Bonjela Oromucosal GelCholine Salicylate 8.714%Cetalkonium Chloride 0.010%

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Choline salicylate; Cetalkonium chloride

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

N02BA; N02BA03

INN (International Name):

Choline salicylate; Cetalkonium chloride

Dosage:

8.714%w/w +0.010 percent weight/weight

Pharmaceutical form:

Oromucosal gel

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Salicylic acid and derivatives; choline salicylate

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

bonjela
Oromucosal Gel
Choline salicylate 8.714%
Cetalkonium chloride 0.010%
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Bonjela carefully to get the best
results from it. Keep this leaflet. You may need to read it again. Ask
your pharmacist if you need more
information or advice. You must contact a doctor if your symptoms
worsen or do not improve after 7 days.
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:
1.
What Bonjela is and what it is used for
2.
Before you use Bonjela
3.
How to use Bonjela
4.
Possible side effects
5.
How to store Bonjela
6.
Further information
1. WHAT BONJELA IS AND WHAT IT IS USED FOR
Bonjela is a clear gel, which is applied to the inside of the mouth or
gums. It contains choline salicylate (a pain killer
and anti-inflammatory) which soothes the sore areas in the mouth, and
antiseptic called cetalkonium chloride, which
kills bacteria and helps prevent infection. Bonjela can be used to
relieve pain and reduce inflammation and help fight
infection in infant teething, mouth ulcers, cold sores, and sore spots
due to dentures in adults and orthodontic
devices in children.
2. BEFORE YOU USE BONJELA
DO NOT USE BONJELA:

if you are allergic (hypersensitive) to the active ingredients or any
of the ingredients listed in section 6.

if you are currently taking aspirin or other salicylate, except under
direction of a doctor

in children under 4 months

if you have active or a history of recurrent stomach ulcer

if you are currently suffering from chicken pox or flu particularly in
children and adolescents under 16 years of
age
TAKE SPECIAL CARE WITH BONJELA

if you are pregnant or breastfeeding, please consult your doctor
before use

if there is no improvement after 7 days, consult your doctor

especially i

Summary of Product characteristics

Health Products Regulatory Authority
23 July 2021
CRN009ZYF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonjela Oromucosal GelCholine Salicylate 8.714%Cetalkonium Chloride
0.010%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
% W/W
Choline salicylate
Cetalkonium chloride
8.714
0.010
Excipient(s) with known effect:
Ethanol
Present at a level of 33.45 % w/w
d-Limonene, anisyl alcohol and linalool (contained in trace amounts in
fragrances of star anise oil)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal gel
Clear, colourless gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of pain and discomfort of common mouth ulcers, cold
sores, denture sore spots, infant teething and mouth ulcers,
and sore spots due to orthodontic devises in children.
To aid healing of sore spots and ulcers due to dentures in adults and
orthodontic devices in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: Using a clean finger, massage approximately one centimetre of
the gel onto the sore area, not more than once every 3
hours.
Children (from four months): Using a clean finger, massage a pea size
amount of gel onto the sore area, not more than once
every 3 hours. Do not apply more than six doses in any 24 hour period.
Not suitable for infants under four months.
Orthodontic devices: Apply to the sore area as described above, not
more than once every 3 hours.
Denture irritation: Apply and leave at least 30 minutes before
re-insertion of the dentures. Do not apply this product directly
to the dentures.
Do not exceed the stated dose.
If symptoms do not improve after 7 days seek medical advice (see
section 4.4).
Older people:
There is no indication that dosage need be modified in the elderly.
Health Products Regulatory Authority
23 July 2021
CRN009ZYF
Page 2 of 5
By topical application to the oral mucosa.
4.3 CONTRAINDICATIONS
Not to be used in patients with hypersensitivity to salicylates,
aspirin or other NSAIDs, to cetylpyridium ch