Lakcid forte

Package Leaflet: Information for the Patient

Lakcid Forte, Hard Capsules

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 taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this 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 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 medication in the form of hard capsules for oral use. It contains Lactobacillus rhamnosusstrains, 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 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 the patient is allergic to the active substance or any of the other ingredients of this medication (listed in section 6), including cow's milk protein.

Warnings and precautions

Before starting treatment with Lakcid, the patient should discuss it with their doctor.
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 patients at increased risk, mainly in premature infants and children born at term but with defects or impaired organ function.

Lakcid Forte with food and drink

The medication is taken independently of meal times.

Pregnancy and breastfeeding

The medication can be used during pregnancy and breastfeeding.

Driving and operating machinery

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

Lakcid Forte contains sucrose, lactose, and orange yellow (E110)

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medication.
The medication may cause allergic reactions.

3. How to take Lakcid Forte

This medication should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose
If the doctor does not recommend otherwise, 2 times a day, one dose (contents of a capsule or the entire capsule).
The medication is taken orally.
The capsule should be swallowed whole, washed down with boiled and cooled water or milk at room temperature.
The contents of the capsule (powder) can be dissolved in about 1/8 cup of boiled and cooled water or milk at room temperature, mixed thoroughly. This method of administration is especially recommended for infants and children.

Use in children

In the case of administering the medication to infants and children, the contents of the capsule (powder) should be dissolved in about 1/8 cup of boiled and cooled water or milk at room temperature, mixed thoroughly.

Overdose of Lakcid Forte

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 any side effects occur, including those not listed in this leaflet, the patient should inform their 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.
The medication should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store in a refrigerator (2°C - 8°C).
Within the validity period, the medication can be stored for 1 month at a temperature of 15°C - 25°C.
Medications should not be disposed of in wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Lakcid Forte contains

Each capsule contains:
minimum 10 billion CFU of Lactobacillus rhamnosusbacteria:
Lactobacillus rhamnosusPen strain

• 40% Lactobacillus rhamnosusE/N strain
• 40% Lactobacillus rhamnosusOxy strain
• 20% Rods 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, sucrose, colloidal silica, and magnesium stearate. Capsule shell: titanium dioxide (E171), hydroxypropyl methylcellulose, copper complex of chlorophyll (E141), orange yellow (E110).

What Lakcid Forte looks like and what the pack contains

What Lakcid Forte looks like

The medication is in the form of cellulose, hard capsules.
Before reconstitution, the powder in the capsule is in the form of loose, powdered particles with a color ranging from light to dark beige.
After reconstitution, a homogeneous suspension is formed, without visible impurities.
Package sizes:
1 blister pack of 5 capsules with 1 dose of powder
1 blister pack of 10 capsules with 1 dose of powder

Marketing authorization holder

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

Manufacturer

Synthaverse S.A.
Uniwersytecka 10, 20-029 Lublin
Date of last update of the leaflet:June 2024