Sonnovan pills 3mg, 30pcs

Composition

of film-coated tablets

1 film-coated tablet contains:

Active ingredient:

melatonin 3 mg;

excipients:

calcium hydrophosphate 112 mg,

pregelatinized corn starch 3.5 mg,

magnesium stearate 1.5 mg,

microcrystalline cellulose 40 mg;

composition of the film shell:

 opadray 85F48105 II white 5 mg, including:

polyvinyl alcohol 2.345 mg,

macrogol (polyethylene glycol 4000) 1.18 mg,

talc 0.87 mg,

titanium dioxide 0.605 mg

Pharmacological action

adaptogenic agent.

Indications

For sleep disorders, including those caused by a violation of the “sleep-wake” rhythm, such as desynchronosis (sudden change of time zones).

Contraindications

Hypersensitivity to the components of the drug, autoimmune diseases, liver failure, severe renal failure, children under 18 years of age.

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization:

very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (

Infectious and parasitic diseases:

rare: herpes zoster.

Disorders of the blood and lymphatic system:

rare: leukopenia, thrombocytopenia.

Immune system disorders:

frequency unknown: hypersensitivity reactions.

Metabolic and nutritional disorders:

rare: hypertriglyceridemia, hypokalemia, hyponatremia.

Mental disorders:

infrequently: irritability, nervousness, restlessness, insomnia, unusual dreams, nightmares, anxiety;

rarely: mood swings, aggression, agitation, tearfulness, stress symptoms, disorientation, early morning awakening, increased libido, low mood, depression.

Nervous system disorders:

infrequently: migraine, headache, lethargy, psychomotor hyperactivity, dizziness, drowsiness;

rarely: fainting, memory impairment, impaired concentration, delirium, restless legs syndrome, poor sleep quality, paresthesia.

Visual disturbances:

rarely: decreased visual acuity, blurred vision, increased lacrimation.

Hearing disorders and labyrinth disorders:

rare: vertigo, positional vertigo.

Disorders of the cardiovascular system:

infrequently: arterial hypertension;

rarely: angina pectoris of tension, palpitation, hot flashes.

Disorders of the gastrointestinal tract:

infrequently: abdominal pain, abdominal pain in the upper abdomen, dyspepsia, ulcerative stomatitis, dry mouth, nausea;

rarely: gastroesophageal disease, gastrointestinal disorder or disorder, bullous stomatitis, ulcerative glossitis, vomiting, increased peristalsis, bloating, hypersecretion of saliva, bad breath, abdominal discomfort, gastric dyskinesia, gastritis.

Liver and biliary tract disorders:

infrequently: hyperbilirubinemia.

Skin and subcutaneous tissue disorders:

infrequently: dermatitis, night sweats, pruritus and generalized pruritus, rash, dry skin;

rarely: eczema, erythema, dermatitis of the hands, psoriasis, generalized rash, itchy rash, nail damage;

frequency unknown: angioedema, oral mucosal edema, tongue edema.

Musculoskeletal and connective tissue disorders:

infrequently: pain in the extremities;

rarely: arthritis, muscle spasm, neck pain, night cramps.

Kidney and urinary tract disorders:

infrequently: glucosuria, proteinuria;

rarely: polyuria, hematuria, nocturia.

Disorders of the genitals and breast:

infrequently: menopausal symptoms;

rarely: priapism, prostatitis;

frequency unknown: galactorrhea.

General disorders and disorders at the injection site:

infrequently: asthenia, chest pain;

rarely: fatigue, pain, thirst.

Laboratory and instrumental data:

infrequently: deviation from the norm of laboratory parameters of liver function, weight gain;

rarely: increased activity of “liver” transaminases, deviation from the norm of blood electrolyte content, deviation from the norm of laboratory test results.

