Tantum Verde

Package leaflet: Information for the user

TANTUM VERDE 0.15% mouthwash

Hydrochloride benzidamine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always take 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

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

1. What Tantum Verde is and what it is used for

Tantum Verde mouthwash is a non-steroidal anti-inflammatory drug with analgesic properties, i.e. a medicine that acts against pain and inflammation of the throat, mouth and gums. Tantum Verde mouthwash also has disinfectant properties and a mild local anesthetic effect.
Tantum Verde mouthwash is used to treat symptoms of inflammations and irritations, even when associated with pain in the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), including those occurring after conservative or extraction dental procedures (e.g. dental caries treatment or tooth extraction).

2. What you need to know before using Tantum Verde

Do not use Tantum Verde

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Tantum Verde.
In a limited number of patients, internal lesions of the mouth and throat may be signs of more serious diseases.
In particular, inform your doctor:

• if you are allergic to acetylsalicylic acid or to other anti-inflammatory drugs;
• if you have previously suffered from breathing disorders, such as asthma.

Prolonged use of Tantum Verde mouthwash may lead to sensitization reactions (allergic phenomena). See section 4, "Possible side effects". If this occurs, discontinue treatment and contact your doctor.

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

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 using this medicine.
Do not use Tantum Verde mouthwash during pregnancy unless clearly necessary and under medical advice. If treatment is required, the lowest effective dose for the shortest possible duration should be used.

Driving and using machines
The use of Tantum Verde mouthwash at the recommended doses does not impair the ability to drive or operate machinery.

Tantum Verde contains methyl parahydroxybenzoate and mint flavouring
Methyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains mint flavouring, which in turn contains benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol and d-limonene.
Benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol and d-limonene may cause allergic reactions.

3. How to use Tantum Verde

Take 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.
Dosage
The recommended dose is 15 ml, 2–3 times a day.
Caution: Do not exceed the recommended doses without medical advice.
Duration of treatment
Use Tantum Verde only for short-term treatment. If you do not feel better after 3 days of treatment, consult your doctor or dentist, as appropriate.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
Administration
You may take Tantum Verde undiluted (without mixing with water) or diluted:

1. Pour Tantum Verde into the measuring cup up to the 15 ml mark (for undiluted use).
2. If using it diluted, add water to the measuring cup already containing Tantum Verde, up to the 30 ml mark (dilution with water).
3. Rinse or gargle (do not swallow).

If you use more Tantum Verde than you should
If you take too much of this medicine or accidentally swallow large amounts, consult your doctor or pharmacist immediately.
If you forget to use Tantum Verde
Do not take a double dose to make up for a forgotten 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 can cause side effects, although not everyone will experience them.
The following side effects may occur with the use of Tantum Verde:

Uncommon (may affect up to 1 in 100 people):

• photosensitivity (skin sensitivity to light);

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions (allergic reaction)
• burning sensation and dryness of the mouth.

Very rare (may affect up to 1 in 10,000 people):

• laryngospasm (difficulty breathing)
• angioedema (sudden swelling of the mouth/throat and mucous membranes causing difficulty in swallowing and/or breathing)

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

• anaphylactic reactions (severe allergic reactions)

If you experience any of the side effects listed above during treatment with Tantum Verde, STOP the treatment immediately and consult your doctor.

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 Tantum Verde

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. The expiry date refers to the last day of that month.
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 Tantum Verde contains

• The active substance is: benzidamine hydrochloride (100 ml of mouthwash contain 0.15 g of benzidamine hydrochloride, equivalent to 0.134 g of benzidamine).
• The other components are: glycerol, ethanol (96 percent), saccharin, methyl 4-hydroxybenzoate (see section “Tantum Verde contains methyl 4-hydroxybenzoate and peppermint flavour”), sodium bicarbonate, peppermint flavour, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water (see section “Tantum Verde contains methyl 4-hydroxybenzoate and peppermint flavour”).

