Luborant
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Luborant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.8ml contains 0.003mg of Sodium Fluoride BP
Nipasept Sodium 1.600mg per 0.8ml contains mixture of sodium hydroxybenzoates which is comprised of sodium p-hydroxybenzoate max. 0.064mg, Sodium Methyl 4-Hydroxybenzoate (E 219) 1.088mg to 1.216mg per 0.8ml; Sodium Ethyl 4-hydroxybenzoate (E 215) 0.208mg to 0.288mg per 0.8ml and Sodium Propyl 4-hydroxybenzoate (E 217) 0.128mg to 0.208mg per 0.8ml.
3 PHARMACEUTICAL FORM
Oromucosal solution.
Pink viscous liquid with an odour of orange.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Saliva deficiency. Luborant is a saliva substitute for use in the management of conditions involving dryness of the mouth. These include xerostomia following radiotherapy or during treatment with anti-depressants or anxiolytics, and other conditions involving a decrease in production of saliva, such as Sjogren's disease.
4.2 Posology and method of administration
Luborant is for oral use.
Adults, including the elderly: Two or three single applications orally up to four times daily or as directed by the physician. The average dose per application is 0.8ml of the product.
4.3 Contraindications
Hypersensitivity to sodium fluoride.
4.4 Special warnings and precautions for use
Mottling of dental enamel has occurred in association with use of Sodium Fluoride in larger amounts than those contained in the dosage recommended for Luborant.
Do not exceed the stated dose.
The contents should be discarded if not used before a date one month after the date of opening.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
There is no known or perceived hazard for use in pregnancy or lactation at the dosage recommended.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
None stated
4.9 Overdose
There are no reports of overdosage. Serious symptoms are unlikely following acute overdosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Salts normally found in saliva. Electrolyte concentration close to whole saliva. No precise pharmacological activity other than electrolyte replacement in oral cavity.
Sodium fluoride: used for the prophylaxis of dental caries, it renders the dentine and enamel of the teeth more resistant to acid.
5.2 Pharmacokinetic properties
Luborant is applied topically to the oral mucous membrane for its local effects within the oral cavity. Although the individual constituent salts may undergo gastro-intestinal absorption, their concentrations in the daily dosages recommended for Luborant represent only a small percentage of the recommended daily human requirements of these salts and cannot, therefore, be expected to influence normal fluid or electrolyte balance.
5.3 Preclinical safety data
No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Potassium Chloride Magnesium Chloride hexahydrate Calcium Chloride dihydrate Potassium Phosphate Dibasic Potassium Phosphate Monobasic Nipasept Sodium
Sorbitol solution 70% Non-crystallizing Sodium carboxymethyl cellulose Orange Flavour IFF VX 1997 Carmoisine Red CI 14720 E122 Hydrochloric Acid Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life
Unopened: 24 months Opened: 1 month
6.4 Special precautions for storage
Keep in outer carton.
Do not store above 25°C.
6.5 Nature and contents of container
60ml high density polyethylene bottle with a pump action applicator packed in cardboard cartons to contain 1 x 60ml and 6 x 60ml bottles.
6.6 Special precautions for disposal
Contents to be discarded if not used before a date one month after the date of opening.
7 MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd
Capital House
85 King William Street
London
EC4N 7BL
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 12762/0227
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/01/1990
10 DATE OF REVISION OF THE TEXT
21/03/2014