Lakcid forte

Package Leaflet: Information for the Patient

Lakcid Forte, Powder for Oral Suspension

Lactobacillus rhamnosus
Minimum 10 billion CFU of Lactobacillus rhamnosusbacteria

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• This leaflet should be kept in case you need to read it again.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Lakcid Forte and what is it used for
• 2. Important information before taking Lakcid Forte
• 3. How to take Lakcid Forte
• 4. Possible side effects
• 5. How to store Lakcid Forte
• 6. Contents of the pack and other information

1. What is Lakcid Forte and what is it used for

Lakcid Forte is a powder for oral suspension. It contains Lactobacillus rhamnosusbacterial strains, which, like other lactic acid bacteria, colonize the intestinal mucosa and normalize the composition of the gut microflora, especially after its depletion due to antibiotic therapy. The results of conducted studies have confirmed that these strains survive in the gastric juice environment and are resistant to the action of bile salts, which enables them to adapt and survive in the gastrointestinal tract.
By competing for substrates and colonization sites on the intestinal mucosa and producing lactic acid as a result of anaerobic sugar decomposition, they create unfavorable conditions for the development of most pathogenic microorganisms.
These strains have natural resistance to a wide range of clinically used antibiotics.
Lakcid Forte is intended for use:

• in post-antibiotic enteritis, with particular emphasis on supportive treatment of pseudomembranous colitis; as the main treatment for recurrent pseudomembranous colitis,
• in the prevention of traveler's diarrhea,
• as supportive treatment during and after antibiotic therapy.

2. Important information before taking Lakcid Forte

When not to take Lakcid Forte

• if you are allergic to the active substances or any of the other ingredients of this medication (listed in section 6), including cow's milk protein.

Warnings and precautions

Before starting to take Lakcid Forte, you should discuss it with your doctor.
The medication is intended for oral use. Do not inject.
There is a risk of bacteremia (sepsis). Single cases of infectious endocarditis in a patient in severe condition caused by Lactobacillus rhamnosusinfection have been reported.
Treatment with a medication containing Lactobacillus rhamnosusmay, in exceptional cases, cause septic infections in a group of patients at increased risk, mainly premature infants and children born at term but with defects or impaired organ function.

Lakcid Forte with food and drink

The medication is administered regardless of meal times.

Pregnancy and breastfeeding

The medication can be used in pregnant and breastfeeding women.

Driving and operating machinery

Lakcid Forte does not affect the ability to drive and operate machinery.

Lakcid Forte contains sucrose, lactose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medication.

3. How to take Lakcid Forte

This medication should always be used exactly as described in the patient leaflet or as advised by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.
Oral administration.
Recommended dose
If your doctor does not advise otherwise, 2 times a day, 1 dose (contents of 1 vial or 1 sachet).
Before use, remove the cap from the vial and pull out the rubber stopper. Add a small amount of boiled and cooled water or milk to the vial, mix well.
Pour the contents of the vial onto a spoon.
Before use, tear the sachet at the notch. Dissolve the contents of the sachet in about ⅛ cup of boiled and cooled water or milk, mix well. The resulting suspension may be non-uniform with visible sediment.

Using a higher dose of Lakcid Forte than recommended

No cases of overdose have been reported.

4. Possible side effects

Like all medications, Lakcid Forte can cause side effects, although not everybody gets them.
The following side effects may occur
Frequency not known (frequency cannot be estimated from the available data):

• bacteremia (sepsis), infectious endocarditis - in patients in severe condition and patients at increased risk (see section Warnings and precautions).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist, or nurse. 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 medication.

5. How to store Lakcid Forte

The medication should be stored out of sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Within the validity period of the medication, it can be stored for 1 month at a temperature of 15°C - 25°C.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lakcid Forte contains

• The active substance of the medication is Lactobacillus rhamnosusbacteria. Each vial or sachet with powder contains: minimum 10 billion CFU of Lactobacillus rhamnosusbacteria: Lactobacillus rhamnosusPen strain
• 40% Lactobacillus rhamnosusE/N strain
• 40% Lactobacillus rhamnosusOxy strain
• 20% Bacteria resistant to: amoxicillin, ampicillin, azlocillin, cefepime, cefotaxime, cefradine, ceftazidime, cefuroxime, doxycycline, erythromycin, gentamicin, imipenem, clindamycin, cloxacillin, colistin, cotrimoxazole, nalidixic acid, meropenem, metronidazole, neomycin, netilmicin, penicillin, piperacillin, streptomycin, teicoplanin, tobramycin, vancomycin.

CFU - Colony Forming Unit.

• Other ingredients are: skimmed milk and sucrose.

What Lakcid Forte looks like and what the pack contains

What Lakcid Forte looks like

The powder in the vial is a colorless or crystalline-needle-like dry mass with a color ranging from light to dark beige.
The powder in the sachet is a loose, crushed particle with a color ranging from light to dark beige.
After reconstitution, the resulting suspension may be non-uniform with visible sediment.

Packaging

5 vials with powder, 1 dose per vial
10 vials with powder, 1 dose per vial
5 sachets with powder, 1 dose per sachet
10 sachets with powder, 1 dose per sachet
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

BIOMED-LUBLIN S.A. Serum and Vaccine Production Plant
Uniwersytecka 10, 20-029 Lublin

Date of last revision of the leaflet: