Cetrifarm

Package leaflet: Information for the user

CETRIFARM 1.5% + 15% concentrate for cutaneous solution

Chlorhexidine gluconate and cetrimide
Please read all of this leaflet carefully before you use 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 advice or information, 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 any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

1. What CETRIFARM is and what it is used for
2. What you need to know before using CETRIFARM
3. How to use CETRIFARM
4. Possible side effects
5. How to store CETRIFARM
6. Contents of the pack and other information

1. What CETRIFARM is and what it is used for

CETRIFARM contains two active substances, chlorhexidine gluconate and cetrimide, which belong to a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
CETRIFARM is indicated for cleaning and disinfecting:

• the skin, both intact and in the presence of minor superficial wounds
• the external genitalia in obstetrics, gynaecology, and urology.

Consult your doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before using CETRIFARM

Do not use CETRIFARM

• if you are allergic to chlorhexidine, cetrimide, or any of the other ingredients of this medicine (listed in section 6);
• to disinfect mucous body cavities, for example for washings or irrigations.

Warnings and precautions
Talk to your doctor or pharmacist before using CETRIFARM.
This medicine is for topical use on the skin only (external use).
Do not apply this medicine to the eyes or ears.
In addition, contact with the brain or the membranes covering the brain (meninges) should be avoided.
CETRIFARM must not be ingested, as serious, even fatal, consequences may occur.
Avoid applying CETRIFARM under non-breathable (occlusive) dressings.
After applying this medicine to the skin, avoid exposure to sunlight.
Do not use this medicine for prolonged treatments, as prolonged use of CETRIFARM may lead to allergic reactions (hypersensitivity phenomena). In such cases, discontinue treatment and consult your doctor, who will determine appropriate therapy.

Children
CETRIFARM may cause chemical burns in newborns, especially in those born prematurely.

Other medicines and CETRIFARM
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
During treatment with CETRIFARM, it is recommended to avoid using other similar medicines (disinfectants or detergents).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
You may use this medicine during pregnancy and while breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use CETRIFARM

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.
This product must be used only diluted in water, as follows:

• external cleansing and disinfection in gynaecology, obstetrics and urology: 20 ml of solution in 2 litres of water;
• disinfection of intact skin: 20 ml of solution in 500 ml of water;
• disinfection and cleansing of small superficial wounds: 20 ml of solution in 1 litre of water.

After appropriate dilution, apply the solution to the skin using a cotton pad soaked in the medicinal solution.
If necessary, repeat the application up to a maximum of 4–5 times daily.
Do not exceed the recommended doses.
If you use more CETRIFARM than you should
No cases of overdose have been reported under normal conditions of use.
Accidental ingestion of this medicine may cause symptoms such as: nausea, vomiting, difficulty in breathing (dyspnoea), bluish discoloration of the skin due to lack of oxygen (cyanosis), suffocation (asphyxia) due to respiratory muscle paralysis, lowering of blood pressure (hypotension), and deep unconsciousness (coma).
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 everyone experiences them.
The following side effects may occur:

• burning or irritation of the skin (intolerance). These effects usually do not require changes in treatment;
• idiosyncratic reactions (unusual reactions to the medicine);
• burns (chemical burns) in newborns (frequency not known).

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

5. How to store CETRIFARM

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 "Expiry". The expiry date refers to the last day of that month.
Store below 30°C in the original packaging to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What CETRIFARM contains

• The active substances are chlorhexidine gluconate and cetrimide. 100 g of solution contain 1.5 g of chlorhexidine gluconate and 15 g of cetrimide.
• The other components are: isopropyl alcohol, purified water.

Description of the appearance of CETRIFARM and contents of the pack
Pack: 1 bottle of 1 litre.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy

Package leaflet: Information for the user

CETRIFARM 0.015%+0.15% cutaneous solution in single-dose container

Chlorhexidine gluconate and cetrimide
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 further information or advice, consult your pharmacist.
• If any of the side effects occur, including those not listed in this leaflet, 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 few days.

