AD, Bulgaria
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims on quality of products from consumers
of Predstavitelstvo Aktavis International Ltd. in
Almaty Republic of Kazakhstan, 050009, Almaty, Mukanov St., 241, office 1.
Ph./fax: 8 (727) 313 74 30, 313 74 31, 313 74 32,
E-mail address: email@example.com, website: www.actavis.com