TANTUM 1.5 MG/ML + 5 MG/ML Oral mucosal spray, solution

Зміст інструкції

1. TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO
   1. What you need to know before using TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY
   2. How to use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY
   3. Possible side effects
   4. Package Contents and Other Information

TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO

1.5 mg/mL + 5 mg/mL spray for oral mucosa, solution
benzidamine hydrochloride/cetylpyridinium chloride

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.
• 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.

Contents of this leaflet

• 1. What is TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO and what it is used for
• 2. What you need to know before you use TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO
• 3. How to use TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO
• 4. Possible side effects
• 5. How to store TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO
• 6. Contents of the pack and other information

1What is TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO and what it is used for
TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO contains the active ingredients benzidamine
hydrochloride and cetylpyridinium chloride, which exert a local anti-inflammatory (act against
inflammation), analgesic (relieve pain) and antiseptic (fight infections) action on the mouth and
throat.
TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO is used in adults (including
the elderly), adolescents and children over 6 years of age for the short-term local supportive anti-inflammatory,
analgesic and antiseptic treatment of irritation of the throat, mouth and gums, in gingivitis, pharyngitis (sore throat) and before and after tooth extractions.
See a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY

ANTI-INFLAMMATORY
Do not use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY

• If you are allergic to benzydamine hydrochloride, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6).
• This medicine should not be used in children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY.

• Do not use this medicine for more than 7 days. If symptoms worsen or do not improve after

3 days or if other symptoms appear, consult a doctor (see section 3).

• The use, especially if prolonged, of topical medicines like TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY may cause sensitization (allergic reactions). If this happens, stop treatment and consult your doctor.
• Avoid contact with the eyes.
• TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY should not be used in association with detergents (anionic compounds), such as those found in toothpastes; therefore, do not use the product immediately before or immediately after brushing your teeth.
• If you have an allergy to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other pain relievers with anti-inflammatory action called non-steroidal anti-inflammatory drugs (NSAIDs), you should not use this medicine, as benzydamine hydrochloride also belongs to the class of non-steroidal anti-inflammatory drugs.
• If you suffer from or have ever suffered from bronchial asthma, consult your doctor or pharmacist before using this medicine. In this case, caution is required.

Children and adolescents
Do not give this medicine to children under 6 years of age, as its pharmaceutical form (oral mucosal spray) is not suitable for children in this age group.

Other medicines and TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use the product at the same time as other antiseptics (products against infections).

TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY with food and drink
Do not use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY with milk, as the latter reduces its effectiveness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY is not recommended during pregnancy.
You should discuss breastfeeding with your doctor, who will decide whether to stop breastfeeding or the therapy with TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY.

Driving and using machines
TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY does not impair the ability to drive vehicles and operate machinery.

TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY contains macrogolglycerol hydroxystearatewhich may cause skin reactions.

TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORYcontains a flavour with allergens
(benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, D-limonene, linalool and eugenol). These allergens may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY

Use 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.

Dosage

Do not exceed the recommended dose.

• Adults (including the elderly) and adolescents over 12 years of age. The recommended dose is 1-2 sprays. Administration should be repeated 3-5 times a day. Wait at least 2 hours between each dose.
• Children aged 6 to 12 years. The recommended dose is 1 spray. Administration should be repeated 3-5 times a day. Wait at least 2 hours between each dose.

Do not use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY in children under 6 years of age.

Method of administration
Rotate the nozzle and press the dispensing button 1-2 times, as shown in the image:

For the first use of the product, press the dispensing button at least 4 times until a regular spray is initiated.
The medicine should not be inhaled. Hold your breath during spraying.
To obtain optimal results, do not use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY immediately before or immediately after brushing your teeth (see section “Warnings and precautions”).

Duration of treatment
Do not use this medicine for more than 7 days without consulting a doctor. If symptoms worsen or do not improve after 3 days, consult your doctor.
Consult your doctor if the disorder is recurrent or if you notice any recent changes in its characteristics.

If you use more TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY than you should
If you use more TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY than you should, consult a doctor immediately or go to the nearest hospital.

If you forget to use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY
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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects, STOP taking this medicine and contact your
doctor immediately:

• hypersensitivity (allergic reactions), including anaphylactic reaction (severe allergic reaction), urticaria, photosensitivity (sensitivity to light) and bronchospasm (narrowing of the airways causing severe breathing difficulties).

Very rare (may affect up to 1 in 10,000 people):
Local irritation or burning sensation in the mouth or throat.
Frequency not known (the frequency cannot be estimated from available data):
Numbness of the oral mucosa (sensation of reduced sensitivity in the mouth).
Generally these side effects are temporary. Following the instructions contained in this

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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5How to store TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY
Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature.
Keep the medicine in the original package to protect it from light.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
“Expiry”. The expiry date refers to the last day of that month. The expiry date refers
to the product in its intact packaging, correctly stored.
Do not use this medicine after 12 months from first opening of the bottle.
Do not use this medicine if the bottle seal is broken.
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.
It is important to always have the information about the medicine at hand. Therefore, keep the carton

6. Package Contents and Other Information

What TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO contains

• The active ingredients are benzydamine hydrochloride and cetylpyridinium chloride. 1 mL of oral spray solution contains 1.5 mg of benzydamine hydrochloride and 5 mg of cetylpyridinium chloride.
• The other ingredients are glycerol (E422), sodium saccharin (E954), citric acid monohydrate, sodium citrate, macrogol hydroxystearate, mint flavour (containing allergens: benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, D-limonene, linalool and eugenol), purified water.

Description of the appearance of TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO and
package contents
TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO is a clear solution from colourless to
light yellow with a pH of 5.0-6.2.
Each package contains a 15 mL plastic bottle (HDPE) equipped with a non-aerosol pump (PE/PP)
dispenser, an applicator with a body (PP) and a foldable cannula (PE). The bottle contains
15 mL of solution and the spray pump delivery is set to 100 microliters per dose.
15 mL of spray for oral mucosa, solution is sufficient for approximately 150 sprays.

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

Manufacturer
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.P.A., Via Vecchia del Pinocchio 22 -
60131, Ancona (AN), Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria: Tantum Verde Protect 1.5 mg/ml + 5 mg/ml Spray zur Anwendung in der Mundhöhle, Lösung

Czech Republic: TANTUM VERDE DUO

Germany: Tantum verde duo 1.5 mg/ml + 5 mg/ml Spray zur Anwendung in der Mundhöhle, Lösung

Hungary: Tantum Verde Duo 1.5 mg/ml + 5 mg/ml szájnyálkahártyán alkalmazott oldatos spray

Italy:TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO

Poland:TANTUM VERDE DUO

Portugal:TANTUM VERDE DUO

Romania:TANTUM VERDE DUO 1.5 mg/ml + 5 mg/ml spray bucofaringian, soluție

Slovakia: TANTUM VERDE DUO
April 2025