Bonjela

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

CHOLINE SALICYLATE, CETALKONIUM CHLORIDE

Saatavilla:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC-koodi:

N02BA03

INN (Kansainvälinen yleisnimi):

CETALKONIUM CHLORIDE 0.01 % (W/W) CHOLINE SALICYLATE 8.714 % (W/W)

Lääkemuoto:

OROMUCOSAL GEL

Koostumus:

CETALKONIUM CHLORIDE 0.01 % (W/W) CHOLINE SALICYLATE 8.714 % (W/W)

Prescription tyyppi:

OTC

Terapeuttinen alue:

ANALGESICS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-04-24

Pakkausseloste

change to "25
°
C" from "30
°
C"

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bonjela
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
%w/w
Specification
Choline salicylate*
8.7 14
Reckitt Benckiser
Cetalkonium chloride
0.0 10
Reckitt Benckiser
*Added as choline salicylate
solution prepared from:
Choline bicarbonate solution
Reckitt Benckiser
Salicylic acid
Ph.Eur
3.
PHARMACEUTICAL FORM
Gel.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of pain, discomfort and inflammation caused by common
mouth ulcers,
cold sores, denture and sore spots, as well as mouth ulcers, and sore
spots due
to orthodontic devices. To help to fight minor mouth infection and aid
healing
of sore spots and ulcers due to dentures and orthodontic devices.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
By topical application of the oral mucosa
Adults and children over the age of 16: Using a clean finger message
approximately half an
an inch of the gel onto the sore area, not more than once every 3
hours.
There is no indication that dosage need be modified in the elderly.
Denture irritation: Apply and leave at least 30 minutes before
reinsertion of the dentures. Do
not apply this product directly to the dentures.
4.3.
CONTRAINDICATIONS
Not to be used in children and adolescents under the age of 16. This
is because there is
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possible association between salicylates and Reye’s syndrome when
given to children.
Reye ‘syndrome is a very rare disease which affects the brain and
liver and can be fatal.
Not to be used in patients suffering from active peptic ulceration or
known to be allergic to
salicylates.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Label warnings:
Do not exceed the stated dose. If symptoms persist for more
than seven days consult your doctor or dentist. Keep out of
the reach of children. Contains ethanol.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Salicylates may enhance the effect of anticoagulants and inhibit the
action of uricosurics.
4.6.
PREGNANCY AND LACTA