COLGATE SENSITIVE FRESH STRIPE
NAME OF THE MEDICINAL PRODUCT
Colgate Sensitive Fresh Stripe
QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients: Potassium Citrate Sodium monofluorophosphate 5.53% w/w 1.14% w/w
(1500 ppm F)
For a full list of excipients, see section 6.1.
CLINICAL PARTICULARS Therapeutic indications Prevention and treatment of teeth sensitivity and caries.
Posology and method of administration 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.
Contraindications There are no known contraindications. Do not use in patients who are known to be sensitive to any of the ingredients.
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.
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).
Pregnancy and lactation There are no contraindications for use during pregnancy and lactation. The product is applied locally and rinsed after brushing.
Effects on ability to drive and use machines None described and identified.
Undesirable effects None described.
Overdose 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.
Pharmacodynamic properties Pharmacotherapeutic group: Caries prophylactic agent with antisensitivity agent. ATC code: A01AA30 Colgate Sensitive Fresh Stripe belongs to the group of toothpastes with antisensitive properties and an anticaries effect. In vitro and animal studies showed that ionic potassium in toothpaste reduces the sensitivity of teeth within minutes by affecting the ionic balance at the pain receptor at the root of the tooth. Clinical studies support the efficacy of dentifrices containing 2% potassium ions (the active entity) including dentifrices containing 5.53% potassium citrate, eg Colgate Sensitive Fresh Stripe. In one study, a desensitizing dentifrice with 5.53% potassium citrate and sodium monofluorophosphate (MFP) was as effective over eight weeks as a previously tested positive control dentifrice with potassium chloride and sodium fluoride in a silica base. In a more recent study, a reduction in sensitivity after only 2 weeks of treatment was demonstrated. Fluoride is known for its protective effect against caries by acid microbial attack. Brushing the teeth removes plaque and bacteria thus reducing breath odor. Mint flavor contributes to the perception of mouth freshness.
Pharmacokinetic properties a) 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. b) 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.
Preclinical safety data
There are no findings of relevance to the health professional, additional to those already included elsewhere in the SPC.
List of excipients
Glycerol Dental Type Silicas Sorbitol 70% Purified Water Macrogol 600 Sodium Laurilsulfate 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.
Shelf life 3 years
Special precautions for storage Do not store above 25C.
Nature and contents of container 19, 50, 75 and 100 ml tubes of laminate polyethylene polymer with a screw flip-top of polypropylene.
100 ml stand up tubes of polyethylene. 100 ml dispenser pump of polypropylene with low density polyethylene piston.
Instructions for use/handling Not applicable.
MARKETING AUTHORISATION HOLDER
Colgate-Palmolive (UK) Ltd Guildford Business Park Middleton Road Guildford Surrey GU2 8JZ
MARKETING AUTHORISATION NUMBER PL 00049/0031
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 June 1994 Date of last renewal: 24 June 2004
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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