TANTUM 0,15% Полоскание

Содержание инструкции

1. TANTUM VERDE 0,15% mouthwash
   1. What is Tantum Verde and what is it 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
2. TANTUM VERDE 0,15% spray for oral mucosa, solution
   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/give Tantum Verde to your child
   4. Possible side effects
   5. How to store Tantum Verde
   6. Package contents and other information
3. TANTUM VERDE 0,30% spray for oral mucosa, solution
   1. What is Tantum Verde and what is it 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

TANTUM VERDE 0,15% mouthwash

Benzydamine hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 is Tantum Verde and what is it used for

Tantum Verde mouthwash is a non-steroidal anti-inflammatory drug with analgesic properties, meaning it is a medicine
that acts against pain and inflammation of the throat, mouth and gums. Tantum Verde mouthwash
also exhibits disinfectant properties and a moderate superficial anesthetic action.
Tantum Verde mouthwash is used for the treatment of symptoms of inflammation and irritation, also associated
with pain of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), even as a result of
conservative or extraction dental therapy (e.g. cavity 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 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 a sign of more
serious diseases.
In particular, inform your doctor:

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

The use of Tantum Verde mouthwash, especially if prolonged, may lead to sensitization phenomena (allergic
reactions). See section 4 “Possible side effects”. In this case, stop treatment and contact your
doctor.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use Tantum Verde only after consulting your doctor and
assessing the benefit/risk ratio in your case with him.

Driving and operating machinery
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 flavour
Methyl parahydroxybenzoate may cause allergic reactions (even delayed).
This medicine contains mint flavour 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 following exactly as stated in this leaflet or as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much
The recommended dose is 15 ml, 2-3 times a day.
Caution: do not exceed the indicated doses without the advice of your doctor.

For how long
Use Tantum Verde only for short periods of treatment. If you do not feel better after 3 days of treatment,
consult your doctor or dentist as needed.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its
characteristics.

How
You can take Tantum Verde in its pure form (without diluting it with water) or diluted:

• 1) Pour Tantum Verde into the measuring cup up to the 15 ml mark (pure use)
• 2) If you take it diluted, pour water into the measuring cup which already contains Tantum Verde up to the 30 ml mark (dilution with water)
• 3) Perform a rinse or gargle (do not swallow).

If you use more Tantum Verde than you should
If you take an excessive amount of medicine or accidentally ingest large quantities, consult
your doctor or pharmacist immediately.

If you forget to use Tantum Verde
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of Tantum Verde, the following side effects may occur:
uncommon (may affect up to 1 in 100 people):

• photosensitivity (skin sensitivity to light);

rare (may affect up to 1 in
1000): - hypersensitivity reactions
(allergic reaction) - burning and dryness of the
mouth.
very rare (may affect up to 1 in 10,000):

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

not known (frequency cannot be estimated based on available data): -
anaphylactic reactions (severe allergic reactions)
If you experience any of the side effects listed above while taking Tantum Verde, STOP
treatment and contact your doctor immediately:

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through 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 which is stated on the pack. The expiry date refers to
the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tantum Verde contains

• the active ingredient is: benzydamine hydrochloride (100 ml of mouthwash contains 0.15 g of benzydamine hydrochloride equivalent to 0.134 g of benzydamine)
• the other components are: glycerol, ethanol (96 percent), saccharin, methyl parahydroxybenzoate(see paragraph “Tantum Verde contains methyl parahydroxybenzoate and mint flavour”), sodium bicarbonate, flavourmint, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water (see paragraph “Tantum Verde contains methyl parahydroxybenzoate and mint flavour”).

Description of the appearance of Tantum Verde and contents of the pack
Tantum Verde 0.15% is presented as a mouthwash in a glass bottle of 120 or 240 ml with a measuring cup. It is
possible that not all pack sizes are marketed.

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

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)
---------------------------------------------------------------------------------------------------------------------------

Health education notes
Some environmental conditions, such as lowering or fluctuations in temperature, increased humidity, etc.,
can cause inflammation of the upper respiratory tract (mouth, nose, throat) because they favour attack by
germs that can cause infections (pathogenic germs).
The characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include, among other things,
a burning sensation and sore throat with difficulty swallowing.
To avoid worsening these symptoms, it is useful to avoid some further irritating factors such as smoking, dry air, smog,
crowded places, etc.
The gums can also be a site of inflammation. The latter could even be a sign of
early dental problems: in this case, a dental check-up may be useful.
Furthermore, following dental conservative therapies (e.g. treatment of cavities), tooth extractions, minor
dental surgical procedures, the gums and oral cavity may be a site of redness, inflammation and
pain. All these situations can be overcome more quickly by also using a mouthwash with
specific activity against inflammation, against pain and surface anaesthetic (local superficial numbing state).

