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DENTINOX INFANT COLIC DROPS

Active substance(s): ACTIVATED DIMETHICONE EMULSION 30% / ACTIVATED DIMETHICONE EMULSION 30% / ACTIVATED DIMETHICONE EMULSION 30%

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STUDIO DETAILS
Client: Dendron
Job No: 02550-16

INFANT

CO L IC DROP S
Activated dimeticone

Version No: V9
Date: 26/09/2016
Originator:
Steve Holman

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amended by:
Steve Holman

Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet, you may need to read it again. If you need more information
or advice speak to your health visitor, pharmacist or doctor.

Description:
Dentinox Colic Drops
PIL – LTD0161

IN THIS LEAFLET:
1. What Dentinox Infant Colic Drops are and what are they used for
2. When not to give Dentinox Infant Colic Drops
3. How to give Dentinox Infant Colic Drops
4. Possible side effects
5. How to store Dentinox Infant Colic Drops
6. Further information
1. WHAT DENTINOX INFANT COLIC DROPS ARE AND WHAT ARE THEY 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
work by helping to release trapped wind. This helps to relieve tummy pain and indigestion.
Dentinox Infant Colic Drops are for the gentle relief of wind and griping pains in babies.
This medicine can be used from birth onwards.
2. WHEN NOT TO GIVE 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 Colic Drops might reduce the amount of this type of medicine that is absorbed,
weakening the effect of their treatment.
Important information about some of the ingredients of Dentinox Infant Colic Drops
Dentinox Infant Colic Drops contain sucrose. If you have been told by your doctor that your baby
has an intolerance to some sugars, contact your doctor before giving these drops. This medicine
may be harmful to the teeth. Dentinox Infant Colic Drops also contains methyl, ethyl, propyl
parahydroxybenzoates (E218, E214, E216), which may cause allergic reactions (possibly delayed).

TA:

N/A

Trim:

165 x 120 mm

Bleed: 3 mm
% of actual size: 100%
Barcode: N/A
Data Matrix: P0351
Colour:
PMS 3285
CYAN - 20%

brayleino.co.uk
Filleigh / Barnstaple / Bristol / London

01598 760 700
Accurate for content only. Refer to
printers proofs for colour matching.

3. HOW TO GIVE DENTINOX INFANT COLIC DROPS
Shake bottle before use. Dosage: 21/2ml (one measured dose of the syringe) should be given with or after
each feed. Dentinox Infant Colic Drops can be added to the baby‘s bottle or given orally directly from the
syringe. Maximum 6 doses per day. After use, rinse the syringe with warm water and dry.
Not suitable for steam sterilisation.
If you give more Dentinox Infant Colic Drops than you should contact your health visitor,
pharmacist or doctor for advice.
If you have any further questions on the use of this product, speak to your health visitor,
pharmacist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dentinox Infant Colic Drops can cause side effects, although these
do not affect everybody.
If you notice any signs of allergy stop using the product and seek medical advice.
There are no known side effects from Dentinox Infant Colic Drops.
Reporting of side effects. If your baby experiences any side effects, consult your doctor
or pharmacist. This includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DENTINOX INFANT COLIC DROPS
Dentinox Infant Colic Drops should be kept out of the sight and reach of children.
Do not store above 25 °C.
Do not use Dentinox Infant Colic Drops after the expiry date as indicated on the box and bottle.
The expiry date refers to the last day of the month.
Medicine should not be disposed of in waste-water or with household waste. Ask your
pharmacist what you should do with medications you no longer need. These measures
will help to protect the environment.
6. FURTHER INFORMATION
What Dentinox Infant Colic Drops contain: The active substance is activated
dimeticone 42mg/5ml. The other ingredients are: purified water, sucrose, carbomer,
dill oil, sodium hydroxide, methyl parahydroxybenzoate E218, ethyl parahydroxybenzoate
E214, and propyl parahydroxybenzoate E216.
What Dentinox Infant Colic Drops look like and contents of the pack:
Dentinox Infant Colic Drops are available in a 100ml round plastic bottle with a 2.5ml syringe.
Marketing Authorisation Holder and Manufacturer:
DDD Limited, 94 Rickmansworth Road, Watford, Hertfordshire, United Kingdom, WD18 7JJ.
This leaflet was last revised in August 2016.

LTD0161

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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