Instructions for use
Registration number: P-8-242 No. 015325/01 dated 08.29.08
Trade name of the drug: MELAXEN
INN: melatonin
Dosage form: film-coated tablets 3 mg.
Composition: Active ingredient -
Melatonin, 3 mg; excipients: calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate; shell: talc, shellac, isopropanol.
Description
: round, biconvex, white to yellowish-white film-coated tablets, with a scored line on one side of the tablet.
PHARMACOTHERAPEUTIC GROUP
. Adaptogenic agent.
ATX CODE
: N05CM17
Characteristics of the drug
:
Melaxen is a chemical analogue of the biogenic amine Melatonin. Chemical formula N-acetyl-5-methoxytryptamine. Molecular weight 232. Dissolves in water, alcohol, lipids. Penetrates well through the blood-brain barrier. Synthesized from amino acids of plant origin.
PHARMACOLOGICAL PROPERTIES
It is a synthetic analogue of the pineal gland hormone. Normalizes circadian rhythms. Regulates the sleep-wake cycle, daily changes in locomotive activity and body temperature. Helps normalize night sleep (accelerates falling asleep, reduces the number of night awakenings, improves well-being after waking up in the morning, does not cause a feeling of lethargy, weakness and fatigue when waking up, dreams become more vivid and emotionally rich).
Adapts the body to rapid changes in time zones, reduces stress reactions.
Shows immunostimulating and pronounced antioxidant properties.
Inhibits the secretion of gonadotropins, and to a lesser extent, other hormones of the adenohypophysis - corticotropin, thyrotropin and somatotropin.
Does not cause addiction or dependence.
Pharmacokinetics
When taken orally, it is quickly and completely adsorbed and easily passes histohematic barriers, including the blood-brain barrier. Has a short half-life.
Indications
As a sleeping pill.
As an adaptogen to normalize biological rhythms.
Contraindications
Hypersensitivity, severe renal impairment, autoimmune diseases, leukemia, lymphoma. Allergic reactions, lymphogranulomatosis, myeloma, epilepsy, diabetes mellitus, chronic renal failure, pregnancy and lactation.
Directions for use and doses
Inside. Adults take ½-1 tablet 30-40 minutes before bedtime once a day. 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 up to 2 tablets per day.
SIDE EFFECT
Allergic reactions to the components of the drug and swelling are possible in the first week of use. Headache, nausea, vomiting, diarrhea, morning drowsiness.
OVERDOSE
In case of accidental overdose: gastric lavage, symptomatic therapy. Increased severity of side effects.
INTERACTIONS WITH OTHER MEDICINES
Enhances the effect of drugs that depress the central nervous system and beta blockers. It is not recommended to take together with hormonal medications.
Incompatible with MAO inhibitors, glucocorticosteroids and cyclosporine.
SPECIAL INSTRUCTIONS
During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. It is necessary to inform women who want to become pregnant that the drug has a weak contraceptive effect.
Release form
12 or 24 tablets in an aluminum foil/PVC blister. One or two blisters along with instructions for use will be placed in a cardboard box.
Storage conditions
At a temperature of 10-30°C, in a dry place, protected from light. Keep out of the reach of children.
BEST BEFORE DATE
4 years. Do not use after expiration date.
Release from pharmacies
Without a doctor's prescription.
Contraindications
- hypersensitivity (allergy) to the components of the drug;
- severe renal dysfunction;
- malignant blood lesions (lymphogranulomatosis, lymphoma, leukemia, myeloma);
- autoimmune diseases;
- diabetes;
- pregnancy and breastfeeding;
- epilepsy;
- chronic renal failure
- congenital galactose intolerance, glucose-galactose deficiency syndrome, congenital lactase deficiency.
Frequently asked questions about the use of Melaxen
- Does Melaxen affect driving?
Although melatonin rarely causes drowsiness when taken correctly, it is still not recommended to drive or operate complex machinery during treatment.
- Is it possible to smoke and drink alcohol during treatment with Melaxen?
Alcohol destroys all the healing effects of melatonin and leads to worsening insomnia
Smoking and drinking alcohol (in any doses) significantly reduce the effectiveness of Melaxen. It may seem that alcohol promotes relaxation and sound sleep, but this is not entirely true. Alcohol, like Melaxen, has an inhibitory effect on the nervous system. Therefore, their interaction leads to disruption of the structure and depth of sleep, which will certainly manifest itself in the morning as lethargy, fatigue, drowsiness and headache. Also, when taken together with alcohol, an increase in the side effects of the drug may be observed. Thus, alcohol destroys all the healing effects of melatonin and leads to worsening insomnia.
- Can Melaxen be taken by children?
The drug is not prescribed to patients under 18 years of age, since studies on the safety and effectiveness of melatonin in children have not been conducted.
