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COLGATE TOTAL FRESH STRIPE TOOTHPASE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Colgate TOTAL Fresh Stripe Toothpaste

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients of Colgate TOTAL Fresh Stripe Toothpaste are: Triclosan Sodium Fluoride 0.30% w/w 0.32% w/w 1450 ppm F

For a full list of excipients see section 6.1.

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PHARMACEUTICAL FORM
Toothpaste. Green pearlescent cream with white stripes and with odour and flavour of mint.

Clinical Particulars 4.1. Therapeutic Indications

To improve gingival health by: 1. Significantly reducing the formation of plaque and calculus. 2. Significantly reducing existing levels of gingival bleeding and inflammation.

To reduce the progression of Periodontitis.

4.2.

Posology and Method of Administration The usual dosage is to apply a ribbon of toothpaste across the head of the toothbrush (approximately 1.0g) and to brush the teeth for one minute twice daily. Children under 7, use a pea-sized amount for supervised brushing to minimise swallowing. If using fluoride supplements, consult your Dentist.

4.3

Contraindications

None known. Individuals with known sensitivities should consult with their dentist before using. 4.4. Special Warnings and Precautions for Use Children under 7, use a pea-sized amount for supervised brushing. If using fluoride supplements, consult your Dentist.

4.5. Interactions with other Medicaments and other forms of Interaction None known. It is important to note that as for any fluoride containing toothpaste in children under systemic fluoride therapy, it is important to evaluate the total exposure to fluoride (fluorosis).

4.6.

Pregnancy and Lactation Use of this product is not contraindicated during pregnancy or lactation.

4.7.

Effects on Ability to Drive and Use Machines None known.

4.8.

Undesirable Effects None known.

4.9.

Overdose Not applicable. Use of this type of product would not be expected to result in an overdose. No acute effects would be expected from the low level of Triclosan (489 mg in a 125 ml tube). Even in the extreme case of prolonged exposure, serious adverse effects would not be expected from Triclosan.

5.1 Pharmacodynamic properties ATC code: A01AA01 Triclosan: Triclosan is a broad-spectrum non-ionic antibacterial with activity against both aerobic and anaerobic gram-positive and gram-negative microbes. It is widely employed as a disinfectant and as an anti-bacterial in external use OTC products. In Colgate TOTAL Fresh Stripe Toothpaste it is combined with a copolymer which enhances the delivery of Triclosan to the site of action. Clinical studies indicate that a single brushing with the triclosan/copolymer dentifrice significantly reduces dental plaque viability (the ratio of live to dead bacteria in dental plaque) compared to a control dentifrice without the antibacterial system. A significant difference is maintained for at least 12 hours after brushing. The results also indicate that the concentrations of triclosan in dental plaque for at least 12 hours after brushing are at levels known to have antibacterial effects in vitro. Sodium fluoride: Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface and by inhibiting the cariogenic microbial process. 5.2. Pharmacokinetic Properties Triclosan: When administered in a dentifrice by toothbrushing, salivary and plaque Triclosan levels range between 1-6 ppm and 25 ppm respectively at 1-2 hours after using a 0.3% dentifrice. Following usage of a dentifrice containing up to 0.6% Triclosan, mean blood levels range between 15 to 25 ppb. Blood levels of Triclosan in subjects brushing with a dentifrice are about 14 per cent of those in subjects who directly ingested an aqueous solution in an equivalent dose level. Sodium Fluoride: After oral administration, fluoride absorption is rapid and extensive with (90 - 100%) peak fluoride plasma levels reached within 30 to 60 minutes after ingestion. Fluoride is widely distributed through the body and

concentrates in the bone and teeth. About 50% of fluoride absorbed is stored. Excretion is primarily through the kidneys with less than 10% being excreted in the faeces and less than 1% in sweat and saliva.

5.3.

Preclinical Safety Data Triclosan: In subchronic oral ingestion studies with rats, dentifrices containing Triclosan were administered for 13 weeks at levels that are conservatively up to 100 times expected human use levels. Animals received daily doses of up to 12 mg/kg of Triclosan and showed no indications of treatment related effects. This dose would be equivalent to 600 mg of Triclosan in 50kg human. Ingestion of 125 ml of a toothpaste (approximately one tube) containing 0.3% Triclosan would give an intake of approximately 489 mg and would not be expected to produce untoward effects. Sodium Fluoride: The total amount of sodium fluoride in a 125 ml tube of Colgate TOTAL Fresh Stripe Toothpaste is 516 mg. his is within the acceptable limits for the amount to be dispensed at one time for safety purposes. Prolonged daily ingestion of excessive fluoride may result in varying degrees of fluorosis.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Glycerol Silica, Dental Type Sorbitol, Liquid (70%) Non-Crystallising Purified Water Poly (Methyl Vinyl Ether) Maleic Acid Sodium Hydroxide (25% Solution) Sodium Laurilsulfate 89-303 Mint Flavour (green stripe) 89-854 Mint Flavour (white stripe) Carmellose sodium Iota Carageenan Titanium Dioxide (E171) Titanium dioxide coated mica Saccharin Sodium Aluminium lake of quinoline yellow (E104) Aluminium lake of Brilliant Blue FCF (E133)

6.2

Incompatibilities

Not applicable 6.3. Shelf Life 3 years.

6.4.

Special Precautions for Storage Do not store above 25C.

6.5

Nature and Contents of Container

Colgate TOTAL Fresh Stripe Toothpaste is packaged in 19, 50, 75, 100, 125, and 150 ml lay down foil laminate tubes and 100, 125 and 150 ml stand-up-tubes consisting of three elements: a) conical shoulder with threaded neck manufactured from high density polyethylene, b) barrier material of polybutyl teraphthalate (PBT) or polyester teraphthalate (PET) below and inside the conical shoulder, c) cylindrical laminated tube body. The lay down tube body is manufactured from 5-ply laminated webstock comprising from outside to inside: Outer layer: Polyethylene Adhesion copolymer Aluminium foil Adhesion copolymer Polyethylene

Inner layer:

The stand-up-tube body is manufactured from polyethylene laminate comprising: Medium density polyethylene Ethylvinyl alcohol barrier Medium density polyethylene. The caps are manufactured from polypropylene and are either screw or snap-on. Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

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

8.

MARKETING AUTHORISATION NUMBER(S) PL 0049/0037

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 June 1996 Date of last renewal: 19 June 2001

10

DATE OF REVISION OF THE TEXT
15/09/2010

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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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