Leaflet: information for the user

Tantum Verde 1.5 mg/ml

mouthwash and oral rinse solution

bencidamine, hydrochloride

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given 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 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 you get worse or do not improve after 2 days.

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

2. What you need to know before using Tantum Verde

3. How to use Tantum Verde

4. Possible side effects

5. Storage of Tantum Verde

6. Contents of the pack and additional information

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

It is used for 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 irritation appears, treatment should be interrupted and a doctor consulted.

Do not use Tantum Verde

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to use Tantum Verde.
• Do not ingest.
• Do not take more than the recommended doses.
• Patients who have suffered or suffer from bronchial asthma should not use this medication, as it may cause bronchospasm (sudden sensation of choking).
• This medication is not recommended for use if you are allergic to acetylsalicylic acid, other analgesics, or anti-inflammatory agents.
• Prolonged use of the medication may lead to sensitization of the treated area, as well as irritation and dryness of the mucous membrane of the mouth. In this case, treatment should be interrupted and the doctor consulted.
• Do not use this medication if fever appears. Interrupt treatment and consult your doctor.

Children

Not to be used in children under 12 years.

Other medications and Tantum Verde

Inform your doctor or pharmacist if you are using, or have used recently, or may need to use another medication.

Do not use at the same time with other medications used in the same area.

Use of Tantum Verde with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

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

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

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

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

This medication contains polysorbates, which may cause allergic reactions.

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

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

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

This medication is for buccal and pharyngeal use. It is applied by rinsing in case of mouth infections or by gargling in case of throat infections .

Brush your teeth and completely rinse off any remaining toothpaste before using this medication.

The recommended dose is:

Adults and adolescents over 12 years old :

Measure 15 ml of Tantum Verde up to the –ml15- mark on the dosing cup. And if you want to use it diluted, complete with 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 indicated doses.

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

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

Use in children

It should not be used in children under 12 years old.

If you use more Tantum Verde than you should:

Due to its buccal and pharyngeal use, it is unlikely that poisoning cases will occur. However, if you use more Tantum Verde than recommended, although it is very rare, you may feel: excitement, convulsions, sweating, gait disturbances, tremors, and vomiting in children.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

-Rare(may affect up to 1 in 100 patients):

• Photosensitivity (sensitivity to sunlight).

-Uncommon(may affect up to 1 in 1,000 patients):

• Excessive anesthetic effect in the application area.
• Burning sensation.
• Dry mouth.
• Burning sensation.

-Very rare(may affect up to 1 in 10,000 patients):

• Laryngospasm (contraction of the laryngeal muscles with a sensation of choking).
• Angioedema (circulatory reaction affecting the deep layers of the skin, causing inflammation and swelling).

-Unknown frequency (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/dizziness, intense itching of the skin or hives, swelling of the face, lips, tongue, and/or throat, and may be potentially fatal.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging, following the abbreviation: CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Tantum Verde:

The active principle is hydrochloride of bencidamina. Each milliliter (ml) of solution contains 1.5 mg of hydrochloride of bencidamina.

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

Appearance of the product and contents of the packaging:

The solution is a transparent green color, with a peppermint flavor, and is packaged in plastic bottles containing 60 or 1000 ml, or glass bottles containing 240 ml of the oral and gargle solution for mouthwash. It includes a measuring cup with measurements of 15 ml (-ml15-) and 30 ml (-ml30-) of the measuring cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ANGELINI PHARMA ESPAÑA, S.L.

C/ Antonio Machado, 78-80.

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona

Spain

Responsible for manufacturing

A.C.R.A.F. SpA

Via Vecchia del Pinocchio, 22

60131 Ancona,

Italy

Date of the last review of this prospectus:August 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es