HURRICAINE 200 mg/g BUCAL GEL
How to use HURRICAINE 200 mg/g BUCAL GEL
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Hurricaine 200mg/goral gel
Benzocaine
Read this package leaflet carefully before you start using this medicine because it contains important information for you.
Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.
- Keep this package leaflet, 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, pharmacist, or nurse, even if it is a side effect not listed in this package leaflet. See section 4.
- You should consult a doctor if it worsens or does not improve after 2 days of treatment.
Contents of the Package Leaflet
- What is Hurricaine gel and what is it used for
- What you need to know before you start using Hurricaine gel
- How to use Hurricaine gel
- Possible side effects
- Storage of Hurricaine gel
- Contents of the pack and further information
1. What is Hurricaine gel and what is it used for
It is a topical anesthetic that acts by suppressing pain when applied externally to the area of the
mouth to be treated.
It is indicated for the local relief of dental or mouth pain, such as that produced by the rubbing of prostheses,
extractions, small mouth sores, canker sores, and small ulcers in adults and children from 6 years old.
You should consult a doctor if it worsens or does not improve after 2 days of treatment.
2. What you need to know before you start using Hurricaine gel
Do not use Hurricaine gel
- If you are allergic to benzocaine, to other local anesthetics derived from p-aminobenzoic acid, or to any of the components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Hurricaine gel
- If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).
- If you have any severe or extensive injury in the mouth.
- Do not take doses higher than those recommended in section 3 (How to take Hurricaine gel).
- If you have asthma, bronchitis, or emphysema.
- Stop taking the medicine and consult your doctor immediately if you notice: headache,
dizziness, shallow breathing, nausea, fatigue, or tachycardia.
- Older, sick, or debilitated people should consult their doctor before taking this
medicine as they are more sensitive to its possible adverse reactions.
- Do not ingest.
- Avoid contact with the eyes.
- Do not eat or drink while the numbness of the mouth persists, due to the risk of biting the tongue or the oral mucosa and choking.
Using Hurricaine gel with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or may need to take any other medicine.
This medicine may interact with:
- Sulfonamides (medicines for treating infections): they should not be used at the same time as benzocaine, as it may decrease the antibacterial effect of sulfonamides
- Medicines containing hyaluronidase: they should not be used at the same time as benzocaine, as it may increase the adverse effects of benzocaine
- Medicines containing cholinesterase, used to treat diseases such as Alzheimer's, myasthenia gravis, or glaucoma, because when used at the same time, the metabolism of benzocaine is inhibited
- Other local anesthetics.
- In people sensitive to benzocaine, hair dyes of the paraphenylenediamine type may cause severe contact dermatitis.
Using Hurricaine gel with food and drinks
Do not use this medicine before meals or before drinking (see warnings and precautions section).
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use benzocaine during pregnancy.
It is not known whether benzocaine is excreted in breast milk, so breastfeeding women should not use this medicine.
Use in people over 65 years old
People over 65 years old and debilitated patients may be more sensitive to the adverse effects
of benzocaine, so they should consult their doctor.
Driving and using machines
It does not affect driving or using machines.
3. How to use Hurricaine gel
Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.
This medicine is for administration in the mouth. Do not ingest.
The recommended dose is:
Adults and adolescents:
Apply to the area to be treated, a small amount of the medicine, with small touches, up to a maximum of 3 or 4 times a day.
Children from 6-12 years old: only under adult supervision, as in the previous case.
Children from 2-6 years old: under medical control
Children under 2 years old: under strict medical control.
Do not apply this medicine more than 3 or 4 times a day.
If it worsens or if the pain persists after 2 days of treatment, consult your doctor.
Wash your hands after applying the medicine.
If you use more Hurricaine gel than you should
The signs of overdose may be: bluish discoloration of the skin, slurred speech,
numbness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating. It may also decrease blood pressure.
In case of overdose or accidental ingestion, consult your doctor immediately or go to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.
4. Possible side effects
Like all medicines, Hurricaine gel can cause side effects, although not everybody gets them.
During the period of use of benzocaine, the following side effects have occurred, whose frequency has not been established with precision:
Hives, edema, anaphylactoid reaction (contact dermatitis). Cross-reactions with other local anesthetics of the ester type. Photosensitivity, bad taste in the mouth, dehydration of the mucous membranes, and difficulty swallowing.
Burning sensation in the mouth
Methemoglobinemia, whose symptoms are: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia).
Prolonged contact of benzocaine with the mucous membranes can cause dehydration of the epithelium and hardening of the mucous membranes.
Reporting of side effects
If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency website: www.notificaram.es.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Hurricaine gel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
Do not store at a temperature above 30°C. Keep in the packaging, perfectly closed to protect it from light.
Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that 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 medicines that you no longer need. This way, you will help protect the environment.
6. Contents of the pack and further information
Composition of Hurricaine gel
- The active ingredient is: Benzocaine.
- The other ingredients are: Polyethylene glycol, Saccharin, Cherry flavor.
Appearance of the product and contents of the pack
Hurricaine gel is a viscous gel of cinnamon color and cherry flavor.
It is presented in a 6 ml polyethylene tube and 30 ml and 50 ml polyethylene bottles with polypropylene (clinical packaging) of gel.
1 ml of gel corresponds to 1.06 grams.
Marketing authorization holder
Laboratorios Clarben S.A.
Av. Valdelaparra 27
28108 Alcobendas, Spain.
Manufacturer
CLARBEN, S.A.
Eduardo Marconi, 2.
Polígono Industrial Codein
Fuenlabrada (Madrid)-Spain
or
B BRAUN MEDICAL S.A.
Ronda de los Olivares, Parcela II,
Polígono Industrial Los Olivares, Jaén – Spain
or
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
Laguna, 66-68-70. Polígono Industrial Urtinsa II,
Alcorcón, Madrid – Spain
or
LABORATORIUM SANITATIS, S.L.
C/ Leonardo da Vinci, 11 (Parque Tecnológico de Álava),
Miñano (Álava) - Spain
This package leaflet was approved inMay 2021.
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Dosage formGEL/PASTE/ORAL LIQUID, 100 ml
- ATC codeN01BA05
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to HURRICAINE 200 mg/g BUCAL GELDosage form: TOPICAL ORAL PRODUCT, 5% benzocaineActive substance: benzocaineManufacturer: Laboratorios Vinas S.A.Prescription not requiredDosage form: TOPICAL ORAL PRODUCT, 20% benzocaineActive substance: benzocaineManufacturer: Laboratorios Clarben S.A.Prescription not requiredDosage form: ORAL SPRAY, 200 mg/mlActive substance: benzocaineManufacturer: Laboratorios Normon S.A.Prescription not required
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