NURSE HARVEYS GRIPE MIXTURE
Active substance(s): SODIUM BICARBONATE
NAME OF THE MEDICINAL PRODUCT
Nurse Harvey's Gripe Mixture
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium bicarbonate BP
50 mg/5 ml
Multidose oral solution
Symptomatic relief of wind, gripe and related pain in infants.
Posology and method of administration
birth to 1 month
1 to 6 months
6 to 12 months
Repeat as required.
Do not exceed 6 doses in 24 hours given by oral
Sucrose intolerance (diabetes).
Special warnings and precautions for use
Interaction with other medicinal products and other forms of interaction
None known with this product. However, sodium bicarbonate is known to
show pharmacologic effects on certain of the following: anorexiants,
benzodiazepines, flecainide, ketoconazole, lithium, salicylates, sulfonylureas,
sympathomimetics, and tolmetin.
Fertility, Pregnancy and lactation
Effects on ability to drive and use machines
Hypernatraemia: symptoms of hypernatraemia may include drowsiness and
irritability, pyrexia, tachypnoea and hypernoea. In more severe cases of
sodium overload, signs of dehydration and convulsions may occur.
The treatment of hypernatraemia includes repair of any dehydration which
may have occurred and gradual reduction of the plasma sodium concentration.
The alkalosis, if present, will usually respond to the treatment of the
hypernatraemia. At all times intensive monitoring of the electrolytes, the
patient’s circulatory and central nervous system are necessary.
In case of severe overdosage, medical advice should be sought immediately.
Sodium bicarbonate acts on a simple acid neutralising principle. The caraway
and dill oils are carminative.
The product acts promptly on administration, reacting with digestive tract
acids. The ionic species join the normal electrolyte system.
Preclinical safety data
No clinical trials have been carried out.
List of excipients
Sodium methyl para-hydroxybenzoate
Sodium ethyl para-hydroxybenzoate
Sodium propyl para-hydroxybenzoate
2 years unopened.
4 weeks after first use
Special precautions for storage
Store below 25ºC.
Nature and contents of container
150 ml glass sloping shoulder flat bottle.
Flexband tamper evident closure (white polypropylene, wadless).
Pack size 145 ml.
Special precautions for disposal
No special instructions.
MARKETING AUTHORISATION HOLDER
Vitane Pharma Limited
49 Peregrine Close
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
07th April 1992 / 31st March 1998
DATE OF REVISION OF THE TEXT