TANTUM VERDE 0,15% spray for oral mucosa, solution

Benzidamine hydrochloride

Read this leaflet carefully before using/giving this medicine to your child as it contains
important information for you.
Always use/give 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 want more information or advice, ask your pharmacist.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better 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/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 spray for oral mucosa 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
spray for oral mucosa also exhibits disinfectant properties and a moderate surface anaesthetic action.
Tantum Verde spray for oral mucosa is used for the treatment of symptoms of inflammation and irritation,
also associated with pain of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), even in
consequence of conservative or extractive dental therapy (e.g. caries treatment or tooth extraction).
Tantum Verde spray for oral mucosa is particularly indicated for patients unable to gargle.

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

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

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

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

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

The use of Tantum Verde oral mucosa spray, especially if prolonged, may lead to sensitization phenomena
(allergic reactions) see section 4 “Possible side effects”. In this 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, suspect or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use Tantum Verde only after consulting your doctor and
assessing the risk/benefit ratio in your case with him.

Driving and operating machinery
The use of Tantum Verde oral mucosa spray, at the recommended doses, does not alter the ability to drive or operate
machinery.

Tantum Verde contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and mint flavour
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (even delayed).
This medicine contains mint flavour which in turn contains anisil alcohol, benzyl alcohol, d-limonene,
linalool and eugenol. Anisil 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 following exactly as stated in this leaflet or as instructed
by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much
Adults and adolescents

4-8 sprays 2-6 times a day (each spray equals 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 every 4 Kg of body weight, up to a maximum of 4 sprays 2-6 times a
day.
Caution: do not exceed the indicated doses without the advice of your doctor.

For how long
Use Tantum Verde only for short periods of treatment. If after 3 days of treatment you/the child do not feel
better, consult your doctor or dentist as needed.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its
characteristics.

How

• 1. Lift the cannula that delivers the spray.

• 2. Insert the cannula into the mouth and direct the spray towards the inflamed area or towards the throat in case of pain and inflammation of the throat. Press firmly with your finger on the knurled area of the button.

Important note:
At the first use of the product, press the pumping button several times into the air, until a
regular nebulization is started.

If you use/give your child too much Tantum Verde
If you take an excessive amount of 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 a missed dose.
If you have any doubts about the use of this medicine, ask your doctor, dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of Tantum Verde, the following side effects may occur:
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 that causes difficulty swallowing and/or breathing)

not known (frequency cannot be estimated based on available data): -
anaphylactic reactions (severe allergic reactions)
If you experience any of the side effects listed above while being treated with Tantum Verde, STOP
treatment and contact your doctor immediately:

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through 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 sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to
the last day of that month.
Do not dispose of any medicine in 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 ingredient is: benzydamine hydrochloride (100 ml of solution contains 0.15 g of benzydamine hydrochloride equivalent to 0.134 g of benzydamine
• the other ingredients are: glycerol, crystallizable liquid sorbitol, sodium saccharin, acesulfame potassium, methyl parahydroxybenzoate, propyl parahydroxybenzoate(see paragraph “Tantum Verde contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and mint flavour”), mint flavour, polysorbate 20, purified water (see paragraph “Tantum Verde contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and mint flavour”).

Description of the appearance of Tantum Verde and package contents
Tantum Verde 0.15% is presented as a spray solution for oral mucosa in a 30 ml spray bottle.

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

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona

NDES
Certain environmental conditions, such as lowering or fluctuations in temperature, increased humidity levels, etc.,
can cause inflammation of the upper respiratory tract (mouth, nose, throat) because they favour attack by
germs that can cause infections (pathogenic germs).
The characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include, among others,
a burning sensation and pain in the throat with difficulty swallowing.
To avoid worsening these symptoms, it is useful to avoid some further irritating factors such as smoking, dry air, smog,
crowded places, etc.
The gums can also be a site of inflammation. The latter could even be a sign of
early dental problems: in this case, a dental check-up may be useful.

