JUANOLGAR 3 mg LOZENGES MINT FLAVOR

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Juanolgar 3 mg Mint Flavored Lozenges

Bencidamine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the package leaflet:

1. What Juanolgar is and what it is used for
2. What you need to know before taking Juanolgar
3. How to take Juanolgar
4. Possible side effects

5 Conservation of Juanolgar

1. Package contents and additional information

1. What Juanolgar is and what it is used for

Juanolgar contains the active ingredient bencidamine, a local anti-inflammatory that belongs to the group of agents for local oral treatment.

Juanolgar is indicated in adults and children over 6 years of age, for local symptomatic treatment to relieve pain and irritation of the mouth and throat.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before taking Juanolgar

Do not take Juanolgar

• 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 taking Juanolgar

• If you have phenylketonuria.
• If you have had or have asthma.
• If you are allergic to acetylsalicylic acid or other anti-inflammatory analgesics (NSAIDs).
• If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medication.
• 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, buco-pharyngeal ulcers can be a sign of serious conditions, consult your doctor or dentist.

Taking Juanolgar with other medications

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

Taking Juanolgar with food and drinks

Food and drinks do not affect the taking of 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.

Juanolgar should not be taken during pregnancy.

Juanolgar should not be taken during breastfeeding.

Driving and using machines

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

Juanolgar contains:

Isomalt: if your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

Aspartame: this medication contains 3.5 mg of aspartame in each lozenge, equivalent to 3.5 mg/3202 mg. Aspartame contains a source of phenylalanine that may be harmful in 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, linalol: may cause allergic reactions.

Butylhydroxyanisole (E-320) which is a component of lemon flavor: may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to take Juanolgar

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years of age: 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 should always be administered under the supervision of an adult.

The pharmaceutical form of lozenges should not be given to children under 6 years of age.

Juanolgar should not be taken for more than 7 days.

How to take:

Buco-pharyngeal use.

Let one lozenge dissolve slowly in the mouth.

Do not swallow.

Do not chew.

If you take more Juanolgar 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 package with you, whether or not there are lozenges left.

Although it can occur very rarely, the symptoms of overdose reported in children are excitement, convulsions, sweating, changes in gait, tremors, and vomiting after oral administration of doses about 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 Juanolgar, go immediately to a medical center or call the Toxicology Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

• Skin sensitivity to sunlight (causing rash or sunburn).

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

• Feeling of burning 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 oral mucosa sensitivity (oral hypoesthesia).
• Allergic reaction (hypersensitivity)
• Severe allergic reaction (anaphylactic reactions), whose signs may include difficulty breathing, pain or pressure in the chest and/or feeling of dizziness/fainting, intense itching of the skin or lumps on the skin, swelling of the face, lips, tongue, and/or throat, and which can be potentially fatal.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Juanolgar

Keep this medication out of sight and reach of children.

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

Do not store at a temperature above 25°C.

Keep in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Juanolgar composition

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

Appearance of the product and package contents

This medication is presented as mint-flavored lozenges, green in color, with a central cavity.

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

Package with 20 or 30 lozenges.

Only some package sizes may be marketed.

Marketing authorization holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer

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 under the following names:

Italy:Tantum Verde P, 3mg pastiglie gusto menta

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

Spain:Juanolgar 3 mg Lozenges, mint flavor

Germany:Tantum Verdemit Minzgeschmack3 mg Lutschtabletten

Denmark:Zyxmint3mg sugetabletter

Sweden: Zyxmint3 mgsugtabletter

United Kingdom:Difflam 3 mg lozenges,mint taste

This package leaflet was approved in December 2022.

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