Vit melatonin

Vit melatonin – medicine with somnolent and sedative action.

Form of release and structure

Vit melatonin release in the form of tablets: ploskotsilindrichesky, white color, with risky and a facet (on 10 pieces in blisters, on 3 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active agent: melatonin – 3 mg;
• Auxiliary components: potato starch, microcrystallic cellulose, monohydrate of lactose, calcium stearate.

Indications to use

• The frustration of a circadian rhythm "dream wakefulness" connected with change of time zones and which are shown in the form of increased fatigue (treatment and prevention);
• Idiopathic hypertensia (the I-II stage) and the increased arterial pressure at elderly patients (along with other medicines);
• Sleep disorders, including chronic sleeplessness of a functional origin, sleeplessness at elderly people (including disturbances against the background of a hypercholesterolemia and an idiopathic hypertensia).

Also Vit melatonin appoint for the purpose of increase in physical and intellectual effeciency and for simplification of depressions of seasonal nature and stressful reactions.

Contraindications

Absolute:

• Myeloma, diabetes mellitus, epilepsy, autoimmune diseases, leukosis, lymphogranulomatosis, lymphoma;
• Simultaneous use with monoamine oxidase inhibitors, corticosteroids, cyclosporine;
• Deficit of lactase of Lapp, intolerance of a galactose or malabsorption of glucose galactose;
• Children's age;
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Relative (use Vita melatonin demands care in the presence of the following diseases / states):

• Hormonal disturbances and/or performing hormonal therapy;
• Allergic diseases;
• Cirrhosis (because of decrease in a metabolic rate of melatonin).

Route of administration and dosage

Vit melatonin accept inside.

With the medical purpose appoint 1-2 tablets a day daily, more preferably – at the same time (in 30 minutes prior to a dream). Therapy carry out to recovery of a physiological rhythm "dream wakefulness", but not longer than 1 month.

For prevention of Vit melatonin usually appoint in the same dosage. Duration of administration of drug is defined by the doctor individually with the course of a disease and specific features of the patient. As a rule, conduct 2 courses for 30 days with a break of 7 days between courses.

For treatment of chronic sleep disorders (including disturbances against the background of a hypercholesterolemia and/or the accompanying idiopathic hypertensia) at elderly patients of Vit melatonin appoint in a minimal effective dose 1/2 tablets (1,5 mg) in 30 minutes prior to a dream once a day. In case of insufficient efficiency increase in a dose is possible twice. It is necessary to cancel administration of drug with a gradual dose decline for 7-14 days.

According to the same scheme of Vit melatonin it is necessary to accept at an idiopathic hypertensia and the increased arterial pressure at elderly patients. It is possible to conduct 3-6 courses for 30 days with seven-day breaks between them.

Side effects

During use of Vit melatonin disturbances from some systems of an organism can develop (≥1/10 – very often; from 1/100 to 1/10 – it is frequent; from 1/1000 to 1/100 – infrequently; from 1/10 000 to 1/1000 – it is rare; <1/10 000 (включая единичные сообщения) – очень редко):

• Cardiovascular system: seldom – heart consciousness, stenocardia;
• Central nervous system: infrequently – migraine, dizziness, the increased psychomotor activity, drowsiness; seldom – disturbance of quality of a dream, decrease in attention, a memory impairment, paresthesia;
• Digestive tract: infrequently – a lock, an abdominal pain, dryness in a mouth, ulcerations of an oral cavity; seldom – a meteorism, vomiting, abnormal intestinal noise, an unpleasant smell from a mouth, saliva hypersecretion, a gastroesophageal reflux;
• Blood and lymphatic system: seldom – thrombocytopenia, a leukopenia;
• Gepatobiliarny system: infrequently – a hyperbilirubinemia; seldom – functional disturbances of a liver, increase in activity of liver enzymes, an aberration of these laboratory tests;
• Urinogenital system: infrequently – a proteinuria, a glucosuria, menopausal symptoms; seldom – a priapism, a polyuria, a nocturia, a hamaturia, prostatitis;
• Skeletal muscles and connecting fabric: infrequently – extremity pain; seldom – neck pains, muscular spasms, arthritis;
• Vascular disorders: seldom – rushes of blood;
• Infections and invasions: seldom – shingles;
• Skin and hypodermic cellulose: infrequently – night perspiration, dermatitis; seldom – psoriasis, a xeroderma, eczema, pruritic rash, an erythema, an itch, injury of nails;
• Metabolism: seldom – a hypocalcemia, a gipertriglitseridemiya, a hyponatremia;
• Mentality: infrequently – unusual dreams, irritability, a bespokoynost, a hyperexcitability, sleeplessness; seldom – aggression, changes of mood, agitation, early morning awakening, tearfulness, strengthening of a libido, a depression;
• Acoustic organ and vestibular mechanism: seldom – dizziness at change of position of a body;
• Organs of sight: seldom – a zatumanennost and decrease in visual acuity, the strengthened dacryagogue;
• Other disturbances: infrequently – increase in body weight; seldom – change of electrolytes;
• General disturbances: infrequently – thorax pain, an adynamy; seldom – thirst, fatigue.

Special instructions

Because of some contraceptive action of Vit melatonin the women planning pregnancy are not recommended to apply.

During therapy it is necessary to avoid bright lighting.

Patients can use drug with a hypercholesterolemia and the increased arterial pressure (in particular systolic). At long therapy at patients with a hypercholesterolemia cholesterol level decreases, however it does not influence cholesterol level in case of its normal content in blood serum. Vit melatonin lowers the level of glucose and insulin in a blood plasma therefore it can be applied at the patients with a hypercholesterolemia and an idiopathic hypertensia who are followed by insulin resistance (the NOMA index is higher than 3 conventional units).

Because melatonin can cause drowsiness, drug should be used with care in cases when probable drowsiness can be connected with danger or risk to health of the patient.

The concomitant use with alcohol lowers efficiency of melatonin.

Vit melatonin patients whose activity demands the high speed of psychomotor reactions and the increased concentration of attention should apply with care.

Medicinal interaction

At simultaneous use of Vit melatonin with some medicines there can be following effects:

• The drugs blocking β-adrenoceptors, флувоксамин, dexamethasone, a clonidine and some other medicines: change of secretion of endogenous melatonin;
• Hormonal drugs (estrogen, androgens, etc.), benzodiazepine: influence on their efficiency (at simultaneous use medical control is necessary);
• Tamoxifenum: potentiation of its antineoplastic effect;
• Metamphetaminum: strengthening of its dopaminergic and serotonergic effects;
• Isoniazid: potentiation of its antibacterial action;
• Lisinopril: strengthening of its effect (perhaps simultaneous use when performing anti-hypertensive therapy for patients with functional insufficiency of pineal gland);
• Fluvoksamin: increase in level of melatonin by inhibition of his metabolism by hepatic isoenzymes of CYP2C19 and CYP1A2 of P450 (CYP) cytochrome, a combination of drugs is not recommended;
• 5-or 8 methoxypsoralen, Cimetidinum, are oestrogenic (for example, contraceptives or replaceable hormonal therapy): increase in level of melatonin in a blood plasma (medical control is necessary);
• CYP1A2 inhibitors (for example, hinolona): assistance to strengthening of effect of melatonin;
• CYP1A2 inductors (for example, rifampicin, carbamazepine): assistance to decrease in concentration of melatonin in a blood plasma.

Smoking can lower melatonin level.

Terms and storage conditions

To store in the place, unavailable to children, in original packaging at a temperature up to 25 °C.

Period of validity – 3 years.