Interaction

Pharmacokinetic interaction

• Melatonin is known to induce the CYP3A isoenzyme in vitro at concentrations significantly higher than therapeutic levels. The clinical significance of this phenomenon is not fully understood. If signs of induction develop, consideration should be given to reducing the dose of concomitantly administered medications.
• At concentrations significantly higher than therapeutic levels, melatonin does not induce CYP1A isoenzymes in vitro. Therefore, the interaction of melatonin with other drugs due to the effect of melatonin on CYP1A isoenzymes is apparently insignificant.
• Melatonin metabolism is mainly mediated by CYP1A isoenzymes. Therefore, melatonin may interact with other drugs due to the effect of melatonin on CYP1A isoenzymes.
• Caution should be exercised in patients taking fluvoxamine, which increases the concentration of melatonin (17-fold increase in AUC and 12-fold Cmax) due to inhibition of its metabolism by cytochrome P450 (CYP) isoenzymes: CYP1A2 and CYP2C19. This combination should be avoided.
• Caution should be exercised in patients taking 5 – and 8-methoxypsoralen, which increases the concentration of melatonin due to inhibition of its metabolism.
• Caution should be exercised in patients taking cimetidine (an inhibitor of CYP2D isoenzymes), as it increases the content of melatonin in plasma by inhibiting the latter.
• Smoking can reduce the concentration of melatonin by inducing the CYP1A2 isoenzyme.
• Caution should be exercised in patients taking estrogens (e. g., contraceptives or hormone replacement therapy) that increase melatonin concentrations by inhibiting their metabolism by the CYP1A1 and CYP1A2 isoenzymes.
• Inhibitors of CYPA2 isoenzymes, such as quinolones, can increase melatonin exposure.
• Inducers of the CYP1A2 isoenzyme, such as carbamazepine and rifampicin, can reduce the plasma concentration of melatonin.
• There is a wealth of data in the current literature regarding the effects of adrenergic and opioid receptor agonists/antagonists, antidepressants, prostaglandin inhibitors, benzodiazepines, tryptophan, and alcohol on endogenous melatonin secretion. Studies of the mutual effect of these drugs on the dynamics or kinetics of melatonin have not been conducted.

Pharmacodynamic interaction

• While taking melatonin, you should not drink alcohol, as it reduces the effectiveness of the drug.
• Melatonin potentiates the sedative effects of benzodiazepine and non-benzodiazepine hypnotics, such as zaleplon, zolpidem, and zopiclone. In a clinical study, clear signs of a transient pharmacodynamic interaction between melatonin and zolpidem were observed one hour after use. Combined use may result in progressive attention, memory, and coordination disorders compared to zolpidem monotherapy.
• In studies, melatonin was co-administered with thioridazine and imipramine, drugs that affect the central nervous system. No clinically significant pharmacokinetic interaction was observed in any of the cases. However, concomitant use with melatonin resulted in an increased sense of calm and difficulty in performing certain tasks compared to imipramine monotherapy, as well as an increased feeling of “blurring in the head” compared to thioridazine monotherapy.

How to take, course of use and dosage

Inside. In case of sleep disorders, desynchronosis – 1 tablet once a day for 30-40 minutes before bedtime.

When used as an adaptogen when changing time zones-1 day before the flight and in the next 2-5 days-1 tablet 30-40 minutes before bedtime.

The maximum daily dose is 6 mg.

Elderly patients

With age, melatonin metabolism decreases, which should be taken into account when choosing a dosage regimen for elderly patients. Taking this into account, in elderly patients, it is possible to take the drug 60-90 minutes before bedtime.

Kidney failure

The effect of varying degrees of renal insufficiency on the pharmacokinetics of melatonin has not been studied, so melatonin should be used with caution in such patients. In patients with severe renal insufficiency, the use of the drug is not recommended.

Overdose

According to the available literature data, the use of melatonin in a daily dose of up to 300 mg did not cause clinically significant adverse reactions.Hyperemia, abdominal cramps, diarrhea, headache, and scotoma were observed when melatonin was administered at doses of 3000-6600 mg for several weeks.

When using very high doses of melatonin (up to 1 g), involuntary loss of consciousness was observed. In case of overdose, drowsiness may develop.

Treatment – gastric lavage and the use of activated charcoal, symptomatic therapy. Clearance of the Active ingredient is expected within 12 hours after oral use.

Special instructions

During the use of Sonnovan®, it is recommended to avoid exposure to bright light.

It is necessary to inform women who want to get pregnant about the presence of a weak contraceptive effect of the drug.

There are no clinical data on the use of melatonin in patients with autoimmune diseases, and therefore, the use in this category of patients is not recommended.

Influence on the ability to drive vehicles and mechanisms

The drug Sonnovan ® causes drowsiness, therefore, during treatment, you should refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Active ingredient

Melatonin

Dosage form

Tablets