TANTUM VERDE 1.5 mg/ml SOLUTION FOR GARGLE AND MOUTH RINSE

Introduction

Leaflet: information for the user

Tantum Verde 1.5 mg/ml

mouthwash and gargle solution

benzydamine, hydrochloride

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the leaflet:

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

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

Tantum Verde contains the active ingredient benzydamine hydrochloride, which belongs to the group of non-steroidal anti-inflammatory medicines.

It is used for the local symptomatic relief of pain and irritation of the throat, mouth, and gums that occur without fever, in adults and adolescents over 12 years old.

If symptoms worsen or last more than 2 days, or if irritation occurs, treatment should be discontinued and a doctor consulted.

2. What you need to know before taking Tantum Verde

Do not use Tantum Verde

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to use Tantum Verde.
• It should not be ingested.
• Do not use more than the recommended dose.
• Patient who have suffered or suffer from bronchial asthma should not use this medicine, as it may cause bronchospasm (sudden feeling of suffocation).
• The use of this medicine is not recommended if you are allergic to acetylsalicylic acid, other analgesics, or anti-inflammatory medicines.
• Prolonged use of the medicine may lead to sensitization of the treated area, as well as irritation and dryness of the mouth mucosa. In such cases, treatment should be discontinued and a doctor consulted.
• Do not use this medicine if fever occurs. Discontinue treatment and consult your doctor.

Children

Do not use in children under 12 years old.

Other medicines and Tantum Verde

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

Do not use at the same time as other medicines for use in the same area.

Using Tantum Verde with food, drinks, and alcohol

Do not eat or drink until 1 hour after using the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, if you think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Do not use Tantum Verde during pregnancy unless clearly necessary and advised by your doctor. If treatment is needed, use the lowest dose for the shortest possible time.

Driving and using machines

This medicine, at the recommended doses and with the indicated use, does not alter the ability to drive or use other machines.

Tantum Verdecontains alcohol (ethanol), methyl parahydroxybenzoate, polysorbate 20, and peppermint flavor.

This medicine contains 1.2 g of alcohol (ethanol) per dose unit (15 ml). The amount in volume of this medicine is equivalent to 31 ml of beer or 13 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

This medicine contains polysorbates, which may cause allergic reactions.

This medicine contains fragrances (peppermint flavor) with allergens: benzyl alcohol, cinnamyl alcohol, citral, d-limonene, citronellol, geraniol, isoeugenol, linalol, and eugenol, which may cause allergic reactions.

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit (15 ml); i.e., it is essentially "sodium-free".

3. How to use Tantum Verde

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medicine is for buccopharyngeal use. It is applied by rinsing in case of mouth conditions or by gargling in case of throat conditions.

Brush your teeth and rinse thoroughly to remove any toothpaste residue before using this medicine.

The recommended dose is:

Adults and adolescents over 12 years old:

Pour 15 ml of Tantum Verde up to the 15-ml mark on the measuring cup. If you want to use it diluted, fill with water up to the 30-ml mark on the measuring cup.

Rinse/gargle for 30 seconds, 2 or 3 times a day.

Wash the measuring cup after each use.

Do not exceed the recommended doses.

Do not eat or drink until 1 hour after using the medicine.

Prolonged use of the medicine may lead to sensitization phenomena. If symptoms persist for more than 2 days, worsen, or if fever or other symptoms occur, discontinue treatment and consult your doctor.

Use in children

Do not use in children under 12 years old.

If you use more Tantum Verde than you should:

Due to its buccopharyngeal use, it is unlikely to produce overdose symptoms. However, if you use more Tantum Verde than recommended, although very rarely, you may feel: excitement, convulsions, sweating, changes in gait, tremors, and vomiting in children.

In case of overdose or accidental ingestion of large amounts of medicine, consult your doctor or pharmacist immediately for advice. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

• Uncommon (may affect up to 1 in 100 patients):
  • Photosensitivity (sensitivity to sunlight).

• Rare (may affect up to 1 in 1,000 patients):
  • Excessive anesthetic effect in the application area.
  • Stinging sensation.
  • Dry mouth.
  • Burning sensation.

• Very rare (may affect up to 1 in 10,000 patients):
  • Laryngospasm (contraction of the laryngeal muscles with a feeling of suffocation).
  • Angioedema (reaction of the blood circulation that affects the deep layers of the skin, causing inflammation and swelling).

• Frequency not known (cannot be estimated from available data):
  • Allergic reaction (hypersensitivity).
  • Severe allergic reaction (anaphylactic shock), whose signs may include difficulty breathing, pain or tightness in the chest and/or feeling of dizziness/fainting, intense itching of the skin or hives, swelling of the face, lips, tongue, and/or throat, and which can be potentially fatal.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tantum Verde

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date shown on the packaging, after the abbreviation: EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Tantum Verde:

The active ingredient is benzydamine hydrochloride. Each milliliter (ml) of solution contains 1.5 mg of benzydamine hydrochloride.

The other components (excipients) are: saccharin, ethanol 10.1% (v/v), glycerol (E-422), sodium hydrogen carbonate, methyl parahydroxybenzoate (E-218), polysorbate 20, quinoline yellow (E-104), patent blue V (E-131), peppermint flavor (which contains fragrances with allergens: benzyl alcohol, cinnamyl alcohol, citral, d-limonene, citronellol, geraniol, isoeugenol, linalol, and eugenol), and purified water.

Appearance of the product and package contents:

The solution is a clear green liquid with a mint flavor and is packaged in plastic bottles containing 60 or 1000 ml, or glass bottles containing 240 ml of the mouthwash and gargle solution. It includes a measuring cup with 15-ml and 30-ml marks.

Marketing authorization holder and manufacturer

Marketing authorization holder

ANGELINI PHARMA ESPAÑA, S.L.

C/ Antonio Machado, 78-80.

3rd floor, module A-Australia building

08840 Viladecans, Barcelona

Spain

Manufacturer

A.C.R.A.F. SpA

Via Vecchia del Pinocchio, 22

60131 Ancona,

Italy

Date of the last revision of this leaflet:September 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es