Package leaflet: Information for the user

Lakcid forte, hard capsules
Lactobacillus rhamnosus
Minimum 10 billion CFU of Lactobacillus rhamnosus rods
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as your
doctor or pharmacist has instructed.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If you do not get better or feel worse, contact your doctor.

Leaflet contents

What Lakcid forte is and what it is used for
Important information before taking Lakcid forte
How to take Lakcid forte
Possible side effects
How to store Lakcid forte
Contents of the pack and other information

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

Lakcid forte is a medicinal product in the form of hard capsules for oral administration. It contains strains of Lactobacillus rhamnosus, which, like other lactic acid bacteria, colonize the intestinal mucosa and normalize the composition of gastrointestinal microflora, particularly after its depletion caused by antibiotic therapy. Research findings have confirmed that these strains survive in gastric juice environment and are resistant to bile salts, enabling their adaptation and viability in the gastrointestinal tract.
By competing for substrates and colonization sites on the intestinal mucosa, and by producing lactic acid through anaerobic sugar breakdown, they create unfavorable conditions for the growth of most pathogenic microorganisms.
These strains possess natural resistance to a broad spectrum of clinically used antibiotics.
Lakcid forte is indicated for:

Post-antibiotic enteritis, particularly as supportive treatment in pseudomembranous colitis; mainly used in recurrent pseudomembranous colitis,
Prevention of travelers' diarrhea,
As supportive treatment during and after antibiotic therapy.

2. Important information before using Lakcid forte

When not to take Lakcid forte

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

Warnings and precautions
Before starting treatment with Lakcid, consult your doctor.
There is a risk of developing bacteremia (sepsis). Single cases of infective endocarditis caused by Lactobacillus rhamnosus have been reported in critically ill patients.
Treatment with a medicinal product containing Lactobacillus rhamnosus may, in rare cases, lead to septic infections in high-risk patient groups, primarily in premature infants and full-term newborns with congenital defects or impaired organ function.

Lakcid forte with food and drink
This medicine can be taken regardless of meal times.

Pregnancy and breastfeeding
Lakcid forte may be used during pregnancy and breastfeeding.

Driving and operating machinery
Lakcid forte has no influence on the ability to drive or operate machinery.

Lakcid forte contains sucrose, lactose, and sunset yellow (E110)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine may cause allergic reactions.

3. How to take Lakcid forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Unless otherwise advised by a doctor, the recommended dose is one dose (the contents of one capsule or the whole capsule) twice daily.
The medicine is taken orally.
The capsule should be swallowed whole with boiled and cooled to room temperature water or milk.
The contents of the capsule (powder) may be dissolved in approximately \⅛ of a glass of boiled and cooled to room temperature water or milk and mixed thoroughly. This method of administration is particularly recommended for infants and children.
Use in children
When administering the medicine to infants and children, the contents of the capsule (powder) should be dissolved in approximately \⅛ of a glass of boiled and cooled to room temperature water or milk and mixed thoroughly.
Overdose of Lakcid forte
No cases of overdose have been reported.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur:
Frequency unknown (frequency cannot be estimated from the available data):

Bacteremia (sepsis), infective endocarditis – in critically ill patients and patients at increased risk (see section Warnings and precautions).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lakcid forte

Keep this medicine out of sight and reach of children.
Do not use this medicine 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).
During the approved shelf life, the medicine may be stored for up to 1 month at a temperature of 15°C - 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Lakcid forte contains
Each capsule contains:
Minimum 10 billion CFU of Lactobacillus rhamnosus rods:
Strain Lactobacillus rhamnosus Pen - 40%
Strain Lactobacillus rhamnosus E/N - 40%
Strain Lactobacillus rhamnosus Oxy - 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: skimmed milk, sucrose, anhydrous colloidal silicon dioxide, and magnesium stearate. Capsule shell: titanium dioxide (E171), hydroxypropylmethylcellulose, chlorophyll copper complex (E141), orange yellow (E110).

What Lakcid forte looks like and contents of the packaging
What Lakcid forte looks like
The medicinal product is available as hard cellulose capsules.
Before reconstitution, the powder inside the capsule consists of free-flowing, granulated particles ranging in colour from light to dark beige.
After reconstitution, a homogeneous suspension is formed, without visible impurities.
Packaging sizes:
1 blister strip containing 5 capsules with powder for 1 dose
1 blister strip containing 10 capsules with powder for 1 dose

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
SYNTHAVERSE S.A.
ul. Uniwersytecka 10, 20-029 Lublin