Lakcid

Leaflet attached to the packaging: patient information

LAKCID powder for oral suspension
Lactobacillus rhamnosus
Minimum 2 billion CFU of Lactobacillus rhamnosusbacteria

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects 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 and what is it 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 packaging and other information

1. What is Lakcid and what is it used for

Lakcid 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 the studies confirmed that these strains survive in the gastric juice environment and are resistant to the action of bile salts, which allows 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 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

When not to take Lakcid

• if the patient is allergic to the active substances or 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, the patient should discuss it with their doctor.
The medicine is intended for oral use. Do not inject.
There is a risk of bacteremia (sepsis). Single cases of infectious endocarditis in patients in severe condition caused by Lactobacillus rhamnosusinfection have been reported.
Treatment with a medicine containing Lactobacillus rhamnosusmay, in rare 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 with food and drink

The medicine is taken independently of meal times.

Pregnancy and breastfeeding

The medicine can be used in pregnant and breastfeeding women.

Driving and operating machinery

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

Lakcid contains sucrose, lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Lakcid

This medicine should always be used exactly as described in the patient leaflet or as directed by
the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Oral administration.
Recommended dose
If the doctor does not recommend otherwise, 3-4 times a day, one dose (contents of an ampoule, vial, or sachet).
Immediately before use, the ampoule should be opened by carefully pressing the neck of the ampoule downwards. The point of pressure on the ampoule is marked with a "dot". A small amount of boiled and cooled water or milk should be added, and the mixture should be shaken well. The edge of the opened ampoule should be touched to the side of a spoon. The suspension will flow onto the spoon.
Procedure for packaging with a multi-use pipette:

• 1. Immediately before use, the ampoule should be opened by carefully pressing the neck of the ampoule downwards. The point of pressure on the ampoule is marked with a "dot".
• 2. Before use, the pipette should be rinsed several times by filling and emptying the water from its container.
• 3. The patient should press the pipette container with their fingers, insert the tip of the pipette into a container with boiled and cooled water or milk. By releasing the pipette container from the finger pressure, a small amount of water or milk should be drawn into the pipette.
• 4. The tip of the pipette should be inserted into the opened ampoule, and the pipette container should be pressed again with the fingers. The liquid from the pipette container will flow into the ampoule. The contents of the ampoule should be mixed well. Any remaining water or milk in the pipette container should be removed.
• 5. Then, the pipette container should be pressed again with the fingers, and the tip of the pipette should be inserted into the ampoule. By releasing the pipette container from the finger pressure, the suspension should be drawn into the pipette.
• 6. The suspension from the pipette should be poured onto a spoon or into a glass.
• 7. After use, the pipette should be rinsed several times by filling and emptying the water from its container.

In the case of packaging with a vial, immediately before use, the cap should be removed from the vial and the rubber stopper should be pulled out. A small amount of boiled and cooled water or milk should be added to the vial, and the mixture should be shaken well. The contents of the vial should be poured onto a spoon.
In the case of packaging with a sachet, immediately before use, the sachet should be torn open at the notch. The contents of the sachet should be dissolved in approximately 1/8 of a glass of boiled and cooled water or milk, and the mixture should be shaken well.

Use of a higher than recommended dose of Lakcid

No cases of overdose have been reported.

4. Possible side effects

Like all medicines, Lakcid 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 any side effects 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 to gather more information on the safety of the medicine.

5. How to store Lakcid

The medicine should be stored out of sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Within the validity period, the medicine can be stored for 1 month at a temperature of 15°C-25°C.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lakcid contains

• The active substance of the medicine is Lactobacillus rhamnosusbacteria. Each ampoule, vial, or sachet contains: minimum 2 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, sucrose.

What Lakcid looks like and what the packaging contains

What Lakcid looks like

The powder in the ampoule or vial is a colorless or crystalline-needle-like dry mass with a color ranging from light to dark beige.
After reconstitution, a uniform suspension is formed, without visible mechanical impurities.
The powder in the sachet is a loose, crushed particle with a color ranging from light to dark beige.
After reconstitution, a uniform suspension is formed, without visible mechanical impurities.

Packaging

10 ampoules with powder for 1 dose
10 ampoules with powder for 1 dose + 1 multi-use pipette
20 ampoules with powder for 1 dose
50 ampoules with powder for 1 dose
10 vials with powder for 1 dose
20 vials with powder for 1 dose
50 vials with powder for 1 dose
10 sachets with powder for 1 dose
20 sachets with powder for 1 dose
50 sachets with powder for 1 dose
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

"BIOMED-LUBLIN" Serum and Vaccine Plant Joint-Stock Company
Uniwersytecka 10, 20-029 Lublin

Date of the last update of the leaflet: