Package leaflet: Information for the user

ECOCILLIN 100,000,000 UFC soft vaginal capsules, 100,000,000 UFC hard vaginal capsules

Lactobacillus plantarum P 17630
Please read this leaflet carefully before using this medicine because it contains important
information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period.

Contents of this leaflet:

What ECOCILLIN is and what it is used for
What you need to know before using ECOCILLIN
How to use ECOCILLIN
Possible side effects
How to store ECOCILLIN
Contents of the pack and other information

1. What ECOCILLIN is and what it is used for

ECOCILLIN contains the active substance Lactobacillus plantarum P 17630.
This bacterium is normally present in the vagina of a healthy woman and prevents the growth of other bacteria that can cause disease (pathogenic microorganisms).
ECOCILLIN is indicated for the treatment of the following vaginal disorders:

infections (vaginitis, vulvovaginitis, vaginitis associated with ovarian insufficiency, infantile vaginitis, senile vaginitis);
itching (vulvar pruritus);
increased secretions (hypochlorhydric leucorrhoea);
mucosal alterations (vaginal dystrophy);
infections caused by a protozoan (Trichomonas vaginitis), in association with other medicinal products that inhibit bacterial growth (chemotherapeutic agents and antibiotics).

Consult your doctor if you do not feel better or if you feel worse after a short period of time.

2. What you need to know before using ECOCILLIN

Do not use ECOCILLIN

if you are allergic to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using ECOCILLIN.
Avoid using ECOCILLIN for prolonged periods, as allergic reactions (sensitization phenomena) and other adverse effects may occur. In such cases, discontinue treatment and inform your doctor.
Do not use ECOCILLIN as a substitute for antibiotic or chemotherapeutic therapy used to treat infections, but only as a complementary treatment. ECOCILLIN restores the normal (physiological) conditions of the vagina, especially at the end of specific infection treatment.

Other medicines and ECOCILLIN
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between ECOCILLIN and other medicines are known.

Pregnancy and breastfeeding
No effects are expected during pregnancy, since systemic exposure to Lactobacillus plantarum P 17630 is negligible.
ECOCILLIN may be used during pregnancy and breastfeeding because Lactobacillus plantarum is a non-pathogenic bacterium normally present in the vagina of a healthy woman.

Driving and use of machines
The use of ECOCILLIN does not impair the ability to drive or operate machinery.

ECOCILLIN soft vaginal capsules contain parahydroxybenzoates
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed-type reactions).

3. How to use ECOCILLIN

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 vaginal capsule daily.
Insert the capsule deeply into the vagina while lying down (supine position), in the evening before going to bed.

If you use more ECOCILLIN than you should
Cases of overdose are not known.
In case of accidental ingestion or overdose of ECOCILLIN, contact your doctor immediately or go to the nearest hospital.

If you forget to use ECOCILLIN
Do not use a double dose to make up for the forgotten vaginal capsule.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
No adverse reactions have been reported with the use of this medicine.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at the following address:
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store ECOCILLIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Soft vaginal capsules: Store in the refrigerator (+2°C / +8°C).
Hard vaginal capsules: Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ECOCILLIN contains

The active substance is Lactobacillus plantarum P 17630. Each vaginal capsule contains at least 100,000,000 colony-forming units (CFU) of Lactobacillus plantarum P 17630.
The other components are:
Soft vaginal capsules: sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, medium-chain triglycerides, silica (aerosil 300), gelatin, glycerol, dimethylpolysiloxane, titanium dioxide (E 171).
Hard vaginal capsules: corn starch, mannitol, sodium croscarmellose, magnesium stearate, hydrated colloidal silica. Capsule components: gelatin, titanium dioxide (E 171).

Description of the appearance of ECOCILLIN and contents of the pack
Box containing 3 or 6 soft vaginal capsules.
Box containing 6 hard vaginal capsules.
Marketing Authorization Holder
PROGE MEDICA S.r.l. – Largo Donegani n. 4/A – 28100 Novara – Italy
Manufacturer
Soft vaginal capsules: CATALENT ITALY S.p.A. – Via Nettunense Km 20.100 – Aprilia (LT) – Italy
Hard vaginal capsules: S.I.I.T S.r.l. - Via Ariosto 50/60 - Trezzano Sul Naviglio (MI) - Italy
…………