What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00014/5236R.


Boots Gripe Mixture 1 Month Plus

PATIENT INFORMATION LEAFLET

Boots GRIPE Mixture

1 MONTH PLUS

Sodium Bicarbonate

(APPLE FLAVOUR)

Relief of wind and griping pain

For use before or after feeds

COLOUR FREE

SUGAR FREE

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 take this medicine

Do not take:

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 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 intolerance to some sugars, unless your doctor tells you to (this medicines 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)

Tetracylclines (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 per 5 ml spoonful. This provides 1 kcal per 5 ml spoonful.

How to take/give/use this medicine

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

1 to 5 months: Take 5 ml, before or after each feed, if you need to.

Don’t give more than 6 times in 24 hours

Age: 6 to 11 months: Take 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 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 in breathing, swelling of the face, neck or 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)

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 4/15

Manufactured for Marketing Authorisation holder

The Boots Company PLC
Nottingham
NG2 3AA

by

BCM Ltd
Nottingham
NG2 3AA

Lot:

Use By:

Item code

Component code

150 ml e