Fodonal 3 mg lozenges honey-orange flavour
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fodonal 3mg Honey-Orange Flavour Lozenges
Hydrochloride Bencidamine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Contents of the leaflet
- What Fodonal is and what it is used for
- What you need to know before taking Fodonal
- How to take Fodonal
- Possible side effects
- How to store Fodonal
- Contents of the pack and other information
1. What Fodonal is and what it is used for
Fodonal contains the active substance benzidamine hydrochloride. The active substance is the component of the tablets 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 fever or worsen after 3 days.
2. What you need to know before starting to take Fodonal
Do not take this medicine
- If you are allergic to benzydamine hydrochloride or to any of the other ingredients (listed in section 6)
Warnings and precautions
Consult a doctor before using Fodonal in the following cases:
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If you have a disease called phenylketonuria.
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If you have asthma or a history of asthma.
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If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or to other analgesic anti-inflammatory drugs known as NSAIDs.
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If, after using the tablets, sore throat worsens or does not improve within 3 days, or if you develop fever, severe throat pain, 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 medicines and Fodonal
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines available without a prescription.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
You should not use Fodonal during pregnancy unless clearly necessary and advised by your doctor. If treatment is required, the lowest effective dose for the shortest possible duration should be used.
Fodonal should not be used during breastfeeding.
Driving and use of machines
Fodonal has not been shown to affect the ability to drive or operate machinery.
Taking Fodonal with food and drinks
Food and drinks do not affect the medicine.
This medicine contains isomalt, aspartame, and cochineal red dye
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains 3.409 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine also contains cochineal red dye, which may cause allergic reactions.
3. How to take Fodonal
To take Fodonal, 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:
In adults and children over 6 years of age: 1 lozenge 3 times a day, to be taken when pain relief is needed. Do not take more than 3 lozenges per day.
Do not use Fodonal for longer than 7 days.
If your symptoms persist or worsen after 3 days, or if you develop fever, severe sore throat, or other symptoms, consult your doctor.
In children aged 6 to 11 years, this medicine should be administered under adult supervision.
Oropharyngeal use:
Allow one lozenge to 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 must contact your pharmacist, your doctor, or the nearest hospital emergency service immediately. Always bring the medicine package with its label, whether or not any tablets remain.
Although very rare, reported overdose symptoms in children include excitement, convulsions, sweating, ataxia, tremor, and vomiting after oral administration of doses of benzidamine approximately 100 times higher than those contained in 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 at telephone number: 915.620.420, stating the name of the medicine and the amount ingested.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Fodonal can cause adverse effects, although not everyone experiences them.
Other possible adverse effects:
- 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
- Burning sensation or dryness of the skin. If this occurs, sip water to reduce the effect of the medicine.
Very rare
- Sudden swelling of the mouth/throat and mucous membranes (angioedema, whose symptoms 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).
- Breathing difficulties (laryngospasm or bronchospasm).
Frequency not known
- Allergic reaction (hypersensitivity).
- Severe allergic reaction (anaphylactic shock), whose signs may include difficulty breathing, chest pain or tightness and/or feeling dizzy/fainting, intense itching of the skin or skin lumps, swelling of the face, lips, tongue and/or throat, which may be potentially fatal.
- Local loss of sensitivity of the oral mucosa (oral hypoesthesia).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Fodonal Storage
Keep this medicine out of the sight and reach of children.
Do not use Fodonal after the expiry date stated on the packaging and blister. The expiry date (EXP) refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fodonal
The active substance is bencidamine hydrochloride. Each tablet 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 flavour
Orange flavour
Peppermint oil
Cochineal red dye (E-124)
Appearance of the product and contents of the pack
Fodonal is available as yellow, round tablets, 19 mm in diameter, with a lemon flavour.
The tablets are presented in PVC-PVDC/aluminum blisters.
Pack sizes: 8, 12, 16, 20, 24 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio Reig Jofre, S.A.
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 (Seville)
Spain
Date of the most recent approval of this package leaflet: September 2025.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/