DICLODENT Oromucosal solution (Mouthwash) (2016)
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Περιεχόμενα
Name of the medicinal product
Diclodent 0.74 mg/ml Mouthwash (Oromucosal Solution). Diclofenac 0.74 mg/ml Mouthwash.
Qualitative and quantitative composition
100 ml of the solution contains: Active substance: 0.074 %w/v Diclofenac free acid. Excipients with known effect: Sorbitol (E420) 50% w/v Sodium Benzoate (E211) 1% w/v Ponceau Red E124 0.005% w/v For a ...
Pharmaceutical form
Oromucosal solution (Mouthwash).
Therapeutic indications
Diclodent/diclofenac mouthwash can be used for the symptomatic treatment of local painful inflammatory diseases of the oral cavity and the throat and/or following dental treatment or dental extraction. ...
Posology and method of administration
Posology The recommended dose is ⅔ rinses or gargles per day with 15 ml of oromucosal solution, undiluted or diluted in a little water for 7 days. For the treatment of mucositis of the oral cavity caused ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to substances that are chemically closely correlated to them, to acetylsalicylic acid or to other non-steroidal ...
Special warnings and precautions for use
Eventual involuntary swallowing of a dose of solution used for the rinses or gargling causes no damage to patient since it is equivalent to one fifth/sixth of the dose recommended for systemic administration. ...
Interaction with other medicinal products and other forms of interaction
No negative interactions have been reported with other drugs commonly used in the patient treatment.
Pregnancy and lactation
Diclodent/diclofenac mouthwash should not be used in pregnancy or lactation unless considered essential by the physician. There are no adequate and well-controlled studies to support its use.
Effects on ability to drive and use machines
Diclofenac mouthwash has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Although no undesirable effects that could definitely be attributed to Diclofenac mouthwash were observed during the clinical trials performed with the product, it is possible, particularly in prolonged ...
Overdose
No cases of overdose with Diclofenac mouthwash have been reported. Diclofenac mouthwash as Diclodent/diclofenac mouthwash has not been marketed.
Pharmacodynamic properties
Pharmacotherapeutic group: 6.1.1 Medicinal product for application on mouth and oropharynges Topical application ATC code: A01AD11 Various When administered systemically, diclofenac has analgesic, antipyretic ...
Pharmacokinetic properties
Spectrofluoroscopy has shown that diclofenac concentrates in the oral mucosa and then is gradually absorbed, thus producing haematic concentrations that are very low, and insufficient to express pharmacological ...
Preclinical safety data
LD50 per os Mouse 1300 Kg after 48 hour 231 mg/kg after 15 days Rat 1500 kg after 48 hour 233 mg/kg after 15 days Guinea Pig 1250 mg/kg after 48 hour Three months of oral treatment in rats with ...
List of excipients
Sorbitol liquid non crystallising (E420) Choline Sodium benzoate (E211) Disodium edetate Acesulfame potassium (E950) Peppermint oil Peach flavour Ponceau red E124 Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in the original package.
Nature and contents of container
200ml amber (type III) glass bottle with child resistance polypropylene closure.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Morningside Healthcare Ltd, 115 Narborough Road, Leicester, LE3 0PA, UK
Marketing authorization number(s)
PL 20117/0112
Date of first authorization / renewal of the authorization
03/03/2016
Date of revision of the text
12/05/2016
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