GARYDOL 5mg/2mg LOZENGES

2. What you need to know before starting to use garydol

Do not use garydol:

• If you are allergic to chlorhexidine, benzocaine, or any of the other components of this medication (listed in section 6).
• If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).

Warnings and precautions

Consult your doctor or pharmacist before starting to use garydol

• If you have any serious or extensive injury in the mouth.
• If you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus (tartar that appears above the gums).
• Do not use more than the recommended amounts in section 3 (How to use garydol).
• If you have asthma.
• Do not use before eating or drinking.
• If you have incisor fillings and if the surface of the filling or its edges are rough, chlorhexidine can cause permanent discoloration.

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

Interference with analytical tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests that use 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.

Children

This medication should not be used in children under 6 years old.

Between 6 and 12 years old, it can only be used under adult supervision.

Use in people over 65 years old

People over 65 years old and debilitated patients may be more sensitive to benzocaine.

Use of garydol with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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) decrease the effectiveness of chlorhexidine, so the mouth should be rinsed well after using toothpaste.

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.

Driving and using machines

No effect on the ability to drive or use machines has been described.

garydol contains Sorbitol (E-420)

This medication contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medication.

3. How to use garydol

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

The recommended dose is:

Adults and children over 12 years old: Dissolve slowly in the mouth 1 lozenge every 2 or 3 hours, up to a maximum of 8 lozenges per day.

Children from 6 to 12 years old: Dissolve slowly in the mouth 1 lozenge every 4 or 5 hours, up to a maximum of 6 lozenges per day.

How to use

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

Dissolve the lozenge slowly in the mouth without chewing or swallowing.

Always use the lowest effective dose.

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

If you notice that after 2 days of starting treatment you have a fever, headache, nausea, or vomiting, you should consult a doctor as soon as possible.

If you take more garydol than you should

Signs of overdose manifest with: slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating, and/or low blood pressure.

In case of overdose or accidental ingestion, go immediately to a medical center 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.

Tooth discoloration may appear. This pigmentation or discoloration occurs mainly in people who have tartar buildup.

Some people may develop altered taste perception.

In some cases, garydolmay cause irritation in the mouth or irritation of the tip of the tongue, which are usually transient, as well as allergic reactions to chlorhexidine or benzocaine.

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

5. Storage of garydol

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of 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 garydol

Each lozenge contains:

• The active ingredients are: chlorhexidine dihydrochloride, 5 mg, and benzocaine, 2 mg.
• The other components (excipients) are: magnesium stearate, povidone (E-1201), sorbitol (E-420), talc (E-553b), sodium saccharin (E-954), and peppermint flavor.

Appearance of the product and package contents

Garydolis presented in the form of cylindrical, beveled, and white lozenges. Each package contains 20 lozenges.

Marketing authorization holder and manufacturer

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10 - Polígono Areta

31620 Huarte - Pamplona (Navarra)

SPAIN

This leaflet was approved in: April 2015

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/