Leaflet: information for the user

GARYDOL FORTE 5 mg / 5 mg lozenges

Chlorhexidine dihydrochloride / Benzocaine

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or 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 doctor, or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

1. What isGARYDOL FORTEand what it is used for.

2. What you need to know before starting to takeGARYDOL FORTE.

3. How to takeGARYDOL FORTE.

4. Possible side effects

5. Storage ofGARYDOL FORTE.

6. Contents of the pack and additional information

Thechlorhexidine and benzocaine,active principles of this medication, act by combiningthe antisepticanddisinfectant action of chlorhexidinewiththe local anesthetic action of benzocaine.

This medication is used for the symptomatic relief of mild infections of the mouth and throat that are accompanied by pain, but not fever, such as: sore throat, hoarseness, and small mouth ulcers.

GARYDOL FORTEmay be used in adults, adolescents, and children aged 6 years and above.

You should consult a doctor if symptoms worsen or do not improve after 2 days.

Do not takeGARYDOL FORTE:

If you are allergic tochlorhexidine dihydrochloride, benzocaine, or any of the other components of this medication (listed in section 6).

Warnings and precautions

• If you cannot tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).
• If you have any severe or extensive injuries in the mouth.
• If you have periodontitis(gum disease),due to the fact that chlorhexidine can cause an increase in supragingival calculus (tartar that appears above the gum line).
• If you have fillings in your incisors and the surface of the filling or its margins are rough, as chlorhexidine can cause permanent discoloration.
• Do not take this medication if you develop mouth and throat ulcers and sores.
• Do not use quantities greater than those recommended in section 3 (How to take GARYDOL FORTE).

It is recommended to maintain good oral hygiene to reduce the accumulation of tartar and the possible discoloration of the teeth that chlorhexidine can cause.

Consult your doctor or pharmacist before starting to take this medication.

Stop taking this medication and seek immediate medical attention if you or a child in your care develop pale or grayish-blue skin, lips, or nail coverings, headache, dizziness, difficulty breathing, fatigue, and tachycardia (rapid heartbeats).

Due to the local anesthetic action of benzocaine, avoid eating or drinking directly after taking a tablet.

Use with adult supervision in young children and individuals with swallowing and aspiration problems, as the tablets are a potential risk of asphyxiation.

If symptoms persist or worsen, or if new symptoms appear, stop using this medication and consult your doctor.

Children

This medication should not be used in children under 6 years old without consulting a doctor.Children may be more sensitive to benzocaine.

Special populations:

Older adults and more debilitated patientsmay be more sensitive to benzocaine.

Other medications and GARYDOL FORTE

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

Although not described in the recommended conditions of use, do not use with other mouth or throat medications without consulting a doctor or pharmacist.

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Cholinesterase inhibitors (medications for Alzheimer's disease).
• Sulfonamides (used for infections).

Anionic compounds and suspending agents (common components of toothpaste), reduce the effectiveness of chlorhexidine, so it is recommended to rinse your mouth well after using toothpaste.

Taking GARYDOL FORTE with food and drinks

Avoid eating or drinking immediately after taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The consumption of medications during pregnancy can be hazardous to the fetus and should be monitored by your doctor.

If you are pregnant or breastfeeding, consult your doctor before using this medication.

Driving and operating machinery

The combination of benzocaine and chlorhexidine is unknown to affect the ability to drive or operate machinery.

Interference with diagnostic tests:

If you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are using this medication, as it may alter the results. This medication may interact with pancreatic function tests that use bentiromide. Do not use this medication at least 3 days before the test and inform your doctor.

GARYDOL FORTE contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is for buccal use, so the chewable tablets must be dissolved slowly in the mouth without chewing or swallowing them, as their action is local and only manifests when the product is in direct contact with the affected area.

The recommended dose is:

Adults, adolescents, and children aged 6 years and above:

1 tablet every 2 or 3 hours, if necessary, up to a maximum of 8 tablets per day.

Dissolve slowly in the mouth without chewing or swallowing.

Always use the lowest effective dose.

If you observe that the symptoms worsen or persist for more than 2 days after starting treatment or if fever, headache, nausea, or vomiting appear, you must consult your doctor as soon as possible.

If you take more GARYDOL FORTE than you should

The signs of overdose are manifested by: slurred speech, drowsiness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating, decreased oxygen levels in the blood (pale, grayish, or blue skin, lips, and nail beds, difficulty breathing, fatigue, confusion, headache, dizziness, and rapid heart rate, and death in the most severe cases).Decreased blood pressure may also occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call theService ofInformationToxicológica, telephone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects that may occur whose frequency has not been determined with exactness are:

Discoloration of the teeth may appear. This pigmentation or discoloration may occur especially in those people who have accumulations of plaque on their teeth.This alteration of the color of the teeth is not permanent and can be eliminated through a dental cleaning.

The color of the fillings may also be altered, in which case, this discoloration may be permanent.

Alteration in the perception of taste may occur.

In some cases, GARYDOL FORTE may present irritation in the mouth or irritation of the tip of the tongue or numbness of the tongue, which are usually transient, lack of sensitivity in the mouth, stomatitis (inflammation of the oral mucosa), peeling of the mucosa, sensation of burning in the mucosa, change in the perception of taste; discoloration of teeth, tongue, fillings, and dentures; increase in plaque, as well as hypersensitivity reactions such as urticaria, angioedema (swelling of certain areas of the skin), anaphylactic reaction or anaphylactic shock, mainly due to chlorhexidine.

There has also been reported inflammation of the parotid gland.

There have been some cases of methemoglobinemia caused by benzocaine, whose symptoms are difficulty breathing, cyanosis (blue discoloration of the skin and mucous membranes), alteration of mental state, headache, fatigue, difficulty exercising, dizziness, and loss of consciousness.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 of Pharmacovigilance of Medicines for Human Usehttps://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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of GARYDOL FORTE

Each lozenge contains:

• The active principles are: dihydrochloride of chlorhexidine 5 mg and benzocaine 5 mg.

• The other components (excipients) are: mannitol (E-421), microcrystalline cellulose (E-460), povidone, magnesium stearate, sodium cyclamate (E-952), sodium saccharin (E-954), peppermint aroma and orange aroma.

Appearance of the product and contents of the packaging

GARYDOL FORTE are orange-flavored lozenges, white-yellowish in color, round, beveled, and scored on one face.

This medication is presented in blister packs of 20 lozenges, conditioned in aluminum foil coated with PVDC and stratified with PVC/PE/PVDC.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing:

Alcalá Farma Laboratories, S.L.

Madrid Avenue, 82

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: September 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/