Topigel 200 mg/g oral gel
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Topigel 200mg/g oral gel
Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve<after 2 days>.
Contents of the leaflet
- What Topigel is and what it is used for
- What you need to know before using Topigel
- How to use Topigel
- Possible side effects
- How to store Topigel
- Contents of the pack and other information
1. What Topigel is and what it is used for
It is a topical anesthetic that works 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 caused by denture irritation, tooth extractions, minor oral injuries, canker sores, and small mouth ulcers in adults and children aged 6 years and older.
You should consult a doctor if symptoms worsen or do not improve after 2 days of treatment.
2. What you need to know before using Topigel
Do not use Topigel
- If you are allergic to benzocaine, to other local anaesthetics derived from para-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 Topigel
- 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 injury in the mouth.
- Do not exceed the recommended dose indicated in section 3 (How to take Topigel).
- If you have asthma, bronchitis, or emphysema.
- Stop taking the medicine and consult your doctor immediately if you experience: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia.
- Elderly or debilitated patients should consult their doctor before taking this medicine, as they may be more sensitive to its possible adverse effects.
- Do not swallow.
- Avoid contact with the eyes.
- Do not eat or drink while numbness in the mouth persists, due to the risk of biting your tongue or oral mucosa and choking.
Use of Topigel with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This medicine may interact with:
- Sulfonamides (medicines used to treat infections): should not be used at the same time as benzocaine, as it may reduce the antibacterial effect of sulfonamides.
- Medicines containing hyaluronidase: 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 conditions such as Alzheimer's disease, myasthenia gravis, or glaucoma, because when used simultaneously, they inhibit the metabolism of benzocaine.
- Other local anaesthetics.
- In individuals sensitive to benzocaine, hair dyes containing paraphenylenediamine may cause severe contact dermatitis.
Use of Topigel with food and drinks
Do not use this medicine before meals or before drinking (see section Warnings and precautions).
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.
Benzocaine should not be used during pregnancy.
It is unknown whether benzocaine is excreted in breast milk; therefore, women who are breastfeeding should not use this medicine.
Use in people aged 65 years and older
People aged 65 years and older and debilitated patients may be more sensitive to the adverse effects of benzocaine; therefore, you should consult your doctor.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
3. How to use Topigel
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is for topical oral application. It must not be swallowed.
Recommended dose:
Adults and adolescents:
Apply a small amount of the medicine to the affected area, using light touches, up to 3 or 4 times a day.
Children aged 6–12 years: only under adult supervision, as in the case above.
Children aged 2–6 years: under medical supervision.
Children under 2 years of age: under strict medical supervision.
Do not apply this medicine more than 3 or 4 times a day.
If your condition worsens or if pain persists after 2 days of treatment, consult your doctor.
Wash your hands after applying the medicine.
If you use more Topigel than you should
Signs of overdose may include: bluish skin discoloration, slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or seizures, ringing in the ears (tinnitus), and increased sweating. Blood pressure may also decrease.
In case of overdose or accidental ingestion, seek immediate medical advice or go to a medical center, or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, Topigel may produce adverse effects, although not everyone experiences them.
During the period of use of benzocaine, the following adverse effects have been reported, although their frequency cannot be precisely determined:
Urticaria, edema, anaphylactoid reaction (contact dermatitis). Cross-reactions with other ester-type local anesthetics. Photosensitivity, bad taste in the mouth, mucosal dehydration, and difficulty swallowing.
Sensation of oral burning. Methemoglobinemia (symptoms include: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia).
Prolonged contact of benzocaine with mucous membranes may cause epithelial dehydration and hardening of the mucosa.
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 website:
www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Topigel
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 30°C. Keep in the original container tightly closed to protect from light.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure how to dispose of unused medicines and their packaging, please consult your pharmacist. This will help protect the environment.
6. Contents of the pack and other information
Composition of Topigel
• The active substance is: Benzocaine.
• The other components are: Polyethylene glycol, Saccharin, Cherry flavour.
Appearance of the product and contents of the pack
Topigel is a viscous, cinnamon-coloured gel with a cherry scent.
It is available in polyethylene tubes containing 11.25 g and 33.75 g of gel.
Marketing Authorization Holder
Laboratorios Clarben S.A.
Av. Valdelaparra 27
28108 Alcobendas, Spain
Manufacturer
INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923 Alcorcón (Madrid), Spain
This leaflet was last approved in
December 2013
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/