SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Woodward’s Gripe Water - Alcohol Free & Sugar Free

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Excipients:

Maltitol Liquid Sodium

Sodium ethyl p-hydroxybenzoate (E215)

Sodium propyl p-hydroxybenzoate (E217)

Sodium methyl p-hydroxybenzoate (E219)

For a full list of excipients see 6.1.

3    PHARMACEUTICAL FORM

Oral solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of distress associated with wind in infants up to one year old.

4.2    Posology and method of administration

For oral use

Adults & the Elderly: Not applicable

Children:    1 - 6 months old - One 5ml spoonful

6 - 12 months old    -    Two 5ml spoonsful

Under one month old -    Not to be used

These doses may be given during or after each feed or up to six times in 24 hours.

4.3 Contraindications

Should not be used where impaired kidney function or hypersensitivity to hydroxybenzoates exists.

4.4 Special warnings and precautions for use

If symptoms persist, medical advice should be sought.

Keep all medicines out of the reach of children.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Label must include equivalent sentences of:

This medicinal product contains 1.4mmol (or 32.2mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

4.5    Interaction with other medicinal products and other forms of interaction

None known

4.6    Fertility, pregnancy and lactation

Not applicable

4.7    Effects on ability to drive and use machines

Not applicable

4.8    Undesirable effects

None known

4.9    Overdose

Symptoms following overdose are rare and are generally due to the effects of sodium hydrogen carbonate. These may include diarrhoea, metabolic alkalosis and hypernatraemia. In the event of severe overdosing, medical advice should be sought immediately.

Symptoms of hypernatraemia may include drowsiness and irritability, pyrexia and tachypnoea. In more severe instances of acute sodium overload, signs of dehydration and convulsions may occur.

The treatment of hypernatraemia includes repair of any dehydration present and gradual reduction of the plasma sodium. The alkalosis, if present, will respond usually to the treatment of hypernatraemia. At all times intensive monitoring of the electrolytes, and patients circulatory and central nervous system are necessary.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Sodium Hydrogen Carbonate has a well-established antacid action. Dill Seed Oil is a widely used aromatic carminative especially for use in the treatment of flatulence in children.

5.2    Pharmacokinetic properties

Not applicable

5.3    Preclinical safety data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glycerol Propylene glycol Maltitol Liquid

Nipasept (Sodium Methyl Parahydroxybenzoate, Sodium Ethyl Parahydroxybenzoate, Sodium Propyl Parahydroxybenzoate)

Disodium Edetate Purified water

6.2    Incompatibilities

None known

6.3    Shelf life

18 months unopened 14 days after opening

6.4    Special precautions for storage

Do not store above 25°C

6.5    Nature and contents of container

Clear, soda-lime-silica Type III pharmaceutical grade glass bottle with an expanded polyethylene wadded cap containing 150ml of product.

6.6    Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) limited

103-105 Bath Road

Slough

Berkshire

SL1 3UH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00063/0698

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/11/1999

10    DATE OF REVISION OF THE TEXT

02/10/2012