Description of the appearance of Tantum Verde and contents of the package
Tantum Verde 0.15% is a mouthwash supplied in 120 ml or 240 ml glass bottles with a dosing cup.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
Istituto de Angeli S.r.l., Loc. Prulli 103/c – 50066 Reggello (FI)

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Health education notes
Certain environmental conditions, such as drops or sudden changes in temperature, increased humidity, etc., may cause inflammation of the upper respiratory tract (mouth, nose, throat), as they favor the attack by germs that can lead to infections (pathogenic germs).
Characteristic symptoms of inflammation in the upper respiratory tract (mouth, nose, throat) include, among others, a burning sensation and sore throat with difficulty swallowing.
To avoid worsening these symptoms, it is advisable to avoid additional irritants such as smoking, dry air, smog, crowded places, etc.
Gums may also become inflamed. This inflammation could even be an early sign of dental problems: in such cases, a dental check-up may be advisable.
Moreover, after conservative dental treatments (e.g. filling of caries), tooth extractions, or minor dental surgeries, gums and the oral cavity may experience redness, inflammation, and pain. These conditions may resolve more quickly with the use of a mouthwash specifically active against inflammation, pain, and providing local surface anaesthesia (local superficial numbing).

Package leaflet: information for the user

TANTUM VERDE 0.15% oral mucosa spray, solution

Benzidamine hydrochloride
Please read this leaflet carefully before using/giving this medicine to your child, as it contains
important information for you.
Always use/give this medicine to your child exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you/your child 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 symptoms worsen after 3 days of treatment.

Contents of this leaflet:

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

1. What Tantum Verde is and what it is used for

Tantum Verde oral mucosa spray is a non-steroidal anti-inflammatory drug with analgesic properties, i.e.
a medicine that acts against pain and inflammation of the throat, mouth and gums. Tantum Verde
oral mucosa spray also exhibits disinfectant properties and a moderate surface anaesthetic effect.
Tantum Verde oral mucosa spray is used to treat symptoms of inflammations and irritations,
including pain of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), even following
conservative or extraction dental procedures (e.g. treatment of caries or tooth extraction).
Tantum Verde oral mucosa spray is particularly suitable for patients unable to perform gargling.

2. What you should know before using/giving Tantum Verde to your child

Do not use/do not give Tantum Verde to your child

• if you/your child are allergic to benzydamine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using/giving Tantum Verde to your child.
In a limited number of patients, internal lesions of the mouth and throat may be signs of more serious diseases.
In particular, inform your doctor:

• if you are allergic to acetylsalicylic acid or to other anti-inflammatory medicines;
• if you have previously suffered from breathing problems, such as asthma.

The use of Tantum Verde oral mucosa spray, especially if prolonged, may lead to sensitization (allergic reactions) – see section 4 “Possible side effects”. In such case, discontinue treatment and contact your doctor.
Other medicines and Tantum Verde
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use Tantum Verde oral mucosa spray during pregnancy unless clearly necessary and on medical advice. If treatment is required, the lowest possible dose for the shortest possible time should be used.
Driving and using machines
The use of Tantum Verde oral mucosa spray at the recommended doses does not impair the ability to drive or operate machinery.
Tantum Verde contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and peppermint flavour
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains peppermint flavour, which in turn contains anisyl alcohol, benzyl alcohol, d-limonene, linalool, and eugenol. Anisyl alcohol, benzyl alcohol, linalool, eugenol, and d-limonene may cause allergic reactions.

3. How to use/give Tantum Verde to your child

Use/give this medicine to your child exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults and adolescents

4-8 sprays 2-6 times a day (each spray corresponds to 0.17 ml of solution).
Use in children

Children (6-12 years): 4 sprays 2-6 times a day.

