1. Name Of The Medicinal Product
2. Qualitative And Quantitative Composition
CALGEL TEETHING GEL contains:
Lidocaine Hydrochloride 0.33% w/w
Cetylpyridinium Chloride 0.10% w/w
For excipients see 6.1.
3. Pharmaceutical Form
Topical gel
4. Clinical Particulars
4.1 Therapeutic Indications
CALGEL TEETHING GEL is indicated for use in teething. CALGEL TEETHING GEL acts quickly to help relieve teething pain and soothe infants' gums. It also has mild antiseptic properties.
4.2 Posology And Method Of Administration
CALGEL TEETHING GEL is suitable for babies from the age of 3 months.
A small quantity of CALGEL TEETHING GEL, approximately one third of an inch (7.5 mm), should be squeezed onto the tip of a clean finger and rubbed gently onto the affected area of the gum.
Application may be repeated after an interval of 20 minutes if necessary, with up to six applications in one day.
4.3 Contraindications
CALGEL TEETHING GEL is contraindicated in patients with known hypersensitivity to the product or any of its ingredients.
4.4 Special Warnings And Precautions For Use
The recommended dose should not be exceeded. Keep out of the reach and sight of children.
Patients with rare hereditary problems of fructose intolerance should not use this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No drug interactions with CALGEL TEETHING GEL are known.
Drug interactions between intravenously administered lidocaine and oral procainamide, oral phenytoin alone or in combination with phenobarbital, primidone or carbamazepine, oral propanolol and non-potassium sparing diuretics including bumetanide, furosemide and thiazide have been reported. These drug effects are unlikely to be relevant to the use of CALGEL TEETHING GEL.
4.6 Pregnancy And Lactation
Not applicable
4.7 Effects On Ability To Drive And Use Machines
Not applicable
4.8 Undesirable Effects
When used according to instructions side effects would not be expected. However, isolated cases of hypersensitivity to lidocaine hydrochloride have been reported in adults and in a child over 12 years following local injection. Hypersensitivity presented in these cases as localised oedema with slight difficulty in breathing or as generalised rash.
Chamomile, a minor ingredient in the herbal flavouring agent, has been documented as causing allergic reactions. Hypersensitivity to chamomile normal manifests as breathing difficulties in atopic individuals. Anaphylactic reactions have been reported in individuals drinking herbal tea infusions containing chamomile (herbal tea asthma). Sensitised individuals may demonstrate positive skin reactions to preparations containing chamomile.
In the event of any unwanted side effects, use should be discontinued and a doctor consulted.
4.9 Overdose
Suppression of pharyngeal sensation with concomitant effects on swallowing may theoretically result from excessive topical oral use of CALGEL TEETHING GEL. Such an effect has been reported in an adult who gargled and swallowed 5 ml of a 2% lidocaine hydrochloride solution (equivalent to 100 mg lidocaine). However, assuming proportionality of body surface area and pharyngeal surface area, this dose would be equivalent to a single dose of 5.4 g of CALGEL TEETHING GEL for a 3 month old child.
It is most unlikely that, even with misuse or excessive application of CALGEL TEETHING GEL, the large amounts of lidocaine hydrochloride or cetylpyridinium chloride required to produce clinically-relevant toxic effects should be reached.
In the event of overdose, use should be discontinued and a doctor consulted.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Established local anaesthetic (lidocaine) for topical application.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
No additional information.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sorbitol solution (70%) (E420)
Xylitol (E967)
Ethanol 96%
Glycerol
Hydroxyethyl cellulose 5000
Macrogolglycerol hydroxystearate (Cremophor RH 40) (castor oil polyoxyl hydrogenated)
Macrogol lauryl ether 9
Macrogol 300
Saccharin sodium
Levomenthol
Pharmaceutical liquid flavour, (containing chamomile)
Caramel (E150)
Citric acid monohydrate
Sodium citrate dihydrate
Purified water
6.2 Incompatibilities
None known
6.3 Shelf Life
36 months unopened
6.4 Special Precautions For Storage
Do not store above 25°C
6.5 Nature And Contents Of Container
10 g collapsible, internally lacquered, aluminium tube, the nozzle of which possesses a membrane.
6.6 Special Precautions For Disposal And Other Handling
None applicable
Administrative Data
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0015
9. Date Of First Authorisation/Renewal Of The Authorisation
04.06.99
10. Date Of Revision Of The Text
7th April 2009
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