Active ingredients: Tylactase
Chewable tablets 2250 units / tablet
Why is Lacdigest used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Digestives - Preparations based on enzymes.
THERAPEUTIC INDICATIONS
Lactose intolerance due to primary and secondary lactase deficiency
Contraindications When Lacdigest should not be used
Known hypersensitivity to the active substance or to other components of the formulation.
Precautions for use What you need to know before taking Lacdigest
Pregnancy and breastfeeding
The lactase enzyme is normally present in the intestine, it does not enter the bloodstream.
However, it is recommended to take the medicine only after consulting your doctor to evaluate the therapeutic benefit against the possible risk especially in the first three months of pregnancy.
Interactions Which drugs or foods can modify the effect of Lacdigest
The presence of sodium and potassium ions increase the activity of lactase in vitro. Calcium ions and those of heavy metals, such as copper, slow down the enzymatic activity in vitro.
Warnings It is important to know that:
If, despite treatment with LACDIGEST, intestinal symptoms persist or if other symptoms not related to lactose intolerance appear, contact your doctor.
Dose, Method and Time of Administration How to use Lacdigest: Posology
The posology must be adapted case by case according to the severity of the symptoms due to lactose intolerance and the quantity of lactose ingested.
The usual dosage is as follows:
Adults and children over three years of age: 1 chewable tablet for every 5 g of ingested lactose (corresponding to the quantity contained in approximately 100 ml of milk). If symptoms persist, the dosage can be increased.
Do not take more than 6 tablets as a single dose and 12 tablets as a daily dose.
The tablets should be chewed, or swallowed whole, just before eating or drinking food containing lactose.
Do not exceed the dosage prescribed by your doctor.
Overdose What to do if you have taken too much Lacdigest
There are no known cases of overdose.
Side Effects What are the side effects of Lacdigest
The lactase enzyme is active only in the intestine and is not absorbed. Therefore, any side effects are localized or linked to cases of hypersensitivity to the active ingredient or to one of the components of the formulation. In this case it is necessary to stop the treatment. the possibility of onset of any effect is limited if it respects the posology prescribed by the doctor.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. It is important to inform your doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Check the expiration date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after this date.
Do not store above 25 ° C.
Store the medicine in the original container to keep it away from moisture.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN.
Composition and pharmaceutical form
COMPOSITION
Each tablet contains:
Active ingredient: tylactase (Lactase, β-D-galactosidase from Aspergillus oryzae) 2250 units
Excipients: glucose monohydrate, corn starch, magnesium stearate, microcrystalline cellulose, sodium citrate (trisodium salt dihydrate), anhydrous glucose, calcium carboxymethylcellulose.
PHARMACEUTICAL FORM AND PACKAGING
Chewable tablets. Jar of 50 and 100 tablets.
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
LACDIGEST 2250 U CHEWABLE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains
Active principle: Tylactase (Lactase, b-D-galactosidase from Aspergillus oryzae) 2250 units
For excipients see 6.1.
03.0 PHARMACEUTICAL FORM
Chewable tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Lactose intolerance due to primary and secondary lactase deficiency.
04.2 Posology and method of administration
The posology must be adapted case by case according to the severity of the symptoms due to lactose intolerance and the quantity of lactose ingested.
The usual dosage is as follows:
Adults and children over three years of age: 1 chewable tablet for every 5 g of ingested lactose (corresponding to the quantity contained in approximately 100 ml of milk). If symptoms persist, the dosage can be increased.
Do not exceed 6 tablets as a single dose or 12 tablets as a daily dose.
The tablets should be chewed or swallowed whole just before eating or drinking lactose-containing foods.
04.3 Contraindications
Known hypersensitivity to the active substance or to other components of the formulation.
04.4 Special warnings and appropriate precautions for use
If, despite treatment with LACDIGEST, intestinal symptoms persist or if other symptoms not related to lactose intolerance appear, suspend the treatment and proceed to investigations to verify the exact etiological nature of the intestinal symptoms. Subsequently, lactose intolerance can be verified (by means of, for example, the deprivation and reintroduction diet, the hydrogen respiratory test, or other).
The medicine is not contraindicated for people with celiac disease.
04.5 Interactions with other medicinal products and other forms of interaction
The presence of sodium and potassium ions increase the activity of lactase in vitro. Calcium ions and those of heavy metals, such as copper, slow down the enzymatic activity in vitro.
04.6 Pregnancy and lactation
The lactase enzyme is normally present in the intestine, it does not enter the bloodstream. However, especially in the first three months of pregnancy, the therapeutic benefit must be carefully weighed against the possible risks.
04.7 Effects on ability to drive and use machines
LACDIGEST does not affect the ability to drive or use machines
04.8 Undesirable effects
The lactase enzyme is active only in the intestine and is not absorbed. Therefore, any side effects are localized or linked to cases of hypersensitivity to the active ingredient or to one of the components of the formulation. In this case it is necessary to stop the treatment.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: digestives, including enzymes - preparations based on enzymes.
ATC code: A09AA04.
The bD-galactosidase from Aspergillus oryzae is an enzyme which, like the lactase produced by intestinal enterocytes at the brush border, is able to separate lactose into its two constituent and absorbable monosaccharides: glucose and galactose. Clinical studies have shown , by means of the hydrogen respiratory test, that the enzyme is active for oral administration without the use of gastro-resistant formulations.
05.2 "Pharmacokinetic properties
There are no studies demonstrating the intestinal availability of lactase or its absorption, metabolism, protein binding and elimination. Pharmacokinetics and metabolism should be compared to those of other enzymes that are administered orally such as pancreatic enzymes used as replacement therapy in pancreatic insufficiency.
05.3 Preclinical safety data
No animal toxicity data with beta-D-galactosidase are reported in the literature.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Glucose monohydrate, corn starch, magnesium stearate, microcrystalline cellulose, sodium citrate (trisodium salt dihydrate), anhydrous glucose, calcium carboxymethylcellulose.
06.2 Incompatibility
None known.
06.3 Period of validity
24 months.
The expiry date indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
Do not store above 25 ° C.
Store the medicine in the original container to keep it away from moisture
06.5 Nature of the immediate packaging and contents of the package
Polypropylene tablet container with polyethylene lid fitted with a "tamper-evident" pull tab for the first opening.
Lacdigest in packs of 100 chewable tablets.
Lacdigest in packs of 50 chewable tablets.
06.6 Instructions for use and handling
To open the jar for the first time, grasp the free edge of the lid tab and pull backwards. Then lift the lid by pressing with your thumb, from bottom to top, on the special shape of the lid.
07.0 MARKETING AUTHORIZATION HOLDER
Italchimici SpA
Via Pontina 5, Km 29
00040 Pomezia (Rome)
08.0 MARKETING AUTHORIZATION NUMBER
Lacdigest 2250 u chewable tablets in packs of 100 tablets, AIC n ° 035245012
Lacdigest 2250 u chewable tablets in packs of 50 tablets, AIC n ° 035245024
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: December 2003
Renewal date: February 2009
10.0 DATE OF REVISION OF THE TEXT
February 2009
