Instruction for use: Helex

Trade name of the drug – Helex

Active substance: Alprazolam (Alprazolamum)

Dosage Form: Tablets
Composition:

Pills. 1 tablet contains 250 mg of alprazolam. Excipients: lactose, povidone, corn starch, magnesium stearate, colorant (E131), coloring agents (E151 and E104), crospovidone, polysorbate 80. in blisters of 30 tablets. Packaged in a cardboard box. Tablets, 500 mg. The pack of 30 tablets. Tablets, 1 mg. The pack of 30 tablets.
Pharmacotherapeutic group:

Anxiolytic (tranquilizer)

ATX Code

N05BA12 Alprazolam

Pharmacological PropertiesPharmachologic effect
Tranquilizer, a benzodiazepine derivative. Helex has anxiolytic (eliminates anxiety and fear), sedative, hypnotic, anticonvulsant, central muscle relaxant and some antidepressant effect. Anxiolytic effect of the drug due to its binding to benzodiazepine receptors in the CNS. Antidepressant effects associated with exposure to adrenergic structures of the brain.

Pharmacokinetics
The data on the pharmacokinetics of the drug is not provided by Helix.

Indications for Helex

Anxiety neurosis and anxiety, stress, anxiety, irritability, sleep disturbance, somatic disorders. Anxiety associated with depression (in the complex therapy). Panic disorder (treatment). Tremor (senile, essential). Insomnia.

Contraindications for Helex

Hypersensitivity, coma, shock, myasthenia gravis, angle-closure glaucoma (acute onset or predisposition), acute alcohol poisoning (with the weakening of vital functions), narcotic analgesics, drugs and psychoactive drugs; Severe COPD (degree of progression of respiratory failure), acute respiratory failure; severe depression (suicidal tendencies may emerge); pregnancy (especially the I trimester), lactation, age 18 years (safety and effectiveness are not determined). C care. Liver failure, chronic renal failure, cerebral and spinal ataxia, drug dependency history, the propensity to abuse drugs, hyperkinesis, organic brain disease, psychosis (possible paradoxical reactions), hypoproteinemia, sleep apnea (or suspected), advanced age.

Helex Dosage and Administration

The optimal dose is determined individually depending on the clinical situation and the effectiveness of therapy. If anxiety or anxiety-depressive disorders adult drug prescribed in the initial dose of 0.25-0.5 mg 3 times / day; elderly - 0.25 mg 2-3 times / day. The maintenance dose is for adults - 0.5-4 mg / day; elderly - 0.5-0.75 mg / day. Multiplicity of reception - 2-3 times / day. When panic disorder drug administered in an initial dose of 0.5-2 mg 3 times / day, and the dose can not be increased by more than 1 mg over 3-4 days. The maintenance dose is 4-10 mg / day, divided into several times. If you need higher doses, they should be increased cautiously to avoid side effects. First, increase the dose to the evening reception, then - for a day. If at the beginning of therapy marked adverse effects, the initial dose should be reduced. Abrupt discontinuation of the drug can cause withdrawal symptoms, Helex must be lifted gradually and over a long period of time, t. / F. if a patient takes a drug at 0.5 mg in the morning, afternoon 0.5 mg and 1 mg in the evening, the daily dose should be reduced by no more than 0.25 mg every 3 days.

Side effect of Helex

From the central and peripheral nervous system: often - dizziness, drowsiness; rarely (less than 1% Propafenone) - dystonia, impaired ability to concentrate, anorexia, memory impairment, loss of coordination, convulsions, sedation, fatigue, speech disorders; in exceptional cases - paradoxical reactions (increased nervous excitability, irritability, insomnia, nightmares, hallucinations).

Chronic administration may develop drug dependence.

From the urogenital system: rarely (less than 1% Propafenone) - incontinence or urinary retention, sexual dysfunction, decreased libido.

