Vicolive Multi Probiotic (Capsules) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vicolive Multi Probiotic

Capsules: 15 pcs.

Dosage Form, Packaging, and Product Composition

Capsules mass of 480 mg.

* recommended level of consumption according to TR TS 022/2011 “Food products in part of its labeling” (Appendix 2).
** adequate level of consumption according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” (Appendix 5).

Auxiliary substances : filler (microcrystalline cellulose), capsule shell (hypromellose).

^# recommended daily intake.

Energy value (100 g): 260 kJ/62 kcal.

15 pcs. – blisters (1) – carton packs.

Therapeutic Category

Dietary supplement for correction of composition of intestinal microflora and strengthening of natural immunity

Indications

• For use as a dietary supplement to support a healthy balance of intestinal microflora, which is essential for overall digestive wellness and function.
• To assist in the restoration of normal gut flora following a course of antibiotic therapy, which can deplete beneficial bacteria and lead to digestive discomfort.
• For the dietary management and support of intestinal comfort in individuals experiencing occasional bloating, gas, or irregularity, helping to promote regular digestive transit.
• To contribute to the strengthening of the body’s natural defenses by supporting gut-associated lymphoid tissue (GALT), as a significant portion of the immune system is located in the gastrointestinal tract.
• As an additional source of zinc, vitamin D3, and iodine, which are vital micronutrients known to play crucial roles in immune function, thyroid health, and bone metabolism.
• For general nutritional support in individuals seeking to maintain a healthy gut microbiome, particularly during periods of stress, dietary changes, or travel, which can disrupt the delicate balance of intestinal bacteria.

Dosage Regimen

The standard recommended dosage for adults and children over 14 years of age is one capsule per day, taken orally. For optimal absorption and to maximize the viability of the probiotic strains, it is advised to take the capsule with a meal, preferably with breakfast or the main meal of the day.

The capsule should be swallowed whole with a sufficient amount of water; it should not be chewed or crushed, as this can damage the delicate probiotic microorganisms and the enteric coating designed to protect them from stomach acid. The duration of use is typically 2 to 4 weeks, which allows sufficient time for the colonization and stabilization of beneficial gut bacteria.

For specific health concerns or for use following antibiotic treatment, a healthcare professional may recommend a different duration. It is important to follow the specific advice of your physician or pharmacist. Do not exceed the recommended daily dose. The use of this product in children under 14 years of age should only be undertaken under the direct supervision and recommendation of a healthcare provider.

Contraindications

• Hypersensitivity or known allergy to any component of the dietary supplement, including the active probiotic strains, zinc, vitamin D3, iodine, or any of the excipients such as microcrystalline cellulose or hypromellose. Discontinue use immediately if any signs of an allergic reaction occur.
• Individuals with a diagnosed medical condition affecting the immune system, such as HIV/AIDS, or those who are immunocompromised due to medical therapy (e.g., chemotherapy, long-term corticosteroid use, or post-organ transplant immunosuppression) should use this product only after thorough consultation with their treating physician, as there is a theoretical risk of infection from probiotic bacteria in severely immunodeficient individuals.
• Patients with severe acute pancreatitis or those with central venous catheters should avoid use unless explicitly recommended by their healthcare provider due to increased risk of systemic infections.
• Contraindicated in cases of severe gastrointestinal disorders including, but not limited to, active inflammatory bowel disease (Crohn’s disease, ulcerative colitis) during a flare-up, short bowel syndrome, or in the immediate postoperative period following major abdominal surgery, as the effects of probiotics in these conditions are not fully established and could be detrimental.
• Due to the presence of iodine from brown algae extract, this product is contraindicated in patients with hyperthyroidism or other thyroid disorders where iodine intake must be strictly controlled and monitored by an endocrinologist.

Adverse Reactions

Vicolive Multi Probiotic is generally well-tolerated when used at the recommended dosage. However, as with any dietary supplement, some individuals may experience adverse reactions, particularly during the initial days of use as the body’s digestive system adjusts to the new bacterial strains.

The most commonly reported adverse effects are mild and transient gastrointestinal in nature. These may include bloating, flatulence, abdominal cramps, rumbling in the intestines, or changes in bowel habits such as constipation or diarrhea. These symptoms typically subside within a few days as the gut microbiome stabilizes. If these symptoms persist or worsen, discontinue use and consult a healthcare professional.

In rare instances, individuals with a predisposition may experience allergic reactions, which can manifest as skin rash, itching, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing. If any signs of a severe allergic reaction occur, seek immediate medical attention.

There are extremely rare reports of systemic infections, such as bacteremia or fungemia, caused by probiotic strains in critically ill or immunocompromised patients. While the risk for healthy individuals is negligible, those with underlying health conditions compromising the immune system should be cautious. If you experience fever, chills, or other signs of systemic illness after starting a probiotic, discontinue use and contact your doctor promptly.

Drug Interactions

Probiotic supplements can interact with certain medications, potentially altering their efficacy or the effects of the probiotic. It is crucial to inform your healthcare provider about all the products you are taking.

Antibiotics are a primary consideration. While this probiotic is often taken to counteract the negative effects of antibiotics on gut flora, the antibiotic can also kill the beneficial bacteria in the supplement. To maximize the benefit, it is generally recommended to take the probiotic at least 2 to 3 hours apart from the antibiotic dose. This timing helps to reduce the direct destruction of probiotic bacteria by the antimicrobial agent, allowing them to reach the colon more effectively.

Concurrent use with immunosuppressant medications (e.g., azathioprine, cyclosporine, tacrolimus, high-dose corticosteroids) may increase the risk of infection from the live microorganisms. Patients on such therapies must use this product only under strict medical supervision.

While not a direct interaction, the zinc content in this supplement can interfere with the absorption of certain oral medications, particularly some antibiotics (e.g., quinolones, tetracyclines) and bisphosphonates (used for osteoporosis). To prevent this, a separation of at least 2 hours between taking zinc and these medications is advised. Consult your pharmacist for specific guidance on timing your doses.

The vitamin D3 component may have additive effects with other vitamin D supplements or medications like calcitriol, potentially leading to hypercalcemia (elevated calcium levels) if doses are excessive. Monitor your total vitamin D intake from all sources.

Overdose

Accidental ingestion of a dose significantly higher than the recommended one capsule per day is unlikely to cause serious acute toxicity due to the nature of the ingredients. However, exceeding the stated dose is not advised.

In the event of a substantial single overdose, the most probable consequences would be an exacerbation of the known gastrointestinal adverse effects. This could include severe bloating, cramping abdominal pain, pronounced flatulence, and profuse diarrhea as the digestive system is overwhelmed by an excessive bacterial load and high mineral content. These symptoms are expected to be self-limiting and should resolve once the product is discontinued and the excess is expelled from the body.

Chronic excessive intake could potentially lead to electrolyte imbalances due to persistent diarrhea, and the high intake of zinc may result in copper deficiency over time, which can manifest as neurological symptoms and anemia. Excessive iodine intake from the brown algae extract can disrupt thyroid function, leading to either hyperthyroidism or hypothyroidism in susceptible individuals. Vitamin D toxicity (hypervitaminosis D) is very unlikely from this product’s dosage but could occur with massive, long-term overdose, resulting in hypercalcemia.

There is no specific antidote for an overdose of this probiotic supplement. Treatment is supportive and symptomatic. In case of suspected overdose, discontinue the product immediately, ensure adequate hydration, and seek medical advice or contact a Poison Control Center. Provide the medical professional with the product packaging for ingredient information.

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.