Medijel Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMINOACRIDINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

Available from:

DDD Limited 94 Rickmansworth Road, Watford Herts WD18 7JJ, United Kingdom

ATC code:

N01BB52

INN (International Name):

AMINOACRIDINE HYDROCHLORIDE 0.05 % (W/W) LIDOCAINE HYDROCHLORIDE 0.66 % (W/W)

Pharmaceutical form:

ORAL GEL

Composition:

AMINOACRIDINE HYDROCHLORIDE 0.05 % (W/W) LIDOCAINE HYDROCHLORIDE 0.66 % (W/W)

Prescription type:

OTC

Therapeutic area:

ANESTHETICS

Authorization status:

Suspended

Authorization date:

2006-03-28

Patient Information leaflet

CND 0739
BN MFR
EXP
The safety of Medijel Gel during pregnancy or lactation has not been
established. Pregnant and breast-feeding mothers should
speak to a doctor or pharmacist before using this product. Contains
small amounts of ethanol (alcohol), less than 100mg per dose.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking Medijel Gel.
CONTAINS SUCROSE. Oral Gel ACTIVE INGREDIENTS: Lidocaine Hydrochloride
0.66% w/w, Aminoacridine Hydrochloride 0.05% w/w.
Also contains Sucrose, Ethanol (96%), Carbomer, Diisopropanolamine 90%
Aqueous, Hydroxypolyethoxydodecane,
Peppermint Oil, Ethyl Vanillin, Saccharin Sodium, Glycerol, Purified
Water.
DO NOT USE AFTER THE EXPIRY DATE STATED ON THE PACK.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
PL 0133/5000R MA 137/00301
Made by the MA holder DDD Ltd., Watford, Herts. WD18 7JJ, UK. Text
revised April 2015.
_ORAL GEL FOR COMMON MOUTH ULCERS_
_ORAL GEL FOR COMMON MOUTH ULCERS_
_ORAL GEL FOR COMMON MOUTH ULCERS_
_ORAL GEL FOR COMMON MOUTH ULCERS_
_GEL _
_GEL _
_GEL _
If symptoms persist for more than 7 days, consult your doctor or
dentist. SIDE EFFECTS: If you
experience any side effects, consult your doctor or pharmacist. You
can also report side effects
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Do
not use Medijel Gel if you
are allergic to Lidocaine or any of the other ingredients.
INSTRUCTIONS FOR USE: The local anaesthetic
action of Medijel Gel provides fast relief from common mouth ulcers,
sore gums and denture
rubbing. Apply a small quantity of Medijel Gel on a clean fingertip
directly to the painful area. Repeat
the application every 20 minutes if necessary. Use only as directed.
Do not store above 25°C.
LIDOCAINE HYDROCHLORIDE
AMINOACRIDINE HYDROCHLORIDE
_FAST EFFECTIVE RELIEF _
_FROM COMMON MOUTH ULCERS,_
_SORE GUMS & DENTURE-RUBBING_
_FAST EFFECTIVE RELIEF _
_FROM COMMON MOUTH ULCERS,_
_SORE GUMS & DENTURE-RUBBING_
_FAST EFFECTIVE RELIEF _
_FROM COMMON MOUTH ULCERS

Summary of Product characteristics

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MEDIJEL GEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride
0.66% w/w
Aminoacridine Hydrochloride
0.05% w/w
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Oral Gel
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The quick, effective relief from the pain of common mouth ulcers,
soreness of gums and
denture rubbing. Medijel Gel is administered directly onto the
affected area with a clean finger
or small pad of cotton wool.
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. If necessary application may be repeated after 20
minutes.
Each dose is approximately 300mg, i.e. 2mg of Lidocaine Hydrochloride
and 0.15mg of
Aminoacridine Hydrochloride.
Medijel Gel can be used as directed for adults and children.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any other of the
ingredients.
Contains sucrose. Patients with rare hereditary problems of fructose
intolerance, glucose-
galactose malabsorption or sucrase-isomaltase insufficiency should not
take this medicine.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
If symptoms persist longer than 7 days following the use of the
product a doctor or dentist
should be consulted.
Page 2 of 4
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None stated.
4.6
PREGNANCY AND LACTATION
The safety of Medijel Gel during pregnancy and lactation has not been
established, but is
considered not to constitute a hazard.
4.7
EFFECT AND ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8
UNDESIRABLE EFFECTS
Hypersensitivity reactions to lidocaine have been reported on rare
occasions.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal product.
Healthcare
professionals
are
asked
to
r