Garydol 5 mg/2 mg lozenges for sucking
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
garydol 5 mg / 2 mg lozenges
Chlorhexidine dihydrochloride/Benzocaine
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you. Follow exactly the instructions for taking the medicine contained in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or 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 2 days.
Leaflet contents:
- What garydol is and what it is used for
- What you need to know before taking garydol
- How to take garydol
- Possible side effects
- How to store garydol
- Contents of the pack and other information
1. What garydol is and what it is used for
The active ingredients in this medicine combine the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.
This medicine is indicated for the local and temporary symptomatic relief of mild infectious and inflammatory conditions of the mouth and throat (oral ulcers, sore throat, hoarseness) associated with pain and without fever, in adults and children aged 6 years and older.
You should consult a doctor if symptoms worsen or do not improve after 2 days.
2. What you need to know before using garydol
Do not use garydol:
- If you are allergic to chlorhexidine, benzocaine, or any of the other components of this medicine (listed in section 6).
- If you are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use garydol:
- If you have a serious or extensive injury in the mouth.
- If you suffer from periodontitis (gum disease), because chlorhexidine may increase supragingival calculus (tartar above the gum line).
- Do not use more than the recommended doses described in section 3 (How to use garydol).
- If you have asthma.
- Do not use before eating or drinking.
- If you have fillings on your incisor teeth and the filling surface or its margins are rough, they may become permanently stained by chlorhexidine.
Maintain proper oral hygiene to reduce tartar buildup and possible tooth staining that may be caused by chlorhexidine.
Interference with diagnostic tests
If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter test results.
This medicine may interfere with pancreatic function tests using bentiromide. Do not use this medicine at least 3 days before such a test, and inform your doctor.
Children
This medicine must not be used in children under 6 years of age.
For children aged between 6 and 12 years, use only under adult supervision.
Use in people aged 65 years and older
People aged 65 years and older and debilitated patients may be more sensitive to benzocaine.
Using garydol with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
This is especially important in the case of:
- Other antiseptics for the mouth or throat.
- Cholinesterase inhibitors (medicines for Alzheimer's disease).
- Sulfonamides (used for infections).
Anionic compounds and suspending agents (common ingredients in toothpastes) reduce the effectiveness of chlorhexidine; therefore, rinse your mouth thoroughly after using toothpaste.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
garydol contains Sorbitol (E-420)
This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult him before using this medicine.
3. How to use garydol
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 12 years of age: Slowly dissolve 1 tablet in the mouth every 2 to 3 hours, up to a maximum of 8 tablets per day.
Children from 6 to 12 years of age: Slowly dissolve 1 tablet in the mouth every 4 to 5 hours, up to a maximum of 6 tablets per day.
How to use
garydol is intended for oropharyngeal use. The lozenges must be slowly dissolved in the mouth without chewing or swallowing, as their action is local and only occurs when the product is in direct contact with the affected area.
Slowly dissolve the tablet in the mouth without chewing or swallowing.
Always use the lowest effective dose.
Consult a doctor if symptoms worsen or do not improve after 2 days of treatment.
If, after 2 days of starting treatment, you develop fever, headache, nausea, or vomiting, consult your doctor as soon as possible.
If you take more garydol than you should
Signs of overdose may include: slurred speech, drowsiness, unsteady 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, seek immediate medical attention at a healthcare facility or call the Toxicology Information Service at telephone (91) 562.04.20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Discoloration of the teeth may occur. This staining or discoloration mainly affects people who have plaque or tartar build-up.
Some people may develop disturbances in taste perception.
In some cases, garydol may cause irritation in the mouth or irritation of the tip of the tongue, which are usually temporary, as well as allergic reactions to chlorhexidine or benzocaine.
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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of garydol
Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Garydol
Each lozenge contains:
- The active substances 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 flavour.
Appearance of the product and contents of the pack
Garydol is presented as cylindrical, bevelled white lozenges. Each pack contains 20 lozenges.
Marketing Authorisation Holder and Manufacturer
LABORATORIOS CINFA, S.A.
Olaz-Chipi, 10 - Polígono Areta
31620 Huarte - Pamplona (Navarra)
SPAIN
This leaflet was last approved in: April 2015
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/