Benzydamine 0.15% mouthwash sugar free

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Benzydamine hydrochloride

Tilgængelig fra:

Advanz Pharma

ATC-kode:

A01AD02

INN (International Name):

Benzydamine hydrochloride

Dosering:

1.5mg/1ml

Lægemiddelform:

Mouthwash

Indgivelsesvej:

Oromucosal

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 12030100; GTIN: 5060064792377

Produktets egenskaber

OBJECT 1
BENZYDAMINE 0.15% W/V MOUTHWASH
Summary of Product Characteristics Updated 12-Dec-2016 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Oroeze 0.15% w/v Mouthwash
Benzydamine 0.15% w/v Mouthwash
2. Qualitative and quantitative composition
Benzydamine hydrochloride 0.15% w/v.
Each 15ml dose contains 22.5mg benzydamine hydrochloride.
Excipients with known effect
Ethanol (96%) 8.1%w/v
Methyl parahydroxybenzoate 0.1 %w/v
It also contains propylene glycol.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Mouthwash.
A clear green solution with an odour of peppermint
4. Clinical particulars
4.1 Therapeutic indications
Oroeze/Benzydamine 0.15% w/v Mouthwash is indicated in adults and
children aged 13 years and over.
A locally acting analgesic and anti-inflammatory treatment for the
relief of painful inflammatory
conditions of the mouth and throat including:
Traumatic conditions: Pharyngitis following tonsillectomy or the use
of a naso-gastric tube.
Inflammatory conditions: Pharyngitis, aphthous ulcers and oral
ulceration due to radiation therapy.
Dentistry: For use after dental operations.
4.2 Posology and method of administration
Posology
PAEDIATRIC POPULATION
Oroeze/Benzydamine 0.15% w/v Mouthwash should not be used in children
aged 12 years or under.
ADULTS AND ELDERLY: Rinse or gargle with 15 ml (approximately 1
tablespoonful) every 1½ to 3
hours as required for pain relief.
The solution should be expelled from the mouth after use.
Oroeze/Benzydamine 0.15% w/v Mouthwash should generally be used
undiluted, but if 'stinging' occurs
the rinse may be diluted with water.
Uninterrupted treatment should not exceed seven days, except under
medical supervision.
Method of administration:
Oromucosal administration.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4 Special warnings and precautions for use
Oroeze/Benzydamine 0.15% w/v Mouthwash should generally be used
undiluted, but i