Nurse Harveys Gripe mixture

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium bicarbonate

Available from:

Harvey-Scruton 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; GTIN: 5012385010012

Patient Information leaflet

Before use, check that the
plastic security seal on the
bottle cap is intact. A slight
colouration of contents is
harmless.
NOT RECOMMENDED FOR
INFANTS UNDER 1 MONTH.
DOSES:
1 month to 6 months
● 5 ml (1 teaspoon)
6 months to 12 months
● 10 ml (2 teaspoons)
Give one dose during or just
after a feed.
Do not exceed 6 doses
in 24 hours.
If symptoms persist
consult your doctor.
This product contains 14.5g
of SUCROSE (a type of
sugar). If your baby has an
intolerance to some sugars,
do not give this medicine
without first consulting your
doctor.
NOT SUITABLE FOR
DIABETICS.
DO NOT GIVE TO BABIES
ON A SALT-RESTRICTED
DIET.
This product also contains
PROPYL, METHYL AND ETHYL
HYDROXYBENZOATES, which
may cause allergic reactions
(possibly delayed), and
exceptionally, bronchospasm.
If your baby seems unwell
after taking this medicine
consult your doctor.
Active ingredient
Sodium bicarbonate BP 1% w/v.
Dill oil BP,
Caraway oil BP,
Sucrose BP,
E215 (ethylhydroxybenzoate),
E217 (propylhydroxybenzoate),
E219 (methyl p-hydroxybenzoate)
KEEP OUT OF REACH
AND SIGHT OF
CHILDREN
Store in carton below 25°C
and do not use after the expiry
date shown on the top flap of
this carton.
Use within 4 weeks of first
opening bottle
Contents 145ml
Made in the UK
for the Product Licence Holder
Vitane Pharma Limited
49 Peregrine Close
Watford
WD25 9AP
UK
PL 46809/0001
Text last revised
September 2016
QUICKLY RELIEVES
BABY’S WIND,
GRIPE PAINS
AND TUMMY
UPSETS
QUICKLY RELIEVES
BABY’S WIND,
GRIPE PAINS
AND TUMMY
UPSETS
ALCOHOL FREE
SODIUM BICARBONATE
SOLUTION
ALCOHOL FREE
SODIUM BICARBONATE
SOLUTION

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurse Harvey's Gripe Mixture
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium bicarbonate BP 50 mg/5 ml
3
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. Do not exceed 6 doses in 24 hours given by oral
administration.
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 dige