Juanolg 0.51 mg/puff solution for oral spray
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Juanolgar 0.51 mg/actuation oral spray solution
bendimidine, hydrochloride
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
Always follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 2 days.
Contents of the leaflet
- What Juanolgar is and what it is used for
- What you need to know before using Juanolgar
- How to use Juanolgar
- Possible side effects
- How to store Juanolgar
- Contents of the pack and other information
1. What Juanolgar is and what it is used for
The active substance in this medicine is bencidamine hydrochloride. It is a topical anti-inflammatory agent for oral use.
Juanolgar is indicated in adults and adolescents over 12 years of age for the local symptomatic relief of soreness and irritation of the throat and mouth associated with pain and without fever.
2. What you need to know before using Juanolgar
Do not use Juanolgar
- If you are allergic to bendidamine or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
- Consult your doctor or pharmacist before starting to use Juanolgar.
- If you are allergic to acetylsalicylic acid and/or other analgesics or anti-inflammatory drugs (e.g. asthma attacks, etc.), the use of Juanolgar is not recommended.
- In patients who have had or currently have bronchial asthma, it may cause bronchospasm (sudden sensation of suffocation); therefore, these patients should exercise caution.
Children:
Its use is not recommended in children under 12 years of age, unless otherwise advised by a physician.
Using Juanolgar with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Using Juanolgar with food, drinks and alcohol
Do not eat or drink for 1 hour after using the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
You should not use Juanolgar during pregnancy unless clearly necessary and advised by your doctor. If treatment is required, the lowest effective dose for the shortest possible time should be used.
Driving and using machines
Topical use of bendidamine at the recommended doses does not impair the ability to drive or operate machinery.
Juanolgar contains alcohol (ethanol), macrogol glycerol hydroxystearate, methyl parahydroxybenzoate and peppermint flavor.
This medicine contains 13.6 mg of alcohol (ethanol) per spray. The volume quantity of this medicine is equivalent to less than 0.34 ml of beer or 0.14 ml of wine. The small amount of alcohol contained in this medicine does not produce any noticeable effect.
This medicine contains macrogol glycerol hydroxystearate, which may cause stomach discomfort and diarrhea.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
This medicine contains fragrances (peppermint flavor) with benzyl alcohol, citronellol, d-limonene, eugenol, geraniol and linalool. Benzyl alcohol, citronellol, d-limonene, eugenol, geraniol and linalool may cause allergic reactions.
This medicine contains less than 1 mmol of sodium (23 mg) per spray; thus, it is essentially "sodium-free".
3. How to use Juanolgar
Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dose:
Adults and adolescents over 12 years of age:
Apply 1 to 3 sprays per day for 4–6 days. Do not eat or drink until 1 hour after using the medicine.
In a limited number of patients, oropharyngeal ulcerations may be a sign of serious underlying conditions. Therefore, patients whose symptoms do not improve within 2 days, worsen, or develop fever should consult a doctor or dentist.
Treatment should not exceed 6 days.
Its use is not recommended in children under 12 years of age, unless otherwise advised by a physician.
This medicine is administered by oropharyngeal route.
| 1 | Lift the spray cannula. |
| 2 | Insert the cannula into the mouth and direct the spray toward the painful area. Press with the finger on the marked area of the spray button. |
When using the product for the first time, press the pump several times without product until a consistent spray is obtained.
If you use more Juanolgar than you should
Due to its topical use, poisoning symptoms are unlikely. However, if you use more Juanolgar than recommended, although very rarely, you may experience: excitement, convulsions, sweating, disturbances in gait, tremors, and vomiting in children.
In case of overdose or accidental ingestion of large amounts of the medicine, consult your doctor or pharmacist immediately for advice. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Juanolgar
Do not use a double dose to make up for forgotten doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Juanolgar may produce adverse effects, although not everyone experiences them.
- Uncommon (affects at least 1 in 1,000 patients): Photosensitivity (sensitivity to sunlight).
- Rare (affects at least 1 in 10,000 patients): Burning sensation, dry mouth.
- Very rare (affects less than 1 in 10,000 patients): Laryngospasm (contraction of the laryngeal muscles causing a sensation of suffocation) and swelling.
- Not known (frequency cannot be estimated from available data):
Allergic reaction (hypersensitivity).
Severe allergic reaction (anaphylactic shock), the signs of which may include difficulty breathing, chest pain or tightness and/or dizziness/fainting, intense skin itching or skin rashes, swelling of the face, lips, tongue and/or throat, which may potentially be fatal.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Juanolgar
This medicine does not require any special storage conditions.
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 EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Juanolgar
The active substance is benzidamine hydrochloride. Each 0.17 ml spray contains 0.51 mg of benzidamine hydrochloride.
The other components are: 96% ethanol, glycerol, macrogol glycerol hydroxystearate 40, peppermint flavour (containing: benzyl alcohol, citronellol, d-limonene, eugenol, geraniol and linalool), methyl parahydroxybenzoate (E-218), sodium saccharin and purified water.
Nature of the product and pack sizes
It is presented as a solution for oral spray.
The solution is a clear, colourless liquid and is supplied in bottles containing 15 ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Date of the most recent revision of this leaflet: September 2025
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/