Tantum Verde 1.5 mg/ml solution for gargle and mouthwash
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tantum Verde 1.5 mg/ml
oral rinse and gargle solution
benzydamine hydrochloride
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use of this medicine as described 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You must consult a doctor if your condition worsens or if you do not improve after 2 days.
Leaflet contents:
- What Tantum Verde is and what it is used for
- What you need to know before using Tantum Verde
- How to use Tantum Verde
- Possible adverse effects
- How to store Tantum Verde
- Contents of the pack and other information
1. What Tantum Verde is and what it is used for
Tantum Verde contains the active substance benzidamine hydrochloride, which belongs to the group of non-steroidal anti-inflammatory drugs.
It is used for the local symptomatic relief of pain and irritation of the throat, mouth and gums without fever, in adults and adolescents over 12 years of age.
If symptoms worsen or last longer than 2 days, or if irritation occurs, treatment should be discontinued and a doctor consulted.
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 starting to use Tantum Verde.
- Must not be swallowed.
- Do not use more than the recommended doses.
- Patients who have had or currently suffer from bronchial asthma should not use this medicine, as it may cause bronchospasm (sudden sensation of suffocation).
- Use of this medicine is not recommended if you are allergic to acetylsalicylic acid, other analgesics, or anti-inflammatory drugs.
- Prolonged use of the medicine may lead to sensitization of the treated area, as well as irritation and dryness of the oral mucosa. In such cases, treatment should be discontinued and a doctor consulted.
- Do not use this medicine if fever develops. Discontinue treatment and consult your doctor.
Children
Do not use in children under 12 years of age.
Other medicines and Tantum Verde
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not use simultaneously with other medicines applied to the same area.
Use of 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
You should not use Tantum Verde during pregnancy unless clearly necessary and advised by your doctor. If treatment is required, the lowest possible dose should be used for the shortest possible time.
Driving and use of machines
This medicine, at the recommended doses and as directed, does not affect the ability to drive or operate machinery.
Tantum Verde contains alcohol (ethanol), methyl parahydroxybenzoate, polysorbate 20, and peppermint essence.
This medicine contains 1.2 g of alcohol (ethanol) per dose unit (15 ml). The volume of alcohol in this medicine is equivalent to 31 ml of beer or 13 ml of wine. The small amount of alcohol contained 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 essence) with benzyl alcohol, cinnamyl alcohol, citral, d-limonene, citronellol, geraniol, isoeugenol, linalool, 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., essentially "sodium-free".
3. How to use Tantum Verde
Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is for oropharyngeal use. It is applied by mouth rinsing in case of oral conditions or by gargling in case of throat conditions.
Brush your teeth and thoroughly rinse away any toothpaste residue before using this medicine.
The recommended dose is:
Adults and adolescents over 12 years of age:
Pour 15 ml of Tantum Verde up to the –ml15– mark on the dosing cup. If you wish to use it diluted, add water up to the –ml30– mark on the dosing cup.
Rinse/gargle for 30 seconds, 2 or 3 times a day.
Wash the dosing cup after each use.
Do not exceed the recommended doses.
Do not eat or drink for 1 hour after using the medicine.
Prolonged use of the medicine may lead to sensitization reactions. If symptoms persist for more than 2 days, worsen, or if fever or other symptoms appear, stop treatment and consult your doctor.
Use in children
This medicine must not be used in children under 12 years of age.
If you use more Tantum Verde than you should:
Due to its oropharyngeal use, intoxication is unlikely. However, if you use more Tantum Verde than recommended, although very rarely, you may experience: excitement, convulsions, sweating, disturbances in gait, tremors, and vomiting in children.
In case of overdose or accidental ingestion of large quantities of the medicine, contact your doctor or pharmacist immediately for advice. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 anaesthetic effect at the application site.
- Burning sensation.
- Dry mouth.
- Burning.
-
Very rare (may affect up to 1 in 10,000 patients):
- Laryngospasm (contraction of the muscles of the larynx causing a sensation of suffocation).
- Angioedema (a circulatory reaction affecting 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, chest pain or tightness, and/or dizziness/fainting, intense itching or skin rash, swelling of the face, lips, tongue, and/or throat, which may be potentially fatal.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tantum Verde
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging, following the abbreviation: EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tantum Verde:
The active substance is benzidamine hydrochloride. Each millilitre (ml) of solution contains 1.5 mg of benzidamine 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 flavour (containing fragrance allergens: benzyl alcohol, cinnamyl alcohol, citral, d-limonene, citronellol, geraniol, isoeugenol, linalool and eugenol), and purified water.
Appearance of the product and contents of the container:
The solution is a transparent green liquid with a mint flavour, supplied in plastic bottles containing 60 ml or 1000 ml, or in glass bottles containing 240 ml of solution for oral rinse and gargling. It includes a measuring cup with markings for 15 ml (labelled "-ml15-") and 30 ml (labelled "-ml30-").
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ANGELINI PHARMA ESPAÑA, S.L.
C/ Antonio Machado, 78-80.
3rd floor, module A-Building Australia
08840 Viladecans, Barcelona
Spain
Manufacturer
A.C.R.A.F. SpA
Via Vecchia del Pinocchio, 22
60131 Ancona,
Italy
Date of the most recent revision of this leaflet: September 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es