Children (under 6 years): 1 spray for each 4 kg of body weight, up to a maximum of 4 sprays 2-6 times a day.
Warning: Do not exceed the indicated doses without medical advice.
For how long
Use Tantum Verde only for short treatment periods. If after 3 days of treatment you/your child do not feel better, consult your doctor or dentist as appropriate.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
How to use

1. Lift the nozzle that delivers the spray.

2. Insert the nozzle into the mouth and direct the spray towards the inflamed area or towards the throat in case of sore throat and inflammation. Press firmly with your finger on the ribbed area of the button.

Important note:
At first use of the product, press the pump button several times without spraying, until a regular mist is produced.
If you use/give your child more Tantum Verde than you should
If you take an excessive amount of the medicine or accidentally ingest large quantities, consult your doctor or pharmacist immediately.
If you forget to use/give Tantum Verde to your child
Do not use/give your child a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor, dentist 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 with the use of Tantum Verde:

Uncommon (may affect up to 1 in 100 people):

• photosensitivity (skin sensitivity to light);

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions (allergic reaction) – burning and dryness of the mouth.

Very rare (may affect up to 1 in 10,000 people):

• laryngospasm (difficulty breathing)
• angioedema (sudden swelling of the mouth/throat and mucous membranes causing difficulty in swallowing and/or breathing)

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

• anaphylactic reactions (severe allergic reactions)

If you experience any of the side effects listed above while being treated with Tantum Verde, STOP the treatment and contact your doctor immediately:

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 may help provide more information on the safety of this medicine.

5. How to store Tantum Verde

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. 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 Tantum Verde contains

• the active substance is: benzidamine hydrochloride (100 ml of solution contain 0.15 g of benzidamine hydrochloride, equivalent to 0.134 g of benzidamine)
• the other components are: glycerol, crystallizable liquid sorbitol, sodium saccharin, acesulfame potassium, methyl parahydroxybenzoate, propyl parahydroxybenzoate (see section “Tantum Verde contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and peppermint flavour”), peppermint flavour, polysorbate 20, purified water (see section “Tantum Verde contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and peppermint flavour”).

Description of the appearance of Tantum Verde and contents of the pack
Tantum Verde 0.15% is an oral mucosa spray solution in a 30 ml spray bottle.
Marketing Authorization Holder
Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy
N D E S
Certain environmental conditions, such as lowering or fluctuations in temperature, increased humidity, etc.,
may cause inflammation of the upper respiratory tract (mouth, nose, throat), as they favour the attack
by germs that can cause infections (pathogenic germs).
Characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include, among others,
a burning sensation and sore throat with difficulty swallowing.
To avoid worsening these symptoms, it is helpful to avoid certain additional irritants such as smoke, dry air,
smog, crowded places, etc.
Gums may also become inflamed. This inflammation could even be a sign of early dental problems: in such cases,
a dental check-up may be advisable.

Package leaflet: Information for the user

TANTUM VERDE 0.30% oral mucosa spray, solution

Benzidamine hydrochloride
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 would like more information or advice, consult your pharmacist.
• If you experience any of the side effects, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Tantum Verde is and what it is used for
2. What you need to know before using Tantum Verde
3. How to use Tantum Verde
4. Possible side effects
5. How to store Tantum Verde
6. Package contents and other information

1. What Tantum Verde is and what it is used for

Tantum Verde oral mucosa spray is a non-steroidal anti-inflammatory drug with analgesic properties, i.e.
a medicine that acts against pain and inflammation of the throat, mouth and gums. Tantum Verde
oral mucosa spray also exhibits disinfectant properties and a mild local anesthetic effect.
Tantum Verde oral mucosa spray is used to treat symptoms of inflammations and irritations,
including pain in the throat, mouth and gums (e.g. gingivitis, stomatitis, pharyngitis), also occurring
following conservative or extractive dental treatments (e.g. dental caries treatment or tooth extraction).
Tantum Verde oral mucosa spray is particularly indicated for patients unable to perform gargling.

2. What you need to know before using Tantum Verde

Do not use Tantum Verde

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

Warnings and precautions
Talk to your doctor or pharmacist before using Tantum Verde.
In a limited number of patients, internal lesions of the mouth and throat may be signs of more serious diseases.
In particular, inform your doctor:

• if you are allergic to acetylsalicylic acid or to other anti-inflammatory medicines;
• if you have previously suffered from breathing disorders, such as asthma.

