Reckitt Benckiser 0005 PL 00063/0698 Variation Type IA Peterlee deregistration

CARRIER

25.0 mm

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5-    How to store this medicine

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Store below 25 °C.

Use within 14 days after first opening. Use before the expiry date shown on the front of the bottle.

6-    Further information

Woodward’s Gripe Water -Alcohol Free & Sugar Free is an oral solution containing Terpeneless Dill Seed Oil 2.3mg/5mL, and Sodium Hydrogen Carbonate 52.5mg/5mL as active ingredients and also Maltitol Liquid, Glycerol, Sodium Salts of Esters of p-Hydroxybenzoic Acid (E215, E217 and E219), Disodium Edetate, Propylene Glycol and Purified Water.

Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd,

103405 Bath Road Slough SL1 3UH Tel 0500 455 456

Manufacturer: FAMAR A.V.E, 49th National Road Athens-Lamia, Avlona Attiki, 19011 Greece

PL 00063/0698

Last leaflet update 08/2014

Read the leaflet carefully before use and for full list of ingredients.

Store below 25°C.

Use within 14 days of first opening the bottle.

MA Holder:

Reckitt Benckiser Healthcare (UK) Ltd, 103405 Bath Road Slough SL1 3UH Tel 0500 455 456

PL 00063/0698

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I GRIPE |

I WATER |

ALCOHOL FREE ft SUGAR FREE

Oral Solution

Terpeneless Dill Seed Oil 2.3mgf5mL Sodium Hydrogen Carbonate 52.5mg/5mL Also contains sodium,

Wiaititol, E215, E217 andE219.

For the symptomatic relief jof distress associated with¹ wind in infants from one month to one year old.

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KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

i Lot No:

Exp date:

;150mLe <^5

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Patient Information Woodward’s Gripe Water -Alcohol Free & Sugar Free

Terpeneless Dill Seed Oil 2.3mg/5mL, Sodium Hydrogen Carbonate 52.5mg/5mL

I - What is this medicine used for

This medicine is an antacid and antiflatulent product. It is used to relieve griping pain or waves of severe abdominal pain (infant colic) in babies, due to trapped air in the tummy. It can be given to babies from 1 to 12 months.

2- Before you use this medicine

Do not give to a baby:

-    who is allergic to any of the ingredients in this product (see section 6)

-    who has kidney problems.

Important information about some of the ingredients

This product is sugar free but contains maltitol, which may affect blood sugar levels. Therefore if your baby has an inherited intolerance to some sugars, check with your doctor before giving this medicine.

This medicine contains hydroxybenzoate derivatives (E215, E217 and E219) which may cause allergic reactions (possibly delayed).

This medicinal product contains 0.7 mmol (or 16.1 mg) sodium per 5mL dose and 1.4 mmol (32.2 mg) per lOmL dose.

3-    How to use this medicine

This medicine is only for babies from 1 to 12 months old.

1-6 months old: one 5mL spoonful 6-12 months old: two 5mL spoonfuls

Give during or after a feed.

Do not use more than 6 times in 24 hours.

If symptoms persist, contact your doctor.

If you give your baby too much of this medicine, speak to a doctor or pharmacist at once.

4-    Possible side effects

If your baby experiences any side effect after using this product, stop using it and seek medical advice.

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63.00 mm

60.00 mm

1.3.1 Package Leaflet

Woodward's Gripe Water - AFSF EU National 2.3mg Dill Oil 52.5mg Sodium h Bicarb

60.00 mm

CUSTOMER INFO: Minimum Point Size = 6.00pt

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