Vivacia Multi Relax With Lemon Balm (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Multi Relax With Lemon Balm

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets weighing 750 mg.

* Griffonia seed extract (Griffonia simplicifolia) from 195 mg of 16:1 extract;
** aerial part of Melissa officinalis leaves (Melissa officinalis) from 36 mg of 4:1 extract.
^# recommended daily intake.

60 pcs. – bottles (1).

Therapeutic Category

Dietary supplement for supporting the function of the nervous system

Indications

• As a dietary supplement to support the normal function of the nervous system and to help maintain a state of mental and emotional balance.
• To provide nutritional support during periods of mild, temporary stress, tension, and anxiety.
• To contribute to the reduction of fatigue and feelings of exhaustion associated with nervous strain.
• To assist in the maintenance of normal psychological function, including mood and sleep patterns, as part of a balanced lifestyle.

The combination of magnesium, B vitamins, and plant extracts is intended to provide a synergistic effect for the overall well-being of the nervous system.

Contraindications

• Hypersensitivity or known allergy to any of the components of the dietary supplement, including Griffonia simplicifolia seed extract, Melissa officinalis (lemon balm), niacin, or magnesium citrate.
• Pregnancy and breastfeeding. Due to the presence of 5-HTP from Griffonia extract and the lack of sufficient safety data for this specific combination during these periods, use is contraindicated.
• Concomitant use with prescription antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or other medications that affect serotonin levels, due to the risk of serotonin syndrome.
• Patients with a history of eosinophilia-myalgia syndrome (EMS) or with a predisposition to this condition, as it has been historically associated with contaminated L-tryptophan and 5-HTP is a direct metabolic precursor.
• Patients with severe hepatic or renal impairment, as the safety of the concentrated extracts has not been established in these populations.
• Children and adolescents under 18 years of age, as safety and efficacy have not been established for this age group.

Dosage Regimen

The recommended adult dosage is three (3) tablets once daily, taken with a meal and a full glass of water. Adherence to this dosage is crucial for safety and efficacy.

The tablets should be swallowed whole and not chewed or crushed. To ensure optimal absorption and minimize any potential gastrointestinal discomfort, it is advised to take the supplement with food. Do not exceed the stated recommended daily intake. The duration of use should be discussed with a healthcare professional, as prolonged, continuous use without medical supervision is not recommended.

If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. A double dose should not be taken to make up for a forgotten one.

Adverse Reactions

Vivacia Multi Relax With Lemon Balm is generally well-tolerated when used at the recommended dosage; however, as with any supplement, adverse reactions may occur.

The most commonly reported adverse reactions are gastrointestinal in nature and may include symptoms such as nausea, heartburn, abdominal discomfort, or diarrhea. These effects are often mild and transient, particularly if the supplement is taken with food.

Due to the presence of niacin (Vitamin B3), some individuals may experience a temporary, harmless flushing sensation, warmth, redness, and itching of the skin, typically of the face, neck, and chest. This “niacin flush” usually subsides within 30 to 60 minutes.

Less frequently, components like 5-HTP from Griffonia seed extract may be associated with drowsiness, dizziness, dry mouth, or changes in dream patterns. It is important to exercise caution when driving or operating machinery until you know how this supplement affects you.

Although rare, serious adverse reactions could occur, particularly with overdose or concomitant use with serotonergic drugs. Be vigilant for symptoms of serotonin syndrome, which may include agitation, confusion, rapid heart rate, high blood pressure, dilated pupils, loss of coordination, heavy sweating, diarrhea, headache, shivering, or muscle rigidity. If any of these or other unexpected or severe reactions occur, discontinue use immediately and seek medical attention.

Drug Interactions

The potential for drug interactions with Vivacia Multi Relax is significant, primarily due to the 5-HTP content, and requires careful consideration.

Extreme Caution – Serotonergic Drugs: Concomitant use with drugs that increase serotonin levels is contraindicated due to the high risk of precipitating serotonin syndrome, a potentially life-threatening condition. This class includes, but is not limited to: SSRIs (e.g., fluoxetine, sertraline, citalopram), SNRIs (e.g., venlafaxine, duloxetine), tricyclic antidepressants (e.g., amitriptyline), MAOIs (e.g., phenelzine, selegiline), triptans for migraines (e.g., sumatriptan), tramadol, meperidine, dextromethorphan, and St. John’s Wort.

Central Nervous System (CNS) Depressants: Lemon balm (Melissa officinalis) has calming properties and may potentiate the effects of alcohol, benzodiazepines, barbiturates, and other sedative medications, leading to increased drowsiness, dizziness, and impaired motor coordination. Caution is advised when combining this supplement with any substance that causes sedation.

Levodopa (L-dopa): 5-HTP may theoretically antagonize the effects of levodopa, a medication used for Parkinson’s disease, and should not be used concurrently without close medical supervision.

Carbidopa: When taken with carbidopa, 5-HTP may be more readily converted to serotonin in peripheral tissues, potentially increasing the risk of adverse effects like nausea and the serotonin syndrome. This combination should be avoided.

It is imperative to inform your doctor and pharmacist about all the medications and supplements you are taking, including prescription, over-the-counter, and herbal products, before starting this dietary supplement.

Overdose

In the event of a suspected overdose, immediate medical attention should be sought. Contact a poison control center or emergency room without delay.

Symptoms of overdose may be an exaggeration of the known adverse effects and could include severe gastrointestinal distress (nausea, vomiting, diarrhea), pronounced dizziness, extreme drowsiness, or sedation.

The most critical risk associated with overdose, particularly in individuals taking other serotonergic agents, is the development of serotonin syndrome. Signs and symptoms to watch for include agitation, hallucinations, rapid heart rate (tachycardia), instability of the autonomic nervous system leading to fluctuating blood pressure and temperature, hyperreflexia (overactive reflexes), muscle rigidity, tremor, incoordination, nausea, vomiting, and diarrhea. Severe cases can be fatal and constitute a medical emergency.

There is no specific antidote for an overdose of this dietary supplement. Treatment is supportive and symptomatic and may include gastric lavage or administration of activated charcoal if the ingestion was recent, along with comprehensive monitoring of vital signs and symptomatic care for any neurological, cardiovascular, or gastrointestinal manifestations.

Storage Conditions

Store at 2°C (36°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.