1. Name Of The Medicinal Product
Colgate Sensitive Fresh Stripe
2. Qualitative And Quantitative Composition
Active ingredients:
Potassium Citrate 5.53% w/w
Sodium monofluorophosphate 1.14% w/w (1500 ppm F)
3. Pharmaceutical Form
Toothpaste
Blue cream with white stripe and with the odour and flavour of spearmint.
4.1 Therapeutic Indications
Prevention and treatment of teeth sensitivity and caries.
4.2 Posology and method of administration
For dental use.
Children from the moment they are capable of spitting out excess toothpaste (e.g. 6 years) and adults.
Place the usual amount of toothpaste on the toothbrush and brush twice a day (morning and after the last meal of the day).
There is no adjustment for renal or liver insufficiency, dialysis or concomitant disease, the drug is applied locally.
4.3 Contra-indications
There are no known contraindications. Do not use in patients who are known to be sensitive to any of the ingredients.
4.4 Special warnings and Precautions for Use
There are no special warnings and precautions. The product is used in the same way as a regular toothpaste. Children under 7 use a pea-sized amount for supervised brushing to minimise swallowing. If using fluoride supplements consult your dentist.
4.5 Interactions with other medicines and other forms of interaction
There are no known interactions with other drugs. 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 Use in pregnancy and lactation
There are no contraindications for use during pregnancy and lactation. The product is applied locally and rinsed after brushing.
4.7 Effects on ability to drive and use machines
None described and identified.
4.8 Undesirable effects
None described.
4.9 Overdose symptoms
The overdose effects are related to the bulk presented by the non-active ingredients and not to the active ingredients. Potassium is rapidly excreted by the kidneys and the fluoride levels are within acceptable limits (1500 ppm).
The management of overdose is either to dilute by drinking water or to vomit, but a physician should be contacted.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: A01AA02
Colgate Sensitive Fresh Stripe belongs to the group of toothpastes with anti-sensitive properties and an anticaries effect. Potassium influences the ionic balance at the level of the pain receptor of the tooth. Fluoride is known for its protective effect against caries by acid microbial attack.
5.2 Pharmacokinetic Properties
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General characteristics of the active substances
Fluoride and potassium are absorbed locally by the teeth. If swallowed, both ions are absorbed and eliminated by the kidneys at the rate of 100% of the 'excess' potassium and 40 to 50% of the 'excess' fluoride, if any.
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Characteristics in patients
In patients there are no variations with respect to confounding factors. Since the drug is applied topically there is no relationship with systemic levels and activity.
5.3 Preclinical Safety Data
There are no findings of relevance to the health professional, additional to those already included elsewhere in the SPC.
6. Pharmaceutical Particulars
6.1 List of excipients
Sorbitol 70%
Glycerol
Dental Type Silicas
Purified Water
Macrogol 600
Sodium Laurilsulphate
Titanium Dioxide
Sodium Carboxymethylcellulose
Xanthan Gum
Sodium Saccharin
Fresh Spearmint Flavour (Anethole 99%, Eugenol, Menthol Levo, Peppermint Mixture Redistilled, Spearmint Mixture)
Colour (E131)
6.2 Incompatibilities
The product being used locally there are no known incompatibilities.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
19, 50, 75 and 100 ml lay down foil laminate tubes and 100 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:
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Outer layer:
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Polyethylene
Adhesion copolymer
Aluminium foil
Adhesion copolymer
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Inner layer:
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Polyethylene
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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.
100 ml dispenser pump of polypropylene with low density polyethylene piston.
6.6 Special precautions for disposal
No special requirements
7.1 Marketing Authorisation Holder
Colgate-Palmolive (U.K.) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
United Kingdom
8. Marketing Authorization Number
PL 00049/0031
9. Date Of First Authorization/Renewal Of Authorization
Date of first authorisation: 24 June 1994
Date of last renewal: 24 June 2004
10. Date Of (partial) Revision Of The Text
9th March 2007
