FODONAL 3 mg LOZENGES HONEY-ORANGE FLAVORED

Introduction

Package Leaflet: Information for the User

Fodonal3mg lozenges with honey-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 the medication contained in this package leaflet or as indicated by your pharmacist exactly.

• 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 it worsens or does not improve after 3 days.

Contents of the Package Leaflet

1. What is Fodonal and what is it used for
2. What you need to know before taking Fodonal
3. How to take Fodonal
4. Possible side effects
5. Storage of Fodonal
6. Package contents and additional information

1. What is Fodonal and what is it used for

Fodonal contains the active ingredient bencidamine hydrochloride. The active ingredient is the component of the lozenges that provides the therapeutic effect you need.

Fodonal is used for the treatment of acute sore throat in adults and children over 6 years of age.

You should consult a doctor if you do not feel better or if you develop a fever or worsen after 3 days.

2. What you need to know before taking Fodonal

Do not take this medication

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

Warnings and precautions

Consult a doctor before using Fodonal 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 sore throat worsens or does not improve within 3 days or if you have a fever or severe pain in the throat or other symptoms, you should consult your doctor.

Children:

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

Use of other medications and Fodonal

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications.

Pregnancy and breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist.

Fodonal should not be used during pregnancy and breastfeeding.

Driving and using machines

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

Taking Fodonal with food and drinks

Food and drinks do not influence the medication.

This medication contains isomalt, aspartame, and cochineal red dye

If you have an intolerance to certain sugars, consult your doctor before taking this medication.

This medication contains 3.409 mg of aspartame in one lozenge. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication also contains cochineal red dye, which may cause allergic reactions.

3. How to take Fodonal

To take Fodonal, follow the administration instructions contained in this package leaflet or as indicated by your doctor or pharmacist exactly. If you have doubts, consult your doctor or pharmacist.

The recommended dose is:

In adults and children over 6 years of age: 1 lozenge to be sucked 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 Fodonal for more than 7 days.

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

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

Buco-pharyngeal use:

Let one lozenge dissolve slowly in the mouth.

Do not swallow it.

Do not chew it

If you take more Fodonal 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 of large amounts of Fodonal, go immediately to a medical center or call the Toxicology Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, Fodonal can cause side effects, although not everyone experiences them.

Other side effects that may occur:

• Very common: may affect more than 1 in 10 people.
• Common: may affect up to 1 in 10 people.
• Uncommon: may affect up to 1 in 100 people.
• Rare: may affect up to 1 in 1,000 people.
• Very rare: may affect up to 1 in 10,000 people.
• Frequency not known: cannot be estimated from the available data.

Uncommon

• Skin sensitivity to sunlight (causing a rash or sunburn).

Rare

• Feeling of burning or dryness of the skin. If this happens to you, take sips of water to reduce the effect of the medication.

Very rare

• Sudden swelling of the mouth/throat and mucous membranes (angioedema, whose symptoms may include difficulty breathing or swallowing, rash, itching, urticaria, or swelling of the face, hands, and feet, eyes, lips, and/or tongue, and dizziness).
• Difficulty breathing (laryngospasm or bronchospasm).

Frequency not known

• 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 hives, swelling of the face, lips, tongue, and/or throat, and which can be potentially fatal.
• 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 Fodonal

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

Do not use Fodonal after the expiration date indicated 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 away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in 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 Fodonal

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)

Honey flavor

Orange flavor

Peanut oil

Cochineal red dye (E-124)

Appearance of the product and package contents

Fodonal is presented in the form of round yellow lozenges, 19 mm in diameter, with a lemon flavor.

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

Package size: 8, 12, 16, 20, 24 lozenges.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Reig Jofre, SA

Gran Capitán, 10 – 08970

San 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 (Sevilla)

Spain

Date of the last approval of this package leaflet: December 2020.

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