Tantum verde contains the active substance benzydamine, a local anti-inflammatory that belongs to the group of agents for local oral treatment.

Tantum verde is indicated in adults and in children over 6 years of age, in the local symptomatic treatment for the relief of pain and irritation of the mouth and throat.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

Do not take Tantum verde

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

Warnings and cautions

Consult your doctor or pharmacist before taking Tantum verde

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

Taking Tantum verde with other medicines

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

Taking Tantum verde with food and drink

Food and drink have no influence when you take this medicine.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist before using this medicine.

Tantum verde should not be taken during pregnancy.

Tantum verde should not be taken while breastfeeding.

Driving and using machines

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

Tantum verde contains:

Isomalt : If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.

Aspartame: this medicine contains 3.5 mg of aspartame in each tablet equivalent to 3.5 mg / 3202 mg. Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (NCF), a rare genetic disease in which phenylalanine accumulates because the body is not able to eliminate it correctly.

Follow exactly the instructions for administration of the medicine 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: 1 lozenge to suck 3 times a day. Do not take more than 3 lozenges in 24 hours.

Use in children

Children from 6 to 11 years: this medicine should always be administered under the supervision of an adult.

The lozenge dosage form should not be given to children under 6 years of age.

Tantum verde cannot be taken for more than 7 days.

How to drink:

Oropharyngeal use.

Allow a lozenge to dissolve slowly in your mouth.

Do not swallow.

Do not chew.

If you take more Tantum Verde than you should

If you accidentally take too many lozenges to suck, contact your pharmacist, doctor, or the nearest hospital emergency department immediately. Always carry the medicine container with you, whether or not there are pills left.

Although it may occur very rarely, overdose symptoms reported in children are excitement, seizures, sweating, gait disturbances, tremors, and vomiting after oral administration of doses about 100 times greater than 1 pill.

If you have any further questions on the use of this product, ask 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 Toxicology Information Service, telephone: 915.620.420, indicating the medicine and the amount ingested.

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

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

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

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

-               Burning sensation or dry mouth. If this happens to you, 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).

Not known (frequency cannot be estimated from the available data):

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

- Allergic reaction (hypersensitivity)

- Serious allergic reaction (anaphylactic reactions), the signs of which may include shortness of breath, chest pain or tightness and / or feeling dizzy / faint, severe itching of the skin or lumps on the skin, swelling of the face, lips , the tongue and / or throat, and which can be potentially fatal.

Communication of adverse effects

If you experience any kind of side effect, talk to your doctor, pharmacist or nurse, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: www.notificaram.es . By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the carton after the abbreviation EXP. The expiration date is the last day of the month indicated.

Do not store above 25ºC .

Store in the original package to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Tantum verde

• The active substance is benzydamine hydrochloride.
• Each lozenge contains 3 mg benzydamine hydrochloride (equivalent to 2.68 mg benzydamine).
• The other ingredients (excipients) are: isomalt (E953), aspartame (E951), levomenthol, citric acid monohydrate, lemon flavor, peppermint flavor, quinoline yellow (E104), indigotine (E132).

What the product looks like and contents of the pack

This medicine comes as green, square lozenges with a central cavity and wrapped in paper.

Each package contains 20 or 30 lozenges to suck.

Only some pack sizes may be marketed.

Marketing authorization holder

ANGELINI FARMACÉUTICA, SA

C. Osi, 7

08034 Barcelona

Responsible for manufacturing

ACRAFSpA,

Via Vecchia del Pinocchio, 22

60131 - Ancona, Italy

This medicine is authorized in the member states of the European Economic Area under the following names:

Italy: Tantum Verde P, 3mg pastiglie mint flavor

Portugal: Tantum Verde ® , pastilhas, 3 mg, mint flavor

Spain: Tantum Verde 3 mg lozenges to suck mint flavor

Germany: Tantum Verde mit Minzgeschmack 3 mg Lutschtabletten

Denmark: Zyx mint 3mg suggesttabletter

Sweden : Zyx mint 3 mg sugtabletter

Ireland: Tantum Verde mint taste 3mg lozenges

UK: Difflam 3 mg lozenges, mint taste

L uxembourg: Tantum Verde P 3 mg, goût menthe

Holland: Tantum Verde P Mintsmaak, zuigtabletten 3 mg

This leaflet was revised in February 2020

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