Juanolgar 3 mg orange-honey flavored lozenges
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Juanolgar 3 mg Orangeflavour honey lozenges
Bendizamidine hydrochloride
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for administration 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Leaflet contents:
- What Juanolgar is and what it is used for
- What you need to know before taking Juanolgar
- How to take Juanolgar
- Possible adverse effects
5 Storage of Juanolgar
- Contents of the pack and other information
1. What Juanolgar is and what it is used for
Juanolgar contains the active substance benzidamine, a local anti-inflammatory agent belonging to the group of locally acting oral medications.
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 your condition 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 benzydamine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Juanolgar
- If you have phenylketonuria.
- If you have had or currently suffer from asthma.
- If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory analgesics (NSAIDs).
- If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
- If mouth or throat pain worsens or persists for more than 3 days, if fever or other symptoms appear, and since in a limited number of patients, oropharyngeal ulcerations may be a sign of serious diseases, consult your doctor or dentist.
Taking Juanolgar with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Taking Juanolgar with food and drink
Food and drink do not affect the use of this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
You must not use Juanolgar during pregnancy unless clearly necessary and advised by your doctor. If treatment is needed, the lowest effective dose for the shortest possible duration should be used.
Juanolgar must not be taken during breastfeeding.
Driving and using machines
The use of Juanolgar does not affect the ability to drive or operate machinery.
Juanolgar contains:
Isomalt : if your doctor has diagnosed you with intolerance to certain sugars, consult him before taking this medicine.
Orange Yellow S (E-110) : may cause allergic reactions.
Orange flavour containing citral, citronellol, d-limonene, geraniol, linalool : may cause allergic reactions.
3. How to take Juanolgar
Follow exactly the instructions for use provided 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 three times a day. Do not take more than 3 lozenges in 24 hours.
Use in children
Children aged 6 to 11 years: this medicine should always be administered under adult supervision.
The lozenge formulation must not be given to children under 6 years of age.
Juanolgar must not be taken for longer than 7 days.
How to take:
Oropharyngeal use.
Allow one lozenge to 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 department immediately. Always carry the medicine packaging with you, whether or not any lozenges remain.
Although very rare, reported overdose symptoms in children include excitement, convulsions, sweating, gait disturbances, tremors, and vomiting after oral administration of doses approximately 100 times higher than the dose of 1 lozenge.
If you have further questions about the use of this product, consult your doctor or pharmacist.
In case of overdose or accidental ingestion of large amounts of Juanolgar, go immediately to a medical center or call the Toxicology Information Service at telephone number: 915.620.420, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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):
- Burning sensation or dryness of the mouth. If this occurs, 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):
- Localised loss of sensitivity of the oral mucosa (oral hypoesthesia).
- Allergic reaction (hypersensitivity).
- Severe allergic reaction (anaphylactic reactions), signs of which may include difficulty breathing, pain or tightness in the chest and/or dizziness/fainting, intense itching of the skin or skin lumps, swelling of the face, lips, tongue and/or throat, and which may be potentially fatal.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Juanolgar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Juanolgar
- The active substance is benzidamine hydrochloride.
- Each pastille contains 3 mg of benzidamine hydrochloride (equivalent to 2.68 mg of benzidamine).
- The other components (excipients) are: isomalt (E953), potassium acesulfame, citric acid monohydrate, orange flavour, honey flavour, levomenthol, quinoline yellow (E 104), orange yellow S (E110).
Appearance of the medicine and contents of the pack
This medicine is presented as square, orange-yellow pastilles with a central cavity.
The pastilles may be packaged in PVC/PE/PVDC – ALU blisters or wrapped in paraffin paper.
Pack sizes: 20 or 30 pastilles.
Only certain pack sizes may be commercially available.
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 Pastillas para chupar sabor naranja-miel
*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 flavour
This leaflet was last approved in: April 2026
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/