Medijel oromucosal gelLidocaine hydrochloride 0.66% w/wAminoacridine hydrochloride 0.05% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aminacrine hydrochloride; Lignocaine hydrochloride

Available from:

Phoenix Labs

ATC code:

D08AA; N01BB52

INN (International Name):

Aminacrine hydrochloride; Lignocaine hydrochloride

Dosage:

0.66 %w/w +0.05 percent weight/weight

Pharmaceutical form:

Oromucosal gel

Therapeutic area:

Acridine derivatives; lidocaine, combinations

Authorization status:

Marketed

Authorization date:

1984-04-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Medijel oromucosal gel
Lidocaine hydrochloride 0.66% w/w
Aminoacridine hydrochloride 0.05% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING MEDIJEL
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine as described in this leaflet or as your
doctor, pharmacist, nurse or
dentist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist,
nurse or dentist. This includes
any possible side
effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1. What Medijel is and what it is used for
2. What you need to know before you use Medijel
3. How to use Medijel
4. Possible side effects
5. How to store Medijel
6. Contents of the pack and other information
1. WHAT IS MEDIJEL AND WHAT IS IT USED FOR
Medijel contains two active substances, Lidocaine Hydrochloride and
Aminoacridine
Hydrochloride. Lidocaine Hydrochloride is one of the most widely used
local anaesthetics.
Aminoacridine Hydrochloride is a disinfectant and is used to treat
local infections of the
mouth.
Medijel is used to provide quick effective relief from pain of common
mouth ulcers, soreness
of gums and denture rubbing. Medijel is used in adults and children
from 6 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEDIJEL
DO NOT TAKE MEDIJEL IF
you are allergic to Lidocaine or any of the excipients in this
medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
If symptoms persist for more than 7 days, consult your doctor or
dentist.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children under 6 years of age.
PREGNANCY AND LACTATION
The safety of Medijel during pregnancy and lactation has not been
established, but is
considered not to constitute a hazard.
DRIVING AND USING MACHINES
Medijel has no influence on the ability to drive and use

Summary of Product characteristics

Health Products Regulatory Authority
05 February 2021
CRN00C4NX
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medijel oromucosal gelLidocaine hydrochloride 0.66% w/wAminoacridine
hydrochloride 0.05% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine hydrochloride 0.66 % w/w.
Aminoacridine hydrochloride 0.05 % w/w.
Excipients: also contains 32 % w/w sucrose and 9.0 % w/w ethanol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal gel
Soft green, slightly opalescent gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the quick and effective relief from the pain of common mouth
ulcers, soreness of gums and denture rubbing.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The gel should be applied directly to the affected area(s) with a
clean finger or small pad of cotton wool.
Adults and adolescents over 12 years of age: Massage a small (up to 1
cm diameter) pea-sized amount of gel (approximately
300 mg) onto the affected area. (300 mg of gel contains 2 mg lidocaine
hydrochloride and 0.15 mg aminoacridine
hydrochloride).
If necessary application may be repeated after 20 minutes and then at
three hourly intervals up to a maximum of eight times
daily (The total amount of lidocaine is 16mg following 8
applications).
Children (from 6 years): Massage a small (up to 1 cm diameter)
pea-sized amount of gel onto the affected area, no more
frequently than every three hours and up to a maximum of six
applications daily (The total amount of lidocaine is 12mg
following 6 applications).
Not suitable for children under 6 years.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist for more than 7 days consult your doctor or
dentist.
Contains sucrose. Patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
Health Products Regulatory Authority
05 February 20