PATIENT INFORMATION LEAFLET

TANTUM VERDE 3 mg Chewable Tablets, Lemon Flavor

Bencidamine Hydrochloride

Read this leaflet carefully before you start taking 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 3 days.

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

2.What you need to know before you start taking Tantum Verde

3.How to take Tantum Verde

4.Possible side effects

5Storage of Tantum Verde

6.Contents of the pack and additional information

Tantum verde contains the active ingredient bencidamina, a local anti-inflammatory agent that belongs to the group of local oral treatment agents.

Tantum verde is indicated for adults and children over 6 years old, for local symptomatic treatment to relieve pain and irritation of the mouth and throat.

Consult a doctor if it worsens or does not improve after 3 days.

Do not take Tantum verde

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

Warnings and precautions

Consult your doctor or pharmacist before taking Tantum verde

• If you suffer from phenylketonuria.
• If you have had or have asthma.
• If you are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medication.
• If the mouth or throat pain worsens or persists for more than 3 days, appears fever or other symptoms and since in a limited number of patients, oral and pharyngeal ulcers may be a sign of serious pathologies, consult your doctor or dentist.

Taking Tantum verde with other medications

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

Taking Tantum verde with food and drinks

Foods and beverages do not affect when taking this medication.

Pregnancy and breastfeeding

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

Tantum verde should not be taken during pregnancy.

Tantum verde should not be taken during breastfeeding.

Driving and operating machines

The use of Tantum verde does not affect the ability to drive or operate machines.

Tantum verde contains:

IsomaltIf your doctor has indicated that you have intolerance to certain sugars, consult with him before taking this medication.

Aspartame:This medication contains 3.26 mg of aspartame in each tablet equivalent to 3.26 mg/3237 mg. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Mint flavor with benzyl alcohol, citronellol, d-limonene, eugenol, geraniol, linalol and lemon flavor with benzyl alcohol, citral, citronellol, d-limonene, geraniol, linalolMay cause allergic reactions.

Benzyl hydroxy anisole (E-320) which is a component of lemon flavorMay cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years old: 1 lozenge 3 times a day. Do not take more than 3 lozenges in 24 hours.

Use in children

Children from 6 to 11 years old: this medication must always be administered under adult supervision.

The lozenge form should not be given to children under 6 years old.

Tantum verde should not be taken for more than 7 days.

How to take:

Oral buccal use.

Leave a lozenge to dissolve slowly in the mouth.

Do not swallow.

Do not chew.

If you take more Tantum verde than you should

If you accidentally take too many lozenges, contact your pharmacist, doctor, or the nearest hospital emergency service immediately. Always carry the medication packaging with you, even if there are no lozenges left.

Although very rarely reported, symptoms of overdose in children include excitement, convulsions, sweating, gait disturbances, tremors, and vomiting after oral administration of doses approximately 100 times higher than those of 1 lozenge.

If you have more questions about the use of this product, consult your doctor or pharmacist.

In case of overdose or accidental ingestion of large quantities of Tantum verde, go immediately to a medical center or call the Toxicological Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

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

Rarely (may affect up to 1 in 100 people):

-Sensitivity of the skin to sunlight (causing rash or sunburn).

Rare (may affect up to 1 in 1,000 people):

-Burning sensation or dryness of the mouth. If this happens, try drinking a glass of water to reduce the effect.

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

-Sudden swelling of the mouth/throat and mucous membranes (angioedema).

-Difficulty breathing (laryngospasm).

Unknown (frequency cannot be estimated from available data):

- Local loss of sensitivity of the oral mucosa (oral hypoesthesia).

- Allergic reaction (hypersensitivity)

- Severe allergic reaction (anaphylactic reactions), 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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.

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

Do not store at a temperature above25°C.

Store in the original packaging to protect it from moisture.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Tantum verde

• The active ingredient is hydrochloride of bencidamina.
• Each lozenge contains 3 mg of hydrochloride of bencidamina (equivalent to 2.68 mg of bencidamina).
• The other components (excipients) are: isomalta (E953), aspartame (E951), citric acid monohydrate, lemon aroma, mint aroma, quinoline yellow (E104), indigotin (E132).

Appearance of the product and contents of the packaging

This medication is presented as yellow-green square lozenges with a central cavity.

The lozenges can be packaged in blister PVC/PE/PVDC – ALU or wrapped in paraffin paper.

Package with 20 or 30 lozenges.

Only some package sizes may be marketed.

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

This medication is authorized in the member states of the European Economic Area with the following names:

Italy:Tantum Verde P, 3mg pastiglie gusto limone

Portugal:Tantum Verde®, pastilhas, 3 mg, sabor a limao

Spain:Tantum Verde 3 mg Pastillas para chupar sabor limón

Germany:Tantum Verde mit Zitronengeschmack 3 mg Lutschtabletten

Denmark:Zyx citron 3mg sugetabletter

Sweden:Zyx citron 3 mg sugtabletter

United Kingdom:Difflam 3 mg lozenges, lemon taste

This prospectus was approved in December 2022.

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