Tantum Verde antiseptic and anti-inflammatory

Package leaflet: Information for the patient

TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY

1.5 mg/mL + 5 mg/mL oral mucosa spray, solution
benzidamine hydrochloride / cetylpyridinium chloride
Please read all of this leaflet carefully before you start 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 advised.
• 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.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet

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

1. What TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY is and what it is used for
TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY contains the active substances 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 ANTISEPTIC AND ANTI-INFLAMMATORY is used in adults (including elderly), adolescents, and children above 6 years of age for short-term local supportive anti-inflammatory, analgesic, and antiseptic treatment of throat, mouth, and gum irritations, gingivitis, pharyngitis (sore throat), and before and after tooth extractions.
Consult your 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
DO NOT use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY

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

Warnings and precautions
Talk to 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 occur, consult a doctor (see section 3).

• The use, especially if prolonged, of topical medicines such as TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY may cause sensitization (allergic reactions). In such cases, discontinue treatment and consult your doctor.

• Avoid contact with the eyes.

• TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY must not be used in combination with detergents (anionic compounds), such as those present in toothpastes; therefore, do not use the product immediately before or after brushing your teeth.

• If you have an allergy to salicylates (e.g., acetylsalicylic acid and salicylic acid) or to other anti-inflammatory analgesics known as non-steroidal anti-inflammatory drugs (NSAIDs), you must not use this medicine, as benzidamine hydrochloride also belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs).

• If you suffer 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 administer this medicine to children under 6 years of age, as its pharmaceutical form (oral mucosa spray) is not suitable for children in this age group.
Other medicines and TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not use the product concurrently with other antiseptics (products against infections).
TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY with food and drink
Do not use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY together with milk, as
milk reduces its effectiveness.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY 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. Discuss breastfeeding with your doctor, who will decide whether you should discontinue breastfeeding or the treatment with TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY.
Driving and using machines
TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY does not affect the ability to
drive or use machinery.
TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY contains macrogol glycerol
hydroxystearate, which may cause skin reactions.
TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY contains a fragrance 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 exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosing
Do not exceed the recommended dose.

• Adults (including elderly) and adolescents over 12 years of age: The recommended dose is 1-2 sprays. Administer 3-5 times daily. Wait at least 2 hours between doses.
• Children aged 6 to 12 years: The recommended dose is 1 spray. Administer 3-5 times daily. Wait at least 2 hours between doses.

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 spray button 1-2 times, as shown in the image:

At first use, press the spray button at least 4 times until a regular spray is produced.
This medicine must not be inhaled. Hold your breath during spraying.
For optimal results, do not use TANTUM VERDE ANTISEPTIC AND ANTI-INFLAMMATORY immediately before or after brushing your teeth (see the section “Warnings and precautions”).
Duration of treatment
Do not use this medicine for longer 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 condition 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 recommended, 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 forgotten 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 any of 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 (cannot be estimated from the available data):
Numbness of the oral mucosa (reduced sensation in the mouth).
Generally, these side effects are temporary. Following the instructions provided in this

Patient information leaflet reduces the risk of adverse effects.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system available at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5 HOW 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 special storage temperature.
Keep the medicine in its original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the bottle and the outer carton after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product when unopened and stored correctly.
Do not use this medicine more than 12 months after first opening the bottle.
Do not use this medicine if the bottle seal is broken.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
It is important to always keep the medicine information readily available. Therefore, retain the carton and the package leaflet.

6. Package contents and other information

What TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO contains

• The active substances are benzidamine hydrochloride and cetylpyridinium chloride. 1 mL of oral spray solution contains 1.5 mg of benzidamine hydrochloride and 5 mg of cetylpyridinium chloride.
• The other components are glycerol (E422), sodium saccharin (E954), citric acid monohydrate, sodium citrate, macrogol glycerol 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
contents of the pack
TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO is a clear solution ranging from colourless to pale yellow, with a pH of 5.0–6.2.
Each pack contains a 15 mL plastic bottle (HDPE) equipped with a non-aerosol dosing pump (PE/PP), a dispenser with body (PP), and a flexible cannula (PE). The bottle contains 15 mL of solution, and the spray pump delivers 100 microlitres per dose.
15 mL of oral mucosal spray, solution, provides approximately 150 doses.
The bottle is packaged in lithographed cardboard boxes, together with the package leaflet.

Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
Austria: Tantum Verde Protect 1.5 mg/mL + 5 mg/mL Spray for application in the oral cavity, solution
Czech Republic: TANTUM VERDE DUO
Germany: Tantum verde duo 1.5 mg/mL + 5 mg/mL Spray for application in the oral cavity, solution
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 buccopharyngeal spray, solution
Slovakia: TANTUM VERDE DUO
September 2025