Reladormum

Reladormum – the combined drug with sedative, somnolent and anxiolytic action.

Form of release and structure

Dosage form of release of Reladormum – a tablet: ploskotsilindrichesky, round, white or grayish-white, with a facet from two parties, on one party – risk (on 10 pieces in planimetric strip and bezjyacheykovy packagings, on 1 packaging in a cardboard pack).

Active agents as a part of 1 tablet:

• Diazepam – 10 mg;
• Calcium cyclobarbital – 100 mg.

Additional components: sodium carboxymethylstarch, potato starch, gelatin, talc, monohydrate of lactose.

Indications to use

Reladormum is appointed for a symptomatic treatment of sleep disorders of various genesis.

Contraindications

Absolute:

• Respiratory insufficiency in a heavy current (irrespective of the reason);
• Syndrome of a night apnoea;
• Hereditary lactose intolerance, deficit of lactase of Lapp or glyukozo-galaktozny malabsorption;
• Renal/liver failure in a heavy current;
• Glaucoma;
• Myasthenia gravis (myasthenia);
• Acute porphyria;
• Alcoholic poisonings or medicines with the oppressing action on the central nervous system;
• Children's and elderly (of 65 years) age;
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components, and also to derivatives 1,4 benzodiazepines and barbituric acid.

Relative (Reladormum should be taken with caution in the presence of the following diseases / states):

• Renal/liver failure of average or easy severity;
• Chronic respiratory insufficiency;
• Not acute forms of a porphyria;
• Depression;
• Suicide thoughts and attempts in the anamnesis;
• Medicinal, alcohol or drug addiction in the anamnesis.

It is not recommended to apply Reladormum to patients with psychoses.

During therapy, and also for 3 days after the termination of a course it is not necessary to take alcoholic drinks.

Route of administration and dosage

Reladormum is accepted inside, washing down with water in a small amount. It is not recommended to accept drug longer than 7 days.

It is necessary to adhere to the dosing mode appointed by the doctor strictly.

As a rule, the adult Reladorm appoint for an hour to a dream on ½ or 1 tablet.

At a renal/liver failure easy or moderate severity it is necessary to accept the smallest recommended dose (½ tablets).

Reception of Reladormum longer than the appointed term (for example, for several weeks) can cause medicinal dependence. In this case sharply it is impossible to interrupt therapy because of probability of development of an abstinence syndrome in the form of frustration of a dream and mood, disturbances of attention and concentration, an acrimony (the gradual, controlled by the doctor dose decline is required).

At the admission of reception of a single dose it needs to be accepted as soon as possible or to pass. It is impossible to double a dose.

Side effects

Expressiveness and frequency of side reactions depend on individual sensitivity of the patient and a dose of Reladormum.

Treat the most frequent side effects: ataxy, dizziness, headache, drowsiness, delay of psychomotor functions, disorientation, confusion of consciousness.

In more exceptional cases development of such disturbances as the general weakness, feeling of dryness in a mouth, a syncope, visual disturbances (in the form of indistinct sight, a diplopia), a dysarthtia (in the form of the muffled speech and the wrong pronunciation), abnormal liver functions, memory disturbance, gastrointestinal frustration, a muscular tremor, disturbances of a libido, disturbance of a menstrual cycle, change of morphological composition of blood (an agranulocytosis, a leukopenia), insignificant lowering of arterial pressure, an urine incontience, skin allergic reactions, paradoxical reactions is observed (in the form of psychomotor excitement, an insomniya, a hyperexcitability and aggression, a muscular tremor, spasms; most often develop at alcohol intake, at elderly patients and at patients with mental diseases).

Are the reason of cancellation of therapy: increase in activity of liver enzymes, anury, vision disorders, dysfunction of the hemopoietic system, jaundice.

Systematic use of Reladormum longer than the term recommended in the instruction can lead to development of medicinal dependence, sharp cancellation of therapy – to developing of an abstinence syndrome.

Special instructions

Before purpose of Reladormum it is necessary to analyze carefully available frustration, having excluded other possible reasons of sleeplessness (psychogenic, somatogenic, addictions).

During therapy for patients it is necessary to establish careful observation.

The risk of development of medicinal dependence has dozozavisimy character. The probability of emergence of this disturbance increases at patients with anamnestic data on existence of dependence to other medicines, at patients with alcohol addiction, and also at long administration of drug. Potentiality of development of medicinal dependence increases at the combined use with cyclobarbital.

The sharp termination of therapy against the background of medicinal dependence can lead to development of an abstinence syndrome (characteristic symptoms: head and muscular pain, emotional pressure, psychomotor excitement, disorientation, sleeplessness, motive concern, confusion of consciousness, acrimony). In hard cases can arise: loss of sense of reality surrounding, frustration of the personality, hypersensitivity to a touch, visual and acoustical irritants, numbness of extremities, feeling of "crawling of goosebumps", attacks of spasms, hallucinations.

Reladormum can lead to development of antegrade amnesia (in most cases in several hours after reception, in particular after reception of a high dose of drug). It is recommended to provide conditions for continuous 7-8 hour dreams, and also to accept Reladormum in 60 minutes prior to a dream.

At emergence of symptoms of paradoxical reactions therapy is cancelled.

Because of probability of development of suicide thoughts, it is necessary to appoint drug with care the patient with symptoms of an endogenous depression (the recommended daily dose – ½ tablets). Also care is demanded by use of Reladormum for the patients inclined to suicide actions (the aggravation of symptoms is possible), at a neosystem to a porphyria form (strengthening of symptoms is possible).

Periodically during therapy it is necessary to conduct researches of morphological composition of peripheral blood, and also functional trials of a liver.

To manage motor transport and to perform other potentially dangerous works during which the increased concentration of attention and bystry psychomotor reactions is necessary during reception of Reladormum, and also for 3 days after its cancellation it is impossible.

Medicinal interaction

At the combined use of Reladormum with some medicinal means / substances the following effects can be observed:

• Sedative, somnolent, antihistaminic drugs, antidepressants, narcotic analgetics, monoamine oxidase inhibitors, drugs for the general anesthesia (anesthetics), hypotensive drugs of the central action: strengthening of the oppressing influence of Reladormum on the central nervous system;
• Narcotic analgetics: development of the expressed euphoria (can lead to more bystry development of medicinal dependence);
• Alcohol: strengthening of its oppressing action on the central nervous system, development of paradoxical reactions (in the form of psychomotor excitement, an agressive behavior, pathological intoxication or emergence of symptoms of deep oppression of function of a brain);
• Indirect anticoagulants – derivatives of coumarin, doxycycline, hypoglycemic drugs, griseofulvin: decrease in their efficiency;
• Levodopa: weakening of its action;
• Phenytoinum, drugs reducing a tone of skeletal muscles: strengthening of their action;
• Cimetidinum, Disulfiramum, antifungal means (for example, кетоконазол), some antibacterial drugs (for example, erythromycin), antiviral drugs (for example, ритонавир): strengthening of pharmacological action of Reladormum;
• Peroral contraceptive means: decrease in their efficiency;
• Rifampicin, theophylline and smoking of tobacco: acceleration of metabolism of diazepam and weakening of its pharmacological action;
• Digoxin, glucocorticosteroids, cyclosporine, theophylline: strengthening of their metabolism;
• Blockers of "slow" calcium channels, alpha adrenoblockers, inhibitors of an angiotensin-converting enzyme, antagonists of receptors of angiotensin II: strengthening of a lowering of arterial pressure.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.