מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lidocaine hydrochloride; Aminoacridine hydrochloride
Dendron Brands Ltd
Lidocaine hydrochloride; Aminoacridine hydrochloride
6.6mg/1gram ; 500microgram/1gram
Oromucosal gel
Oromucosal; Gingival
No Controlled Drug Status
Valid as a prescribable product
BNF: 12030100; GTIN: 5011784030126
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 קרא את המסמך השלם