Infant Gripe Water
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Infant Gripe Water
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Terpeneless Dill Seed Oil 2.3mg/5ml.
Sodium Bicarbonate BP 52.5mg/5ml.
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 and the elderly: not applicable Children: 1 - 6 months old - one 5ml spoonful
6 - 12 months old - two 5ml spoonfuls 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.
Contraindications
4.3
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
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 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 bicarbonate. These may include diarrhoea, metabolic alkalosis and hypematraemia. In the event of severe overdosing, medical advice should be sought immediately.
Symptoms of hypematraemia 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 hypematraemia includes repair of any dehydration present and gradual reduction of the plasma sodium. The alkalosis, if present, will respond usually to the treatment of hypematraemia. 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 bicarbonate 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.
6.1 List of excipients
Glycerol, antifoam M compound, polysorbate 80, lycasin 80/55, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, disodium EDTA, purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
12 months unopened.
1 month after opening.
6.4 Special precautions for storage
Store below 25 °C.
6.5 Nature and contents of container
Clear, white, flint glass bottle with an expanded polyethylene wadded cap containing 75, 100, 125, 150 or 200ml of product
6.6
Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
AYRTON SAUNDERS LIMITED NORTH WAY
WALWORTH INDUSTRAIL ESTATE
ANDOVER
SP10 5AZ
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0154
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 May 1996
10 DATE OF REVISION OF THE TEXT
07/03/2008
11 DOSIMETRY (IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)