Propalgar 3 mg lozenges for sucking
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Propalgar 3 mg lozenges for sucking
Honey and orange flavour
Bendizamidine hydrochloride
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the administration instructions for this medicine provided in this leaflet or as indicated by your 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 pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you do not feel better or if your condition worsens after 3 days.
Contents of the leaflet
- What Propalgar is and what it is used for
- What you need to know before taking Propalgar
- How to take Propalgar
- Possible adverse effects
- How to store Propalgar
- Contents of the pack and other information
1. What Propalgar is and what it is used for
Propalgar contains the active substance bencidamine hydrochloride.
This medicine is used for the local symptomatic treatment of acute sore throat in adults and children over 6 years of age.
You should consult a doctor if your condition worsens or does not improve after 3 days.
2. What you need to know before starting to take this medicine
Do not take this medicine
- If you are allergic to bencidamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult a doctor or pharmacist before using this medicine in the following cases:
- If you have a disease called phenylketonuria.
- If you have asthma or a history of asthma.
- If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or to other analgesic anti-inflammatory medicines known as NSAIDs.
- If, after using the tablets, mouth or throat pain worsens or does not improve within 3 days, or if you develop fever, severe throat pain, or other symptoms, you must consult your doctor.
Children
Due to the type of pharmaceutical form, this medicine must not be given to children under 6 years of age.
Other medicines and Propalgar
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Propalgar with food and drinks
Food and drinks do not affect this medicine.
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 medicine.
You must not use Propalgar during pregnancy unless clearly necessary and advised by your doctor. If treatment is required, the lowest effective dose for the shortest possible duration should be used.
This medicine must not be used during breastfeeding.
Driving and using machines
Propalgar has not been observed to affect the ability to drive or operate machinery.
This medicine contains carmine red dye, isomalt, and aspartame.
This medicine contains 3.409 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
This medicine contains isomalt. If you have intolerance to certain sugars, consult your doctor before taking this medicine. This medicine also contains carmine red dye, which may cause allergic reactions.
3. How to take Propalgar
Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
In adults and children over 6 years: 1 tablet 3 times a day, to be taken when pain relief is needed. Do not take more than 3 tablets per day.
Do not use this medicine for longer than 7 days.
If your symptoms persist or worsen after 3 days, or if you develop fever, severe sore throat, or other symptoms, consult your doctor.
In children aged 6 to 11 years, this medicine should be administered under adult supervision.
Buccopharyngeal use:
Allow one tablet to dissolve slowly in the mouth.
Do not swallow it.
Do not chew it.
If you take more Propalgar than you should
If you accidentally take too many tablets, contact your pharmacist, your doctor, or the nearest hospital emergency service immediately. Always take the medicine pack with its label, whether tablets remain or not.
You may also call the Toxicology Information Service at telephone number: 915.620.420, stating the medicine and the amount ingested.
Although very rare, reported overdose symptoms in children include excitation, convulsions, sweating, ataxia, tremor, and vomiting after oral administration of doses of benzidamine approximately 100 times higher than the tablet dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Propalgar may cause adverse effects, although not everyone experiences them.
Uncommon ( may affect up to 1 in 100 people)
- Skin sensitivity to sunlight (causing a rash or sunburn).
Rare ( may affect up to 1 in 1,000 people)
- Burning sensation or dryness of the skin. If this occurs, sip water to reduce the effect of the medicine.
Very rare ( may affect up to 1 in 10,000 people)
- Symptoms that may include difficulty breathing or swallowing, skin rash, pruritus [intense itching], hives, or swelling of the face, hands and feet, eyes, lips and/or tongue, and dizziness (angioedema).
- Breathing difficulties (laryngospasm or bronchospasm).
Frequency not known ( cannot be estimated from available data)
- Allergic reaction (hypersensitivity).
- Severe allergic reaction (anaphylactic shock), whose signs 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, which may potentially be fatal. If you experience any of these symptoms, seek immediate medical attention at the nearest hospital.
- Local loss of sensitivity of the oral mucosa (oral hypoesthesia).
Reporting of adverse effects
If you experience any type of 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 Propalgar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date (EXP) refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Propalgar
The active substance is benzidamine hydrochloride. One tablet contains 3 mg of benzidamine hydrochloride (equivalent to 2.68 mg of benzidamine).
The other components are: isomalt (E-953), citric acid monohydrate, aspartame (E-951), quinoline yellow (E-104), peppermint oil, cochineal red colour (E-124), orange flavour, honey flavour (contains propylene glycol (E-1520)).
Appearance of the product and contents of the pack
Orange, round tablets, 19±1 mm in diameter, with an orange and honey flavour.
The tablets are presented in PVC-PVDC/aluminum blisters.
Pack sizes: 12, 20, 24 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder
Bayer Hispania, S.L.
Av. Baix Llobregat, 3-5
08970 Sant Joan Despí
Barcelona - Spain
Manufacturer
LOZY’S PHARMACEUTICALS S.L.
Campus Empresarial
31795 Lekaroz (Navarra)
Spain
or
INFARMADE
c/Torre de los Herberos, 35. PI « Carretera de la Isla »
41703 Dos Hermanas (Seville)
Spain
or
Terapia SA
Strada Fabricii nr. 124, Cluj-Napoca
Romania
or
Dr.Max Pharma s.r.o
Na Florenci 2116/15
Nové Mesto
110 00 Prague 1
Czech Republic
Date of the most recent revision of this leaflet: January 2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/