Active ingredients: Probiotics (Bifidobacterium bifidum + Lactobacillus acidophilus)
Infloran hard capsules
Why is Infloran used? What is it for?
Infloran contains Bifidobacterium bifidum and Lactobacillus acidophilus, microorganisms normally present in the intestine and which balance and replenish the "intestinal bacterial flora". Infloran is used for:
- prevent changes in the intestinal flora that cause for example diarrhea, stomach pain, bloating (gastrointestinal dysmicrobial syndromes);
- to deal:
- diarrhea, colitis, inflammation of the intestine of the adult and infant which can cause symptoms such as cramps, diarrhea and absorption problems (non-specific enteritis);
- alterations of the intestinal flora due to antibiotics (antibiotic dysmicrobism);
- digestive disturbances in infant formula fed infants;
- along with other therapy, intestinal infections due to antibiotic-resistant bacteria.
Talk to your doctor if you don't feel better or if you feel worse after a few days.
Contraindications When Infloran should not be used
Do not take Infloran
- if you are allergic to the active substances or any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Infloran
Do not use for prolonged treatments; consult your doctor if you do not notice any improvement after a few days of treatment.
Also consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in symptoms.
Differences in the color of the product may be observed between different packs: this is due to the other components of this medicine, and does not mean that the product is altered.
Interactions Which drugs or foods can modify the effect of Infloran
Other medicines and Infloran
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Infloran with food, drink and alcohol
There are no known interactions.
Warnings It is important to know that:
Children and adolescents
This medicine can be used in children and adolescents.
Pregnancy and breastfeeding
The medicine can be used during pregnancy and breastfeeding. If you are unsure, ask your doctor or pharmacist for advice before using the medicine.
Driving and using machines
Infloran does not affect the ability to drive or use machines.
Infloran contains sucrose and lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Infloran: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended adult dose is 1 capsule 3 times a day before meals. Swallow the capsule with a small amount of non-hot drink.
Use in children
Follow the same doses indicated in the adult.
For infants, pour the contents of the capsule into a small amount of soft drink or sugar water, not hot.
Duration of treatment: use only for short periods of treatment.
Do not exceed the recommended doses without the advice of your doctor.
Side Effects What are the side effects of Infloran
Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the recommended doses no undesirable effects are reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website: www.agenziafarmaco.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Store in a refrigerator (2 ° C / 8 ° C). Store in the original package to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other Information
What Infloran contains
In a capsule:
- The active ingredients are: freeze-dried live Bifidobacterium bifidum not less than 1,000 million, freeze-dried live Lactobacillus acidophilus not less than 1,000 million.
- The other ingredients are sucrose, sodium citrate, magnesium stearate, dibasic potassium phosphate, lactose monohydrate. The shell is composed of: gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132), quinoline yellow (E104).
What Infloran looks like and contents of the pack
Infloran comes in a pack of 20 hard capsules in blisters.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
INFLORAN HARD CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains:
Active principles:
- Bifidobacterium bifidum live freeze-dried not less than 1,000 million
- Lactobacillus acidophilus live lyophilized not less than 1,000 million
Excipients with known effects: sucrose, lactose monohydrate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Hard capsule.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Prophylaxis.
Prevention of gastrointestinal dysmicrobial syndromes.
Therapy.
Diarrheal and dyspeptic syndromes due to altered bacterial flora (diarrhea, non-specific enteritis of adults and infants, colitis). Antibiotic dysmicrobisms. Digestive disorders in the bottle-fed infant. Adjuvant in the elimination of pathogenic enterobacteria resistant to chemoantibiotics.
04.2 Posology and method of administration
Dosage
One capsule three times a day
Method of administration:
Swallow with some non-hot liquid in both children and adults before meals.
Pediatric population
In infants, pour the contents of the capsule into a little liquid or sugared water, not hot.
Do not exceed the recommended dose.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. Differences in the color of the lyophilisate can be observed between one batch and another, due to the excipients of the preparation.
The medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
The medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Do not report.
04.6 Pregnancy and breastfeeding
Infloran can be administered during pregnancy and breastfeeding.
04.7 Effects on ability to drive and use machines
Infloran does not affect the ability to drive or use machines.
04.8 Undesirable effects
At the recommended doses no undesirable effects are reported.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No overdose reactions have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: lactic acid producing organisms, combinations, ATC code: A07FA51
Mechanism of action
Eubiotic saprophytes of the human intestine. They balance and reintegrate the intestinal bacterial flora; they inhibit the colonization of pathogenic germs with an antibiotic mechanism; they act against intestinal dismicrobism by chemoantibiotics.
05.2 Pharmacokinetic properties
They colonize rapidly, activate the physiological functions of the intestinal flora and survive in the intestine being components of the normal enteroflora.
05.3 Preclinical safety data
No data from animal model studies are available
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sucrose, sodium citrate, magnesium stearate, dibasic potassium phosphate, lactose monohydrate
Excipients of the wrapper
Gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132), quinoline yellow (E104).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store in a refrigerator (2 ° C - 8 ° C).
Store in the original package to protect the medicine from light.
06.5 Nature of the immediate packaging and contents of the package
Infloran comes in a pack of 20 hard capsules in PVC / PVDC and aluminum blisters.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Pharmaceutical Laboratory S.I.T. S.r.l. - Via Cavour 70 - 27035 Mede (PV).
08.0 MARKETING AUTHORIZATION NUMBER
024037018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 12 October 1979
Date of most recent renewal: 1 June 2010.
