Leaflet: information for the user

Propalgar3 mg lozenges

Honey and orange flavor

Bencidamine hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for this medicine contained in this leaflet or those 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 side effects, consult your pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you do not get better or if you get worse after 3 days.

1. What isPropalgarand what it is used for

2. What you need to know before starting to takePropalgar

3. How to takePropalgar

4. Possible side effects

5. Storage ofPropalgar

6. Contents of the pack and additional information

Propalgar contains the active ingredient hydrochloride of bencidamina.

This medication is used for the local symptomatic treatment of acute sore throat in adults and children over 6 years old.

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

Do not take this medicine

-If you are allergic to hydrochloride of bencidamine or to any of the other components of this medicine (included 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 have a history of asthma.

-If you are allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or to other analgesic anti-inflammatory drugs called NSAIDs.

-If, after taking the pills, the mouth or throat pain worsens or does not improve within 3 days or if you have a fever or strong pain in the throat or other symptoms, you must consult your doctor.

Children

Due to the type of pharmaceutical form, this medicine should not be administered to children under 6 years old.

Other medicines and Propalgar

Inform your doctor or pharmacist if you are taking or have taken recently or may have to take any other medicine.

Propalgar with food and drinks

Foods and drinks do not affect the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy and breastfeeding.

Driving and operating machines

Propalgar has not been observed to affect the ability to drive or operate machines.

This medicine contains cochineal red, isomalt and aspartame.

This medicine contains 3.409 mg of aspartame in each pill.

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 an intolerance to certain sugars, consult your doctor before taking this medicine. This medicine also contains cochineal red, which may cause allergic reactions.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

For adults and children over 6 years: 1 tablet 3 times a day, which should be taken as needed to relieve pain. Do not take more than 3 tablets a day.

Do not use this medication for more than 7 days.

If your symptoms persist or worsen after 3 days or if you have a fever, severe sore throat or other symptoms, consult your doctor.

For children aged 6 to 11 years, this medication should be administered under the supervision of an adult.

Buccal administration:

Leave one tablet to dissolve slowly in the mouth.

Do not swallow.

Do not chew.

If you take too much Propalgar

If you accidentally take too many tablets, you must contact your pharmacist, doctor or the nearest hospital emergency service immediately. Always carry the medication packaging with you, with or without tablets.

You can alsocall the Toxicological Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

Although rare, symptoms of overdose reported in children are excitement, convulsions, sweating, ataxia, tremors and vomiting after oral administration of doses of bencidamine around 100 times greater than those of the tablet.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Propalgarmay produce adverse effects, although not all people will experience them.

Rare (may affect up to 1 in 100 people)

-Sensitivity of the skin to sunlight (causing a rash or sunburn).

Uncommon (may affect up to 1 in 1,000 people)

-Burning or dryness of the skin. If this occurs, take sips of water to reduce the effect of the medication.

Very rare (may affect up to 1 in 10,000 people)

-Symptoms that may include difficulty breathing or swallowing, skin rash, intense itching, urticaria, or swelling of the face, hands, and feet, eyes, lips, and/or tongue, and dizziness (angioedema).

-Difficulty breathing (laryngospasm or bronchospasm).

Unknown frequency (cannot be estimated from available data)

-Allergic reaction (hypersensitivity).

-Severe allergic reaction (anaphylactic shock), whose signs may include difficulty breathing, chest pain or tightness, and/or feeling of dizziness/dizziness, intense itching of the skin or skin bumps, swelling of the face, lips, tongue, and/or throat, and may be potentially fatal. If you experience any of these symptoms, seek immediate medical attention at the nearest hospital.

-Local loss of sensitivity of the oral mucosa (buccal hypoesthesia).

Reporting Adverse Effects

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

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

Do not use this medication after the expiration date indicated on the box and on the blister pack. The expiration date (EXP) is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Propalgar

The active ingredient is hydrochloride of bencidamina. A tablet contains 3 mg of hydrochloride of bencidamina (equivalent to 2.68 mg of bencidamina).

The other components are: isomalta (E-953), citric acid, monohydrate, aspartame (E-951), quinoline yellow (E-104), peppermint oil, cochineal red colorant (E-124), orange aroma, honey aroma (contains propylene glycol (E-1520)).

Appearance of the product and content of the container

Orange-colored round tablets, 19±1 mm in diameter, with orange and honey flavor.

The tablets are presented in PVC-PVDC/aluminum blisters.

Container size: 12, 20, 24 tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing

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 (Sevilla)

Spain

or

Terapia SA

Strada Fabricii nr. 124, Cluj-Napoca

Romania

or

Pharmazet Group s.r.o.

Trtinová 260/1, 196 00 Praha 9

Czech Republic

Last review date of this leaflet:June 2023

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