Medijel oromucosal gel

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Lidocaine hydrochloride; Aminoacridine hydrochloride

Verfügbar ab:

Dendron Brands Ltd

INN (Internationale Bezeichnung):

Lidocaine hydrochloride; Aminoacridine hydrochloride

Dosierung:

6.6mg/1gram ; 500microgram/1gram

Darreichungsform:

Oromucosal gel

Verabreichungsweg:

Oromucosal; Gingival

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 12030100; GTIN: 5011784030126

Fachinformation

OBJECT 1
MEDIJEL GEL
Summary of Product Characteristics Updated 21-Mar-2016 | DDD Limited
1. Name of the medicinal product
MEDIJEL GEL
2. Qualitative and quantitative composition
Lidocaine Hydrochloride BP
0.66% w/w
Aminoacridine Hydrochloride BP 1968
0.05% w/w
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 precautions for use
If symptoms persist longer than 7 days following the use of the
product a doctor or dentist should be
consulted.
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 Effects on 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 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
aske