Bactocin
Italy
Table of Contents
Package leaflet: Information for the user
BACTOCIN vaginal soft capsules
Lactobacillus plantarum P 17630
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.
- 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, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short time.
Contents of this leaflet:
- What BACTOCIN is and what it is used for
- What you need to know before using BACTOCIN
- How to use BACTOCIN
- Possible side effects
- How to store BACTOCIN
- Contents of the pack and other information
1. What BACTOCIN is and what it is used for
BACTOCIN contains Lactobacillus plantarum P 17630 as the active substance. This bacterium is normally present in the vagina of a healthy woman and, by colonizing and multiplying on the vaginal mucosa, helps restore the natural bacterial flora to balance and prevents the growth of other bacteria that may cause disease (pathogenic microorganisms).
BACTOCIN 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 (hypochlorous leukorrhea);
- mucosal abnormalities (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 should know before using BACTOCIN
Do not use BACTOCIN
- 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 BACTOCIN.
Do not use BACTOCIN as a substitute for antibiotic or chemotherapeutic treatment used for the management of infections, but only as an adjunct. BACTOCIN restores the normal physiological conditions of the vagina, especially at the end of specific anti-infective treatment.
Other medicines and BACTOCIN
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between BACTOCIN and other medicines are currently known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
BACTOCIN can 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 using machines
The use of BACTOCIN does not impair the ability to drive vehicles or operate machinery.
3. How to use BACTOCIN
Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 vaginal capsule per day.
Insert the capsule deeply into the vagina while lying down (supine position), in the evening before going to bed.
If you use more BACTOCIN than you should
Cases of overdose are unknown.
If you accidentally ingest or take an excessive dose of BACTOCIN, inform your doctor immediately or go to the nearest hospital.
If you forget to use BACTOCIN
Do not use a double dose to make up for the forgotten vaginal 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 will experience them.
No side effects have been reported with the use of this medicine.
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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store BACTOCIN
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.
Store in a refrigerator (+2°C – +8°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 BACTOCIN 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 ingredients are: medium-chain triglycerides, silica (aerosil 300), gelatin, glycerol, dimethylpolysiloxane, titanium dioxide (E 171).
Description of the appearance of BACTOCIN and package contents
Carton pack containing 3 or 6 soft vaginal capsules.
Marketing Authorization Holder
Proge Farm S.r.l. - Largo Donaegani 4/A - 28100 Novara - Italy
Manufacturers
Catalent Italy S.p.A. – Via Nettunense Km 20.100 – Aprilia (LT) – Italy
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Package leaflet: information for the user
BACTOCIN vaginal solution
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 of the side effects listed in this leaflet, including those not listed, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period.
Contents of this leaflet:
- What BACTOCIN is and what it is used for
- What you need to know before using BACTOCIN
- How to use BACTOCIN
- Possible side effects
- How to store BACTOCIN
- Contents of the pack and other information
1. What BACTOCIN is and what it is used for
BACTOCIN contains the active substance Lactobacillus plantarum P 17630. This bacterium is normally present in the vagina of a healthy woman and, by colonizing and multiplying on the vaginal mucosa, restores the balance of the normal bacterial flora and prevents the growth of other bacteria that may cause disease (pathogenic microorganisms).
BACTOCIN 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 (hypolactic leucorrhoea);
- mucosal alterations (vaginal dystrophy);
- infections caused by a protozoan (trichomonal 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 should know before using BACTOCIN
Do not use BACTOCIN
- 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 BACTOCIN.
Do not use BACTOCIN as a substitute for antibiotic or chemotherapeutic therapy used to treat infections, but only as an adjunct. BACTOCIN restores the normal physiological conditions of the vagina, especially after completion of specific infection treatment.
Other medicines and BACTOCIN
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between BACTOCIN and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
BACTOCIN can be used during pregnancy and while breastfeeding because Lactobacillus plantarum is a non-pathogenic bacterium normally present in the vagina of a healthy woman.
Driving and using machines
The use of BACTOCIN does not affect the ability to drive or operate machinery.
BACTOCIN contains benzoic acid
This medicine contains benzoic acid, which may cause mild irritation to the skin, eyes, and mucous membranes.
3. How to use BACTOCIN
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 solution per day.
Perform an irrigation with the vaginal solution preferably in the morning after using BACTOCIN soft capsules.
Instructions for use: Press the bulb to remove the separating cap. Shake the solution well. Break off the capsule nozzle and insert the cannula, then proceed with the irrigation.
If you use more BACTOCIN than you should
Cases of overdose are not known.
If you accidentally swallow or ingest an excessive dose of BACTOCIN, contact your doctor immediately or go to the nearest hospital.
If you forget to use BACTOCIN
Do not use a double dose to make up for the missed dose.
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 may cause side effects, although not everyone experiences them.
No side effects have been reported with the use of this medicine.
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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store BACTOCIN
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.
Store in a refrigerator (+2°C – +8°C).
The solution must be used immediately after reconstitution.
Do not dispose of medicines 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 BACTOCIN contains
- The active substance is Lactobacillus plantarum P 17630. Each vaginal solution contains at least 100,000,000 colony-forming units (CFU) of Lactobacillus plantarum P 17630.
- The other components are:
Reservoir: medium-chain triglycerides, silica (aerosil 300).
Vial: trimethylcetylammonium p-toluenesulfonate, benzoic acid, Tween 20, lactic acid, purified water.
Description of the appearance of BACTOCIN and package contents
Box containing 1 vial of 150 ml + 1 vaginal applicator.
Box containing 5 vials of 150 ml + 5 vaginal applicators.
Marketing Authorization Holder
Proge Farm S.r.l. - Largo Donegani 4/A - 28100 Novara - Italy
Manufacturer
Sofar S.p.A. - Via Firenze, 40 - Trezzano sul Naviglio (MI)
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