Sonnovan, 3 mg 30 pcs

• .Melatonin is known to induce the CYP3A isoenzyme in vitro at concentrations significantly higher than therapeutic. 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 drugs.
• In concentrations significantly greater than therapeutic, melatonin does not induce CYP1A isoenzymes in vitro. Hence, interactions between melatonin and other drugs due to the effect of melatonin on CYP1A group isoenzymes appear to be insignificant.
• Metabolism of melatonin is mainly mediated by CYP1A isoenzymes. Therefore, melatonin may interact with other medicinal products due to the effect of melatonin on CYP1A isoenzymes.
• Cautions should be taken in patients taking fluvoxamine which increases melatonin concentrations (17 fold AUC and 12 fold Cmax) due to inhibition of its metabolism by cytochrome P450 (CYP) isoenzymes: CYP1A2 and CYP2C19. This combination should be avoided.
• Cautions should be taken in patients taking 5- and 8-methoxypsoralen, which increases melatonin concentrations due to inhibition of its metabolism.
• Cautions should be taken in patients taking cimetidine (CYP2D isoenzyme inhibitor) as it increases melatonin plasma levels by inhibiting the latter.
• Smoking may decrease melatonin concentration due to induction of CYP1A2 isoenzyme.
• Cautions should be taken in patients taking estrogens (e.g., contraceptives or hormone replacement therapy) that increase melatonin concentrations by inhibiting their metabolism by CYP1A1 and CYP1A2 isoenzymes.
• CYPA2 isoenzyme inhibitors, such as quinolones, can increase melatonin exposure.
• CYP1A2 isoenzyme inducers, such as carbamazepine and rifampicin, can decrease the plasma concentration of melatonin.
• Today’s literature is full of data regarding the effects of adrenergic and opioid receptor agonists/antagonists, antidepressants, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol on endogenous melatonin secretion. No studies have been performed on the reciprocal effects of these drugs on melatonin dynamics or kinetics.

Pharmacodynamic interaction

• Do not drink alcohol while taking melatonin, as it reduces the effectiveness of the drug.
• Melatonin potentiates the sedative effects of benzodiazepine and non-benzodiazepine sleeping pills such as zaleplon, zolpidem and zopiclone. In a clinical study, there were clear signs of transient pharmacodynamic interaction between melatonin and zolpidem one hour after their administration. Combined use can lead to progressive impairment of attention, memory and coordination 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 interactions were found in any of the cases. However, concomitant use with melatonin resulted in an increased sense of calmness and difficulty performing certain tasks compared to imipramine monotherapy, as well as an increased sense of “blurring in the head” compared to thioridazine monotherapy.

Special Instructions

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

Women who want to get pregnant should be informed about the weak contraceptive effect of the drug.

There is no clinical data available on the use of melatonin in patients with autoimmune diseases; therefore, it is not recommended for this patient population.

Influence on driving and operating ability

The drug Sonnovan® causes somnolence and therefore the patient should refrain from driving and engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reaction.

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Contraindications

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

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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 (< 1/10000), including individual reports; frequency is unknown (the frequency of occurrence cannot be ascertained from the available data).

Infectious and parasitic diseases:

Rarely: herpes zoster.

Disorders of the blood and lymphatic system:

rarely: leukopenia, thrombocytopenia.

Immune system disorders:

frequency unknown: hypersensitivity reactions.

Metabolic and nutritional disorders:

recommon: hypertriglyceridemia, hypokalemia, hyponatremia.

Mental disorders:

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

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

Nervous system disorders:

infrequent: migraine, headache, drowsiness, psychomotor hyperactivity, dizziness, drowsiness;

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

Visual organ disorders:

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

Hearing organ and labyrinth disorders:

Rarely: vertigo, positional vertigo.

Cardiovascular disorders:

infrequent: arterial hypertension;

rare: angina pectoris, palpitations, flushes.

Gastrointestinal tract disorders:

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

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

Liver and biliary tract disorders:

infrequent: hyperbilirubinemia.

Skin and subcutaneous tissue disorders:

infrequent: dermatitis, night sweats, itching and generalized itching, rash, dry skin;

rarely: eczema, erythema, hand dermatitis, psoriasis, generalized rash, itchy rash, nail lesions;

frequency unknown: Quincke’s edema, oral mucosal edema, tongue edema.

Musculoskeletal and connective tissue disorders:

infrequent: pain in the extremities;

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

Renal and urinary tract disorders:

infrequent: glucosuria, proteinuria;

rare: polyuria, hematuria, nycturia.

Renital and breast disorders:

infrequent: Menopausal symptoms;

rarely: priapism, prostatitis;

frequency unknown: galactorrhea.

General disorders and disorders at the site of administration:

infrequent: asthenia, chest pain;

rare: fatigue, pain, thirst.

Laboratory and instrumental data:

infrequent: abnormal laboratory values of liver function, increased body weight;

rare: increased activity of “hepatic” transaminases, deviation from normal blood electrolyte content, deviation from normal results of laboratory tests.

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Overdose

According to the available literature, the use of melatonin at a daily dose of up to 300 mg has not caused clinically significant adverse reactions. Hyperemia, abdominal cramps, diarrhea, headache, and scotoma have been observed with melatonin doses of 3000 to 6600 mg for several weeks.

In very high doses of melatonin (up to 1 g), involuntary loss of consciousness has been observed. In overdose, drowsiness may develop.

The treatment is gastric lavage and activated charcoal, symptomatic therapy. Clearance of the active substance is assumed within 12 hours after ingestion.

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Similarities

Melaxen, Melarena, Melatonin, Wellson, Strengthen Your Immunity by Evalar