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:

D.D.D. Limited

ATC code:

D04AB; D04AB01; D08AA

INN (International Name):

Aminacrine hydrochloride; Lignocaine hydrochloride

Dosage:

0.66 %w/w +0.05 percent weight/weight

Pharmaceutical form:

Oromucosal gel

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anesthetics for topical use; lidocaine; Acridine derivatives

Authorization status:

Marketed

Authorization date:

1984-04-30

Patient Information leaflet

DDD Profile ‘C’
220mm x 160mm 160mm x 22mm
Text free area
Profile C 220 x 160
19/11/02, 4:22 pm
1
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
4. Possible side effects
2. What you need to know before you use Medijel
5. How to store Medijel
3. How to use 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 machines.
Medijel contains sucros

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medijel oromucosal gel
Lidocaine hydrochloride 0.66% w/w
Aminoacridine 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.
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