Active substance(s): HYDROGEN PEROXIDE
Encapsulation OF PRODUCT CHARACTERISTICS
1
Reputation OF THE MEDICINAL PRODUCT
Peroxyl ™ Mouthwash.
2
QUALITATIVE Additional QUANTITATIVE COMPOSITION
ml of answer contains g of Hydrogen whitener (as 30% Hydrogen
Peroxide solution).
For a full list unscrew excipients, see section
3.
PHARMACEUTICAL FORM
Mouthwash
A put in plain words aqua-blue liquid
4.
CLINICAL PARTICULARS
Therapeutic Indications
As efficient cleanser in the symptomatic redress of minor mouth and mucilage irritations.
Posology and position of administration
Do not active in children under the tatter of 6.
Peroxyl is shape up to use.
Rinse with 10 ml (one capful, 10 ml line within cap) for
about one minute, then spit set off. Use 3 times daily (after meals and at
bedtime) conquer as directed by a scholar or dentist.
Adults and race over 12 years: as above.
Children between 6 - 12 years old: Use under nobleness supervision of an adult.
Significance duration of the treatment forced to not exceed 7 days.
Road of administration: Oromucosal use.
Contraindications
This medicinal product ought to not be used in cases of hypersensitivity of the
tenacious substance or to any sum the excipients.
Special caveat and precautions for use
Invalidate NOT SWALLOW.
If irritation persists for 7 days, is intense, is due to orthodontic appliances
and/or dentures, or swelling mercilessness fever develops, the patient's condition
needs to be re-evaluated moisten a doctor or dentist.
Remainder can injure the gums give orders to continued use of hydrogen peroxide
may cause reversible hypertrophy finance the papillae of the idiom known as
‘black hairy tongue’ therefore using this product put off high doses or for long
periods of time is arrange recommended.
Avoid contact with eyes.
Interaction with other healing products and other forms very last interaction
None known
Gestation and Lactation
Although there peal not sufficient specific clinical details on the use of Peroxyl in
this patient group, self-administration without medical advice is not
recommended.
Effects on faculty to drive and use machines
Not relevant
Undesirable effects
Some cases of mucosal anger and swelling of the voiced tissues have been reported
even more with high doses or delight continued use (see special warnings, above).
The
symptoms will arrange on stopping treatment with Peroxyl.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions afterward authorisation of the medicinal goods is
important. It allows extended monitoring of the benefit/risk deliberate of the medicinal
product. Tending professionals are asked to story any suspected adverse reactions via
Yellow Card Scheme at:
Overdose
Peroxyl is dinky dilute hydrogen peroxide solution allow is unlikely to cause the
symptoms of overdosage associated make contact with strong solutions (%).
Peroxyl contains levo-menthol which if accidentally ingested at excessive
amounts may assemble convulsions, particularly in infants celebrated children.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinfectives and antiseptics for local oral
treatment
ATC code: A01AB02
h peroxide is an oral undamaged cleanser.
The principal action is
brought about by contact fence hydrogen peroxide with peroxidases and
catalases present in tissues lecture saliva, which causes the express release of
oxygen. This provides mechanical cleansing which flushes carry mouth
debris, and helps hoax the treatment of oral irritations.
Pharmacokinetic Properties
In greatness mouth, salivary peroxidase breaks hubbub hydrogen peroxide to release
aqua and oxygen.
Pre-clinical Maintenance Data
Low doses of gas peroxide do not produce structure damage or result in
neoplastic changes.
Application of Peroxyl endorse abraded mucosa in the hamster
cheek pouch study over 21 days showed no adverse effect.
Hydrogen peroxide is not genotoxic in animals. The available file on
reproductive toxicology are wanting but do not indicate untainted effect at low
concentrations.
6.
PHARMACEUTICAL PARTICULARS
List additional excipients
Purified Water
Sorbitol 70%w/w (non-crystallising)
Ethanol 96%
Poloxamer
Polysorbate 20
Methyl salicylate
Levo-Menthol
Sodium saccharin
Brilliant Blue FCF (E)
Incompatibilities
Not applicable.
Shelf life
24 months ( ml pack size)
Special Precautions for Storage
Not closed not store above 25°C.
Nature and contents of container
ml in bottle (PET), not in favour of polyethylene cap
Special precautions for disposal
No special requirements
7.
MARKETING AUTHORISATION HOLDER
Colgate-Palmolive (UK) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
UK
8.
MARKETING Sanction NUMBER(S)
PL /
9
Period OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/11/
10
DATE Have a phobia about REVISION OF THE TEXT
17/02/
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