Broxo Din

Package leaflet: Information for the user

Broxo Din 200 mg/100 g mouthwash

chlorhexidine digluconate
Please read all of this leaflet carefully before you start 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.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact 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 your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What Broxo Din is and what it is used for

Broxo Din is an antiseptic for the oral mucosa, containing chlorhexidine digluconate, which is an antibacterial substance.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before using Broxo Din

Do not use Broxo Din

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Do not use for prolonged treatments; consult your doctor or dentist if you do not notice improvement after a few days of treatment.
• The use, especially if prolonged, of topical products (for local use) may lead to sensitization reactions (excessive body reaction to foreign substances it has come into contact with). In such cases, discontinue treatment and consult your doctor to start appropriate therapy.
• If, following the use of this product, pain, swelling or irritation of the mouth occurs, stop treatment and consult your doctor or dentist.
  • During the initial stages of treatment, alterations in taste, numbness or burning sensation of the tongue may occur. These are usually temporary effects that resolve with continued use. If they persist, consult your doctor or dentist.
• This product is for external use only and must not be swallowed. Avoid contact with eyes or ears: if the product comes into contact with eyes or ears, rinse immediately with water.
• If symptoms such as skin rash, swelling of lips, tongue, throat or face, or breathing difficulties (indicative of a severe allergic reaction) occur, stop using the product and seek immediate medical attention. Also consult your doctor if you have previously experienced such reactions.
• Chlorhexidine gluconate may cause superficial staining of the tongue, teeth and dental materials (e.g., fillings and prostheses).
• To help prevent staining, it is important to maintain daily oral hygiene using a toothbrush, toothpaste and dental floss. It may be helpful to rinse with water between Broxo Din applications or at other times during the day.
• Staining can be removed by professional dental cleaning, although it may persist if tooth surfaces are damaged.

Other medicines and Broxo Din
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Avoid simultaneous use of other disinfectants and detergents.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning pregnancy, or breastfeeding, consult your doctor before using this medicine.

Driving and using machines
No effects on the ability to drive vehicles or operate machinery are known.

Broxo Din mouthwash contains:
Ethoxylated hydrogenated castor oil (i.e., macrogol glycerol hydroxystearate), which may cause localized skin reactions.

3. How to use Broxo Din

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:

• during the first week: rinse twice daily after main meals;
• thereafter: one rinse daily in the evening, before going to bed.

Do not exceed the recommended dose.

Instructions for use:
Dilute 1 tablespoon of mouthwash in a glass with an equal amount of water. Rinse your mouth thoroughly.
This medicine may also be used undiluted on the gums and in the interdental spaces.

If you use more Broxo Din than you should
In case of accidental ingestion or overdose of Broxo Din 200 mg/100 g mouthwash, contact your doctor immediately or go to the nearest hospital.
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.
Possible side effects include: allergic reactions (both local and generalized), burning sensation, irritation, coated tongue, tongue pain, discoloration of the tongue and teeth, pain, swelling and desquamation of the mouth, dry mouth, taste disturbances and altered oral sensitivity.

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Broxo Din

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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. Contents of the pack and other information

What Broxo Din contains

• The active substance is chlorhexidine digluconate.
• The other components are: xylitol, triply rectified peppermint flavour, sodium saccharin, ethanol, macrogol glycerol hydroxystearate, purified water.

Description of the appearance of Broxo Din and contents of the pack
Broxo Din is presented in an amber-coloured bottle containing 250 ml of mouthwash.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Laboratorio Farmaceutico SIT S.r.l. – Via Provinciale per Lecco, 78 – 22038 Tavernerio (CO)

Patient Information Leaflet: Information for the User

Broxo Din 200 mg/100 g gingival gel

chlorhexidine digluconate
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 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, 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 Broxo Din is and what it is used for
2. What you need to know before using Broxo Din
3. How to use Broxo Din
4. Possible side effects
5. How to store Broxo Din
6. Package contents and other information

1. What Broxo Din is and what it is used for

Broxo Din is a disinfectant for the oral mucosa, containing chlorhexidine digluconate, which is an antibacterial substance.
Consult your doctor if you do not feel better or feel worse after a few days.

2. What you need to know before using Broxo Din

Do not use Broxo Din

• if you are allergic to the active substance or to any of the other components of this medicinal product (listed in section 6).

Warnings and precautions

• Do not use for prolonged treatments; consult your doctor or dentist if you do not notice any improvement after a few days of treatment.
• The use, especially if prolonged, of topical products (for local use) may lead to sensitization reactions (excessive reaction of the body to foreign substances it has come into contact with). In such cases, discontinue treatment and consult your doctor to start an appropriate therapy.

If, following the use of the product, pain, swelling or irritation of the mouth occur, discontinue treatment and consult your doctor or dentist.

• In the initial stages of treatment, alterations in taste, numbness or burning of the tongue may occur. These are usually temporary effects that resolve with continued use. If they persist, consult your doctor or dentist.
• This product is for external use only and must not be swallowed.
• Avoid contact with eyes or ears: if the product comes into contact with eyes or ears, rinse immediately with water.
• If symptoms such as skin rash, swelling of lips, tongue, throat or face, or breathing difficulties (indicative of a severe allergic reaction) occur, stop using the product and seek immediate medical attention. Also consult a doctor if you have experienced such reactions in the past.
• Chlorhexidine gluconate may cause superficial staining of the tongue, teeth and dental materials (e.g., fillings and prostheses).
• To prevent staining, it is important to maintain daily oral hygiene using a toothbrush, toothpaste and dental floss. Rinsing with water between Broxo Din applications or at other times during the day may also be helpful.
• Staining can be removed by professional cleaning, although it may persist if surfaces are damaged.

Other medicines and Broxo Din
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid simultaneous use of other disinfectants and detergents.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicinal product.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery are known.
Broxo Din gingival gel contains nipagin (methyl parahydroxybenzoate). It may cause allergic reactions (including delayed-type reactions).

3. How to use Broxo Din

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:

• two applications daily until irritation decreases;
• thereafter, one application daily in the evening, before going to bed.

Method of use:
Gently massage the gums for about 1 minute using 2 cm of gingival gel.
The product may be applied with the fingers or using a soft toothbrush.
Do not exceed the recommended dose.
If you use more Broxo Din than you should
In case of accidental ingestion/overdose of Broxo Din 200 mg/100g gingival gel, contact your doctor immediately or go to the nearest hospital.
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 everybody experiences them.
Possible side effects include: allergic reactions (both local and generalized), burning sensation, irritation, coated tongue, tongue pain, discoloration of the tongue and teeth, pain, swelling and desquamation of the mouth, dry mouth, taste disturbances and altered oral sensitivity.

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Broxo Din

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 Broxo Din contains

• The active substance is chlorhexidine digluconate.
• The other components are: vegetable malva gel, vegetable chamomile gel, menthol, hydroxyethylcellulose, non-crystallizable liquid sorbitol, sodium saccharin, nipagine (methyl parahydroxybenzoate), patent blue V dye, purified water.

Description of the appearance of Broxo Din and contents of the pack
Broxo Din is a gingival gel presented in a 30 ml tube.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)