Lakcid

Package Leaflet: Information for the Patient

LAKCID hard capsules
Lactobacillus rhamnosus
Minimum 2 billion CFU of Lactobacillus rhamnosusrods

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

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

• This package 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 not listed in this package 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 Package 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 package and other information

1. What is Lakcid and what is it used for

Lakcid is a medicine in the form of hard capsules for oral use. It contains Lactobacillus rhamnosusstrains, which, like other lactic acid bacteria, colonize the mucous membrane of the intestines and normalize the composition of the gut microflora, especially after its depletion due to antibiotic therapy. The results of the conducted studies have confirmed that these strains survive in the gastric juice environment and are resistant to the action of bile acids, 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 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 substance 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.
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 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 with food and drink

The medicine is taken independently of meal times.

Pregnancy and breastfeeding

The medicine can be used during pregnancy and breastfeeding.

Driving and using machines

Lakcid does not affect the ability to drive and use machines.

Lakcid contains sucrose and 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 taken exactly as described in this package leaflet for the patient or as advised by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose
If the doctor does not recommend otherwise, 3-4 times a day, one dose (the contents of the capsule or the entire capsule).
The medicine 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 administering the medicine is especially recommended for infants and children.

Use in children

In the case of administering the medicine 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

No cases of overdose have been reported.

4. Possible side effects

Like all medicines, this medicine 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 package 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.
By reporting side effects, you can help provide more information on the safety of this 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.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. 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 package and other information

What Lakcid contains

Each capsule contains:
minimum 2 billion CFU of Lactobacillus rhamnosusrods:
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, anhydrous colloidal silica, and magnesium stearate. Capsule shell: titanium dioxide (E171), hydroxypropyl methylcellulose, copper complex of chlorophyll (E141), yellow iron oxide (E172).

What Lakcid looks like and what the package contains

What Lakcid looks like

The medicine is in the form of cellulose, hard capsules.
Before reconstitution, the powder in the capsule is in the form of loose, crushed particles with a color from light to dark beige.
After reconstitution, a homogeneous suspension is formed, without visible impurities.
Package sizes:
1 blister pack of 10 capsules with 1 dose of powder
2 blister packs of 10 capsules with 1 dose of powder
5 blister packs of 10 capsules with 1 dose of powder
Not all package 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 Production Plant Joint Stock Company
Uniwersytecka 10, 20-029 Lublin

Date of the last update of the package leaflet: