Package leaflet: Information for the patient

Lakcid Intima
vaginal capsules, hard
Lactobacillus gasseri DSM 14869 not less than 10 CFU*
Lactobacillus rhamnosus DSM 14870 not less than 10 CFU*
*CFU (Colony Forming Unit) – colony forming unit
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

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 possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 8 days of treatment, or if your condition worsens, contact your doctor.

Table of contents

What Lakcid Intima is and what it is used for
Important information before using Lakcid Intima
How to use Lakcid Intima
Possible side effects
How to store Lakcid Intima
Contents of the pack and other information

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

Lakcid Intima is available in the form of vaginal capsules containing lyophilized live
lactic acid bacteria (Lactobacillus gasseri DSM 14869 and Lactobacillus rhamnosus DSM 14870).
These bacteria possess strong adhesive properties to the vaginal epithelium, enabling them to
colonize and survive within the vagina. Both strains produce lactic acid, and the strain
Lactobacillus gasseri DSM 14869 additionally produces hydrogen peroxide, thereby creating an
unfavorable environment for the growth of pathogenic bacteria and yeasts (most commonly
Candida albicans). Due to these properties, they help maintain microbial balance by limiting the
proliferation of harmful microorganisms. By maintaining an appropriate acidic vaginal pH, they may reduce symptoms such as itching, burning, discharge, and unpleasant odor.
Factors affecting the vaginal microbial balance include:

use of antibiotics or contraceptive agents,
inadequate hygiene during menstruation or travel,
use of tampons,
pregnancy and postpartum period,
menopause,
stress,
frequent use of swimming pools or saunas,
frequent sexual intercourse,
poor hygiene habits, such as frequent vaginal douching.

Disruption of the vaginal bacterial flora may lead to recurrent bacterial, fungal, or mixed (bacterial and fungal) vaginal infections.

Indications
Lakcid Intima is recommended for maintaining or restoring normal vaginal bacterial flora.
If no improvement occurs after 8 days, or if symptoms worsen, consult a doctor.

2. Important information before using Lakcid Intima

When not to use Lakcid Intima

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Lakcid Intima, discuss this with a doctor or pharmacist.
Exercise particular caution when using Lakcid Intima if:

there is a severe immunological system disorder.

Children and adolescents
In girls aged 12 to 16 years (who have started menstruation), the medicine can be used on a doctor's advice.
Lakcid Intima and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to use.
Do not use Lakcid Intima during antibiotic therapy, because Lactobacillus gasseri DSM 14869 and Lactobacillus rhamnosus DSM 14870 are sensitive to antibiotics.
Pregnancy, breastfeeding and fertility
Lakcid Intima may be used during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Lakcid Intima has no influence on the ability to drive and operate machinery.

3. How to use Lakcid Intima

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 16 years and above
Prophylactically:
One capsule once daily (before bedtime) for 4–6 days, administered intravaginally.
In menstruating women – after menstruation.
After antibiotic therapy:
One capsule once daily (before bedtime) for 6–8 days, administered intravaginally.
Children and adolescents
In girls aged 12 to 16 years (who have started menstruation), this medicine may be used on a doctor's advice, at the same doses as in adults.
Use of a higher than recommended dose of Lakcid Intima
There are no data on overdose.
Missed use of Lakcid Intima
Continue dosing according to the prescribed schedule and apply the next dose at the appropriate time.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If allergic to any of the ingredients of the medicine, a burning sensation at the site of application may occur.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 Intima

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lakcid Intima contains
The active substances in this medicinal product are:

Lactobacillus gasseri DSM 14869 rods – not less than 10 CFU* per capsule
Lactobacillus rhamnosus DSM 14870 rods – not less than 10 CFU* per capsule
*CFU (from English: Colony Forming Unit) – colony forming unit

Other ingredients: lactitol monohydrate, corn starch, xanthan gum, anhydrous glucose,
magnesium stearate; capsule shell: gelatin, titanium dioxide (E 171).

What Lakcid Intima looks like and contents of the pack
An aluminium container containing 8 or 10 vaginal capsules in a cardboard box.
Not all pack sizes may be marketed.

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

Manufacturer
Deerland Probiotics & Enzymes A/S
Bogbinderivej 6
3390 Hundested
Denmark