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Floristore Capsules

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Probiotic Culture Concentrate Not less than 2.5Billion CFU Capsules

Each veg capsule contains:

Probiotic Culture Concentrate not less than 2.5 Billion CFU.

[Lactobacillus Acidophillus (NCM),

Lactobacillus Paracasei (LPC-37),

Bifidobacterium Lactis (Bi-07),

Bifidobacterium Lactis (Bi-04)]

Capsule, 2.5 Billion CFU

4.1 Therapeutic indication

  • Management and restoration of disturbed gut flora.

4.2 Posology and method of administration

  • 1 - 2 capsules per day

4.3 Contraindications

  • Subjects known to have shown a previous reaction, including anaphylaxis or an allergy to milk or to any component of Floristore.

4.4 Special warnings and precautions for use

  • Avoid taking Floristore along with oral antibiotics; preferably keep a gap of 2 hours between antibiotics and Floristore capsule.
  • Floristore should be taken during and continued for 1-2 weeks post antibiotic therapy to fully restore the gut microflora and minimize the opportunity for antibiotic-related side effects.

4.5 Drugs interactions

No known drug-drug interaction

4.6 Use in special populations

Usage in pregnancy & lactation

Floristore is generally considered as safe during pregnancy & lactation. However, pregnant and lactating women should consult physician before starting treatment with Floristore.

Usage in pediatrics

Safety and efficacy in children has not been established.

4.7 Effects on ability to drive and use machines

It is not known whether Floristore capsule alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.

4.8 Undesirable effects

During clinical studies patients reported less adverse events in Floristore group (4.2%) as compared to placebo (7.2%) The adverse events reported in both groups included: allergy to seafood, arrhythmia, fever, headache, left upper arm fracture, runny nose, and vomiting.

4.9 Overdose

No data on overdosage of this product. Available clinical studies demonstrate that floristore is safe and no significant adverse or toxic effects of Floristore are observed in humans.

5.1 Pharmacodynamic properties

Floristore may affects intestinal bacteria by increasing the populations of the beneficial anaerobic bacteria and decreasing the population of potentially pathogenic microorganisms.

Floristore affects the intestinal ecosystem by stimulating mucosal immune mechanisms and by stimulating nonimmune mechanisms through antagonism/competition with potential pathogens. These phenomena are thought to mediate most beneficial effects, including reduction of the incidence and severity of diarrhea, which is one of the most widely, recognized uses for probiotics.

5.2 Pharmacokinetic properties

Floristore provides a high concentration of live bacteria that survives the hostile gastric acid, bile and pancreatic secretions and colonizes the gastrointestinal lumen. Studies show that supplementation of Floristore promotes more rapid return to pre-antibiotic baseline faecal bacterial microbiota. Therefore, Floristore taken during and after antibiotic therapy minimizes the antibiotic induced disturbances of fecal microbiota. 

6.1 Animal Toxicology or Pharmacology

No known animal toxicology data

Floristore is a probiotic culture concentrate containing not less than 2.5 Billion CFU. The Floristore formulation is designed to provide 50% by count of those bacteria that are adapted to the upper intestine—specifically the Lactobacillus species: L. acidophilus NCFM and L. paracasei Lpc-37. The remaining 50% by count is provided by Bifidobacterium species, which are adapted to the lower intestinal tract. These strains are B. lactis Bi-07and B. lactis Bl-04. All the four strains are proportionate (25%).

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

24 months

8.3 Packaging information

1 blister strip of 10 capsules.

8.4 Storage and handing instructions

Store below 25oC.

Keep out of reach of children.

  • Not for medicinal use. This product is not intended to diagnose, treat, cure or prevent any disease.
  • Not to exceed the stated recommended daily dose.
  • If you are pregnant or nursing, please ask a healthcare professional.
  • Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

05.07.2024

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Floristore® is and what it is used for

2. What you need to know before you use Floristore®

3. How to use Floristore®

4. Possible side effects

5. How to store Floristore®

6. Contents of the pack and other information

Floristore® is a brand of probiotics that includes various strains of beneficial or friendly bacteria, such as Lactobacillus acidophilus and Bifidobacterium lactis. These probiotics are known for their ability to support digestive health and overall well-being by maintaining a healthy balance of gut flora.

