Active ingredients: Lactobacillus LB (L. fermentum and L. delbrueckii)
LACTEOL 10 billion oral powder and 5 billion hard capsules and sachets
Why is Lacteol used? What is it for?
Pharmacotherapeutic group
Antidiarrheal of microbial origin
THERAPEUTIC INDICATIONS
Symptomatic treatment of diarrhea due to altered bacterial flora in children and adults.
Contraindications When Lacteol should not be used
Known hypersensitivity to the product
Precautions for use What you need to know before taking Lacteol
The product can be used during pregnancy and while breastfeeding.
N.B .: in infants under two years of age the product must be used together with rehydration therapy.
Above two years, treatment with the product does not exclude rehydration therapy, if necessary. The degree of rehydration (oral or intravenous) must adapt to the severity of the diarrhea, age and health conditions of the patient.
Interactions Which drugs or foods can modify the effect of Lacteol
No interactions have been reported with the use of other systemic or topical drugs.
Warnings It is important to know that:
Effects on driving and use of machines
The product does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Lacteol: Posology
Dose, method and frequency of administration
Capsules: 2 to 4 capsules per day. In case of acute diarrhea: 2 capsules 3 times a day on the first day, 2 capsules twice a day until the second day after the symptoms disappear.
Sachets: 1 to 2 sachets per day. In case of acute diarrhea: 1 sachet 3 times a day on the first day, 2 times a day until the second day after the symptoms disappear.
Duration of treatment
In relation to the severity of the disease, according to the doctor's instructions.
Indications for use
Capsules: Swallow one capsule with water.The contents of the capsule can be dissolved in the bottle with water or milk.
Sachets: Dissolve the granules of the sachet in half a glass of water. The contents of a sachet can be dissolved in the bottle with water or milk.
Side Effects What are the side effects of Lacteol
At the recommended doses the product is well tolerated. The patient should report any undesirable effect to the treating physician or pharmacist, if any.
Expiry and Retention
The expiry date refers to the product in intact packaging, correctly stored.
Attention
Do not use the medicine after the expiry date indicated on the package.
Keep this medicine out of the reach and sight of children.
Special precautions for storage of the medicinal product.
Lacteol sachets: no special storage precautions.
Lacteol capsules: store at a temperature not exceeding 25 ° C.
Composition
Capsules:
One capsule contains: Lactobacillus LB (L. Fermentum and L. delbrueckii) (inactivated and freeze-dried microbial bodies) 5 billion.
Excipients: neutralized and lyophilized culture medium, lactose monohydrate, calcium carbonate, silicic acid, talc, magnesium stearate, anhydrous lactose, gelatin.
Sachets:
One sachet contains: Lactobacillus LB (L. fermentum and L. delbrueckii) (inactivated and freeze-dried microbial bodies) 10 billion.
Excipients: neutralized and lyophilized culture medium, lactose monohydrate, calcium carbonate, silicic acid, banana-orange flavor, sucrose.
Pharmaceutical form
20 capsules of 0.235 g.
10 sachets of 0.800 g.
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
LACTEOL 10 BILLION ORAL POWDER AND 5 BILLION HARD CAPSULES.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains:
-Active principle:
Lactobacillus LB * powder (inactivated and freeze-dried microbial bodies) in fermented culture broth ............ 170 mg.
corresponding to:
- 5 billion Lactobacillus LB *
One sachet contains:
-Active principle:
Lactobacillus LB * powder (inactivated and freeze-dried microbial bodies) in fermented culture broth ............ 340 mg.
Corresponding to:
- 10 billion Lactobacillus LB *
* Lactobacillus fermentum andLactobacillus delbrueckii
For excipients see par. 6.1
03.0 PHARMACEUTICAL FORM
Capsules
Pack containing 20 capsules - oral use.
Sachets
Pack containing 10 sachets - oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Diarrheal and dyspeptic syndromes due to altered bacterial flora (diarrhea, non-specific enteritis of infants and adults, colitis). Intestinal dysmicrobism due to antibiotics. Digestive disorders in the bottle-fed infant. Adjuvant in the elimination of pathogenic enterobacteria resistant to chemo-antibiotics.
