LjLacto

Package leaflet

LJLACTO 100,000,000 CFU VAGINAL SOFT CAPSULES

Lactobacillus plantarum P 17630
PHARMACOTHERAPEUTIC CATEGORY
Vaginal bacterial flora restorer.

THERAPEUTIC INDICATIONS
LJLACTO vaginal soft capsules are indicated in cases of vaginitis and vulvovaginitis in general, as the lactobacilli contained therein, by implanting and multiplying on the vaginal mucosa, not only restore the balance of the indigenous bacterial flora, but also indirectly inhibit, through competitive antagonism, colonization by pathogenic microorganisms.

Thus, LJLACTO is used, starting from reproductive age, as topical treatment for vaginal infections caused by pathogenic germs. In particular, it is indicated for vaginitis associated with ovarian insufficiency, hypofollicular leucorrhea, senile vaginitis, vulvar pruritus, and vaginal dystrophy.

LJLACTO is also used as an adjunct in chemotherapeutic and antibiotic treatment of trichomonal vaginitis.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

PRECAUTIONS FOR USE
LJLACTO does not replace antibiotic or chemotherapeutic therapy, but serves as a useful adjunct, especially at the end of specific treatment, by restoring physiological conditions of the vaginal environment.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.
No interaction studies have been conducted.

SPECIAL WARNINGS
The use, particularly if prolonged, of topical products may lead to sensitization reactions and cause undesirable effects. In such cases, treatment must be discontinued and medical advice sought.

PREGNANCY AND BREAST-FEEDING
Consult your doctor or pharmacist before taking any medicinal product.
Lactobacillus plantarum is a non-pathogenic, habitual resident of the vaginal flora; therefore, LJLACTO may be used during pregnancy and/or breastfeeding.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
LJLACTO does not affect the ability to drive or operate machinery.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION

• One vaginal capsule daily.
  Method of use: Insert one capsule deeply into the vagina while lying down in a supine position, preferably in the evening before going to bed.

OVERDOSE
No cases of overdose have been reported.
In case of accidental ingestion or intake of an excessive dose of LJLACTO, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of LJLACTO, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, LJLACTO can cause side effects, although not everybody experiences them.
No adverse reactions related to the use of this medicinal product have been reported.
Following the instructions provided in this leaflet reduces the risk of adverse effects.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide more information on the safety of this medicinal product.

EXPIRY DATE AND STORAGE INSTRUCTIONS
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, undamaged packaging under recommended conditions.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
Store the medicinal product at a temperature between +2°C and +8°C.
Keep the medicine out of the reach and sight of children. Medicinal products must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

COMPOSITION
LJLACTO 100,000,000 CFU VAGINAL SOFT CAPSULES
Each vaginal soft capsule contains:
Active substance:
Lactobacillus plantarum P 17630, at least 10 CFU at time of manufacture
Excipients:
Medium-chain triglycerides – Silica (Aerosil 300) – Sodium p-hydroxybenzoate – Propyl p-hydroxybenzoate – Gelatin – Glycerol – Dimethylpolysiloxane – Titanium dioxide (E 171) – Lactose – Cryoprotectant (skim milk powder – Sucrose – Sorbitol – Sodium ascorbate – Tween 80).

PHARMACEUTICAL FORM AND CONTENT
Vaginal soft capsules: pack containing 3 or 6 capsules.

MARKETING AUTHORISATION HOLDER
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

MANUFACTURER
CATALENT ITALY S.p.A. - Via Nettunense Km 20.100 - Aprilia (LT)

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AGENZIA ITALIANA DEL FARMACO):