ZOTRINA 3 mg LOZENGES HONEY & ORANGE FLAVORED

Introduction

Package Leaflet: Information for the User

Zotrina 3 mg lozenges with honey and orange flavor

Bencidamine, hydrochloride

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

Follow the administration instructions for this medication exactly as stated 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 Zotrina and what is it used for
2. What you need to know before taking Zotrina
3. How to take Zotrina
4. Possible side effects
5. Storage of Zotrina
6. Package contents and additional information

1. What is Zotrina and what is it used for

Zotrina contains the active ingredient bencidamine hydrochloride.

Bencidamine hydrochloride 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 medication

Do not take this medication

• If you are allergic to bencidamine hydrochloride or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult a doctor or pharmacist before using Zotrina 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 nonsteroidal 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 medication should not be administered to children under 6 years of age.

Other Medications and Zotrina

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

Taking Zotrina with Food and Drinks

Food and drinks do not affect the medication.

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 medication.

Zotrina should not be used during pregnancy and breastfeeding.

Driving and Using Machines

Zotrina has not been observed to affect the ability to drive or use machines.

This Medication Contains Isomalt, Aspartame, and Ponceau 4R Colorant

If you have an intolerance to certain sugars, consult your doctor before taking this medication. This medication 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 medication also contains the Ponceau 4R colorant, which may cause allergic reactions.

3. How to Take Zotrina

Follow the administration instructions for this medication exactly as stated 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 Zotrina 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 medication 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 Zotrina 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 medication package with its label, whether there are lozenges left or not.

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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

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

4. Possible Side Effects

Like all medications, Zotrina can cause side 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)

• Feeling of burning or dryness of the skin. If this happens, 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, 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 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 sensitivity of the oral mucosa (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 medication.

5. Storage of Zotrina

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Zotrina

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, Ponceau 4R (E-124), orange flavor, honey flavor (contains propylene glycol (E-1520)).

Appearance of the Product and Package Contents

Zotrina is presented in the form of round orange 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

Dr. Max Pharma s.r.o.

Na Florenci 2116/15

Nové Mesto

11000 Praga 1

Czech Republic

Manufacturer

LOZY’S PHARMACEUTICALS S.L.

Business Campus

31795 Lekaroz (Navarra)

Spain

or

INFARMADE, S.L.

c/Torre de los Herberos, 35. PI «Carretera de la Isla» 41703 Dos Hermanas (Sevilla)

Spain

or

Dr. Max Pharma s.r.o.

Na Florenci 2116/15

Nové Mesto

11000 Praga 1

Czech Republic

Date of Last Approval of this Package Leaflet: February 2025

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