Atkinsons & Barkers Infant Gripe mixture

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium bicarbonate

Available from:

Torbet Laboratories Ltd

ATC code:

B05XA02

INN (International Name):

Sodium bicarbonate

Dosage:

10mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010102

Patient Information leaflet

LEAFLET TEXT FOR BABY GRIPE MIXTURE, PL 48259/0018, NOVEMBER 2017
(ALSO FOR DINNEFORDS GRIPE MIXTURE, DINNEFORDS BABY GRIPE MIXTURE,
DINNEFORDS INFANT GRIPE MIXTURE ,
ATKINSONS & BARKERS INFANT GRIPE MIXTURE, SNUFFLEBABE GRIPE MIXTURE)
PATIENT INFORMATION LEAFLET
Baby Gripe Mixture
(Dinnefords Gripe Mixture, Dinnefords Baby Gripe Mixture, Dinnefords
Infant Gripe
Mixture, Atkinsons & Barkers Infant Gripe Mixture, Snufflebabe Gripe
Mixture)
(Sodium Bicarbonate)
Please read this leaflet carefully as it contains important
information about this medicine.
If you have any further questions or queries. Please ask your doctor
or pharmacist.
Baby Gripe Mixture contains the active ingredient sodium bicarbonate
50.0mg/5ml. Also
contains: sorbitol sodium, propylene glycol, dill oil terpeneless,
caraway oil terpeneless,
purified water and nipsept (methyl, ethyl and propyl hydroxybenzoates)
(E218, E214,
E216)
Baby Gripe Mixture is a water white to pale straw coloured syrup with
a spicy odour. It
is available in bottles containing either 100ml, 140ml or 150ml of
product.
MA HOLDER:
Northumbria Pharma Limited, Netpark, Thomas Wright Way,
Sedgefield, County Durham TS21 3FD, UK.
MANUFACTURER:
Cupal Ltd., King Street, Blackburn, BB2 2DX, UK
USES
To relieve griping pains and wind in babies
BEFORE GIVING BABY GRIPE MIXTURE
PLEASE READ THE FOLLOWING
•
Do not give to babies with heart or kidney problems, high blood
pressure or water
retention problems
•
Do not give to babies if they are sensitive to any of the ingredients
listed above
•
Do not exceed the stated dose.
•
Seek medical advice if symptoms persist or worsen.
INSTRUCTIONS FOR USE
Liquid for oral use
Babies one to six months
One 5ml spoonful to be given every four hours if necessary
Babies six months to one year
Two 5ml spoonfuls to be given every four hours if necessary
This product is not recommended for babies under one month or over one
year.
In the event of accidental or deliberate overdose, seek medical
attention immediately.
LEAFLET TEXT FOR BABY GRIPE MIXTURE,

Summary of Product characteristics

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
FERTILITY, 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.
5
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