Theraligen retard, 20 mg 30 pcs

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Indications

As a sedative (sedative), anxiolytic (anti-anxiety) agent and as a remedy to improve sleep:

– dementia (including dementia due to epilepsy) proceeding with manifestations of psychomotor agitation, anxiety affect (as part of combined therapy);

– organic anxiety disorder (as monotherapy or as part of combined therapy);

– mood disorders (affective disorders) – as part of combined therapy;

– generalized anxiety disorder (as part of combined therapy);

– obsessive-compulsive disorder (as part of combined therapy);

– severe stress reaction and adaptation disorders (acute stress reaction, post-traumatic stress disorder, unspecified severe stress reaction, other reactions to severe stress) – as part of combined therapy;

– dissociative (conversion) disorders (as part of combined therapy);

– somatoform disorders (somatization disorder, undifferentiated somatoform disorder, hypochondriacal disorder, somatoform autonomic nervous system dysfunction, persistent somatoform pain disorder, unspecified somatoform disorder, other somatoform disorders) – as part of combined therapy in case of severe anxiety or if standard therapy fails;

– Unspecified autonomic nervous system disorder, other autonomic nervous system disorders (in combination therapy);

– anorexia nervosa (in combination therapy);

– emotionally unstable personality disorder (impulsive and borderline types) – in combination therapy;

– hysterical personality disorder, anxious (avoidant, avoidant) personality disorder (as part of combination therapy);

– persistent personality change after experiencing a disaster (as part of combination therapy);

– hyperkinetic behavior disorder (as part of combination therapy);

– behavioral disorder restricted to the family (as part of combination therapy when standard therapy is ineffective);

– nonsocialized behavior disorder (as monotherapy or as part of combination therapy);

– anxiety, agitation and other symptoms and signs related to emotional state (as part of combined therapy);

– other neurotic disorders (neurasthenia, unspecified neurotic disorder) – as part of combined therapy;

– insomnia of inorganic etiology (as part of combined therapy when standard therapy is ineffective).

As an anti-allergic agent:

– Itching regardless of location and etiology (itching in photocontact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings by non-venomous insects or other non-venomous arthropods, varicella, measles, Hodgkin’s disease, diabetes, shingles, anal itching, vulvar itching, unspecified anogenital itching) as monotherapy or as part of combination therapy;

– Unspecified allergy (as monotherapy or in combination therapy).

Active ingredient

Composition

One tablet contains:

The active ingredient: alimazine (alimazine tartrate) – 20 mg or 40 mg or 60 mg;

Excipients: Microcrystalline cellulose (type 101), hypromellose, colloidal silicon dioxide, magnesium stearate;

Shell: Opadray II 85F230124 (for 20 mg dosage), Opadray II 85F230060 (for 40 mg dosage), Opadray II 85F265071 (for 60 mg dosage): partially hydrolyzed polyvinyl alcohol, titanium dioxide E 171, macrogol-3350, talc, iron oxide yellow E 172, iron oxide red E 172.

How to take, the dosage

Internal. Without chewing. The action of the drug is dose-dependent, the doses are selected depending on the therapy goals. The drug is prescribed in the required dose once a day or twice a day at 12-hour intervals at the same time.

In order to determine tolerability of alimazine, it is possible to use a prolonged form after taking Teralijen in its immediate-release dosage form (tablets, solution for intramuscular injection).

To achieve a vegetative stabilizing effect, 20-60 mg/day.

To achieve an anxiolytic effect 20-80 mg/day.

Sleeping and sedative effects can be achieved with a single administration of 20-60 mg.

For symptomatic treatment of allergic reactions, 20-40 mg/day.

The duration of course of treatment may be 2 to 6 months or more and is determined by the physician.

The highest dose for adults is 500 mg/day, and for elderly people (over 60 years of age) 200 mg/day.

Interaction

When alimemazine is coadministered with antiepileptic drugs and barbiturates the threshold of seizure activity is reduced (dose adjustment is required).

In co-administration of alimazine with beta-adrenoblockers a significant decrease in BP and arrhythmias are possible.

Alimemazine weakens the effect of bromocriptine. Simultaneous use in breastfeeding mothers may increase the concentration of prolactin in the blood serum.

The simultaneous use of alimumazine and MAO inhibitors (concomitant use is not recommended) and alimumazine and phenothiazine derivatives increases the risk of arterial hypotension and extrapyramidal disorders.

The risk of myelosuppression increases when alimumazine is used concomitantly with drugs that inhibit medullary hematopoiesis.

The co-administration of phenothiazine derivatives (which include alimemazine) with hepatotoxic drugs may increase the hepatotoxicity of the latter.

Special Instructions

Alimemazine may mask the ototoxic effects (tinnitus, dizziness) of co-administered drugs.

Alimemazine increases the body’s need for riboflavin.

The drug should be discontinued 72 hours before allergy testing to prevent distorted results of skin allergen scarification tests.

False positive results for pregnancy are possible during treatment. Alcohol should not be consumed during treatment.

When taking the drug, do not use the drug for activities requiring high concentration and quick psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, work of dispatcher and operator).

Synopsis

Contraindications

– Hypersensitivity to the components of the drug;

– Closed angle glaucoma;

– Prostate hyperplasia;

– Severe hepatic and/or renal insufficiency;

– Parkinsonism;

– myasthenia gravis;

– Reye’s syndrome;

– concomitant use of monoamine oxidase inhibitors (MAOIs);

– pregnancy;

– lactation period;

– childhood under 18 years of age (for this dosage form).

The drug should be used with caution if there is a history of complications with phenothiazine drugs; bladder neck obstruction; predisposition to urinary retention; epilepsy; open-angle glaucoma; jaundice; suppression of bone marrow function; arterial hypotension.

Side effects

Side effects are extremely rare and mild.

Nervous system disorders: drowsiness, lethargy, rapid fatigability (occurs mainly in the first days of use and rarely requires drug withdrawal), paradoxical reactions (anxiety, agitation, nightmares, irritability), confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor).

Sensory organs: blurred vision (paresis of accommodation), tinnitus or ringing in the ears.

Cardiovascular system: dizziness, decreased blood pressure (BP), tachycardia.

Digestive system disorders: dry mucous membrane of the mouth, gastrointestinal atony, constipation, decreased appetite.

Respiratory system: dryness in the nose, pharynx, increased viscosity of bronchial secretion.

Perior urinary system disorders: bladder atony, urinary retention.

Others: allergic reactions, inhibition of medullary hematopoiesis, increased sweating, muscle relaxation, photosensitization.

Overdose

Symptoms: aggravation of the described side effects, except for allergic reactions.

Treatment: drug withdrawal, symptomatic therapy.

Pregnancy use