PROPALGAR 3 mg LOZENGES

Introduction

Package Leaflet: Information for the User

Propalgar3 mg lozenges

Honey and orange flavor

Bencidamine, hydrochloride

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of this medicine contained in this package leaflet or as indicated by your pharmacist.

• Keep this package 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 pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if you do not feel better or if you worsen after 3 days.

Contents of the Package Leaflet

1. What is Propalgar and what is it used for
2. What you need to know before taking Propalgar
3. How to take Propalgar
4. Possible side effects
5. Storage of Propalgar
6. Package Contents and Additional Information

1. What is Propalgar and what is it used for

Propalgar contains the active ingredient 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 you worsen or do not improve after 3 days.

2. What you need to know before taking this medicine

Do not take this medicine

• If you are allergic to bencidamine hydrochloride or to any of the other components 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 non-steroidal anti-inflammatory analgesics called NSAIDs.
• If, after using the lozenges, the mouth or throat pain worsens or does not improve within 3 days, or if you have a fever or severe throat pain or other symptoms, you should consult your doctor.

Children

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

Other Medicines and Propalgar

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

Taking Propalgar with Food and Drinks

Food and drinks do not affect the medicine.

Pregnancy and Breastfeeding

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

This medicine should not be used during pregnancy and breastfeeding.

Driving and Using Machines

It has not been observed that Propalgar affects the ability to drive or use machines.

This medicine contains the red dye cochineal, isomalt, and aspartame.

This medicine contains 3.409 mg of aspartame in each lozenge.

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 the red dye cochineal, which may cause allergic reactions.

3. How to Take Propalgar

Follow exactly the administration instructions of this medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

In adults and children over 6 years of age: 1 lozenge 3 times a day, which should be taken when needed to relieve pain. Do not take more than 3 lozenges per day.

Do not use this medicine for more than 7 days.

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

In children from 6 to 11 years of age, this medicine should be administered under adult supervision.

Buccopharyngeal use:

Let a lozenge 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 lozenges, you should contact your pharmacist, doctor, or the nearest hospital emergency service immediately. Always carry the medicine package with its label, whether there are lozenges left or not.

You can also call the Toxicology Information Service, phone: 915.620.420, indicating the medicine and the amount ingested.

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

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

4. Possible Side Effects

Like all medicines, Propalgar can cause side effects, although not everyone gets 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)

• Feeling of burning or dryness of the skin. If this happens to you, take sips of 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), urticaria, or swelling of the face, hands, and feet, eyes, lips, and/or tongue, and dizziness (angioedema).
• Difficulty breathing (laryngospasm or bronchospasm).

Frequency Not Known (cannot be estimated from the available data)

• Allergic reaction (hypersensitivity).
• Severe allergic reaction (anaphylactic shock), whose signs may be difficulty breathing, pain or pressure 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. If you experience any of these symptoms, you should seek immediate medical attention at the nearest hospital.
• Local loss of oral mucosa sensitivity (oral hypoesthesia).

Reporting 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 package 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. Storage of Propalgar

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

Do not use this medicine after the expiration date stated on the box and blister. The expiration date (CAD) is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. 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 Propalgar

The active ingredient is bencidamine hydrochloride. One lozenge contains 3 mg of bencidamine hydrochloride (equivalent to 2.68 mg of bencidamine).

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

Appearance of the Product and Package Contents

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

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

Package size: 12, 20, 24 lozenges.

Only some package 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.

Business Campus

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

Dr.Max Pharma s.r.o

Na Florenci 2116/15

Nové Mesto

110 00 Prague 1

Czech Republic

Date of the Last Revision of this Package Leaflet:June 2023

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/