Bonjela Cool Mint gel

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Choline salicylate

Beschikbaar vanaf:

Reckitt Benckiser Healthcare (UK) Ltd

ATC-code:

N02BA03

INN (Algemene Internationale Benaming):

Choline salicylate

Dosering:

87mg/1gram

farmaceutische vorm:

Oromucosal gel

Toedieningsweg:

Oromucosal

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 12030100; GTIN: 5000158065727

Bijsluiter

choline salicylate, cetalkonium chloride
_MINT GEL_
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 COOL MINT GEL IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
BONJELA COOL MINT GEL
3. HOW TO USE BONJELA COOL MINT GEL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BONJELA COOL MINT GEL
6. CONTENTS OF THE PACK AND FURTHER
INFORMATION
1. WHAT BONJELA COOL MINT GEL IS AND
WHAT IT IS USED FOR
BONJELA COOL MINT GEL 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 Cool Mint Gel 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 COOL MINT GEL IS INTENDED FOR ADULTS
AND CHILDREN OVER THE AGE OF 16.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
BONJELA COOL MINT GEL
DO NOT GIVE TO CHILDREN OR ADOLESCENTS UNDER
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 ing

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bonjela Cool Mint Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
%w/w
Choline salicylate*
8.714
Cetalkonium chloride
0.010
*Added as choline salicylate
solution prepared from:
Choline bicarbonate solution
Salicylic acid
Excipients with known effect:
Ethanol 46.83 mg/dose
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 exceed the stated dose. Consult your doctor or
dentist
before use if you are in the first or second trimester of pregnancy or
when