Leaflet: information for the user

Fodonal3mg lozenges, orange-honey flavor

Bencidamina hydrochloride

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

Follow exactly the administration instructions 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 get worse or do not improve after 3 days.

1. What isFodonaland what it is used for

2. What you need to know before starting to takeFodonal

3. How to takeFodonal

4. Possible side effects

5. Storage ofFodonal

6. Contents of the pack and additional information

Fodonalcontains the active ingredient hydrochloride of bencidamina. The active ingredient is the component of the tablets that provides the therapeutic effect you need.

Fodonalis used for the treatment of acute sore throat in adults and children over 6 years old.

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

Do not take this medication

• If you are allergic to hydrochloride of bencidamine or to any of the other components (included 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 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 sore throat worsens or does not improve within 3 days or if you have fever or strong 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 old.

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, intend to become pregnant or are breastfeeding, consult your doctor or pharmacist.

Fodonal should not be used during pregnancy and breastfeeding.

Driving and operating machines

No adverse effects on the ability to drive or operate machines have been observed.

Taking Fodonal with food and drinks

Foods and beverages do not affect the medication.

This medication contains isomalta, aspartame and cochineal red 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 one tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

To takeFodonal, follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:

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

Do not useFodonalfor 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 adult supervision.

Oral mucosal use:

Leave one lozenge to dissolve slowly in the mouth.

Do not swallow.

Do not chew

If you take tooFodonal

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

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

In case of overdose or accidental ingestion of large quantities of Fodonal, go immediately to a medical center or call the Toxicological Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

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

Like all medications,Fodonalmay cause adverse effects, although not all people will experience them.

Other adverse 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.
• Unknown frequency: cannot be estimated from available data.

Uncommon

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

Rare

• Sensation of burning or dryness of the skin. If this occurs, 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, skin rash, intense itching, urticaria, or swelling of the face, hands, and feet, eyes, lips, and/or tongue, and dizziness).
• Difficulty breathing (laryngospasm or bronchospasm).

Unknown frequency

• Allergic reaction (hypersensitivity).
• Severe allergic reaction (anaphylactic shock), whose signs may include difficulty breathing, chest pain or tightness, and/or feeling dizzy or faint, intense itching of the skin or hives, swelling of the face, lips, tongue, and/or throat, and may be potentially fatal.
• Local loss of sensitivity of the oral mucosa (hypoaesthesia of the mouth).

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 for 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 useFodonalafter 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofFodonal

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)

Honey aroma

Orange aroma

Mint oil

Cochinilla red colorant (E-124)

Appearance of the product and contents of the packaging

Fodonalis presented in the form of round yellow tablets, 19 mm in diameter, with a lemon flavor.

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

Packaging size: 8, 12, 16, 20, 24 tablets.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

Laboratorio Reig Jofre, SA

Gran Capitán, 10 – 08970

San Joan Despí, Barcelona

Spain

Responsible for the manufacture

LOZY'S PHARMACEUTICALSS.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 prospectus: December 2020.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/