Nightwell (Capsules) Instructions for Use

Marketing Authorization Holder

UNIPHARM, LLC (Russia)

Manufactured By

Grokam, sp. z o.o. (Poland)

Groups

POLAND of GROUP MASTER PHARM, S.A. (Poland)

Dosage Form

Nightwell

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 645 mg.

Composition: microcrystalline cellulose (carrier), magnesium oxide, gelatin, Passionflower herb extract, Common hop strobile extract, Lemon balm leaf extract, extract of Valeriana officinalis root, silicon dioxide (anti-caking agent), vitamin B₆ (Pyridoxine hydrochloride), magnesium salts of fatty acids (anti-caking agent), titanium dioxide (colorant), indigo carmine (colorant).

15 pcs. – blisters (2) – cardboard packs.

Therapeutic Category

Dietary supplement – an additional source of vitamin B₆ and magnesium

Properties

A dietary supplement to food. It is a combination of natural plant components, enhanced with magnesium and vitamin B₆, which helps relieve emotional tension, sleep disorders, and insomnia.

The product helps to normalize and improve sleep quality, provides relaxation before sleep, and supports the natural process of falling asleep.

The positive effect of the product on the function of the human nervous system is due to the complex influence of the plant components, magnesium, and vitamin B₆ included in its composition on the production of serotonin and the improvement of GABA activity, which is involved in the initiation and maintenance of sleep: GABA helps reduce excitation and suppress neurotransmitters that maintain wakefulness. In addition, GABA is important for mitigating the stress response.

Common hop has a calming effect on the CNS. The main mechanism of action of the components included in common hop is associated with an increase in GABA activity, the main neurotransmitter involved in central inhibition processes, including the organization of sleep. GABA relieves excitation and has a calming effect. Hops also affect the production of serotonin and adenosine, which are actively involved in the mechanisms of organizing night sleep. Thus, hops have a mild sedative effect, modulate the sleep/wake rhythm, promote sleep initiation, reduce increased nervous excitability, affecting sleep quality and the time it takes to fall asleep. Under the influence of GABA, the brain’s energy processes are activated, tissue respiratory activity increases, the brain’s utilization of glucose improves, and blood supply improves, which in turn contributes to increased cognitive functions: concentration of attention, improved perception of information and memorization, memory, and performance. It helps to normalize cyclic processes in women and eliminate autonomic manifestations.

Passiflora incarnata/passion flower is one of the main soothing herbal remedies. It helps reduce anxiety and influences the activation of mechanisms for initiating natural physiological sleep. It alleviates manifestations of mental tension, as well as accompanying disorders of the autonomic nervous system, including rapid heartbeat, increased sweating, and facial redness.

Passion flower helps improve mood by suppressing MAO in brain tissue, resulting in the formation of more serotonin, one of the main neurotransmitters, often called the “hormone of good mood” and the “happiness hormone.” In turn, serotonin is a precursor to melatonin, which plays a key role in the process of sleep organization, affecting sleep quality and depth, and is involved in the regulation of daily and seasonal cycles, including the alternation of sleep and wakefulness. Thus, passion flower, by activating melatonin synthesis, promotes the natural process of falling asleep, improves sleep, and does not cause unpleasant heavy feelings after waking up.

Lemon balm has a mild sedative effect (reduces irritability), which leads to a decrease in nervous excitation and improves the process of falling asleep.

Valeriana officinalis has a calming effect on the CNS and regulates cardiac activity. It has been established that valerian root reduces the subjective experience of stress without reducing memory and attention functions.

Magnesium plays a central role in the regulation of nervous activity and neuromuscular transmission. It is a co-factor for ATP synthesis and is also involved in regulating cellular energy expenditure according to the daily cycle. The most important role of magnesium is that it serves as a natural anti-stress factor, inhibits the development of excitation processes in the CNS, and reduces the body’s sensitivity to external influences. Magnesium deficiency can lead to manifestations such as increased irritability, fatigue, and sleep disorders. Replenishing magnesium deficiency helps increase stress resistance, muscle relaxation, reduce fatigue and nervous system excitation, normalize sleep, and increase performance.

Vitamin B₆ (pyridoxine) has a significant and selective modulating effect on the central synthesis of serotonin and GABA. Vitamin B₆ is directly involved in protein metabolism, the synthesis and transport of amino acids, lipid metabolism, energy production in the body, the synthesis of neurotransmitters of the peripheral nervous system, and supports the synthesis of transport proteins in the axial cylinders of nerve cells. Vitamin B₆ helps improve metabolism in brain tissues by participating in amino acid metabolism. It helps increase brain performance, improve memory and mood.

The product promotes relaxation and reduction of nervous excitability, which helps to fall asleep faster (easier); activation of the mechanism of normal physiological sleep, improvement of sleep quality and depth; reduction of fatigue; increase in concentration, memory, and performance.

Scope of Application

As a dietary supplement to food – an additional source of vitamin B₆ and magnesium.

ICD codes

Dosage Regimen

Adults – 1 single dose/day.

Duration of administration is 2-3 weeks. If necessary, the course of administration can be repeated after one month.

Contraindications

Hypersensitivity to the product components, pregnancy, breastfeeding period.

Use during pregnancy and lactation

Contraindicated for use during pregnancy and breastfeeding.

Special instructions

A dietary supplement to food, not a medicinal product.

Consultation with a doctor is recommended before use.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.