DENTINOX INFANT COLIC DROPS

Active substance: ACTIVATED DIMETHICONE EMULSION 30%

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Dentinox Infant Colic Drops
Activated Dimeticone

PACKAGE LEAFLET: INFORMATION FOR THE USER
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.

In this leaflet:
1. What Dentinox Infant Colic Drops is and what it is used for
2. When not to give Dentinox Infant Colic Drops
3. How you give Dentinox Infant Colic Drops
4. Possible side effects
5. How to store Dentinox Infant Colic Drops
6. Further information
7. About infant colic

1. What Dentinox Infant Colic Drops is and what it is 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. 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 contains 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 Nipasept, which may cause allergic reactions (possibly delayed).

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3. How you give Dentinox Infant Colic Drops
Shake bottle before use.
Dosage: 2½ ml (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. However, if you think this
medicine is causing the baby any problems speak to your health visitor, pharmacist or doctor.

5. How to store Dentinox Infant Colic Drops
Dentinox Infant Colic Drops should be kept out of the reach and sight of children.
Do not store above 25 °C.
Do not use Dentinox Infant Colic Drops after the expiry date as indicated on the box.
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 contains: The active substance is
activated dimeticone 42 mg/5ml. The other ingredients are: purified water, sucrose,
carbomer, dill oil, sodium hydroxide and nipasept [methylhydroxybenzoate E218,
ethylhydroxybenzoate E214, propylhydroxybenzoate E216].
What Dentinox Infant Colic Drops look like and contents of the pack
Dentinox Infant Colic Drops are available in a 100 ml round plastic bottle with a 2.5 ml syringe.
Marketing Authorisation Holder and Manufacturer:
DDD Limited, 94 Rickmansworth Road, Watford, Hertfordshire, United Kingdom, WD18 7JJ.

7. About infant colic
When babies feed they produce gastric juices and acids. These acids can curdle milk which can
trap air bubbles and lead to colic. The air bubbles may stop the natural movement of food down
the gut. Dentinox Colic Drops gently disperses the air bubbles. The released air can then rise
to the top of baby’s tummy and become a satisfying burp.
This leaflet was last revised in August 2012.

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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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