Lakcid Intima

Leaflet attached to the packaging: patient information

Lakcid Intima

vaginal capsules, hard
sticks of Lactobacillus gasseriDSM 14869 not less than 10 CFU*
sticks of Lactobacillus rhamnosusDSM 14870 not less than 10 CFU*
*CFU (English Colony Forming Unit) - colony forming unit

Read the leaflet carefully 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 additional information, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 8 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Lakcid Intima and what is it used for
• 2. Important information before using Lakcid Intima
• 3. How to use Lakcid Intima
• 4. Possible side effects
• 5. How to store Lakcid Intima
• 6. Package contents and other information

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

Lakcid Intima is in the form of vaginal capsules that contain lyophilized live lactic acid bacteria (Lactobacillus gasseriDSM 14869 and Lactobacillus rhamnosusDSM 14870).
These bacteria have strong adhesive properties to the vaginal epithelium, which enables them to colonize and survive in the vagina. Both strains produce lactic acid, and the Lactobacillus gasseriDSM 14869 strain also produces hydrogen peroxide, creating an unfavorable environment for the multiplication of pathogenic bacteria and yeast (most commonly Candida albicans). Thanks to their properties, they affect the microbiological balance, limiting the development of pathogenic microorganisms, as they maintain the appropriate acidic pH of the vagina, which can reduce symptoms such as itching, burning, discharge, and unpleasant odor.
Risk factors affecting the microbiological balance in the vagina:

• use of antibiotics or contraceptives,
• improper hygiene during menstruation and travel,
• use of tampons,
• pregnancy, postpartum,
• climacterium,
• stress,
• frequent use of swimming pools, saunas,
• intensive sexual intercourse,
• poor hygiene habits, such as frequent use of vaginal douches. Consequences of disturbances in the vaginal bacterial flora may be recurrent bacterial, fungal, and mixed (bacterial and fungal) inflammatory conditions of the vagina.

Indications for use

Lakcid Intima is recommended for use to maintain or restore the normal bacterial flora of the vagina.
If there is no improvement after 8 days or the patient feels worse, they should consult a doctor.

2. Important information before using Lakcid Intima

When not to use Lakcid Intima

Warnings and precautions

Before starting to use Lakcid Intima, discuss it with your doctor or pharmacist.
Exercise special caution when using Lakcid Intima if:

• there is a severe immune system disorder.

Children and adolescents
In girls aged 12 to 16 (who have started menstruating), the medicine can be used after consultation with a doctor.

Lakcid Intima and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not use Lakcid Intima during antibiotic therapy, as Lactobacillus gasseriDSM 14869 and Lactobacillus rhamnosusDSM 14870 are sensitive to antibiotics.

Pregnancy, breastfeeding, and fertility

Lakcid Intima can be used during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Lakcid Intima does not affect the ability to drive or operate machines.

3. How to use Lakcid Intima

This medicine should always be used as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents over 16 years old
Prophylactically:
One capsule per day (before bedtime) for 4-6 days, vaginally.
In menstruating women - after menstruation.
After antibiotic therapy:
One capsule per day (before bedtime) for 6-8 days, vaginally.
Children and adolescents
In girls aged 12 to 16 (who have started menstruating), the medicine can be used after consultation with a doctor, in the same doses as for adults.

Using a higher dose of Lakcid Intima than recommended

There is no data on overdose.

Missing a dose of Lakcid Intima

Continue dosing according to the established schedule and take the next dose at the right time.
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of an allergy to any of the ingredients of the medicine, burning may occur at the site of administration.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. 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 Intima

Keep the medicine out of sight and reach of children.
Store in a temperature 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 given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Lakcid Intima contains

The active substances of the medicine are:

• sticks of Lactobacillus gasseriDSM 14869 not less than 10 CFU* per capsule
• sticks of Lactobacillus rhamnosusDSM 14870 not less than 10 CFU* per capsule *CFU (English Colony Forming Unit) - colony forming unit

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

What Lakcid Intima looks like and what the package contains

An aluminum container containing 8 or 10 vaginal capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

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

Date of last update of the leaflet: