Instruction for use: Rudotel

Dosage form: tablets

Active substance: Medazepam*

ATX

N05BA03 Medazepam

Pharmacological group:

Anxiolytics

The nosological classification (ICD-10)

F10.3 Abstinence: Alcohol withdrawal syndrome; Abstinence syndrome; Abstinence syndrome with alcoholism; Abstinence; Alcohol abstinence; Alcohol withdrawal status; Alcohol withdrawal syndrome; Postabstinctive disorder; Post-abstinence condition; Hangover syndrome; Abstinence syndrome; Alcohol abstinence syndrome; Alcohol withdrawal syndrome; Abstinence condition

F41 Other anxiety disorders: Anxiety status; Anxiety; Chronic alarm; Sense of anxiety; Anxious-hypothetical states; Stopping an alarm; Nonpsychotic anxiety disorders

F48 Other neurotic disorders: Neurosis; Neurological diseases; Neurotic disorders; Neurotic condition; Psychoneurosis; Anxious-Neurotic Conditions; Chronic neurotic disorders; Emotional reactive disorders

G43 Migraine: The pain of migraine; Migraine; hemiplegic migraine; Migraine headache; A migraine attack; Continuous headache; hemicranias

G47.0 Disorders of falling asleep and maintaining sleep [insomnia]: Insomnia; Insomnia, especially difficulty falling asleep; desynchronosis; Prolonged sleep disturbance; Difficulty falling asleep; Short-term and transient insomnia; Short-term and chronic sleep disorders; Short or shallow sleep; Violation of sleep; Disturbed sleep, especially in the phase of falling asleep; Infringements sleep; sleep disturbances; Neurotic sleep disturbance; Shallow superficial sleep; shallow sleep; Poor quality of sleep; Night awakening; sleep Pathology; Postsomnic violation; transient insomnia; Trouble falling asleep; Early awakening; Early morning awakening; Early awakening; sleep disorder; somnipathy; persistent insomnia; difficult to fall asleep; difficulty falling asleep; Difficulty falling asleep in children; persistent insomnia; Worsening sleep; Chronic insomnia; Frequent night and / or early morning awakening; Frequent nocturnal awakening and a sense of the depth of the non-sleep; Night waking

N95.1 menopausal and menopausal status of women: Atrophy of the mucosa of the lower genital tract, caused by estrogen deficiency; Vaginal dryness; Autonomic dysfunction in women; gipoestrogeniya state; Deficiency of estrogen in menopausal women; Degenerative changes of the mucous membrane in the menopause; Natural menopause; an intact uterus; climacteric; Menopause women; Menopause in women; menopausal depression; Climacteric ovarian dysfunction; Menopause; Climacteric neurosis; Menopause; Menopausal symptoms complicated psychovegetative; Climacteric syndrome; Climacteric vegetative disorders; Climacteric psychosomatic disorder; menopausal disorders; Menopausal disorders in women; menopausal condition; Climacteric vascular disorders; Menopause; Menopausal vasomotor symptoms; menopausal period; Lack of estrogen; Feeling the heat; Pathological menopause; perimenopause; menopause; postmenopausal; Premature menopause; premenopauznom period; tides; hot flashes; flushing in the Meno and postmenopausal; Hot flashes / hot flashes in menopause; Heart attack during menopause; Early menopause in women; Disorders of menopause; climacteric syndrome; Vascular complications of menopause; Physiological menopause; Estrogendefitsitnye state; premature Menopause

R45.1 Anxiety and agitation: Agitation; Anxiety; Explosive excitability; Internal stimulation; Excitability; Excitation; Excitation acute; Psychomotor agitation; Hyperexcitability; Motor excitement; Cessation of psychomotor agitation; Nervous excitement; Restlessness; Night trouble; Acute stage of schizophrenia with excitation; Acute mental agitation; Paroxysm of excitation; Overexcitation; Increased excitability; Increased nervous excitability; Increased emotional and cardiac excitability; Increased agitation; Mental arousal; Psychomotor agitation; Psychomotor agitation in psychoses; Psychomotor agitation of an epileptic nature; Psychomotor paroxysm; Psychomotor fit; Symptoms of Excitation; Symptoms of psychomotor agitation; The state of agitation; A state of anxiety; Excitation status; A state of heightened concern; The state of psychomotor agitation; Conditions of anxiety; Excitation conditions; The state of excitement in somatic diseases; Excitation level; Feelings of anxiety; Emotional arousal

R45.4 Irritability and anger: Neurosis with increased irritability; Outbursts of anger; Anger; Resentment; Increased irritability; Increased irritability of the nervous system; Irritability; Irritability in neuroses; Irritability in psychopathic disorders; Symptoms of irritability; Dysphoria

R45.7 Condition of emotional shock and stress, unspecified: Exposure to stress factors; Exposure to extreme situations; Neuropsychic stresses; Professional stress; Psychoemotional overload and stress; Psychoemotional stress; Stressful condition; Stress; Stress loading; Stressful condition; Stressful situations; Stress of everyday life; Chronic stress; Long-term emotional stress; Psychological stress in air flights; Psychoemotional stress in stressful situations

Composition and release form

Tablets - 1 table.

