Dentinox Infant Colic Drops 21 mg/2.5 ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dimeticone, activated

Available from:

D.D.D. Limited

ATC code:

A03AX; A03AX13

INN (International Name):

Dimeticone, activated

Dosage:

21 mg/ 2.5 millilitre(s)

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other drugs for functional gastrointestinal disorders; silicones

Authorization status:

Marketed

Authorization date:

1983-10-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DENTINOX INFANT COLIC DROPS
21 MG/2.5 ML ORAL SUSPENSION
ACTIVATED DIMETICONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
- Keep this leaflet. You may need to read it again.
- If you notice any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
- If you need more information or advice on the medicine or your
baby’s condition, or if the
symptoms persist, speak to your health visitor, pharmacist or doctor.
IN THIS LEAFLET:
1. What Dentinox Infant Colic Drops are and what they are used for
2. What you need to know before you use Dentinox Infant Colic Drops
3. How to use Dentinox Infant Colic Drops
4. Possible side effects
5. How to store Dentinox Infant Colic Drops
6. Contents of the pack and other information
7. About infant colic
1. WHAT DENTINOX INFANT COLIC DROPS ARE AND WHAT THEY ARE USED FOR
Dentinox Infant Colic Drops contain the active ingredient activated
dimeticone.
This product belongs to a group of medicines called surface active
substances.
Dentinox Infant Colic Drops works by helping to release trapped wind.
This helps
to relieve tummy pain and indigestion.
Dentinox Infant Colic Drops is for the gentle relief of wind and
griping pains in babies.
This medicine can be used from birth onwards.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DENTINOX INFANT COLIC DROPS
DO NOT GIVE DENTINOX INFANT COLIC DROPS IF YOUR BABY IS BEING TREATED
FOR A THYROID DISORDER; SEEK ADVICE FROM YOUR DOCTOR INSTEAD.
DO NOT GIVE DENTINOX INFANT COLIC DROPS IF YOU THINK YOUR BABY MIGHT
BE ALLERGIC (hypersensitive) TO DIMETICONE OR ANY OTHER INGREDIENTS OF
DENTINOX INFANT COLIC DROPS (listed in section 6 of this leaflet).
TAKING OTHER MEDICINES:
If your baby is being treated with levothyroxine for a thyroid
disorder, using Dentinox
Infant Coli

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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
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.
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