04.2 Posology and method of administration
Capsules: 2 to 4 capsules per day. In case of acute diarrhea: 2 capsules 3 times a day on the first day, 2 capsules twice a day until the second day after the symptoms disappear.
Swallow one capsule with water. The contents of the capsule can be dissolved in the bottle with water or milk.
Sachets: 1 to 2 sachets per day. In case of acute diarrhea: 1 sachet 3 times a day on the first day, 2 times until the second day after the symptoms disappear. Dissolve the granules of the sachet in half a glass of water. The contents of a sachet can be dissolved in the bottle with water or milk.
04.3 Contraindications
Individual hypersensitivity to the drug.
04.4 Special warnings and appropriate precautions for use
Keep out of the reach and sight of children.
N.B .: in infants under two years of age the product must be used together with rehydration therapy.
Above two years, treatment with the product does not exclude rehydration therapy, if necessary.
The degree of rehydration (oral or intravenous) must adapt to the severity of the diarrhea, age and health conditions of the patient.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions have been reported with the use of other systemic or topical drugs.
04.6 Pregnancy and lactation
No teratogenic effects are known. No overdose was recorded due to the passage of the product into the mother's milk during lactation.
04.7 Effects on ability to drive and use machines
The product does not interfere with driving ability or the use of machines.
04.8 Undesirable effects
They are not known.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Antidiarrheal of microbial origin.
The active ingredients are metabolic products from inactivated Lactobacillus LB after culture in a whey-based medium.
* In vitro and in vivo pharmacological studies have highlighted 4 types of mechanisms:
Direct bacteriostatic action due to chemicals produced by Lactobacillus LB (lactic acid, natural bacteriostatic substances of unknown composition);
Nonspecific immunostimulation of the mucous membranes (increased IgA synthesis)
Stimulation of the growth of the defensive acid-forming flora mainly due to the presence of numerous B vitamins.
Adhesion of inactivated Lactobacillus LB to absorbent and muco-secretory human intestinal cells. The presence of inactivated Lactobaccilus LB and its fermented culture broth inhibits the adhesion and enterocytic invasion of the microorganisms responsible for diarrhea in a cell culture model.
Administration of inactivated Lactobacillus LB inhibits (in mice) the systemic dissemination of Campylobacterr jejuni from the digestive tract.
* The clinical efficacy of the drug for the treatment of diarrhea is not documented by tests, controls using the currently recognized criteria (in particular the reduction of the daily amount of faeces).
05.2 "Pharmacokinetic properties
No specific studies have been performed, considering the nature of the active principle which acts by contact on the intestinal mucosa without a "systemic activity.
05.3 Preclinical safety data
Studies carried out on rodents have not shown any toxic effects associated with the administration of Lacteol administered orally. Each batch of product was regularly subjected to safety tests which were always negative. On the other hand, clinical use for over a decade has never shown any toxicity of the product.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Capsules:
Fermented and lyophilized culture broth, Lactose monohydrate, Calcium carbonate, Silicic acid, Talc, Magnesium Stearate, Anhydrous lactose, Gelatin
Sachets:
Fermented and lyophilized culture broth, Lactose monohydrate, Calcium carbonate, Silicic acid, Banana-orange flavor, Sucrose.
06.2 Incompatibility
Lacteol has no known incompatibility with other drugs.
06.3 Period of validity
In intact packaging Lacteol capsules and sachets: valid for 36 months.
06.4 Special precautions for storage
Lacteol capsules: store at a temperature not exceeding 25 ° C.
Lacetol sachets: no special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Lacteol capsule is contained in heat-sealed blisters composed of an aluminum and a PVC foil; in Lacteol sachets the powder is contained in heat-sealed sachets consisting of cellulose, aluminum and polythene sheets.
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
BRUSCHETTINI S.R.L. Via Isonzo 6, Genoa (Italy).
Pharmaceutical Production Workshop: Axcan Pharma S.A., Route de Bû, 78550 Houdan, (France).
Secondary packaging operations: Bruschettini S.r.l. - Genoa
08.0 MARKETING AUTHORIZATION NUMBER
Box of 20 capsules: A.I.C. n. 028962013
Pack of 10 sachets: A.I.C. n. 028962025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
January 1995 / October 2004.
10.0 DATE OF REVISION OF THE TEXT
April 2008.
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