Package leaflet: Information for the patient

Dicoflorelle Ginecologico 100 000 000 CFU vaginal soft capsules, vaginal hard capsules

Lactobacillus plantarum P 17630
Please read all of 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period.

Contents of this leaflet

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

1. What Dicoflorelle Ginecologico is and what it is used for

Dicoflorelle Ginecologico is a medicinal product for vaginal use.
The bacterial strain Lactobacillus plantarum contained in Dicoflorelle Ginecologico is part of the natural
vaginal microbial flora.
Dicoflorelle Ginecologico is used:

To normalize the vaginal microbiota altered after antibiotic treatment of bacterial vaginosis.
To maintain a normal vaginal microbiota in case of recurrent vaginal infections.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment with
Dicoflorelle Ginecologico.
In bacterial vaginosis (bacterial vaginal infections), the normal bacterial balance of the vagina is
disrupted. There is an increase in certain types of bacteria and, as a result, the vaginal pH value rises.
Typical symptoms may include increased discharge with an unpleasant fishy odour, itching, and burning.
Bacterial vaginosis (bacterial vaginal infections) is usually treated with antibiotics, and Dicoflorelle Ginecologico may be used for maintenance treatment.
Dicoflorelle Ginecologico replenishes the vagina with live lactobacilli, which are part of the natural
vaginal flora. These bacteria produce lactic acid, helping to restore the physiological vaginal pH value.
Furthermore, by adhering to the vaginal mucosa, the lactobacilli limit the ability of undesirable bacteria to proliferate.

2. What you need to know before using Dicoflorelle Ginecologico

Do not use Dicoflorelle Ginecologico

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 Dicoflorelle Ginecologico.
Do not use Dicoflorelle Ginecologico as a substitute for antibiotic or chemotherapeutic therapy used to treat infections, but only as an adjunct. Dicoflorelle Ginecologico restores the normal (physiological) conditions of the vagina, especially at the end of specific treatment for infection.
Do not use Dicoflorelle Ginecologico together with condoms or other local contraceptive methods (e.g. diaphragm), as a reduction in their effectiveness cannot be ruled out. Do not perform vaginal douching with antiseptic preparations during treatment with Dicoflorelle Ginecologico.

Other medicines and Dicoflorelle Ginecologico
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions between Dicoflorelle Ginecologico and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Dicoflorelle Ginecologico can be used during pregnancy and breastfeeding, as no effects on pregnancy or breastfeeding in newborns/infants are expected, due to negligible systemic exposure to Lactobacillus plantarum P 17630.

Driving and using machines
The use of Dicoflorelle Ginecologico does not affect the ability to drive or operate machinery.

Dicoflorelle Ginecologico Soft Vaginal Capsules contain parahydroxybenzoates
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to use Dicoflorelle Ginecologico

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose for adult women is:

After antibiotic treatment for bacterial vaginosis (bacterial vaginal infections): insert deeply into the vagina, in the evening before going to bed, 1 capsule daily for 6 days.
To maintain a physiological vaginal microbiota in case of recurrent vaginal infections: insert deeply into the vagina, in the evening before going to bed, 1 vaginal capsule daily for 6 consecutive days. If necessary, the cycle may be repeated once a month for an additional 2 consecutive months. Women who menstruate should start treatment immediately after the end of their menstrual period.

Use in children and adolescents
Dicoflorelle Ginecologico must not be used in children and adolescents under 18 years of age.
Insert the capsule deeply into the vagina while lying down (supine position), in the evening before going to bed.

If you use more Dicoflorelle Ginecologico than you should
To date, cases of overdose are not known.
In case of accidental ingestion or overdose of Dicoflorelle Ginecologico, contact your doctor immediately or go to the nearest hospital.

If you forget to use Dicoflorelle Ginecologico
Do not use a double dose to make up for the missed capsule.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency:
Common (may affect up to 1 in 10 people)

Vulvovaginal burning sensation

Not known (frequency cannot be estimated from the available data)

Vaginal discharge
Vaginal irritation
Vaginal pain
Vaginal bleeding
Vulvovaginal discomfort
Vulvovaginal pruritus
Allergic reaction
Itching
Rash
Nausea
Abdominal pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Dicoflorelle Ginecologico

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 Dicoflorelle Ginecologico contains

The active substance is Lactobacillus plantarum P 17630. Each vaginal capsule contains 100,000,000 colony-forming units (CFU) of Lactobacillus plantarum P 17630.
Other ingredients 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), lactose.
Hard vaginal capsules: maize starch, mannitol, sodium croscarmellose, magnesium stearate, hydrated colloidal silica. Capsule components: gelatin, titanium dioxide (E 171).

Description of the appearance of Dicoflorelle Ginecologico and contents of the pack
Soft vaginal capsules:
Carton pack containing 3 or 6 soft vaginal capsules.
Hard vaginal capsules:
Carton pack containing 3 or 6 hard vaginal capsules.

Marketing Authorization Holder
Dicofarm S.p.A., Via del Casale della Marcigliana 29, 00138 Roma, Italy

Manufacturers
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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Cocil 100 000 000 UFC Cápsulas moles vaginais | Cápsulas vaginais
Estonia: Cocillo 100 000 000 KMÜ vaginaalpehmekapslid | vaginaalkõvakapslid
Lithuania: Cocillo 10 KSV minkštosios makšties kapsulės | kietosios makšties kapsulės
Latvia: Cocillo 100 000 000 KVV mīkstās vaginālās kapsulas | cietās vaginālās kapsulas
Romania: Softigyn min 100.000.000 UFC Capsule moi vaginale | Capsule vaginale
Poland: Protrivagin 100 000 000 CFU Kapsułki dopochwowe twarde
Greece: Softigyn 100.000.000 CFU κολπικά καψάκια, μαλακά | κολπικά καψάκια, σκληρά
Bulgaria: Softigyn 100 000.000 CFU меки вагинални капсули | твърди вагинални капсули
Cyprus: Softigyn 100.000.000 CFU κολπικά καψάκια, μαλακά | κολπικά καψάκια, σκληρά
Spain: Intibiotics vaginal 100 000 000 UFC cápsulas vaginales blandas | cápsulas vaginales duras
Germany: KadeFlora Milchsäurebakterien Vaginalkapseln 100 000 000 CFU Weichkapseln zur vaginalen Anwendung | Hartkapseln zur vaginalen Anwendung