JUANOLGAR 3 mg LOZENGES ORANGE-HONEY FLAVORED

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Juanolgar 3 mg Orange-Honey Flavored Lozenges

Bencidamine Hydrochloride

Read all of 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 as 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 side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this 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 is Juanolgar and what is it 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 is Juanolgar and what is it 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 the 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 medicine (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 nonsteroidal anti-inflammatory drugs (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 appears, or other symptoms, 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 medicines

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

Taking Juanolgar with food and drinks

Food and drinks do not affect the taking of this medicine.

Pregnancy and lactation

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 medicine.

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 an intolerance to certain sugars, consult with them before taking this medicine.

Orange Yellow S (E-110): may cause allergic reactions.

Orange flavor with citral, citronellol, d-limonene, geraniol, linalool: may cause allergic reactions.

3. How to take Juanolgar

Follow exactly the administration instructions of the medicine contained in this 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 medicine 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 cannot be taken for more than 7 days.

How to take:

Buco-pharyngeal use.

Let a lozenge dissolve slowly in the mouth.

Do not swallow.

Do not chew.

If you take moreJuanolgarthan you should

If you accidentally take too many lozenges, contact your pharmacist, doctor, or the nearest hospital emergency service immediately. Always carry the medicine 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, alterations 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 medicine and the amount ingested.

4. Possible side effects

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

Not known (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 oppression in the chest and/or feeling of dizziness/fainting, intense itching of the skin or bumps 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Juanolgar

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

Do not use this medicine after the expiration date that appears 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 30°C.

Keep in the original packaging to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Juanolgar

• 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), acesulfame potassium, citric acid monohydrate, orange flavor, honey flavor, levomenthol, quinoline yellow (E 104), orange yellow S (E110).

Appearance of the product and package contents

This medicine is presented as orange-yellow colored lozenges 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-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Manufacturer

A.C.R.A.F. S.p.A.,

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 gusto arancia-miele

Portugal:Tantum Verde, pastilhas, 3 mg, sabor a orange-mel

Spain:Juanolgar 3 mg Lozenges, orange-honey flavor

Germany:Tantum Verde Orange-Honig 3 mg Lutschtabletten

Denmark:Zyx appelsin-honning 3mg sugetabletter

Sweden: ZyxApelsin & Honung3 mg sugtabletter

United Kingdom:Difflam 3 mg Lozenges, orange-honey flavor

This package leaflet was approved in December 2022.

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