Calgel Teething Gel
CALGEL TEETHING GEL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CALGEL TEETHING GEL contains:
Lidocaine Hydrochloride 0.33% w/w Cetylpyridinium Chloride 0.10% w/w
Excipients: sorbitol solution (E420), xylitol (E967), ethanol 96% and glycerol. For the full list of excipients, see section 6.1.
CALGEL TEETHING GEL is indicated for use in teething. CALGEL TEETHING GEL acts quickly to help relieve teething pain and soothe toddlers’ and infants’ gums. It also has mild antiseptic properties.
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, 0.22g), 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.
Hypersensitivity to lidocaine hydrochloride and/or cetylpyridinium chloride or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
The recommended dose should not be exceeded. Keep out of the sight and reach of children.
Patients with rare hereditary problems of fructose intolerance should not use this medicine.
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.
The medicinal product is indicated for use in toddlers and infants, therefore use during pregnancy and lactation is not applicable.
Calgel Teething Gel has no influence on the ability to drive and use machines.
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 normally 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.
Adverse drug reactions (ADRs) identified during post-marketing experience with Cetylpyridinium/Lidocaine are included in Table 1. The frequencies are provided according to the following convention:
Very common >1/10
Common >1/100 and < 1/10
Uncommon >1/1,000 and <1/100
Rare >1/10,000, and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
Table 1: Adverse Drug Reactions Identified During Post-Marketing Experience with Cetylpyridinium/Lidocaine Frequency Category Estimated from Clinical Trials or Epidemiology Studies_
Immune System Disorders
Adverse Event Preferred Term
Hypersensitivity (including Dermatitis)
General Disorders and Administration Site Conditions
Application site reactions (including Erythema)
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.
Ingestion of cetylpyridinium in large doses may cause gastric upset and central nervous system depression. Concentrations where overdose symptoms were observed were 70 times higher than the concentrations of cetylpyridinium chloride found in this product.
Systemic toxic effects with local anaesthetics (all forms of administration) may include central nervous system and cardiac effects.
No symptoms of overdosage have been identified from the analysis of postmarketing data for this product.
Pharmacotherapeutic group: Anaesthetics, local (Amides) Lidocaine combinations ATC code: N01 BB52
Established local anaesthetic (lidocaine) for topical application.
No additional information.
Sorbitol solution (70%) (E420)
Hydroxyethyl cellulose 5000
Macrogolglycerol hydroxystearate (Cremophor RH 40) (castor oil polyoxyl hydrogenated)
Macrogol lauryl ether 9 Macrogol 300 Saccharin sodium
Pharmaceutical liquid flavour, (containing chamomile) Caramel (E150)
Citric acid monohydrate Sodium citrate dihydrate Purified water
6.3 Shelf life
3 years (unopened)
Do not store above 25°C
10 g collapsible, internally lacquered, aluminium tube, the nozzle of which possesses a membrane.
6.6 Special precautions for disposal
No special requirements for disposal
McNeil Products Limited
PL 15513/0015 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION