Europe — EMA
Normaflore Extra (Bacillus Clausii)
GNH USA supplies Normaflore Extra (Bacillus clausii), a probiotic for acute and antibiotic‑associated diarrhea and intestinal dysbiosis.
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What is Bacillus Clausii?
Bacillus clausii, the active ingredient in Normaflore Extra, is a probiotic presented as an oral preparation for oral use. It helps restore normal intestinal flora and is indicated for the prevention and treatment of acute diarrhea, antibiotic‑associated diarrhea and intestinal dysbiosis in children and adults.
GNH USA supplies Normaflore Extra as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product complies with EU quality standards and is distributed under strict Good Distribution Practice.
What is Bacillus Clausii used for?
Normaflore Extra is a probiotic that works within the gastrointestinal tract to rebalance microbial populations, supporting digestive health in various conditions.
Acute diarrhea: reduces stool frequency and duration by restoring normal gut flora. Antibiotic‑associated diarrhea: prevents overgrowth of pathogenic bacteria during or after antibiotic therapy. Intestinal dysbiosis: helps re‑establish a balanced microbiome in patients with disrupted intestinal flora.
What are the side effects of Bacillus Clausii?
Like all probiotics, Normaflore Extra may be associated with occasional adverse reactions.
Common Side Effects: - Mild abdominal discomfort: transient bloating or gas. - Flatulence: increased intestinal gas. - Nausea: occasional feeling of queasiness. - Transient constipation: occasional reduced bowel movements.
Serious or Rare Side Effects: - Sepsis in immunocompromised patients: rare systemic infection. - Allergic reaction: rash, itching, or swelling.
What precautions apply to Bacillus Clausii?
Before using Normaflore Extra, consider the following precautions. - Immunocompromised patients: assess risk of systemic infection. - Severe underlying disease: consult physician before use. - Infants under one month: avoid unless directed by a healthcare professional. - Concurrent antibiotic therapy: probiotic efficacy may be reduced; consider timing of administration. - Store at ambient temperature: keep below 25 °C, in the original packaging, protected from moisture.
What does Bacillus Clausii interact with?
Bacillus clausii may interact with certain medications, requiring attention to avoid reduced efficacy or safety concerns.
Major Interactions (Avoid): - Broad‑spectrum antibiotics: may kill the probiotic organisms, negating benefit. - Immunosuppressive agents: increased risk of opportunistic infection.
Moderate Interactions (Monitor Closely): - Antifungal agents: may affect probiotic balance, monitor clinical response. - Probiotic‑containing foods: cumulative dosing may cause gastrointestinal discomfort. - Vaccines containing live attenuated organisms: theoretical risk of interference, monitor.