- Compatibility of Melaxen and oral contraceptives
Preparations containing estrogens (replacement therapy and oral contraceptives) increase the concentration of Melaxen in the blood. In such cases, consultation with a specialist is required.
- Is Melaxen allowed during pregnancy and lactation?
Studies of the effect of melatonin on pregnant women have not been conducted, so taking the drug is contraindicated. Melatonin is also secreted into breast milk, so it should not be used during lactation.
It is also not recommended to use melatonin preparations for women planning pregnancy.
- Is it possible to take Melaxen for snoring and obstructive sleep apnea?
In case of obstructive sleep apnea, self-administration of any sleeping pills or melatonin is unacceptable.
Most often, patients with sleep apnea suffer from excessive daytime sleepiness, and the night may seem sleepless to them. Therefore, such people may try various sleeping pills to improve their sleep. However, all sleeping pills cause excessive relaxation of the muscles and a strong inhibitory effect on the nerve centers. These effects contribute to further relaxation of the muscles of the pharynx and the occurrence or increase of apnea - stopping breathing during sleep. Benzodiazepine drugs such as phenazepam, diazepam and triazolam are especially dangerous. Taking them worsens the course of the disease and can even lead to death. Melaxen does not have a similar effect, therefore it is absolutely safe for patients with obstructive sleep apnea. However, in no case should this lead to self-prescribing sleeping pills, even Melaxen. With such a dangerous disease as obstructive sleep apnea, only a somnologist can correctly select the course of treatment, including CPAP therapy.
- Are there analogues of Melaxen?
The long-acting drug Circadin has similar effects. But, unlike Melaxen, it contains 2 mg of melatonin.
Domestic manufacturers produce melatonin under the brand names Malarena, Sonnovan, Melarithm.
Melatonin tablets can also be found in sports nutrition stores. However, it is worth remembering that dietary supplements, unlike drugs, may contain low-quality raw materials or a dose that differs from the declared one. Long-term use of dietary supplements of questionable quality can have an unpredictable effect on the body and the course of insomnia.
Melatonin is safe and harmless
Melaxen is an absolutely safe drug, but still, to determine the exact causes of insomnia and effectively combat it, it is better to consult a somnologist.
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Melatonin – the hormone of sleep and youth
Melatonin is a hormone that regulates many processes in our body, including biological rhythms.
The main part of melatonin is produced by the pineal gland - the pineal gland, located in the brain.
Overdose and intake in large doses
As already indicated, there is no such thing as an overdose for Melaxen.
This fact causes some skepticism among people who take sleeping pills. We are accustomed to the fact that an extra half tablet can lead to severe side effects (difficulty waking up in the morning, headaches, incoordination, daytime sleepiness), and regular or significant excess of the dose can cause an overdose with convulsions, vomiting and the need to call an ambulance.
Another point: for some sleeping pills (especially the “old” ones: phenazepam, barbiturates) there is the concept of a “narrow therapeutic corridor”. This means that the toxic dose of the drug is only slightly (usually 2-4 times) higher than the therapeutic dose. Thus, it is very easy to overdose.
And then they introduce us to Melaxen, which is supposedly impossible to overdose on. Suspicious? Undoubtedly. But it's true. The active components of most sleeping pills are substances that directly and crudely suppress the activity of the nervous system.
The active component of the product is melatonin, a chemical copy of the natural sleep hormone:
It works more gently and is used by the body only in the amount necessary for a therapeutic effect;
It is non-toxic, its excess is quickly eliminated from the body.
That is why, even if you take an excess amount of the drug, it will not harm your health. Accordingly, a lethal dose of Melaxen also does not exist as a concept.
IMPORTANT! To fall asleep, it is enough to take the recommended dosage of Melaxen 3-6 mg. Further increase in dose does not increase the effect!
special instructions
The drug has its own characteristics that must be taken into account before taking it. Women who are planning to conceive a child in the near future should also refrain from taking the drug, since Melaxen has a mild contraceptive effect.
At the time of therapy, it is better to avoid sunbathing, since the active substances tend to disintegrate under the influence of solar radiation.
Also, during the treatment process, you should not drive a vehicle or operate other dangerous mechanisms.
In the course of the studies, it was found that the medicine can enhance the effect of sedative medications. Interactions with drugs affecting the central nervous system have not been established. But still, when they are taken in parallel, a feeling of anxiety and problems with perceiving what is happening around may appear.
Drug interactions
Melaxen is incompatible with cyclosporine, MAO inhibitors and glucocorticosteroids.
It is not recommended for use during any hormonal therapy, treatment with non-steroidal anti-inflammatory drugs, as well as drugs that depress the central nervous system (thioridazine, imipramine).
Strengthens the effect of beta-blockers and sleeping pills.
Cimetidine and quinolones increase melatonin concentrations.
Melatonin improves sleep
