SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

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.

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 toddlers’ and 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, 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.

Contraindications

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.

4.5    Interactions 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    Fertility, pregnancy and lactation

The medicinal product is indicated for use in toddlers and infants, therefore use during pregnancy and lactation is not applicable.

4.7    Effects on ability to drive and use machines

Calgel Teething Gel has no influence on the ability to drive and use machines.

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 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.

Post-marketing Data:

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)

Reporting of suspected adverse reactions

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.

4.9 Overdose

Cetylpyridinium

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.

Lidocaine

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.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Anaesthetics, local (Amides) Lidocaine combinations ATC code: N01 BB52

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

3 years (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

No special requirements for disposal

7    MARKETING AUTHORISATION HOLDER

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8.    MARKETING AUTHORISATION NUMBER

PL 15513/0015 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

04.06.99

DATE OF REVISION OF THE TEXT

02/09/2016