Bonjela Original gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Choline salicylate

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

N02BA03

INN (International Name):

Choline salicylate

Dosage:

87mg/1gram

Pharmaceutical form:

Oromucosal gel

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12030100; GTIN: 5000158062139

Patient Information leaflet

INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
Always use this medicine exactly as described in
this leaflet or as your doctor or pharmacist have
told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more
information or advice.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel
better or if you feel worse after 7 days.
What is in this leaflet:
1. WHAT BONJELA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BONJELA
3. HOW TO USE BONJELA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BONJELA
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
1. WHAT BONJELA IS AND WHAT IT IS
US
ED FOR
BONJELA IS USED TO
•
relieve the pain and discomfort of common
mouth ulcers and cold sores.
• aid healing of sore spots and ulcers due to
dentures and braces.
bonjela is a clear, almost colourless gel, which is
applied to the inside of the mouth or gums. It
contains choline salicylate (a pain killer and
anti-inflammatory) which soothes sore areas in the
mouth and an antiseptic called cetalkonium
chloride, which kills bacteria and helps prevent
infection.
BONJELA IS INTENDED FOR ADULTS AND CHILDREN
OVER THE AGE OF 16.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE BONJELA
DO NOT GIVE TO CHILDREN OR ADOLESCENTS
UN
DER 16 YEARS OF AGE. THIS IS BECAUSE
THERE IS A POSSIBLE LINK BETWEEN SALICYLATES
AND REYE’S SYNDROME WHEN GIVEN TO
CHILDREN. REYE’S SYNDROME IS A VERY RARE
DISEASE WHICH AFFECTS THE BRAIN AND LIVER
AND CAN BE FATAL.
DO NOT USE IF YOU ARE
• suffering from a stomach ulcer
• allergic to salicylates, Asprin or other NSAIDs
(e.g. ibuprofen), or to any other ingredients in this
product (see section 6)
WARNINGS AND PRECAUTIONS
This product contains salicylates. Talk to your
doctor before taking this product with Aspirin or
other salicy

Summary of Product characteristics

OBJECT 1
BONJELA
Summary of Product Characteristics Updated 20-Apr-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
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
Excipients with known effect:
Ethanol
For the full list of excipients, see section 6.1.
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 to the oral mucosa.
Adults and children over the age of 16: Using a clean finger massage
approximately half an inch of the
gel onto the sore area, not more than once every 3hours.
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 a possible
association between salicylates and Reye's syndrome when given to
children. Reye's 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.
Not to be used in patients with hypersensitivity to salicylates,
Acetylsalicylic Acid (Aspirin) or other
NSAIDs, or to any of the excipients.
Salicylates and Acetylsalicylic acid: doses > 100 mg/day during the
third trimester of pregnancy
4.4 Special warnings and precautions for use
Label warnings: Do not exce