LAKCID

Package leaflet: Information for the patient

LAKCID, powder for oral suspension
Lactobacillus rhamnosus
Minimum 2 billion CFU of Lactobacillus rhamnosus rods
Please read carefully the entire leaflet 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.

• Keep this leaflet, as you may need to read it again.
• 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 there is no improvement or if you feel worse, please contact your doctor.

Table of contents

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 package and other information

1. What Lakcid is and what it is used for

Lakcid is a powder for oral suspension. It contains strains of Lactobacillus rhamnosus bacteria, which, like other lactic acid bacteria, colonize the intestinal mucosa and normalize the composition of gastrointestinal microbiota, particularly after its depletion caused by antibiotic therapy. Research results have confirmed that these strains survive in gastric juice 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, 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 is intended for use:

• in post-antibiotic enteritis, particularly as supportive treatment in pseudomembranous colitis; mainly for recurrent pseudomembranous colitis,
• in the prevention of traveler's diarrhea,
• as supportive treatment during and after antibiotic therapy.

2. Important information before using Lakcid

When not to use Lakcid

• if the patient is allergic to the active substances 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.
This medicine is intended for oral use only. Do not inject.
There is a risk of developing bacteremia (sepsis). Isolated cases of infective endocarditis caused by Lactobacillus rhamnosus have been reported in patients with severe underlying conditions.
Treatment with a medicine containing Lactobacillus rhamnosus may exceptionally lead to septic infections in high-risk patient groups, primarily in premature infants and full-term infants with congenital defects or impaired organ function.

Lakcid with food and drink
The medicine can be taken independently of meals.

Pregnancy and breastfeeding
Lakcid may be used in pregnant and breastfeeding women.

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

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

3. How to use Lakcid

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral administration.
Recommended dose
Unless otherwise advised by a doctor, the recommended dose is one dose (the contents of an ampoule, vial, or sachet) 3–4 times daily.
Immediately before use, open the ampoule by gently pressing the neck of the ampoule downwards. The point of pressure on the ampoule is marked with a "dot". Add a small amount of boiled and cooled to room temperature water or milk, and mix well. Touch the edge of the opened ampoule to the side of a spoon. The suspension will flow onto the spoon.

Instructions for use with a multi-dose pipette:

1. Immediately before use, open the ampoule by gently pressing the neck of the ampoule downwards. The point of pressure on the ampoule is marked with a "dot".
2. Before use, rinse the pipette several times by drawing in and emptying water from its container.
3. Squeeze the pipette container with fingers, insert its tip into a container with boiled and cooled to room temperature water or milk. Releasing the pressure from the container, draw a small amount of water or milk into the pipette.
4. Insert the pipette tip into the opened ampoule, then squeeze the container again with fingers. The liquid from the container will enter the ampoule. Mix the contents of the ampoule thoroughly. Remove any remaining water or milk from the pipette container.
5. Then, squeeze the pipette container with fingers and insert its tip into the ampoule. Releasing the pressure, draw the suspension into the pipette.
6. Transfer the suspension from the pipette onto a spoon or into a glass.
7. After use, rinse the pipette several times by drawing in and emptying water from its container.

For vial packaging: Immediately before use, remove the cap from the vial and take out the rubber stopper. Add a small amount of boiled and cooled to room temperature water or milk to the vial, mix well. Pour the contents of the vial onto a spoon.
For sachet packaging: Immediately before use, tear the sachet open at the marked notch. Dissolve the contents of the sachet in approximately ⅛ glass of boiled and cooled to room temperature water or milk, and mix thoroughly.

Use of a dose higher than recommended of Lakcid
No cases of overdose have been reported.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may occur:
Frequency unknown (frequency cannot be estimated from the available data):

• bacteraemia (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, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 continued monitoring of the safety of the medicine.

5. How to store Lakcid

Keep the 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 a temperature 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 required. This will help protect the environment.

6. Contents of the package and other information

What Lakcid contains

• The active substance in the medicine is Lactobacillus rhamnosus bacteria. Each ampoule, vial, or sachet contains: minimum 2 billion CFU of Lactobacillus rhamnosus bacteria:
  Strain Lactobacillus rhamnosus Pen - 40%
  Strain Lactobacillus rhamnosus E/N - 40%
  Strain Lactobacillus rhamnosus Oxy - 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.

• The other ingredients are: skimmed milk, sucrose.

What Lakcid looks like and contents of the pack
What Lakcid looks like
The powder in the ampoule or vial is an amorphous or crystalline-needle-like dry mass, ranging in color from light to dark beige.
After reconstitution, a uniform suspension is formed, without visible mechanical impurities.
The powder in the sachet consists of free-flowing, finely divided particles, ranging in color from light to dark beige.
After reconstitution, a uniform suspension is formed, without visible mechanical impurities.

Pack contents
10 ampoules with powder for 1 dose
10 ampoules with powder for 1 dose + 1 reusable 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 Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
"BIOMED-LUBLIN" Vaccines and Sera Manufacturing Joint-Stock Company
ul. Uniwersytecka 10, 20-029 Lublin