It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

DDD Limited

DDD Limited

Summary of Product Characteristics last updated on medicines.ie: 6/3/2013

Dentinox Infant Colic Drops

1. NAME OF THE MEDICINAL PRODUCT

Dentinox Infant Colic Drops 21 mg/2.5 ml Oral Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Activated Dimeticone 21.0 mg/2.5 ml.

Excipients: also includes sucrose, 0.396 g per 2.5 ml and Nipasept* 7.913 mg per 2.5 ml.

*Nipasept contains Methylhydroxybenzoate (E218), Ethylhydroxybenzoate (E214) and Propylhydroxybenzoate (E216)

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension

A colourless to translucent white viscous emulsified suspension with a characteristic odour.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

In the management of infant colic.

4.2 Posology and method of administration

½ teaspoon (2.5 ml) with or after each feed. May be added to the infant's bottle or given orally using the spoon provided. Maximum 6 doses per day.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

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 precautions for use

Shake before use.

This product contains parahydroxybenzoates, which may cause allergic reactions (possibly delayed).

Keep all medicines out of 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 Fertility, pregnancy and lactation

Not applicable.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

None known.

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 Corning, it has been demonstrated in the rat that all the Dimeticone was recovered in the faeces and that there was no increase in urinary silicate output. In four human subjects given 376.5 mg 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

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water

Sucrose

Carbomer

Dill Oil

Sodium Hydroxide

Nipasept*

* Nipasept contains Methyl hydroxy benzoate (E218), Ethyl hydroxy benzoate (E214), Propyl hydroxy benzoate (E216).

6.2 Incompatibilities

Not applicable.

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

100ml HDPE round bottle with a white polyethylene jay cap tamper evident closure.

The product also includes a polypropylene 5 ml measuring spoon with 2.5 ml embossed on inside scoop of the spoon.

6.6 Special precautions for disposal and other handling

Shake before use.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

DDD Limited

94 Rickmansworth Road

Watford

Hertfordshire

United Kingdom WD18 7JJ

8. MARKETING AUTHORISATION NUMBER(S)

PA 302/3/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 5 October 1983

Date of last renewal: 5 October 2008

10. DATE OF REVISION OF THE TEXT

February 2013

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.