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DURAPHAT 2800PPM FLUORIDE TOOTHPASTE

Active substance(s): SODIUM FLUORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
DURAPHAT 2800 ppm FLUORIDE TOOTHPASTE

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Fluoride 0.619 % w/w (2800 ppm F)
For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM

Toothpaste
Smooth White Paste
For dental use

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the prevention and treatment of dental caries (coronal and root) in adults
and children over 10 years.

4.2

Posology and method of administration

Posology
Children under 10 years old: not recommended
Adults and children over 10 years old: Use daily instead of the normal toothpaste.
The usual dosage is to apply a 1 cm line of paste across the head of a toothbrush and
brush the teeth thoroughly for one minute morning and evening. Spit out after use; for
best results do not drink or rinse for 30 minutes.

Elderly: use as for adults.
Method of administration
For dental use

4.3

Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients
Individuals with known sensitivities should consult their dentist before using
Not to be used in children under 10 years old

4.4.

Special warnings and precautions for use
Not to be swallowed.

4.5.

Interactions with other medicinal products and other forms of interaction
None known.

4.6

Fertility, pregnancy and lactation
Epidemiological studies in humans indicate that fluoride has no adverse effects in
pregnancy or on the health of the foetus or newborn child.
No effects during pregnancy are anticipated, since systemic exposure to Sodium
Fluoride is negligible. Duraphat 2800 Toothpaste can be used during pregnancy.
No effects on the breastfed newborn/infant are anticipated since the systemic
exposure of the breast-feeding woman to Sodium Fluoride is negligible. Duraphat
2800 Toothpaste can be used during breast-feeding.

4.7.

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
When used as recommended there are no side effects.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms:
In very high doses, fluoride can have an acute toxic effect. Doses of several
milligrams of fluoride per kg of body weight may cause nausea, vomiting, and
diarrhoea. Tetany and convulsion can occur, as well as cardiovascular disorders.
Increased risk of bone fracture and skeletal fluorosis (stiffness of joints and skeletal
deformities) will only be observed in cases of very high chronic intake of fluoride.
Management:
Treatment and management should be symptomatic.
In case of mild gastrointestinal overdose symptoms a small glass of milk to drink
should be given to bind fluoride ion.
It should be noted that gut decontamination is contraindicated. Charcoal is of no
benefit.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: caries prophylactic agents
ATC code: A01AA01
This product is a toothpaste in which the active ingredient is Sodium Fluoride present
at a level of 0.619% which corresponds to 280 mg fluoride per 100 g paste.
Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting
demineralisation and promoting remineralisation of the tooth surface. It is effective
on both enamel and exposed dentine.

5.2.

Pharmacokinetic Properties
This product is not intended to be swallowed and therefore only minimal
systemic exposure is expected.

5.3

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies
of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential
and toxicity to reproduction and development.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycerol (E 422)
Purified Water
Sorbitol, liquid (non-crystallizing) (E 420)
Silicas
Polyethylene glycol 600
Sodium lauryl sulphate
Sodium carboxymethylcellulose (E 467)
Mint Flavour
Titanium dioxide (E 171)
Sodium saccharin (E954)

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf life
3 years

6.4.

Special precautions for storage
o
Do not store above 25 C.

6.5

Nature and contents of container
75 ml polyethylene/aluminium/polyethylene laminated tube with a
polypropylene screw closure. Pack sizes: 1 x 75ml tube or 2 x 75ml tubes.

6.6

Special precautions for disposal and other handling
Not applicable

7.

MARKETING AUTHORISATION HOLDER
Colgate-Palmolive (U.K.) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00049/0039

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

4 December 2000

10

DATE OF REVISION OF THE TEXT
20/01/2015

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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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