The use of Tantum Verde oral mucosa spray, especially if prolonged, may lead to sensitization (allergic reactions); see section 4 “Possible side effects”. In such a case, discontinue treatment and contact your doctor.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use Tantum Verde oral mucosa spray during pregnancy unless clearly necessary and as directed by your doctor. If treatment is required, the lowest possible dose for the shortest possible duration should be used.

Driving and using machines
When used at the recommended doses, Tantum Verde oral mucosa spray does not affect the ability to drive or operate machinery.

Tantum Verde contains methyl parahydroxybenzoate, mint flavour and polyoxyl 40 hydrogenated castor oil
Methyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains mint flavour which contains benzyl alcohol, citronellol, linalool, eugenol and D-limonene.
Benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol and D-limonene may cause allergic reactions.
Polyoxyl 40 hydrogenated castor oil may cause localized reactions.

3. How to use Tantum Verde

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

Dosage

Adults

2-4 sprays 2-6 times daily (each spray corresponds to 0.17 ml of solution).
Caution: Do not exceed the recommended doses without medical advice.

Duration of treatment

Use Tantum Verde only for short-term treatment. If you do not feel better after 3 days of treatment, consult your doctor or dentist, as appropriate.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.

Instructions for use

1. Lift the nozzle that delivers the spray.

2. Insert the nozzle into the mouth and direct the spray towards the inflamed area or towards the throat in case of sore throat and inflammation. Press firmly with your finger on the ribbed area of the button.

Important note:
At first use, press the pump button several times without spraying, until a regular mist is produced.

If you use more Tantum Verde than you should

If you take too much of this medicine or accidentally swallow large amounts, contact your doctor or pharmacist immediately.

If you forget to use Tantum Verde

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, dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with the use of Tantum Verde:

Uncommon (may affect up to 1 in 100 people):

• photosensitivity (skin sensitivity to light);

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions (allergic reaction)
• burning and dryness of the mouth

Very rare (may affect up to 1 in 10,000 people):

• laryngospasm (difficulty breathing)
• angioedema (sudden swelling of the mouth/throat and mucous membranes causing difficulty in swallowing and/or breathing)

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

• anaphylactic reactions (severe allergic reactions)

If you experience any of the above side effects while using Tantum Verde, STOP treatment immediately and contact your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform 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 Tantum Verde

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 pack. 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 Tantum Verde contains

• The active substance is: benzidamine hydrochloride (100 ml of solution contain 0.30 g of benzidamine hydrochloride, equivalent to 0.268 g of benzidamine).
  The other components are: glycerol, 96% ethanol, methyl parahydroxybenzoate (see section “Tantum Verde contains methyl parahydroxybenzoate and peppermint flavour”), hydrogenated polyoxycastor oil 40, sodium saccharin, peppermint flavour, purified water (see section “Tantum Verde contains methyl parahydroxybenzoate, peppermint flavour and hydrogenated polyoxycastor oil”).

Description of the appearance of Tantum Verde and contents of the pack
Tantum Verde 0.30% is an oral mucosa spray solution in a 15 ml spray bottle.
Marketing Authorization Holder
Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy
N D E S
Certain environmental conditions, such as low temperatures or sudden temperature changes, increased humidity, etc.,
can cause inflammation of the upper respiratory tract (mouth, nose, throat), as they favour the onset of infections caused by germs (pathogenic microorganisms).
Typical symptoms of inflammation in the upper respiratory tract (mouth, nose, throat) include, among others, a burning sensation and sore throat, with difficulty swallowing.
To avoid worsening these symptoms, it is advisable to avoid additional irritating factors such as smoking, dry air, smog, crowded places, etc.
Gums may also become inflamed. Such inflammation could even be an early sign of dental problems: in this case, a dental check-up may be advisable.