Probiotics like Floristore® help maintain gut flora through several mechanisms.

  • Restoring Balance: Floristore® help restore and maintain a healthy balance of beneficial bacteria in the gut. They compete with harmful bacteria for resources and space, thereby preventing the overgrowth of potentially harmful microbes.
  • Enhancing Digestion: Lactobacillus acidophilus and Bifidobacterium lactis aid in the digestion of certain foods, particularly carbohydrates and lactose. This can help reduce symptoms of digestive discomfort such as bloating, gas, and diarrhea.
  • Supporting Immune Function: A significant portion of the body's immune system resides in the gut. Floristore® probiotics can help support immune function by promoting the production of certain immune cells and enhancing their activity. Producing Beneficial Substances: Some strains of Floristore®, including Lactobacillus acidophilus and Bifidobacterium lactis, produce short-chain fatty acids (SCFAs) and other compounds that provide nourishment to the cells lining the gut and contribute to overall gut health.

Do not use Floristore®:

- if you are allergic to Floristore®, or any of the other ingredients of this medicine. - Subjects known to have shown a previous reaction, including anaphylaxis or an allergy to milk or to any component of Floristore.

Warnings and precautions

  • Avoid taking Floristore along with oral antibiotics; preferably keep a gap of 2 hours between antibiotics and Floristore capsule.
  • Floristore should be taken during and continued for 1-2 weeks post antibiotic therapy to fully restore the gut microflora and minimize the opportunity for antibiotic-related side effects.
  • Take special care with Floristore®, if you have severe disorder of the immune system. In this case, ask your doctor for advice before using i Floristore®.

Children

Floristore® is not recommended for children because of lack of data regarding the safety and efficacy.

Other medicines and Floristore®

Avoid taking Floristore along with oral antibiotics; preferably keep a gap of 2 hours between antibiotics and Floristore capsule.

Tell your doctor if you are taking or have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

Floristore is generally considered as safe during pregnancy & lactation. However, pregnant and lactating women should consult physician before starting treatment with Floristore.

Driving and using machines

Generally using Floristore capsule has no influence on ability to drive and use machines.

Generally recommended daily dose for adults is 1 - 2 capsules per day.

Use best before 24 months from the date of manufacturer. If you have any further questions on the use of Floristore® capsules, ask your doctor or pharmacist.

If you take more Floristore® than you should

A higher dose of the medicine does not pose any threat for the patient. However, if you may have used more Floristore® than you should, talk to a doctor or a pharmacist immediately. No case of overdose has been reported.

If you forget to use Floristore®

If you forget to use Floristore®, use the next dose at the usual time. Do not use a double dose to make up a forgotten dose.

If you stop using Floristore®

Do not stop taking Floristore® without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor.

During clinical studies patients reported less adverse events in Floristore group (4.2%) as compared to placebo (7.2%) The adverse events reported in both groups included: allergy to seafood, arrhythmia, fever, headache, left upper arm fracture, runny nose, and vomiting.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top of the home page. https://www.zuventus.co.in/drug-safety-reporting By reporting side effects, you can help provide more information on the safety of this medicine.

Store below 25oC. Keep out of reach of children.

Each Floristore® veg capsule contains:

Probiotic Culture Concentrate not less than 2.5 Billion CFU.

[Lactobacillus Acidophillus (NCM),

Lactobacillus Paracasei (LPC-37),

Bifidobacterium Lactis (Bi-07),

Bifidobacterium Lactis (Bi-04)]

What Floristore® looks like and contents of the pack

1 blister strip of 10 capsules.

Marketing Authorisation Holder

Zuventus Healthcare Limited

Zuventus House Plot No. Y2, CTS No: 358/A2,

near Nahur Railway Station, off Raycon IT Park Road,

Nahur West, Mumbai, Maharashtra 400078

This leaflet was last revised in July 2024.

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