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NURSE HARVEYS GRIPE MIXTURE

Active substance(s): SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nurse Harvey's Gripe Mixture

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium bicarbonate BP

3

50 mg/5 ml

PHARMACEUTICAL FORM
Multidose oral solution

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Symptomatic relief of wind, gripe and related pain in infants.

4.2

Posology and method of administration
Babies :
birth to 1 month
not recommended
1 to 6 months
5 ml
6 to 12 months
10 ml
Repeat as required.
administration.

Do not exceed 6 doses in 24 hours given by oral

4.3

Contraindications
Sucrose intolerance (diabetes).

4.4

Special warnings and precautions for use
Not known.

4.5

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.

4.6

Fertility, Pregnancy and lactation
Not applicable.

4.7

Effects on ability to drive and use machines
No effect.

4.8

Undesirable effects
Not known.

4.9

Overdose
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Sodium bicarbonate acts on a simple acid neutralising principle. The caraway
and dill oils are carminative.

5.2

Pharmacokinetic properties
The product acts promptly on administration, reacting with digestive tract
acids. The ionic species join the normal electrolyte system.

5.3

Preclinical safety data
No clinical trials have been carried out.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Caraway oil
Dill oil
Sodium methyl para-hydroxybenzoate
Sodium ethyl para-hydroxybenzoate
Sodium propyl para-hydroxybenzoate
Sucrose

6.2

Incompatibilities
Not known.

6.3

Shelf life
2 years unopened.
4 weeks after first use

6.4

Special precautions for storage
Store below 25ºC.

6.5

Nature and contents of container
150 ml glass sloping shoulder flat bottle.
Flexband tamper evident closure (white polypropylene, wadless).
Pack size 145 ml.

6.6

Special precautions for disposal
No special instructions.

7

MARKETING AUTHORISATION HOLDER
Vitane Pharma Limited
49 Peregrine Close
Watford
WD25 9AP
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 46809/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07th April 1992 / 31st March 1998

10

DATE OF REVISION OF THE TEXT
01/12/2016

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