Benzydamine 0.15% oromucosal spray sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benzydamine hydrochloride

Available from:

Advanz Pharma

ATC code:

A01AD02

INN (International Name):

Benzydamine hydrochloride

Dosage:

1.5mg/1ml

Pharmaceutical form:

Spray

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12030100; GTIN: 5060064791219

Summary of Product characteristics

OBJECT 1
BENZYDAMINE 0.15%W/V OROMUCOSAL SPRAY
Summary of Product Characteristics Updated 21-Feb-2017 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Oroeze Spray 0.15% w/v Oromucosal Spray
Benzydamine 0.15% w/v Oromucosal Spray
2. Qualitative and quantitative composition
Benzydamine hydrochloride 0.15% w/v.
Each spray contains 262.5 micrograms of 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
Oromucosal spray.
A clear solution with an odour of peppermint in a multidose spray
container fitted with a metering pump
and nozzle.
4. Clinical particulars
4.1 Therapeutic indications
Oroeze Spray is a locally acting analgesic and anti-inflammatory
treatment for the throat and mouth.
It is especially useful for the relief of pain in traumatic conditions
such as following tonsillectomy or the
use of a naso-gastric tube; dental surgery.
4.2 Posology and method of administration
Posology
ADULTS AND ELDERLY: 4 to 8 sprays, 1½ - 3 hourly.
Paediatric population
CHILDREN (6-12): 4 sprays, 1½ - 3 hourly.
CHILDREN UNDER 6: One spray to be administered per 4 kg body weight,
up to a maximum of 4
sprays, 1½ - 3 hourly.
Because of the small amount of drug applied, elderly patients can
receive the same dose as adults.
Method of administration
Oromucosal administration.
4.3 Contraindications
Hypersensitivity to active substance or to any of the excipients,
listed in section 6.1
4.4 Special warnings and precautions for use
Avoid contact with the eyes.
Oroeze Spray/Benzydamine 0.15% w/v Oromucosal Spray contains methyl
parahydroxybenzoate which
may cause allergic reactions (possibly delayed). It also contains
propylene glycol which may cause skin
irritation.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
Oroeze Spray/Benzydamine