Bobodent

Package Leaflet: Information for the Patient

BOBODENT

0.5 g/100 g, gel

Lidocaini hydrochloridum monohydricum

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed.
• If there is no improvement after a few days or the patient feels worse, the doctor should be contacted.

Table of Contents of the Leaflet

• 1. What is Bobodent and what is it used for
• 2. Important information before using Bobodent
• 3. How to use Bobodent
• 4. Possible side effects
• 5. How to store Bobodent
• 6. Package contents and other information

1. What is Bobodent and what is it used for

Bobodent contains lidocaine, which, acting locally as an anesthetic, relieves pain:

• during teething and the eruption of wisdom teeth,
• in the course of inflammatory conditions of the oral mucosa and gums. The onset of action is observed after 1-5 minutes, and the anesthetic effect lasts for 15-30 minutes.

2. Important information before using Bobodent

When not to use Bobodent:

• if the patient is allergic to the active substance, local anesthetics of the amide group, or any of the other ingredients of this medicine (listed in point 6);
• in the case of significant damage to the oral mucosa and gums in the form of trophic changes, swelling, or ulcers.

Warnings and precautions

Before starting to use Bobodent, the doctor or pharmacist should be consulted.
The medicine should be used with caution after neurological damage and in heart failure.

Bobodent and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient,
as well as any medicines that the patient plans to use.
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Concomitant use of lidocaine and class IB antiarrhythmic drugs or other local anesthetics may cause the addition of side effects of these drugs. Bobodent should be used with caution in combination with MAO inhibitors, tricyclic antidepressants, phenothiazine derivatives, and anticoagulants.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Lidocaine passes through the placenta and into breast milk.

Driving and operating machinery

There is no data on the effect of the medicine on the ability to drive and operate machinery.
Bobodent contains propylene glycoland may cause skin irritation.
Bobodent contains methyl parahydroxybenzoate and propyl parahydroxybenzoateand may cause allergic reactions (possible late reactions).

Bobodent contains sorbitol

If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using the medicine.

3. How to use Bobodent

This medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The medicine is applied locally to the oral mucosa.
A pea-sized amount of gel should be rubbed into the painful area with a clean finger or swab. The procedure should be repeated 3 times a day (maximum 6 times), especially after meals and before bedtime.
The medicine is intended for temporary use.

Using a higher dose of Bobodent than recommended

In the event of application to significantly damaged mucous membranes or in a manner inconsistent with the recommendations, reactions related to overdose of the medicine may occur. Lidocaine may disrupt the function of the central nervous system and the cardiovascular system.
Overdose symptoms may include dizziness and numbness around the mouth, difficulty focusing, ringing in the ears, nausea, vomiting, and a drop in blood pressure.
If such symptoms occur, the use of the medicine should be stopped and a doctor consulted.

Missing a dose of Bobodent

A double dose should not be used to make up for a missed dose.

Stopping the use of Bobodent

In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.
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The medicine is intended for local use and, when used as directed, is generally well tolerated.
Allergic reactions, such as hives or swelling at the site of administration, may occur.
The use of lidocaine in the oral cavity may cause numbness of the taste buds and, consequently, taste disturbances. The anesthetic effect of lidocaine on the oral part of the throat may lead to the elimination of the gag reflex.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Bobodent

Store at a temperature below 25°C.
Store in a closed, original package.
After opening the package, the medicine can be used for 12 months.
The medicine should be stored out of sight and out of reach of children.
The medicine should not be used after the expiration date stated on the package. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of in the sewage system or household waste containers. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Bobodent contains

• The active substance of the medicine is lidocaine hydrochloride monohydrate (Lidocaini hydrochloridum monohydricum). 100 grams of gel contain 0.5 g of lidocaine hydrochloride monohydrate.
• The other ingredients (excipients) are: dry chamomile extract, dry thyme extract, liquid sorbitol, non-crystallizing, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carbomer 5984, propylene glycol, disodium edetate, polysorbate 20, sodium hydroxide, 30% solution, purified water.

What Bobodent looks like and what the package contains

Bobodent is a yellow-brown gel with a characteristic odor.
One package of the medicine contains 10 g of gel.

Marketing authorization holder and manufacturer

“HASCO-LEK” Pharmaceutical Production Company S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
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Information about the medicine
phone: +48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet:

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