Gripe Mixture
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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 Special Precautions for Use
Not known.
4.5. Interactions 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. 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. Pre-clinical 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 25°C.
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. Instructions for Use/Handling
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Harvey Scruton Ltd North Lane/Malton Road York
YO32 9SU
8. MARKETING AUTHORISATION NUMBER(S)
PL 00968/0002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
07th April 1992 / 31st March 1998
10. DATE OF (PARTIAL) REVISION OF THE TEXT
December 2004