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Gripe Mixture

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FRONT OF PACK (Refer to Brand Principles and readability guideline)


Children’s GRIPE Mixture Sodium Bicarbonate APPLE FLAVOUR

X Relief of wind and griping pain X For use before or after feeds

COLOUR FREE SUGAR FREE

150 ml e

BACK OF PACK (Refer to readability guideline)

Read all of this carton for full instructions.

What this medicine is for

This medicine contains Sodium Bicarbonate, which belongs to a group of medicines called antacids. It can be used to relieve wind and griping pain in babies.

Before you give this medicine

X Do not give:

   If your child is under 1 month old or 1 year and over

   If your child is allergic to any of the ingredients

   If your child has liver or kidney problems

   If your child has high blood pressure, heart failure, or fluid retention

   If your child has low levels of calcium in the blood, or if you have been told their blood is too alkaline

   If your child is producing too much of a hormone from the adrenal gland

   If your child is not producing enough stomach acid

   If your child is on a low salt (sodium) diet (each 5 ml spoonful contains 15 mg of sodium, which may be harmful to your child)

   If your child has an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid)

If your child takes other medicines

Before you give this liquid, make sure that you tell your pharmacist about ANY other medicines you might be giving your child at the same time, particularly the following:

•    Salicylates (such as aspirin, for Kawasaki’s Disease)

•    Tetracyclines (for bacterial infections)

•    Barbiturates (for epilepsy)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for your child,

including herbal and homeopathic remedies.

Information for people with diabetes: This medicine contains 0.3 g of maltitol. This provides 1 kcal per 5 ml spoonful.

S How to give this medicine

Check the seal is not broken before first use. If it is, do not give the medicine.

Use the measuring spoon provided (the big end of the spoon measures 5 ml).

Give this medicine to your baby to swallow.

Do not add this medicine to feeds or bottles.

Age

How much to give

How often to give

1 to 5 months

5 ml

Before or after each feed, if you need to. Don’t give more than 6 times in 24 hours.

6 to 11 months

10 ml

Before or after each feed, if you need to. Don’t give more than 6 times in 24 hours.

Do not give to babies under 1 month.

Do not give to babies of 1 year and over.

Do not give more than the amount recommended above.

If symptoms do not go away talk to your pharmacist or doctor.

! If you give too much: Talk to a doctor straight away - your baby may be drowsy, irritable, have a fever or breathing problems.

Possible side effects

Most people will not have problems, but some may get some.

! If your child gets any of these serious side effects, stop giving the liquid.

See a doctor at once:

•    Difficulty breathing, swelling of the face, neck, tongue or throat (severe allergic reaction)

! If too much is given, or too often, your baby may get:

•    Changes in the chemistry of the blood - your baby may be drowsy, irritable, or have breathing problems - talk to a doctor straight away if you notice this

If your child gets any of the following side effects see your pharmacist or doctor:

•    Other allergic reactions (e.g. skin rash)

•    Stomach cramps, being sick, burping, wind

•    Your child may appear generally unwell (e.g. lacking in energy, feverish)

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Throw away any Gripe Mixture remaining 12 weeks after opening.

Active ingredient

Each 5 ml of liquid contains Sodium Bicarbonate 50 mg.

Also contains: purified water, glycerol (E422), maltitol liquid (E965), sodium citrate, domiphen bromide, apple flavour.

PL 00014/5236 Text prepared 02/14

Manufactured for the Marketing Authorisation Holder The Boots Company PLC, Nottingham, NG2 3AA by BCM Ltd, Nottingham NG90 2PR

150 ml e

Lot:

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Bar code Item code Component code

BRAILLE NAME

Children’s GRIPE Mixture