Trilac

Package Leaflet: Information for the User

Trilac

1.6 x 10 CFU* lactic acid bacteria
hard capsules
composite product

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet, as you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Trilac and what is it used for
• 2. Important information before taking Trilac
• 3. How to take Trilac
• 4. Possible side effects
• 5. How to store Trilac
• 6. Package contents and other information

1. What is Trilac and what is it used for

During antibiotic treatment, the natural flora of the gastrointestinal tract is severely disrupted, which can lead to infection with pathogenic microorganisms.
Trilac has a beneficial effect on the human gastrointestinal tract, as it contains lactic acid bacteria that lower the pH in the gastrointestinal tract, allowing the development of normal intestinal flora and preventing the colonization and growth of pathogenic microorganisms.
The bacterial composition of Trilac has been selected as follows:

• Lactobacillus acidophiluscolonizes and multiplies in the small and large intestine. It creates favorable conditions for the development of Bifidobacterium animalissubsp. lactis, bacteria whose amount in the gastrointestinal tract decreases in older people.
• Lactobacillus delbrueckiisubsp. bulgaricusis not part of the natural, permanent intestinal flora, but it is important for the gastrointestinal environment, as it produces natural compounds with antibiotic properties.

Indications for use:

• post-antibiotic enteritis, with particular emphasis on supportive treatment of pseudomembranous colitis, mainly in recurrent pseudomembranous colitis,
• prevention of traveler's diarrhea,
• supportive treatment after antibiotic therapy.

2. Important information before taking Trilac

When not to take Trilac

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to cow's milk protein.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
The safety of Trilac during pregnancy has not been studied.
Trilac can be used in women during breastfeeding in accordance with the recommended dosage.
Before taking the medicine, the patient should consult her doctor.

Driving and using machines

Trilac does not affect the ability to drive or operate machines.

Trilac and other medicines

Trilac taken simultaneously with an antibiotic may exhibit weaker probiotic activity.

3. How to take Trilac

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose
1-2 capsules orally 3 times a day for 2 weeks to 1 month, then 1-2 capsules can be taken per day.
Best taken with a large amount of liquid during a meal or 1 hour before a meal.

In case of overdose:

There is no data on overdose.

In case of missed dose:

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported so far.
In case of side effects, the patient should inform their doctor.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Trilac

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging: EXP.
The expiry date refers to the last day of the month.
Blister pack of 20 capsules
Store in a refrigerator at 2°C - 8°C. During treatment, it can be stored in a dry place at a temperature below 25°C.
Aluminum container for 30 or 90 capsules.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Trilac contains

The active substances of the medicine are lactic acid bacteria:

• Lactobacillus acidophilus(La-5) 37.5%
• Lactobacillus delbrueckiisubsp. bulgaricus(Lb-Y27) 25%
• Bifidobacterium animalissubsp. lactis(Bb-12) 37.5% One capsule contains 1.6 x 10 CFU* lactic acid bacteria *CFU (from English: colony forming unit) - colony-forming unit

Other ingredients are:
skimmed milk powder, yeast extract, sodium ascorbate, inositol, sodium glutamate, sodium alginate, magnesium stearate, anhydrous glucose.
Capsule shell: titanium dioxide, gelatin.

What Trilac looks like and what the package contains

Hard capsules
The capsule is a white or white-cream-colored gelatin capsule filled with a powder or a brittle consistency wafer of light beige to salmon color.
Packaging:
20 hard capsules, packaged in an aluminum/PVC/TE/PVDC blister pack, in a cardboard box.
30 and 90 hard capsules, packaged in an aluminum container, closed with a polyethylene cap equipped with a desiccant, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Krotex Pharm Sp. z o.o. Sp.k.
ul. Dostępna 56
01-490 Warsaw

Manufacturer

Farmina Sp. z o.o.
ul. Cegielskiego
232-400 Myślenice
Allergon AB
Välingevägen 309
S-262 92 Ängelholm
Sweden

Date of last update of the leaflet:

02/2021