Sonnovan, 3 mg 10 pcs

Interaction

Pharmacokinetic interaction

• 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. In the case of signs of induction, a dose reduction of concomitant medications should be considered.
• In concentrations well above therapeutic, melatonin does not induce the CYP1A isoenzymes in vitro. Therefore, there seems to be little interaction between melatonin and other drugs due to the effect of melatonin on the 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 concentration 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.
• In the current literature, there are numerous 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

• Alcohol should not be consumed 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.

Directions for use

Orally.
In case of sleep disturbance, desynchronosis – 1 tablet once a day 30-40 minutes before sleep.

When used as an adaptogen when changing time zones – 1 day before the flight and during the next 2-5 days – 1 tablet 30-40 minutes before sleep. Maximal daily dose is 6 mg.

Elderly patients. With age melatonin metabolism decreases and this fact should be considered while choosing a dosage regimen for elderly patients. Taking this into account in elderly patients the drug may be administered 60-90 min before sleep.

Renal insufficiency. Influence of various degrees of renal insufficiency on pharmacokinetics of melatonin has not been studied, therefore in such patients melatonin should be used with caution. Patients with severe renal insufficiency are not recommended to use the drug.

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, use in this patient population is not recommended.

Influence on driving and operating ability

The drug Sonnovan® causes somnolence and therefore during the treatment period the patient should avoid driving and engaging in potentially dangerous activities requiring increased concentration and rapid psychomotor reaction.

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Contraindications

Hypersensitivity to the drug components, 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 (< 1/10000), including individual reports; frequency unknown (based on available data the incidence cannot be determined).
Infectious and parasitic diseases:
rarely: herpes zoster.

Blood and lymphatic system disorders:
rarely: leukopenia, thrombocytopenia.

Immune system disorders:
frequency unknown: hypersensitivity reactions.

Metabolism and nutrition disorders:
rare: hypertriglyceridemia, hypokalemia, hyponatremia.

Mental disorders:
infrequent: irritability, nervousness, anxiety, 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, lethargy, psychomotor hyperactivity, dizziness, somnolence;
rarely: fainting, memory disturbance, concentration disorders, delirium, syndrome “restless legs”, poor sleep quality, paresthesias.

Visual organ disorders:
rare: decreased visual acuity, blurred vision, increased lacrimation.

Auditory organ and labyrinth disorders:
rare: vertigo, positional vertigo.

Cardiovascular system disorders:
infrequent: arterial hypertension;
rare: angina pectoris, palpitations, hot flashes.

Gastrointestinal tract disorders:
infrequent: abdominal pain, upper abdominal pain, dyspepsia, ulcerative stomatitis, dry mouth, nausea;
rare: gastroesophageal disease, gastrointestinal disturbance or disorder, bullous stomatitis, ulcerative glossitis, vomiting, increased peristalsis, abdominal bloating, salivary hypersecretion, bad breath, abdominal discomfort, gastric dyskinesia, gastritis.

Liver and biliary tract disorders:
infrequently: 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;
rare: arthritis, muscle spasm, neck pain, night cramps.

Renal and urinary tract disorders:
infrequent: glucosuria, proteinuria;
rare: polyuria, hematuria, nycturia.

Genital and breast disorders:
infrequent: menopausal symptoms;
rare: 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 liver function tests, increased body weight;
rare: increased “liver” transaminases activity, abnormal blood electrolytes content, abnormal laboratory test results.

Overdose

According to the available literature, 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 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 case of overdose somnolence may occur.

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

Similarities

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