Leaflet: information for the user

Garydol 5 mg/ 2 mg lozenges

Chlorhexidine dihydrochloride/Benzocaine

Read this leaflet carefully before you start to use this medicine because it contains important information for you. Follow exactly the administration instructions of 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.

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

This medication is indicated for the symptomatic relief of mild, temporary infections and inflammatory processes of the mouth and throat (mouth ulcers, throat irritation, hoarseness) that are accompanied by pain and without fever in adults and children aged 6 years and above.

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

No use garydol:

• If you are allergic to chlorhexidine, benzocaine, or any of the other components of this medication (listed in section 6).
• If you cannot 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 severe or extensive injuries in the mouth.
• If you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus (tartar above the gum line).
• Do not use quantities greater than those recommended in section 3 (How to use garydol).
• If you have asthma.
• Do not use before eating or drinking.
• If you have dental fillings on your incisors and the surface of the filling or its margins are rough, chlorhexidine may cause permanent discoloration.

Maintain good oral hygiene to reduce the accumulation of tartar and the possible discoloration of the teeth that chlorhexidine may cause.

Interference with laboratory 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.

Children

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

Between 6 and 12 years old, they can only use it under adult supervision.

Use in people over 65 years

People over 65 years old and those who are debilitated may be more sensitive to benzocaine.

Use of garydol with other medications

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

This is especially important in the case of:

• Other mouth or throat antisetics.
• 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 necessary to rinse your mouth well after using toothpaste.

Pregnancy and breastfeeding

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

Driving and operating machinery

No effects on the ability to drive or operate machinery have 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.

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

The recommended dose is:

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

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

How to use

garydolis for buccal use, so the tablets for sucking should 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.

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

Always use the smallest dose that is effective.

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

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

If you take more garydol than you should

The signs of overdose are manifested with: slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement or convulsions, tinnitus, increased sweating and/or low blood pressure.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone (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.

Discoloration of the teeth may appear. This pigmentation or discoloration, mainly occurs in people who have accumulations of tartar plaque.

Some people may develop alterations in the perception of taste.

In some cases,garglingmay produce temporary irritation in the mouth or irritation at the tip of the tongue, as well as allergic reactions to chlorhexidine or benzocaine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30º 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.

Medicines 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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of garydol

Each lozenge contains:

• The active principles 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 aroma.

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Areta Industrial Estate

31620 Huarte - Pamplona (Navarra)

SPAIN

This leaflet was approved in: April 2015

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