Universal reference book for medicines
Product name: PHEZAM ® (PHEZAM ® )

Active substance: cinnarizine, piracetam

Type: A drug that improves blood circulation and brain metabolism

Manufacturer: BALKANPHARMA-DUPNITSA (Bulgaria) manufactured by FHI ZDRAVLJE (Serbia)
Composition, form of production and packaging
Capsules
hard gelatinous, size №0, cylindrical, white;
the content of the capsules is a powder mixture from white to almost white, conglomerates are allowed, which, when pressed with a glass rod, are easily converted into a powder.
1 caps.

piracetam 400 mg

cinnarizine 25 mg

Excipients: lactose monohydrate - 55 mg, silicon colloidal dioxide - 15 mg, magnesium stearate - 5 mg.

The composition of the capsule shell: titanium dioxide - 2%, gelatin - 98%.

10 pieces.
- blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Combined drug with pronounced antihypoxic, nootropic and vasodilating action.
The components mutually potentiate the decrease in the resistance of the blood vessels of the brain and contribute to the increase in blood flow in them.
Pyracetam is a nootropic agent.
Activates metabolic processes in the brain by enhancing energy and protein metabolism, accelerating the utilization of glucose by cells and increasing their resistance to hypoxia. Improves interneuronal transmission in the central nervous system and regional blood flow in the ischemic zone.
Cinnarizine is a selective blocker of slow calcium channels and an antagonist of histamine H 1 receptors.
It was found that it inhibits the entry of calcium ions into cells and reduces their content in the plasmolemma depot. Reduces the tone of the smooth muscle arterioles, reduces their response to biogenic vasoconstrictors (catecholamines, angiotensin and vasopressin). Has a vasodilating effect (especially with respect to cerebral vessels, enhancing the antihypoxic effect of piracetam), without having a significant effect on blood pressure. It shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, increases the tone of the sympathetic nervous system. Increases the elasticity of erythrocyte membranes, their ability to deform, reduces the viscosity of the blood.
PHARMACOKINETICS

Suction

After ingestion, the drug is completely absorbed from the digestive tract.

With max piracetam in plasma is created in 2-6 hours. The bioavailability of pyracetam is 100%.

Absorption of cinnarizine is slow.
With max cinnarizine in plasma is achieved in 1-4 hours.
Distribution

Pyracetam does not bind to plasma proteins.
The apparent V d is about 0.6 l / kg. Pyracetam freely penetrates through the BBB. With max pyracetam in cerebrospinal fluid is reached in 2-8 hours. It penetrates into all organs and tissues, penetrates through the placental barrier. Selectively accumulates in the cerebral cortex, mainly in the frontal, parietal and occipital lobes, the cerebellum and basal ganglia.
The binding of cinnarizine to plasma proteins is 91%.

Metabolism

Pyracetam is not metabolized.

Cinnarizine is actively and completely metabolized in the liver by dealkylation with the participation of the CYP2D6 isoenzyme.

Excretion

T 1/2 pyracetam from the blood plasma is 4-5 hours, from the cerebrospinal fluid is 8.5 parts. 80-100% of piracetam is excreted by the kidneys unchanged by renal filtration.
The renal clearance of piracetam in healthy volunteers is 86 ml / min.
T 1/2 cinnarizine - 4 h. 1/3 metabolites are excreted in the urine, 2/3 - with feces.

Pharmacokinetics in special clinical cases

T 1/2 pyracetam is elongated with renal failure.
The pharmacokinetics of pyracetam do not change in patients with hepatic insufficiency. It penetrates the hemodialysis apparatus through the filter membranes.
INDICATIONS

- Insufficiency of cerebral circulation (atherosclerosis of cerebral vessels, recovery period of ischemic and hemorrhagic strokes, after craniocerebral trauma, encephalopathy of various origins);

- intoxication;

- diseases of the central nervous system, accompanied by a decrease in intellectual-mnestic functions (memory, attention, mood);

- conditions after a craniocerebral injury;

- psychoorganic syndrome with symptoms of asthenia and adynamia predominating;

- asthenic syndrome of psychogenic genesis;

- Labyrinthopathy (dizziness, noise in the ears, nausea, vomiting, nystagmus);

- Meniere's syndrome;

- prevention of kinetosis;

- prevention of migraine;

- as part of complex therapy with low learning ability in children with psycho-organic syndrome.

DOSING MODE

Adults prescribe 1-2 capsules.
3 times / day for 1-3 months depending on the severity of the disease. The course of treatment - 2-3 times a year.
Children over 5 years of age are prescribed 1-2 caps.
1-2 times / day. The course of treatment is 1.5-3 months.
SIDE EFFECT

From the nervous system: hyperkinesia, nervousness, drowsiness, depression;
in isolated cases - dizziness, headaches, ataxia, imbalance, insomnia, confusion, agitation, anxiety, hallucinations.
Allergic reactions: very rarely - skin rash, dermatitis, itching, swelling, photosensitivity.

On the part of the digestive system: in some cases - increased salivation, nausea, vomiting, diarrhea, abdominal pain.

Other: increased sexual activity.

CONTRAINDICATIONS

- renal failure of severe degree (CC <20 ml / min);

severe hepatic impairment;

- psychomotor agitation at the time of prescribing;

- Huntington's chorea;

- Pregnancy;

- the period of lactation (breastfeeding);

- Children's age till 5 years;

- Hypersensitivity to the components of the drug.

With caution should prescribe the drug for Parkinson's disease, violations of the liver and / or kidney, violation of hemostasis, severe bleeding.

PREGNANCY AND LACTATION

Despite the lack of data on teratogenic effects of piracetam and cinnarizine, Fezam ® is contraindicated in pregnancy.

Piracetam is excreted in breast milk, so if you need to use the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe renal dysfunction.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe violations of liver function.

APPLICATION FOR CHILDREN

Contraindication: children under 5 years.

SPECIAL INSTRUCTIONS

With caution, appoint patients with liver and / or kidney disease.

For renal insufficiency of mild and moderate severity (CC less than 60 ml / min), the therapeutic dose should be reduced or the interval between doses should be increased.

In patients with impaired liver function, it is necessary to monitor the content of liver enzymes.

Patients should avoid drinking alcohol while taking Fezam.

The drug strengthens the activity of thyroid hormones and can cause tremors and anxiety.

Impact on the ability to drive vehicles and manage mechanisms

When taking Fezam ®, patients should be careful when driving vehicles and working with machines and equipment, because at the beginning of treatment, cinnarizine can cause drowsiness.

OVERDOSE

Fezam ® is well tolerated by patients, in case of an overdose there are no serious side effects that require drug discontinuation.

Symptoms: pain in the abdomen is possible.

Treatment: should wash the stomach, induce vomiting;
symptomatic therapy; if necessary, hemodialysis. There is no specific antidote.
DRUG INTERACTION

When used simultaneously with the preparation of Fezam ®, it is possible to increase the sedative effect of agents that depress the activity of the central nervous system, tricyclic antidepressants, and also ethanol.

Fezam ® potentiates the action of nootropic and antihypertensive agents.

With the simultaneous use of vasodilators enhance the effect of the drug.

Fezam ® improves the tolerability of antipsychotic drugs and tricyclic antidepressants.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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