ACTION AND MECHANISM

Lactobacillus plantarum is part of the vaginal ecosystem of healthy women and represents the main natural defense mechanism against the development of pathogenic microorganisms.

This situation is achieved mainly through the transformation, carried out by lactic acid bacteria, of the glycogen in the epithelial cells into lactic acid, followed by a decrease in vaginal pH to values ​​between 3.8 and 4.4, optimal for the proliferation of lactobacilli, but unfavorable for the proliferation of pathogenic microorganisms.

The balance of the vaginal habitat can be altered by certain physiological or pathological conditions and by iatrogenic causes.

Locally or systemically applied antibiotics and sulfonamides, although essential in the treatment of specific vaginitis, also destroy non-pathogenic flora, increasing the risk of recurrence or other infections.

PATIENT ADVICE

- Make sure you fully understand the administration instructions for this medication before using it. Consult your pharmacist if necessary.

- If you miss a dose, take it as soon as possible, unless it's almost time for your next dose. Then, continue treatment at your usual times. Do not double the next dose to make up for a missed one.

- Consult your doctor and/or pharmacist if symptoms continue or worsen during treatment.

- Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant before starting treatment.

- Inform your doctor if you are breastfeeding before starting treatment.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication.

ADVANCED AGE

There is no recommendation for use in these patients.

EFFECTS ON DRIVING

The influence on the ability to drive and use machines is negligible or null.

PREGNANCY

Animal safety: no data available.

Safety in humans: can be used during pregnancy.

Effects on fertility: No specific studies have been conducted in humans.

INDICATIONS

In adult women for:

- Normalization of altered vaginal microbiota after antibiotic treatment of [BACTERIAL VAGINOSIS].

- Maintenance of a normal vaginal microbiota in cases of recurrent [EXCESSIVE VAGINAL DISCHARGE].

INTERACTIONS

- It should not be used in combination with condoms or other local contraceptive methods (e.g., diaphragms), as a reduction in function cannot be ruled out. Vaginal douching with antiseptics should not be performed during treatment.

LACTATION

Animal safety: no data available.

Safety in humans: can be used during breastfeeding.

CHILDREN

Safety and efficacy in children and adolescents under 18 years of age have not been evaluated, so it is recommended to avoid its use.

RULES FOR CORRECT ADMINISTRATION

Insert one vaginal capsule deep into the vagina, lying supine, at night before going to bed.

POSOLOGY

After antibiotic treatment for bacterial vaginosis: Insert 1 capsule deep into the vagina at night before going to bed for 6 days.

To maintain a normal vaginal microbiota in cases of recurrent vaginal infections: Insert 1 capsule deeply into the vagina at night before going to bed for 6 consecutive days. If necessary, this cycle can be repeated once a month for 2 more consecutive months.

Menstruating women should start treatment immediately after menstruation.

- Children and adolescents < 18 years: not recommended.

DOSAGE IN LIVER FAILURE

No specific dosage recommendations have been made.

DOSAGE IN RENAL FAILURE

No specific dosage recommendations have been made.

PRECAUTIONS

It does not replace antibiotic or chemotherapy therapy, but rather represents a useful complement to restoring the physiological conditions of the vaginal environment, especially at the end of specific antimicrobial treatment.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, considering very frequent (>10%), frequent (1-10%), unfrequent (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Immune system disorders: unknown [ALLERGY]

- Gastrointestinal disorders: [NAUSEA], [ABDOMINAL PAIN]

- Skin and subcutaneous tissue disorders: [PRURITUS], [SKIN RASHES].

- Reproductive system and breast disorders: common [URETHRAL BURNING]; unknown [EXCESSIVE VAGINAL DISCHARGE], vaginal irritation, vaginal pain, bloody vaginal discharge, discomfort, [VAGINAL ITCHING].