Other: rarely (less than 1% Propafenone) - jaundice, muscle weakness, skin itching, change in body weight, hyperprolactinemia. Side effects are more frequent at the beginning of treatment and disappear with continued therapy.

Helex at Pregnancy and breast-feeding
The drug is contraindicated during pregnancy. If necessary, the appointment during lactation should abandon breastfeeding.

Cautions when taking the drug Helex
Contraindicated in severe hepatic dysfunction. With great care the drug is prescribed to patients with mild to moderate hepatic impairment.

Overdose of Helex

Symptoms: incoordination, depression of consciousness of varying severity, hypotension, respiratory depression; in more severe cases - coma, respiratory arrest and cardiac arrest.

Treatment: If the patient is conscious, induce vomiting is necessary, otherwise the show intubation and gastric lavage. Helexabsorption from the gastrointestinal tract decreases the appointment of activated carbon and mineral laxatives. The patient should be kept under observation in the intensive care unit. In severe cases, especially with respiratory failure shows the use of a specific benzodiazepine antagonist flumazenil receptors.

Interaction
With simultaneous use of Helex(like all benzodiazepines) with other psychotropic drugs (barbiturates, opioids, neuroleptics, antidepressants, agents for general anesthesia, anticonvulsants, and antihistamines, ethanol) may increase the inhibitory effect of drugs on the central nervous system. Pharmacokinetic interactions With simultaneous use of Helexat doses up to 4 mg of imipramine and clomipramine steady concentration of the latter in the blood plasma can be increased by 30% and 20%, respectively. Concomitant use of Helexand fluvoxamine causes an increase in the level of concentration of Helexin plasma by approximately 30%. Concomitant use of Helexwith ketoconazole, itraconazole and other antifungals azole group, macrolide antibiotics (erythromycin, oleandomycin), cimetidine, oral hormonal contraceptives, fluoxetine, sertraline, diltiazem, nefazodone may reduce the biotransformation of Helexin the liver and to enhance its effects

SPECIAL INSTRUCTIONS

During treatment Helex patients strictly prohibited the use of ethanol. The efficacy and safety of the drug in patients younger than 18 years have not been established. In renal / hepatic failure and prolonged treatment is necessary to monitor the pattern of peripheral blood and "liver" enzymes. Patients not taking psychoactive drugs earlier, "responsible" for the drug at lower doses compared to patients taking antidepressants, anxiolytics or suffering from alcoholism. When endogenous depression Helexcan be used in combination with antidepressants. In the application of Helexpatients with depression were cases of hypomania and mania. Like the others. Benzodiazepines, Helexhas the ability to cause drug dependence during chronic administration in high doses (more than 4 mg / day). With the sudden discontinuation of Helexmay experience a syndrome of "lifting" (depression, irritability, insomnia, sweating, etc.), Particularly during chronic administration (more than 8-12 weeks). If you have patients with such unusual reactions, as increased aggressiveness, acute state of excitement, anxiety, suicidal thoughts, hallucinations, increased muscle cramps, difficult to fall asleep, shallow sleep, treatment should be discontinued. The gestation period is used only in exceptional cases and only for the "life" testimony. It has a toxic effect on the fetus and increase the risk of birth defects when used in the I trimester of pregnancy. Therapeutic dose in the later stages of pregnancy can cause depression of the central nervous system of the newborn. The constant use during pregnancy may lead to physical dependence with the development of the syndrome of "cancellation" of the newborn. Children, especially at a younger age, are very sensitive to the CNS depressant effects of benzodiazepines. Using just before birth or during labor may cause neonatal respiratory depression, decreased muscle tone, hypotension, hypothermia and a weak act of sucking (syndrome "flaccid child"). During the period of treatment must be careful when driving and other lesson. Potentially hazardous activities that require high concentration and psychomotor speed reactions.

Storage conditions

In a dry, dark place at a temperature of 10-30 ° C.
Keep out of the reach of children.
Shelf life

3 years.
Do not use beyond the expiration date printed on the package.
Conditions of supply of pharmacies
On prescription.