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

5.1 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

3^rd November 1992 / 9^th December 1998

10. DATE OF (PARTIAL) REVISION OF TEXT

June 2001