Leaflet: information for the user

Tantum Verde 0.51 mg/ pulse solution for oral spray

bencidamine, hydrochloride

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 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.

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

2. What you need to know before starting to use 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

The active ingredient of this medication is benzydamine hydrochloride. It is a topical oral anti-inflammatory.

Tantum Verde is indicated in adults and adolescents over 12 years old for the local symptomatic relief of throat and mouth irritations that are accompanied by pain and without fever.

No 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.

- If you have an allergy to salicylic acid and/or other analgesics or anti-inflammatory agents (asthmatic crises, etc…), the use of Tantum Verde is not recommended.

- In patients who have suffered or suffer from bronchial asthma, it may cause bronchospasm (sudden feeling of suffocation), so these patients must be cautious.

Children:

It is not recommended to use it in children under 12 years, unless medical advice is given.

Use of Tantum Verde with other medications

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

Use of Tantum Verde with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

The topical use of bencidamine, at the indicated doses, does not alter the ability to drive or use other machines.

Tantum Verde contains alcohol (ethanol), macrogolglycerol hydroxystearate, methyl parahydroxybenzoate, and peppermint aroma.

This medication contains 13.6 mg of alcohol (ethanol) in each spray. The volume of this medication is equivalent to less than 0.34 ml of beer or 0.14 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

This medication contains macrogolglycerol hydroxystearate that may cause stomach discomfort and diarrhea.

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

This medication contains fragrances (peppermint aroma) with benzyl alcohol, citronellol, d-limonene, eugenol, geraniol, and linalol. Benzyl alcohol, citronellol, d-limonene, eugenol, geraniol, and linalol may cause allergic reactions.

This medication contains less than 1 mmol of sodium (23 mg) per spray; it is essentially "sodium-free".

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Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 12 years old:

Apply 1 to 3 sprays per day for 4-6 days. Do not eat or drink until 1 hour after using the medication.

In a limited number of patients, oral and pharyngeal ulcers are often a sign of serious pathologies. Therefore, patients in whom symptoms do not disappear in 2 days, worsen, or fever appears should consult their doctor or dentist.

The treatment should not exceed 6 days.

It is not recommended to use it in children under 12 years old, unless medical judgment dictates otherwise.

This medication is used orally.

On the first use of the product, press the trigger several times to the vacuum until a regular spray is obtained.

If you use more Tantum Verde than you should

Due to its topical use, it is unlikely that you will experience an overdose. 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.

If you forgot to use Tantum Verde

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Tantum Verde may produce adverse effects, although not all people will experience them.

-Rare (at least 1 in every 1,000 patients): Photosensitivity (sensitivity to sunlight).

-Uncommon (at least 1 in every 10,000 patients): Burning sensation, dry mouth.

-Very rare (less than 1 in every 10,000 patients): Laryngospasm (contraction of the laryngeal muscles with a sensation of choking) and swelling.

-Unknown (the frequency cannot be estimated from the 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 which may be potentially fatal.

If you experience adverse effects, consult your doctor or pharmacist, even if they are effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special conservation conditions are required.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Composition of Tantum Verde

The active principle is bencidamine hydrochloride. Each 0.17 ml spray contains 0.51 mg of bencidamine hydrochloride.

The other components are: 96% ethanol, glycerol, macrogol 40 hydroxystearate, peppermint aroma (contains: benzyl alcohol, citronellol, d-limonene, eugenol, geraniol, and linalol), methyl parahydroxybenzoate (E-218), sodium saccharin, and purified water.

Appearance of the product and contents of the packaging

It is presented in the form of a buccal spray solution.

The solution is transparent and colorless and is presented in bottles containing 15 ml of solution.

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. S.p.A.,

Via Vecchia del Pinocchio,22

60131 – Ancona,

Italy

Date of the last review of this leaflet: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/