Tantum Verde Duo

Leaflet attached to the packaging: patient information

Tantum Verde Duo, 1.5 mg/ml + 5 mg/ml, spray for oral use, solution
Benzydamine hydrochloride + Cetylpyridinium chloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Tantum Verde Duo and what is it used for
• 2. Important information before using Tantum Verde Duo
• 3. How to use Tantum Verde Duo
• 4. Possible side effects
• 5. How to store Tantum Verde Duo
• 6. Contents of the packaging and other information

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

Tantum Verde Duo contains the active substances: benzydamine hydrochloride and cetylpyridinium chloride, which act locally on the mouth and throat as an anti-inflammatory (anti-inflammatory), analgesic (pain-relieving), and antiseptic (anti-infective) agent.
Tantum Verde Duo is used in adults (including the elderly), adolescents, and children over 6 years of age for short-term, supportive local anti-inflammatory, analgesic, and antiseptic treatment of throat, mouth, and gum irritations, gingivitis, pharyngitis (sore throat), and before and after tooth extraction.
If there is no improvement after 3 days or if the patient feels worse, they should consult their doctor.

2. Important information before using Tantum Verde Duo

When not to use Tantum Verde Duo

• If the patient is allergic to benzydamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6).
• The medicine must not be used in children under 6 years of age.

Warnings and precautions

Before starting to use Tantum Verde Duo, the patient should discuss it with their doctor or pharmacist.

• 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, the patient should consult their doctor (see section 3).
• Using local medicines, such as Tantum Verde Duo, especially for a long period, may cause sensitization (allergic reactions). In such cases, treatment should be discontinued and medical advice sought.
• Avoid contact with the eyes.
• Tantum Verde Duo must not be used in combination with detergents (anionic compounds) found in toothpastes. Therefore, the medicine should not be used immediately before or after brushing teeth.
• If the patient is allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other anti-inflammatory painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), they should not use this medicine, as benzydamine hydrochloride also belongs to the group of non-steroidal anti-inflammatory drugs.
• If the patient has or has had asthma, the use of this medicine should be discussed with a doctor or pharmacist. In such cases, caution is advised.

Children and adolescents

The medicine must not be given to children under 6 years of age, as the pharmaceutical form (oral spray) is not suitable for this age group.

Tantum Verde Duo and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The medicine must not be used with other antiseptic medicines (anti-infective products).

Tantum Verde Duo with food and drink

The medicine should not be used with milk, as milk reduces its effectiveness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Tantum Verde Duo is not recommended during pregnancy.
The patient should discuss breastfeeding with their doctor, who will decide whether to discontinue breastfeeding or stop using Tantum Verde Duo.

Driving and using machines

Tantum Verde Duo has no influence on the ability to drive and use machines.
Tantum Verde Duo contains macrogolglycerol hydroxystearate, which may cause skin reactions.
Tantum Verde Duo contains a flavor with allergens(benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, d-limonene, linalol, and eugenol). These may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to use Tantum Verde Duo

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their 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. The dose should be repeated 3 to 5 times a day. There should be an interval of at least 2 hours between doses.
• Children between 6 and 12 years of age. The recommended dose is 1 spray. The dose should be repeated 3 to 5 times a day. There should be an interval of at least 2 hours between doses.

Tantum Verde Duo must not be used in children under 6 years of age.
Method of administration
Turn the actuator and press the spray button 1-2 times, as shown in the picture:

When using the product for the first time, press the pump at least four times until a uniform spray is obtained.
The medicine should not be inhaled. The patient should hold their breath while spraying.
To achieve the best results, the medicine should not be used immediately before or after brushing teeth (see "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, the patient should consult their doctor.
The patient should inform their doctor if the condition recurs or if they notice a change in symptoms.

Using a higher dose of Tantum Verde Duo than recommended

In case of using a higher dose of Tantum Verde Duo than recommended, the patient should immediately contact their doctor or go to the nearest hospital.

Missing a dose of Tantum Verde Duo

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tantum Verde Duo can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should STOP using this medicine and contact their doctor immediately:

• Hypersensitivity (allergic reactions), including anaphylactic reaction (severe allergic reaction), urticaria, hypersensitivity to light, and bronchospasm (constriction of the airways, which can cause serious 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 sensitivity in the mouth).
The above side effects are usually temporary. Following the instructions in this patient leaflet will help minimize the risk of side effects.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Tantum Verde Duo

The medicine should be stored out of sight and reach of children.
There are no special storage temperature recommendations for this medicine.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the bottle and carton after: EXP. The expiry date refers to the last day of the month stated.
Do not use this medicine after 12 months of opening the bottle.
Do not use this medicine if the bottle cap is damaged.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.
It is important to always carry information about the medicine with you. Therefore, the patient should keep the carton and leaflet that come with the packaging.

6. Contents of the packaging and other information

What Tantum Verde Duo contains

• The active substances are: benzydamine hydrochloride and cetylpyridinium chloride. 1 ml of the 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, macrogolglycerol hydroxystearate, peppermint flavor (containing allergens: benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, d-limonene, linalol, and eugenol), purified water.

What Tantum Verde Duo looks like and contents of the packaging

Tantum Verde Duo is a clear, colorless to slightly yellowish solution with a pH between 5.0 and 6.2.
Each pack contains one 15 ml plastic bottle (HDPE) with a pump (PE/PP) for non-aerosol dosing, a dispenser with a casing (PP), and a folding tube (PE). The bottle contains 15 ml of solution, and the spray pump is set to deliver a dose of 100 microliters.
15 ml of the oral spray solution is sufficient for approximately 150 doses.
The bottle is packaged in a lithographed cardboard box with a patient information leaflet.

Marketing authorization holder and manufacturer

Marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
Al. Jerozolimskie 181B
02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]

Manufacturer

Aziende Chimiche Piunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 ANCONA
Italy

This medicine is authorized in the Member States of the European Economic Area under 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
Date of last revision of the leaflet:April 2025