SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Dentinox Infant Colic Drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Activated Dimeticone

Methyl parahydroxybenzoate E218 Ethyl parahydroxybenzoate E214 Propyl parahydroxybenzoate E216

For all excipients, see 6.1

3. PHARMACEUTICAL FORM

Oral suspension Translucent white liquid

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

For the gentle relief of wind and griping pains in infants, caused by the accumulation of ingested air. Facilitates eructation. Can be used from birth onwards.

4.2. Posology and method of administration

2/ ml (one measured dose of the syringe) with or after each feed. May be added to the infant’s bottle or given orally directly from the syringe. Maximum 6 doses per day. For infants can be used from birth onwards.

Contraindications

Hypersensitivity to the active substances or to any other of the ingredients.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4.    Special warnings and special precautions for use

Keep all medicines out of the reach of children.

If symptoms persist obtain medical advice.

4.5.    Interaction with other medicinal products and other forms of interaction

Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Dentinox Infant Colic Drops are given concurrently to infants treated for thyroid disorders.

4.6.    Pregnancy and lactation

Not applicable.

4.7.    Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

None known.

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, website: www.mhra.gov.uk/yellowcard.

4.9. Overdose

From the literature it would appear that all the silicone will be excreted unchanged and that there was no increase of urinary silicate output or of absorption of the silicone.

It was concluded that the Activated Dimeticone carried no significant carcinogenic hazard, and that no other significant toxic effect attributable to Activated Dimeticone has been observed.

Overdosage may prove a problem with diabetics because of the sugar content.

5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties

Excessive swallowing of air results in collection of gas in the intestine. This can be the result of too rapid eating, excessive use of a pacifier (dummy), finger sucking or yelling. When the swallowed air is in the intestine, bubbles are formed, which makes it more difficult for the gas to pass through the intestine canal, resulting in abdominal distension and pain. Activated Dimeticone is a surface active substance which changes the surface tension of the intestinal mucus. Thus, the air bubbles burst and the gas is released. The elimination of the gas, air or foam from the gastro-intestinal tract, relieves abdominal distension and dyspepsia.

5.2. Pharmacokinetic properties

Activated Dimeticone is chemically inert and is not absorbed. Its effect is local on the intestinal contents.

No side effects from the substance are reported from the literature.

From the toxicity trials undertaken by Dow Coming, it has been demonstrated in the rat that all the Dimeticone was recovered in the faeces and that there was no increase in urinary salicate output.

In four human subjects given 376.5mg of Activated Dimeticone, twice daily for 10 days, it was found that there was no increase in their urinary silicate output and no evidence of absorption of the silicone.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified Water, Sucrose, Carbomer, Dill Oil, Sodium Hydroxide, Methyl parahydroxybenzoate E218, Ethyl parahydroxybenzoate E214, Propyl parahydroxybenzoate E216.

6.2. Incompatibilities

None known.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Pack size 100ml

100ml HDPE round bottle with a jay cap tamper evident closure with 2.5ml oral dosing syringe.

Pack size 2.5ml

Sample sachets:

40gsm craft paper, 10 gsm polyethylene, 8gsm aluminium foil and 30gsm surlyn

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

After use, rinse the syringe with warm water and dry. Not suitable for steam sterilisation.

7.    MARKETING AUTHORISATION HOLDER

DDD Limited,

94, Rickmansworth Road Watford

Hertfordshire WD18 7JJ

8. MARKETING AUTHORISATION NUMBER(S)

PL 0133/0022

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29 November 1976 / 09 September 2008

10 DATE OF REVISION OF THE TEXT

29/03/2016