Snufflebabe Gripe Mixture
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Baby Gripe Mixture Dinnefords Gripe Mixture Dinnefords Baby Gripe Mixture Dinnefords Infant Gripe Mixture Atkinsons & Barkers Infant Gripe Mixture Snufflebabe Gripe Mixture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium bicarbonate 50.0mg/5ml
3 PHARMACEUTICAL FORM
Liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To relieve griping pains and wind in babies
4.2 Posology and method of administration
Route of Administration: Oral
Babies one to six months
One 5m1 spoonful to be given every four hours if necessary Babies six months to one year
Two 5m1 spoonsful to be given every four hours if necessary
This product is not recommended for babies under one month or over one year.
4.3 Contraindications
Should be used with caution in babies with cardiac problems, hypertension, impaired renal function or peripheral or pulmonary oedema.
4.4 Special warnings and precautions for use
Do not exceed the stated dose. Seek medical advice if symptoms persist or worsen.
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
Excessive intake could cause hypernatraemia
4.9 Overdose
Symptoms of hypernatraemia may include drowsiness and irritability, pyrexia, tachypnoea and hyperpnoea. In more severe instances of acute sodium overload, signs of dehydration and convulsions may occur.
Treatment
The treatment of hypernatraemia includes repair of any dehydration present and gradual reduction of the plasma sodium. The alkalosis if present will respond to the treatment of hypernatraemia. At all times intensive monitoring of the electrolytes, and patient’s circulatory and central nervous system are necessary.
PHARMACOLOGICAL PROPERTIES
5
5.1 Pharmacodynamic properties
Antacid
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol solution non-crystallising
Dill oil, terpeneless Caraway oil, terpeneless Propylene glycol Nipasept Water
6.2 Incompatibilities
None
6.3 Shelf life
24 months
After first opening: 1 month
6.4 Special precautions for storage
Store below 20°C
6.5 Nature and contents of container
i) Amber glass sirop bottle fitted with polypropylene EPE wadded cap containing 100 or 140m1 of product, in printed cartons.
ii) Clear glass sirop bottle fitted with polypropylene EPE wadded cap or polypropylene child resistant cap containing 150m1 of product, in printed cartons.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
AYRTON SAUNDERS LIMITED NORTH WAY
WALWORTH INDUSTRAIL ESTATE
ANDOVER
SP10 5AZ
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0096
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
3rd November 1992 / 9th December 1998
10. DATE OF (PARTIAL) REVISION OF TEXT
June 2001