Siviten (Capsules) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

Siviten

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules mass of 500 mg.

Auxiliary substances : gelatin, lactose, polyvinylpyrrolidone, anti-caking agents (silicon dioxide amorphous, magnesium stearate), dye (titanium dioxide).

10 pcs. – blisters (3) – packs cardboard.

Therapeutic Category

Dietary supplement – source of organic compounds, vitamins, macro- and microelements, necessary for maintaining of vital activity of male organism

Indications

• As a dietary supplement to the diet, Siviten is intended to provide additional nutritional support for the male body.
• It serves as a source of amino acids (L-tyrosine, L-glutamine, 5-HTP), magnesium, zinc, and vitamin B6, which are essential cofactors in numerous metabolic processes.
• It may be used to help compensate for deficiencies of these nutrients that can arise from an unbalanced diet, increased physical or mental stress, or other lifestyle factors.
• The components are selected to support the normal functioning of the nervous system, contribute to the reduction of tiredness and fatigue, and aid in the maintenance of normal protein synthesis and macronutrient metabolism.

Contraindications

• Hypersensitivity to any of the components of the dietary supplement, including the active ingredients or any of the auxiliary substances such as gelatin or lactose.
• Phenylketonuria, due to the presence of the amino acid L-tyrosine, which requires specific metabolic pathways that are impaired in this condition.
• Concomitant use with monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such therapy, due to the theoretical risk of serotonin syndrome from the 5-Hydroxytryptophan (5-HTP) component.
• Severe renal impairment or end-stage renal disease, as the accumulation of minerals and amino acids could pose a risk; consultation with a healthcare professional is mandatory in cases of pre-existing kidney conditions.
• Pregnancy and breastfeeding are contraindications for use, as the safety profile of this specific combination of ingredients has not been established for these populations.
• The product is not intended for use by children and adolescents under the age of 18.

Dosage Regimen

The recommended dosage for adult men is one capsule per day, taken with a meal and a full glass of water.

Adherence to the recommended daily dose is crucial; do not exceed one capsule in a 24-hour period. The capsule should be swallowed whole and not chewed or crushed. The duration of continuous use should not exceed one to two months. If a longer course is desired, it is advisable to consult with a healthcare provider to assess individual needs and safety. The supplement is intended to be used as part of a balanced and varied diet and is not a substitute for a healthy lifestyle.

Adverse Reactions

Siviten is generally well-tolerated when taken at the recommended dosage; however, as with any supplement, adverse reactions are possible. Gastrointestinal discomfort, such as nausea, abdominal pain, bloating, or diarrhea, may occur, particularly at the initiation of therapy.

Due to the presence of 5-Hydroxytryptophan (5-HTP), there is a potential for serotonin-related side effects, including drowsiness, dizziness, or mild headache, especially during the first few days of use. These effects are typically transient and subside as the body adjusts.

In rare cases, allergic reactions to the components, such as skin rash, itching, or urticaria, may develop. If any adverse reaction is severe, persistent, or causes concern, discontinuation of the product and consultation with a physician is recommended. Reporting suspected adverse reactions to the manufacturer or a national pharmacovigilance system is encouraged.

Drug Interactions

The most significant potential interaction involves drugs that affect serotonin levels in the central nervous system. The 5-HTP in Siviten may have additive effects when taken concurrently with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, triptans, or the herbal supplement St. John’s Wort. This combination increases the risk of serotonin syndrome, a potentially serious condition characterized by agitation, confusion, rapid heart rate, and high blood pressure.

Concomitant use with Levodopa (L-dopa) should be avoided, as the amino acids L-tyrosine and L-glutamine may compete with L-dopa for absorption in the gastrointestinal tract and transport across the blood-brain barrier, potentially reducing its efficacy in treating Parkinson’s disease.

High doses of zinc can interfere with the absorption of antibiotics from the quinolone and tetracycline classes. To minimize this interaction, Siviten should be taken at least 2 hours before or 4-6 hours after taking these medications. Patients on any long-term medication, especially for chronic conditions, should consult their doctor or pharmacist before starting this supplement.

Overdose

In case of accidental ingestion of a significantly higher than recommended dose, seek immediate medical attention or contact a Poison Control Center.

Symptoms of overdose may be an exaggeration of the known adverse effects and could include severe gastrointestinal distress (nausea, vomiting, diarrhea), pronounced neurological symptoms such as significant drowsiness, dizziness, or headache due to the 5-HTP component, and potential electrolyte imbalances from the mineral content.

There is no specific antidote; treatment is supportive and symptomatic. It is important to inform healthcare professionals of the product ingested and the approximate quantity. Do not induce vomiting unless instructed to do so by a medical professional. Always store the product in its original packaging and out of reach of children to prevent accidental overdose.

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.