Relakson

Relakson – a hypnagogue.

Form of release and structure

Dosage form – tablets, film coated: a round form, from two parties convex, white color (in blister strip packagings on 5 or 10 tablets, in a pack cardboard 1, 2, 3 or 4 packagings; on 5 or 20 tablets in dark glass jars, in a pack of cardboard 1 bank).

Active agent: зопиклон – 7,5 mg in 1 tablet.

Additional components: sodium carboxymethylstarch (примогель), macrogoal 4000 (polyethyleneglycol 4000), magnesium stearate, lactose (sugar milk), talc, metiloksipropiltsellyuloz, titanium dioxide, silicon dioxide colloid (aerosil), cellulose microcrystallic, povidone (polyvinylpirrolidone), potato starch.

Indications to use

Relakson – the drug used at situational, passing and chronic sleeplessness of various etiology (including at difficulties with backfillings, night and early awakenings).

Contraindications

• Syndrome of a "night" apnoea;
• The expressed respiratory insufficiency;
• Heavy myasthenia;
• Heavy liver failure;
• Age up to 18 years;
• Period of pregnancy and lactation;
• Hypersensitivity to drug components.

Route of administration and dosage

Relakson it is necessary to accept before going to bed on 1 tablet. Increase in a dose up to 2 tablets is in some cases allowed.

Duration of treatment of passing sleeplessness makes 2-5 days, situational – 2-3 weeks.

Duration of therapy of chronic sleeplessness is defined individually.

It is not necessary to accept drug more than 4 weeks in a row. Lengthening of terms of treatment is possible only after repeated assessment of a condition of the patient.

Elderly people, patients with abnormal liver functions and chronic pulmonary insufficiency are recommended to begin therapy about ½ tablets. In some cases the doctor can increase a dose to 1 tablet.

The patient with a renal failure appoint ½ tablets.

Side effects

The most frequent side effect of Relakson is bitter smack in a mouth.

Other possible undesirable reactions:

• From the central nervous system: residual drowsiness after awakening, a headache, dizziness;
• From the alimentary system: dyspepsia, dryness in a mouth, nausea;
• Allergic skin reactions: itch, enanthesis; extremely seldom – anaphylactic and angioneurotic reactions;
• Mental and paradoxical reactions: seldom – the suppressed mood, confusion, irritability, a lack of coordination of movements, hallucinations, confusion of consciousness, aggression, nightmares, inadequate behavior with possible development of amnesia, a depression;
• Others: seldom – a withdrawal, ricochet sleeplessness; separate cases – slight increase of transaminases and/or an alkaline phosphatase in blood serum.

Special instructions

At night attacks of bronchial asthma at patients who receive drugs of a metilksantinovy row (for example, theophylline) Relakson urezhat asthma attacks in early hours at dawn, reduces their duration and intensity.

Despite the minimum risk, at purpose of drug it is necessary to consider probability of development of accustoming and abuse of drug. The risk arises in the following cases:

• Disturbance of a dose and/or duration of therapy;
• Abuse of other medicines and/or alcohol;
• Concomitant use of other psychotropic drugs and/or alcohol.

Relakson can exert a negative impact on the speed of reactions and ability to concentration of attention therefore during therapy it is recommended to refuse whenever possible driving of the car and performance of potentially dangerous types of works or to observe extra care.

In rare instances there is an ecmnesia, especially at interruption of a night dream and after a wide interval of time between Relakson's reception and withdrawal to a dream. To reduce risk of emergence of amnesia, it is recommended to take a pill directly before going to bed and to provide the minimum 6-hour duration of a dream.

Zopiklon can mask depression symptoms.

After the end of treatment, especially long, there is a probability of development of ricochet sleeplessness and a withdrawal therefore drug should not be cancelled sharply, it is necessary to reduce a dose gradually.

Medicinal interaction

During treatment it is necessary to refuse alcohol intake as it strengthens sedation.

Zopiklon reduces concentration of a trimipramin in a blood plasma.

Strengthening of the oppressing influence on the central nervous system is noted in case of simultaneous use of the following medicines: other somnolent drugs, neuroleptics, tranquilizers, sedatives, antidepressants, antiepileptic means, narcotic analgetics, anesthetics, antihistamines with sedation, erythromycin.

Terms and storage conditions

To store in protected from light and moisture, the place, unavailable to children.

Period of validity – 3 years.