Instruction for use: Phenzitat

Trade name of the drug – Phenzitat

Active substance: Bromdihydro-chlorphenyl-benzodiazepine (Bromdihydro-chlorphenyl-benzodiazepinum)

Chemical rational name: 7-Bromo-5- (2-chlorophenyl) -1,3-dihydro-2H-1,4-benzodiazepin-2-one

Dosage Form: tablets

Compositionactive substance:
Bromdihydro-chlorphenyl-benzodiazepine - P(based on 100% basis) 0.5 mg/ 1 mg/ 2.5 mg
Excipients: lactose (milk sugar); potato starch; Povidone (Kollidon 25); calcium stearate; talc

Description of Phenzitat

Tablets are white, flat-cylindrical, with a facet. Anxiolytic of Group Benzodiazepines.
Pharmacotherapeutic group: Anxiolytic (tranquilizer)

ATX Code

N05BX Anxiolytics other

Pharmacological Properties of PhenzitatPharmachologic effect

Mode of action - an anticonvulsant, anxiolytic, muscle relaxant, hypnotic, sedative.

Indications for Phenzitat

neurotic, neurosis, psychotic, psychopathic and other conditions accompanied by anxiety, fear, increased irritability, tension, and emotional lability; reactive psychosis and hypochondriacal syndrome (including resistant to the action of other tranquilizers); autonomic dysfunction and sleep disorders; prophylaxis of conditions of fear and emotional stress; temporal and myoclonic epilepsy (as an anticonvulsant); treatment of hyperkinesis and tics, muscle rigidity, autonomic lability.

Contraindications for Phenzitat

hypersensitivity (including other benzodiazepines); coma; shock; myasthenia gravis; angle-closure glaucoma (acute onset or predisposition); acute alcohol poisoning (with the weakening of vital functions), narcotic analgesics and hypnotics; Severe COPD (possibly increasing respiratory failure); acute respiratory failure; severe depression (suicidal tendencies may emerge); pregnancy (I term); lactation; childhood and adolescence to 18 years (the safety and effectiveness are not determined).
Precautions: hepatic and / or renal failure, cerebral and spinal ataxia, drug dependency history; the propensity to abuse drugs; organic brain disease, psychosis (possible paradoxical reactions), hypoproteinemia, sleep apnea (or suspected) patients of advanced age.

Phenzitat Dosage and Administration

Inside.

When sleep disorders - 0.5 mg for 20-30 minutes before bedtime.

For the treatment of neurotic, psychopathic, neurosis and psychopathy-like states initial dose - 0.5-1 mg 2-3 times a day. After 2-4 days in view of efficacy and tolerability, the dose can be increased to 6.4 mg / day.

In severe agitation, fear, anxiety, treatment is initiated with a dose of 3 mg / day, quickly increasing the dose to produce a therapeutic effect.

In the treatment of epilepsy - 2.10 mg / day.

For the treatment of alcohol withdrawal - 2-5 mg / day.

The average daily dose - 1.5-5 mg, it is separated into 2-3 doses, usually 0.5-1 mg in the morning and afternoon, and 2.5 mg at night. In neurological practice for diseases with muscle hypertonicity appoint 2-3 mg 1-2 times a day.

The maximum daily dose - 10 mg.
In order to avoid the development of drug dependence at course treatment duration fenazepama application is 2 weeks (in some cases the duration of treatment can be increased up to 2 months). If you cancel Phenazepam reduce the dose gradually.

Side effect of Phenzitat

From the central and peripheral nervous system: at the beginning of treatment (particularly in elderly patients) - drowsiness, fatigue, dizziness, decreased ability to concentrate, ataxia, disorientation, unsteady gait, slowing of mental and motor reactions, confusion; rarely - headache, euphoria, depression, tremors, loss of memory, impaired motor coordination (particularly at high doses), depressed mood, dystonic extrapyramidal reactions (uncontrolled movements, including the eyes), fatigue, muscle weakness, dysarthria, epileptic seizures (epilepsy patients); very rarely - paradoxical reaction (aggressive outbursts, agitation, anxiety, suicidal tendencies, muscle spasms, hallucinations, agitation, irritability, anxiety, insomnia).

From the side of hematopoiesis: leukopenia, neutropenia, agranulocytosis (chills, pyrexia, sore throat, extreme tiredness or weakness), anemia, thrombocytopenia.

From the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, loss of appetite, constipation or diarrhea; abnormal liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice.

From the urogenital system: urinary incontinence, urinary retention, renal dysfunction, decreased or increased libido, dysmenorrhea.

Allergic reactions: skin rash, pruritus.

Other: addiction, drug dependency, lowering blood pressure; rarely - blurred vision (diplopia), weight loss, tachycardia.

With a sharp decrease in dose or discontinuation - withdrawal symptoms (irritability, nervousness, sleep disturbances, dysphoria, a spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, including hyperacusis, paresthesia, photophobia, tachycardia, seizures, rare - acute psychosis).

Release form of Phenzitat

Tablets, 0.5 mg, 1 mg and 2.5 mg. At 10 or 25 pieces. in contour cell packages from PVC film and aluminum foil printed patent. 50 pcs. banks with plastic covers the first opening control. 5 packs of 10 pieces. or 2 packs of 25 pcs., or 1 jar placed in a stack of cardboard.

Storage conditions of Phenzitat
In a dry, dark place at a temperature no higher than 25 ° C.
Keep out of the reach of children.

Shelf life of Phenzitat
3 years.
Do not use beyond the expiration date printed on the package.

Conditions of supply of Phenzitat from pharmacies
On prescription.