Contents of this leaflet:

1. What CETRIFARM is and what it is used for
2. What you need to know before using CETRIFARM
3. How to use CETRIFARM
4. Possible side effects
5. How to store CETRIFARM
6. Contents of the pack and other information

1. What CETRIFARM is and what it is used for

CETRIFARM contains two active substances, chlorhexidine gluconate and cetrimide, which belong to a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
CETRIFARM is indicated for cleaning and disinfecting:

• the skin, both intact and in the presence of lesions (wounds, burns);
• the external genitalia in obstetrics, gynaecology and urology.

Consult your doctor if you do not feel better or if you feel worse after several days of treatment.

2. What you need to know before using CETRIFARM

Do not use CETRIFARM

• if you are allergic to chlorhexidine, cetrimide, or any of the other ingredients of this medicine (listed in section 6);
• for disinfecting body mucosal cavities, for example, for washes or irrigations.

Warnings and precautions
Talk to your doctor or pharmacist before using CETRIFARM.
This medicine is for topical use on the skin only (external use).
Do not apply this medicine to the ear.
In addition, contact with the brain or the membranes covering the brain (meninges) should be avoided.
CETRIFARM must not come into contact with the eyes due to the risk of visual damage. If contact occurs, rinse immediately and thoroughly with water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.
Serious cases of permanent corneal injury (damage to the surface of the eye) have been reported following accidental exposure of similar products to the eye during surgical procedures in patients under general anesthesia (induced deep sleep). Such injuries may require corneal transplantation.
CETRIFARM must not be ingested, as this may lead to severe, even fatal, consequences.
Avoid applying CETRIFARM under non-breathable (occlusive) dressings.
After applying this medicine to the skin, avoid exposure to sunlight.
Do not use this medicine for prolonged treatments, as prolonged use of CETRIFARM may lead to allergic reactions (hypersensitivity phenomena). In such cases, discontinue treatment and consult your doctor, who will determine appropriate therapy.

Children
CETRIFARM may cause chemical burns in newborns, particularly in those born prematurely.

Other medicines and CETRIFARM
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
During treatment with CETRIFARM, it is recommended to avoid using other similar medicinal products (disinfectants or detergents).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
You may use this medicine during pregnancy and while breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

CETRIFARM contains ethanol
This medicine contains 57 mg of alcohol (ethanol) in 100 ml of solution, equivalent to 0.057% w/v. It may cause a burning sensation on damaged skin.

3. How to use CETRIFARM

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.
This product can be used on both damaged and intact skin.
Apply the medicine to the skin using a cotton pad soaked in the solution.
If necessary, repeat the application up to a maximum of 4–5 times a day.
Do not exceed the recommended doses.
If you use more CETRIFARM than you should
Cases of overdose have not been reported under normal conditions of use.
Accidental ingestion of this medicine may cause symptoms such as: nausea, vomiting, breathing difficulties (dyspnoea), bluish discoloration of the skin due to lack of oxygen (cyanosis), suffocation (asphyxia) due to respiratory muscle paralysis, low blood pressure (hypotension), and deep unconsciousness (coma).
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.
The following side effects may occur:

• burning or irritation of the skin (intolerance). These effects usually do not require changes in treatment;
• idiosyncratic reactions (abnormal reactions to the medicine);
• chemical burns (chemical burns) in newborns (frequency not known);
• corneal trauma (injury to the surface of the eye) and permanent eye damage, including permanent vision impairment (after accidental exposure of the eyes during surgical procedures on the head, face and neck) in patients under general anaesthesia (induced deep sleep) (frequency not known).

Reporting of side effects
If you experience any side effects, 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 the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CETRIFARM

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 "Expiry".
Store in the original packaging.
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 CETRIFARM contains

• The active substances are chlorhexidine gluconate and cetrimide. 100 g of solution contain 0.015 g of chlorhexidine gluconate and 0.150 g of cetrimide. The other components are: ethanol 95°, purified water.

Description of the appearance of CETRIFARM and package contents
Pack containing 1 sachet with 25 ml of sterile, clear solution.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. – Via W. Flemming, 7 – Settimo di Pescantina (VR) – Italy