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BLUE DISCLOSING TABLETS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Blue Disclosing Tablets
Boots Advanced Disclosing Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Patent Blue V HSE

3.

3 mg

PHARMACEUTICAL FORM
Tablet

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
As a disclosing agent and aid to teaching correct teeth cleaning technique.

4.2.

Posology and Method of Administration
These tablets can be used by adults and children over 6 years of age.
• One tablet should be thoroughly chewed to spread saliva to all tooth and
gum surfaces
with tongue.
• Rinse mouth out with water. Areas of plaque will be stained blue.
• DO NOT SWALLOW THE TABLET.
• Brush teeth until the blue stain is removed.
Children should be supervised when using these tablets.
It is advisable to use Disclosing Tablets at night because mouth may remain
coloured for several hours.

If accidentally splashed on clothing or towel, wash with a little soap and
plenty of water until the stain is removed.

4.3.

Contra-Indications
Disclosing Tablets should not be administered to individuals with a known
hyper-sensitivity / allergy to Patent Blue.

4.4.

Special Warnings and Special Precautions for Use
No other known side-effects. Patent Blue V is a widely used food dye.

4.5. Interactions with other Medicinal Products and other Forms of
Interaction
None known by this route used and in the quantity used.

4.6.

Pregnancy and Lactation
Patent Blue V and erytbrosine are widely used food dyes, no effects on
pregnancy and lactation are known.

4.7.

Effects on Ability to Drive and Use Machines
None

4.8.

Undesirable Effects
None known by this route used and in the quantity used.

4.9.

Overdose
Overdose is extremely unlikely, if not impossible, due to the methods of
administration. In the unlikely event that it does occur, seek medical advice.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
The active constituent is patent blue V El 31 and is well established as a
disclosing agent of dental plaque and other debris.

5.2.

Pharmacokinetic Properties
Not applicable

5.3.

Pre-clinical Safety Data
No formal pre-clinical safety testing of this combination of active ingredients
has been carried out.
No tests have been carried out on the effects of this combination on the foetus,
pregnant or lactating female, which are therefore unknown.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Dextrose Monohydrate
Talc
Magnesium stearate
Trusil Blackcurrant
Powder Flavour H9965
Opaseal (dry wt approx)*
Talc (approx)*
* in varnish coat of tablet

6.2.

Incompatibilities
None known

6.3.

Shelf Life
36 months

6.4.

Special Precautions for Storage
None required.

6.5.

Nature and Content of Container
Strip packs of 12 tablets each, in printed carton with leaflet
(Pack size = 12 Shelf life = 36 months)
and
One strip packs of 500 tablets, in clear cellophane in a polythene bag. (Pack
size = 500 Shelf life = 36 months)

6.6.

Instructions for Use, Handling and Disposal
Not applicable

7.

Marketing Authorisation Holder
Synpart Ltd
8 Hampstead Gate
1A Frognal
London NW3 6AL

8.

MARKETING AUTHORISATION NUMBER
PL 1424/0014

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
First authorisation

29/01/82

Approval Last Renewal

10

19/08/97

DATE OF REVISION OF THE TEXT
21/11/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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