GARYDOL FORTE 5 mg/5 mg LOZENGES

Introduction

Leaflet: information for the user

GARYDOL FORTE 5 mg / 5 mg lozenges

Chlorhexidine dihydrochloride / Benzocaine

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

Follow exactly the administration instructions of the medication contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the leaflet:

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

1. What GARYDOL FORTE is and what it is used for

The active ingredients of this medication, chlorhexidine and benzocaine, act by combining the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medication is used for the symptomatic local and temporary relief of mild mouth and throat infections that occur with pain and without fever, such as throat irritation, hoarseness, and small mouth ulcers.

GARYDOL FORTE can be used in adults, adolescents, and children from 6 years of age.

You should consult a doctor if it worsens or does not improve after 2 days.

2. What you need to know before taking GARYDOL FORTE

Do not takeGARYDOL FORTEif:

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

Warnings and precautions

• If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a hair dye component).
• If you have any severe or extensive injury in the mouth.
• If you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus (tartar above the gums).
• If you have fillings on your front teeth and if the surface of the filling or its edges are rough, as chlorhexidine can cause permanent discoloration.
• Do not take this medication if you have sores and ulcers in your mouth and throat.
• Do not use more than the recommended amount in section 3 (How to take GARYDOL FORTE).

It is recommended to maintain good oral hygiene to reduce the accumulation of tartar and possible tooth discoloration that may be caused by chlorhexidine.

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

Stop taking this medication and consult your doctor immediately if you or a child in your care develop pale, gray, or blue skin, lips, or nail edges, headache, dizziness, difficulty breathing, fatigue, and rapid heartbeat.

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

Use under adult supervision in small children and individuals with aspiration and swallowing problems, as lozenges are a potential choking hazard.

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 of age without consulting a doctor first. Children may be more sensitive to benzocaine.

Special populations:

The elderly and more debilitated patients may be more sensitive to benzocaine.

Other medications and GARYDOL FORTE

Inform your doctor or pharmacist if you are taking, have recently taken, 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 your 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 toothpastes) reduce the effectiveness of chlorhexidine, so the mouth should be rinsed 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Taking medications during pregnancy can be hazardous to the embryo, fetus, or breastfeeding child and should be monitored by your doctor.

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

Driving and using machines

It is unknown whether the combination of benzocaine and chlorhexidine has an effect on the ability to drive or operate machinery.

Interference with analytical tests:

If you are going to undergo any diagnostic test (including blood tests, urine tests, 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 using 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 lozenge; it is essentially "sodium-free".

3. How to take GARYDOL FORTE

Follow exactly the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medication is for buccopharyngeal use, so the lozenges should be dissolved slowly in the mouth without chewing or swallowing, as its action is local and only occurs when the product is in direct contact with the affected area.

The recommended dose is:

Adults, adolescents, and children from 6 years of age:

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

Dissolve slowly in the mouth without chewing or swallowing.

Always use the lowest effective dose.

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

If you take more GARYDOL FORTE than you should

Signs of overdose are: slurred speech, numbness, stumbling gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, increased sweating, decreased oxygen in the blood (pale, gray, or blue skin, lips, and nail edges, difficulty breathing, fatigue, confusion, headache, dizziness, and rapid heartbeat), and death in severe cases. It may also cause a decrease in blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

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

Side effects whose frequency has not been determined with precision are:

Tooth discoloration may occur. This pigmentation or discoloration can occur especially in people with tartar buildup. This alteration of tooth color is not permanent and can be removed by a dental cleaning.

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

Alteration in taste perception may occur.

In some cases, GARYDOL FORTE may cause 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), desquamation of the mucosa, burning sensation in the mucosa, change in taste perception; tooth, tongue, filling, and denture discoloration; increased tartar, as well as hypersensitivity reactions such as urticaria, angioedema (swelling of certain skin areas), anaphylactic reaction, or anaphylactic shock, mainly due to chlorhexidine.

There have also been reports of parotid gland inflammation.

Some cases of methemoglobinemia caused by benzocaine have been reported, with symptoms such as difficulty breathing, cyanosis (bluish discoloration of the skin and mucous membranes), altered mental state, headache, fatigue, difficulty exercising, dizziness, and loss of consciousness.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of GARYDOL FORTE

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of GARYDOL FORTE

Each lozenge contains:

• The active ingredients are: chlorhexidine dihydrochloride 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), menthol flavor, and orange flavor.

Appearance of the product and package contents

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

This medication is presented in packages of 20 lozenges, packaged in aluminum blister packs coated with PVDC and layered with PVC/PE/PVDC.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of the last revision of this leaflet: September 2021

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/