Florimax Capsules

Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria capsules

Each vegetable capsule contains not less than 112.5 billion colony forming units (CFU) of following 8 bacterial strains :

Streptococcus Thermophilus DSM 24731

Bifidobacterium Breve DSM 24732

Bifidobacterium Longum DSM 24736

Bifidobacterium Infantis DSM 24737

Lactobacillus Acidophilus DSM 24735

Lactobacillus Plantarum DSM 24730

Lactobacillus Paracasei DSM 24733

Lactobacillus Delbrueckii Subsp. Bulgaricus DSM 24734

Approved colours used in capsule shell.

Appropriate overages added to compensate loss on storage.

Capsule, 112.5 billion CFU

4.1 Therapeutic Indication

Florimax is indicated for the treatment of irritable bowel syndrome.

4.2 Posology & Method of Administration

Irritable Bowel Syndrome : The usually recommended dose of Florimax is 2-4 capsules per day.

4.3 Contraindications

Hypersensitivity to the active substance.

4.4 Warning & Precautions

The effectiveness of Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules has been evaluated in patients with various gastro-intestinal disorders including: Irritable bowel syndrome, Pouchitis, Ulcerative colitis, Crohn’s disease, hepatic disorders and radiation induced diarrhoea. In addition to demonstrating efficacy, these studies support the safety of Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules in these patient groups.

4.5 Drug Interactions

Patients should avoid taking Florimax concomitantly with antibiotics. Antibiotics may inactivate some strains of bacteria in Florimax.

4.6 Special populations

Pregnancy & Lactation

Florimax is not contraindicated in pregnancy and lactation. However, pregnant or breastfeeding women should consult their doctor before taking this or any other food supplement.

4.7 Effects on ability to drive and use machines

None anticipated.

4.8 Undesirable Effects

A minority of subjects consuming Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules at very high dosages have complained of one or more of the following symptoms: bloating, diarrhoea, abdominal pain and rarely vomiting and nausea. These symptoms are commonly related to a diet rich in carbohydrates and fats.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to : medico@zuventus.com  By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

As of today, there have been no reports of an overdose with Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules or other probiotic products. Available experimental and clinical studies have firmly demonstrated that Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules are safe and no significant adverse or toxic effects related to the treatment have been observed in experimental animals or human beings who consumed the product

5.1 Mechanism of Action / Pharmacodynamic Properties

The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized. The presence of adequate concentrations of beneficial bacteria, particularly bifidobacteria and lactobacilli, in the gastrointestinal tract may help prevent the overgrowth of more harmful bacteria, such as clostridia and enterobacteria. In addition, many carbohydrates (e.g., starches, dietary fibers) are not digested in the upper gastrointestinal tract but degraded by colonic bacteria known to produce enzymes and substances with nutritional functions, such as short chain fatty acids, butyrate and lactic acid. Several studies have demonstrated that patients with Irritable Bowel Syndrome (IBS) typically may have decreased luminal or faecal concentrations of lactobacilli and bifidobacteria compared with healthy individuals. IBS patients may benefit from consuming significantly high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. This is particularly important for these patients in view of their frequent antibiotic treatment and recent evidence implicating harmful intestinal bacteria in inflammatory bowel diseases and functional bowel disorders. Studies have demonstrated that the consumption of Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules helps modulate intestinal inflammation, reduce colonic permeability, and enhance epithelial barrier function. Patients who received Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules were found to have increased concentrations of the anti-inflammatory cytokine IL-10 and reduced levels of the proinflammatory cytokines IL-1α, IL-1β, interferon-γ, and tumour necrosis factor-α.

5.2 Pharmacokinetic properties

Live Freeze-Dried Lactic Acid Bacteria and Bifidobacteria Capsules provide nutritional support for the treatment of IBS patients by delivering a high concentration of several strains of live bacteria in a formulation that survives gastric fluid, bile, and pancreatic secretions, and colonizes the gastrointestinal tract. Analysis of fecal samples obtained from healthy volunteers and patients with inflammatory bowel disease (IBD) showed that consumption of the product on a regular basis results in a significant increase of lactobacilli and bifidobacteria counts in feces.

6.1 Animal Toxicology or Pharmacology

No known animal toxicology data

Florimax is a probiotic containing 112.5 billion CFU of live freeze dried lactic acid bacteria and bifidobacteria.

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on the pack.

8.3 Packaging information

A blister strip of 10 capsules / 2 capsules (PS).

8.4 Storage and handing instructions

Store protected from moisture at a temperature between 2°C to 8°C. Do not freeze.

Keep out of reach of children.

Mild abdominal bloating has been occasionally reported during the first few days of consuming Florimax. This is generally a readjustment of the microbiota, which usually diminishes within 3-4 days. If bloating persists, the patient should reduce their intake for a few days

07 November 2022