LAKCID

Package leaflet: Information for the patient

LAKCID, hard capsules
Lactobacillus rhamnosus
Minimum 2 billion CFU of Lactobacillus rhamnosus rods
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed
by the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, 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 symptoms do not improve or worsen, consult your doctor.

Table of contents of the leaflet

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

1. What Lakcid is and what it is used for

Lakcid 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 help normalize the composition of gastrointestinal microbiota, particularly after its disruption 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 survival in the gastrointestinal tract.

By competing for substrates and colonization sites on the intestinal mucosa, and by producing lactic acid through anaerobic carbohydrate breakdown, these bacteria create unfavorable conditions for the growth of most pathogenic microorganisms.

These strains possess natural resistance to a broad spectrum of antibiotics used in clinical practice.

Lakcid is indicated for:

• Post-antibiotic intestinal inflammation, particularly as supportive treatment in pseudomembranous colitis; primarily in recurrent pseudomembranous colitis,
• Prevention of traveler's diarrhea,
• Supportive treatment during and after antibiotic therapy.

2. Important information before using Lakcid

When not to take Lakcid

• 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, discuss this with your doctor.
There is a risk of bacteremia (sepsis). Isolated cases of infective endocarditis caused by Lactobacillus rhamnosus have been reported in severely ill patients.
Treatment with a medicinal product containing Lactobacillus rhamnosus may exceptionally lead to septic infections in patients at increased risk, primarily in preterm infants and full-term infants with congenital defects or impaired organ function.

Lakcid with food and drink
The medicine can be taken regardless of meal timing.

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

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

Lakcid contains sucrose and lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Lakcid

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician 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 a capsule or a whole capsule) 3-4 times daily.
The medicine should be 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 dispersed 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 dispersed in approximately ⅛ of a glass of boiled and cooled to room temperature water or milk, and mixed thoroughly.
Use of a higher than recommended dose of Lakcid
No cases of overdose have been reported.

4. Possible adverse reactions

Like all medicines, this medicine can 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
Tel.: + 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 enables better assessment of the benefit-risk balance of the medicine.

5. How to store Lakcid

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Within the valid shelf-life period, the medicine may be stored for 1 month at temperatures of 15°C - 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the package and other information

What Lakcid contains
Each capsule contains:
at least 2 billion CFU of Lactobacillus rhamnosus rods:
Lactobacillus rhamnosus strain Pen - 40%
Lactobacillus rhamnosus strain E/N - 40%
Lactobacillus rhamnosus strain 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, magnesium stearate. Capsule shell: titanium dioxide (E171), hydroxypropylmethylcellulose, copper chlorophyllin complex (E141), yellow iron oxide (E172).

What Lakcid looks like and contents of the pack
What Lakcid looks like
The medicine is available as cellulose hard capsules.
Before reconstitution, the powder inside the capsule consists of free-flowing, granular particles ranging in colour from light to dark beige.
After reconstitution, a homogeneous suspension is formed, free from visible impurities.
Pack sizes:
1 blister pack containing 10 capsules with powder for 1 dose
2 blister packs containing 10 capsules with powder for 1 dose each
5 blister packs containing 10 capsules with powder for 1 dose each
Not all pack sizes may be marketed.

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

Manufacturer
„BIOMED-LUBLIN” Wytwórnia Surowic i Szczepionek Spółka Akcyjna
ul. Uniwersytecka 10, 20-029 Lublin