Garydol Forte 5 mg/5 mg lozenges
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
GARYDOL FORTE 5 mg / 5 mg sucking tablets
Chlorhexidine dihydrochloride / Benzocaine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 FORTE is and what it is used for.
- What you need to know before taking GARYDOL FORTE.
- How to take GARYDOL FORTE.
- Possible side effects.
- How to store GARYDOL FORTE.
- Contents of the pack and other information.
1. What GARYDOL FORTE is and what it is used for
Chlorhexidine and benzocaine, the active substances in this medicine, work by combining the antiseptic and disinfectant action of chlorhexidine with the local anesthetic effect of benzocaine.
This medicine is used for the local and temporary symptomatic relief of mild infections of the mouth and throat associated with pain, and without fever, such as: sore throat irritation, hoarseness, and minor mouth ulcers.
GARYDOL FORTE can be used in adults, adolescents, 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 taking GARYDOL FORTE
Do not take GARYDOL FORTE:
If you are allergic to chlorhexidine dihydrochloride, benzocaine, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- If you are intolerant to other local anaesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
- If you have a severe or extensive lesion in the mouth.
- If you suffer from periodontitis (gum disease), because chlorhexidine may increase supragingival calculus (tartar above the gum line).
- If you have fillings in your incisor teeth and the filling surface or its margins are rough, as they may become permanently discoloured with chlorhexidine.
- Do not take this medicine if you develop sores or ulcerations in your mouth or throat.
- Do not use amounts exceeding those recommended in section 3 (How to take GARYDOL FORTE).
It is recommended to maintain adequate oral hygiene to reduce tartar buildup and possible tooth discoloration that may be caused by chlorhexidine.
Consult your doctor or pharmacist before starting to take this medicine.
Stop taking this medicine and seek immediate medical attention if you or a child under your care develops pale, gray, or bluish skin, lips, or nail beds, headache, dizziness, difficulty breathing, fatigue, or tachycardia (rapid heartbeat).
Due to the local anaesthetic effect of benzocaine, avoid eating or drinking immediately after taking a tablet.
Use under adult supervision in young children and in individuals with aspiration or swallowing difficulties, as the tablets pose a potential choking hazard.
If symptoms persist or worsen, or if new symptoms appear, stop using this medicine and consult your doctor.
Children
This medicine should not be used in children under 6 years of age without prior consultation with a doctor. Children may be more sensitive to benzocaine.
Special populations:
Elderly individuals and debilitated patients may be more sensitive to benzocaine.
Other medicines and GARYDOL FORTE
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Although no interactions have been reported under recommended conditions of use, this medicine should not be used with other oral or throat medications without consulting your doctor or pharmacist.
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.
Taking GARYDOL FORTE with food and drinks
Avoid eating or drinking immediately after taking this medicine.
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.
Taking medicines during pregnancy may be harmful to the embryo, fetus, or nursing infant and should be monitored by your doctor.
If you are pregnant or breastfeeding, consult your doctor before using this medicine.
Driving and use of machines
It is unknown whether the combination of benzocaine and chlorhexidine affects the ability to drive or operate machinery.
Interference with diagnostic tests:
If you are scheduled to undergo any diagnostic tests (including blood and urine analyses, 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.
GARYDOL FORTE contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.
3. How to take GARYDOL FORTE
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for oropharyngeal use; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing them, as its action is local and only becomes effective when the product is in direct contact with the affected area.
Recommended dose:
Adults, adolescents and children aged 6 years and older:
1 lozenge every 2 or 3 hours, if necessary, up to a maximum of 8 lozenges per day.
Slowly dissolve 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 occur, consult your doctor as soon as possible.
If you take more GARYDOL FORTE than you should
Signs of overdose may include: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or convulsions, tinnitus, increased sweating, reduced oxygen levels in the blood (pale, grayish or bluish skin, lips and nail beds, difficulty breathing, fatigue, confusion, headache, sensation of dizziness, rapid heartbeat, and death in the most severe cases). A drop in blood pressure may also occur.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The possible adverse effects whose frequency has not been precisely determined are:
Discoloration of the teeth may occur. This pigmentation or discoloration mainly affects people who have accumulations of dental plaque. This change in tooth color is not permanent and can be removed by professional oral cleaning.
The color of dental fillings may also be altered, in which case such discoloration may be permanent.
Altered taste perception may occur.
In some cases, GARYDOL FORTE may cause irritation in the mouth or irritation at the tip of the tongue, or tongue numbness, which are usually temporary, loss of sensation in the mouth, stomatitis (inflammation of the oral mucosa), desquamation of the mucosa, burning sensation in the mucosa, altered taste perception, discoloration of teeth, tongue, fillings, and dentures, increased tartar formation, as well as hypersensitivity reactions such as urticaria, angioedema (swelling of certain areas of the skin), anaphylactic reaction, or anaphylactic shock, primarily due to chlorhexidine.
Parotid gland inflammation has also been reported.
There have been rare cases of methemoglobinemia caused by benzocaine, whose symptoms include difficulty breathing, cyanosis (bluish discoloration of the skin and mucous membranes), altered 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of GARYDOL FORTE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of GARYDOL FORTE
Each lozenge contains:
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Active substances: chlorhexidine dihydrochloride 5 mg and benzocaine 5 mg.
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Other components (excipients): 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 medicinal product and contents of the pack
GARYDOL FORTE are orange-flavored, white-yellowish, round, bevelled lozenges, scored on one side.
This medicine is available in packs of 20 lozenges, presented in aluminum blisters coated with PVDC and laminated 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 most recent revision of this leaflet: September 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/