Medazepam 10 mg

auxiliary substances: lactose monohydrate; potato starch; gelatin; talc; magnesium stearate; Sikovit yellow-orange 85 (E110)

in bottles of dark glass for 50 pcs .; in a pack of cardboard 1 bottle.

Description of dosage form

Round flat tablets with smooth surfaces, light orange, with a risk on one side and with bevelled undamaged edges.

Characteristic

Daytime tranquilizer from the benzodiazepine group.

Pharmachologic effect

Mode of action - anxiolytic.

To a lesser extent, it has a hypnotic, anticonvulsant and muscle relaxant effect. Competitively stimulates GABA receptors.

Indications for the Rudotel

Neurotic disorders accompanied by fear, anxiety, anxiety, psychosomatic and psycho-vegetative disorders (including sleep disorders, migraine, functional cardiovascular and gastrointestinal disorders), climacteric syndrome.

Contraindications

Hypersensitivity, alcohol and drug dependence, severe myasthenia gravis, impaired breathing during sleep, severe liver and kidney dysfunction, pregnancy (I trimester), children's age (up to 10 years).

Application in pregnancy and breastfeeding

Contraindicated in pregnancy (I trimester). Long-term use of the Rudothel during pregnancy can lead to the development of abstinence in the newborn. For the duration of treatment, breastfeeding should be stopped.

Side effects

From the nervous system and sense organs: inhibition, drowsiness, fatigue, slowing down of reactivity, dizziness, headache, confusion, ataxia, anterograde amnesia, rarely depression, respiratory depression, articulation disorders, gait and movement uncertainty, visual disturbances, hallucinations , Paradoxical reactions (excitement, fear, suicidal thoughts, sleep disturbances, attacks of increased aggression, seizures of various muscle groups).

On the part of the intestine: rarely - dry mouth, nausea, vomiting, pain in the epigastric region, diarrhea, constipation, jaundice.

On the part of the respiratory system: rarely - laryngospasm, chest pain.

From the cardiovascular system and blood (hematopoiesis, hemostasis): a sharp drop in blood pressure, bradycardia.

From the genitourinary system: rarely - urine retention, decreased sexual desire, violation of the menstrual cycle.

Allergic reactions: rarely - redness, exanthema, itching.

Interaction

Strengthens (mutually) the effect of antidepressants, hypnotics, neuroleptics, antihistamines, alcohol, anesthetics, analgesics. Oppressing the action of levodopa and biotransformation of phenytoin. Cimetidine, omeprazole, disulfiram intensify or lengthen the action. Theophylline eliminates the soothing effect of the Rudotel.

Phenobarbital and phenytoin stimulate metabolism.

Dosing and Administration

Inside, on an empty stomach, with plenty of fluids. Adults: daily dose - 1-3 tablets. (10-30 mg), divided into 2-3 doses per day or once in the evening (on an empty stomach 0.5 h before going to bed). The maximum daily dose, if necessary, can be increased to 40 mg on an outpatient basis and to 60 mg in a hospital setting.

In acute conditions of emotional stress, agitation or fear, the use of the Rudotel is limited to single doses or several days.

In chronic conditions of emotional stress, agitation or fear, the duration of use should not exceed 4 weeks.

Cancellation of the drug after prolonged use (more than 1 week) should be carried out gradually reducing the dose.

Children over 10 years of age: the daily dose is 0.5-1.0 mg / kg, the maximum daily dose is 1.0 mg / kg.

Elderly patients: a daily dose of 10-20 mg.

Overdose

Symptoms: confusion, drowsiness, ataxia, dysarthria, a sharp decrease in blood pressure, muscle weakness, in severe cases - cyanosis, loss of consciousness, stopping breathing and heart.

Treatment: gastric lavage, application of flumazenil.

Precautionary measures

Caution should be exercised in appointing elderly and debilitated patients, patients with spinal and cerebellar ataxia, organic brain lesions, chronic obstructive respiratory failure, impaired liver and kidney function, and glaucoma. It is necessary to avoid long uncontrolled reception (more than 4 weeks), because It is possible to develop addiction and drug dependence. During treatment should refrain from drinking alcohol. Do not use during work drivers of vehicles and people whose profession is associated with increased concentration of attention. To prevent the development of the "withdrawal" syndrome, a gradual discontinuation of treatment is necessary.

Storage conditions of the drug Rudotel

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life of the drug Rudotel

5 years.

Do not use after the expiry date printed on the package.