TANTUM VERDE 0,30% spray for oral mucosa, solution

Benzydamine hydrochloride

Read this leaflet carefully before using this medicine as 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 want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better 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 is Tantum Verde and what is it used for

Tantum Verde spray for oral mucosa 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 spray for oral mucosa also exhibits disinfectant properties and a moderate surface anaesthetic action. Tantum Verde spray for oral mucosa is used for the treatment of symptoms of inflammation and irritation, also associated with pain in the throat, mouth and gums (e.g. gingivitis, stomatitis, pharyngitis), even as a result of conservative or extraction dental therapy (e.g. caries treatment or tooth extraction). Tantum Verde spray for oral mucosa is particularly indicated for patients unable to gargle.

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
Consult your doctor or pharmacist before using Tantum Verde.
In a limited number of patients, internal lesions of the mouth and throat may be a sign of more
serious illnesses.
In particular, inform your doctor:

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

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding with breast milk, use Tantum Verde only after consulting your doctor and
assessing the risk/benefit ratio in your case with him.

Driving and operating machinery
The use of Tantum Verde oral mucosa spray, at the recommended doses, does not alter the ability to drive or operate
machinery.

Tantum Verde contains methyl parahydroxybenzoate, mint aroma and hydrogenated castor oil polyoxyethylene
Methyl parahydroxybenzoate may cause allergic reactions (even delayed).
This medicine contains mint aroma which in turn contains benzyl alcohol, citronellol, linalool, eugenol and
D-limonene.
Benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol and Dlimonene.
may cause allergic reactions.
Hydrogenated castor oil polyoxyethylene may cause localized reactions

3. How to use Tantum Verde

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.

How much
Adults

2-4 sprays 2-6 times a day (each spray delivers 0.17 ml of solution).
Caution: do not exceed the indicated doses without the advice of your doctor.

For how long
Use Tantum Verde only for short periods of treatment. If you do not feel better after 3 days of treatment, consult your doctor or dentist as needed.
Consult your doctor if the condition recurs or if you have noticed any recent change in its characteristics.

How

• 1. Lift the spray dispensing cannula.

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

Important note:
For the first use of the product, press the pump button several times into the air, until a regular spray is initiated.

If you use more Tantum Verde than you should
If you take an excessive amount of medicine or accidentally ingest a large quantity, consult your doctor or pharmacist immediately.

If you forget to use Tantum Verde
Do not use a double dose to make up for a missed dose.
If you have any doubts about using 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.
With the use of Tantum Verde, the following side effects may occur:
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 swallowing and/or breathing)

not known (frequency cannot be estimated from available data): -
anaphylactic reactions (severe allergic reactions)
If you experience any of the side effects listed above while taking Tantum Verde, STOP
treatment and contact your doctor immediately

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through 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 sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to
the last day of that month.
Do not dispose of any medicine in waste water 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 ingredient is: benzydamine hydrochloride (100 ml of solution contains 0.30 g of benzydamine hydrochloride equivalent to 0.268 g of benzydamine) the other ingredients are: glycerol, 96% ethanol, methyl parahydroxybenzoate(see paragraph “Tantum Verde contains methyl parahydroxybenzoate and mint flavour”), castor oil 40 polyoxidated hydrogenated, sodium saccharin, mint flavour, purified water (see paragraph “Tantum Verde contains methyl parahydroxybenzoate, mint flavour and hydrogenated polyoxidated castor oil”)

Description of the appearance of Tantum Verde and package contents
Tantum Verde 0.30% is presented as a solution for oral mucosa in a 15 ml spray bottle.

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

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona

NDES
Certain environmental conditions, such as lowering or fluctuations in temperature, increased humidity levels, etc.,
can cause inflammation of the upper respiratory tract (mouth, nose, throat) because they promote the attack by
germs that can cause infections (pathogenic germs).
The characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include, among others,
a burning sensation and pain in the throat with difficulty swallowing.
To avoid worsening these symptoms, it is useful to avoid some further irritating factors such as smoke, dry air, smog,
crowded places, etc.
The gums can also be the site of inflammation. The latter could even be a sign of
early dental problems: in this case, a dental check-up may be useful.