1. Name Of The Medicinal Product
Children's Gripe Mixture or Gripe Mixture or Infant Sugar Free Gripe Mixture or Children's 1 Month Plus Gripe Mixture or Boots Gripe Mixture 1 Month Plus
2. Qualitative And Quantitative Composition
|
|
|
|
3. Pharmaceutical Form
Liquid
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of wind and griping pains.
4.2 Posology And Method Of Administration
Babies up to 1 month: Not Recommended.
Infants 1 - 6 months: 5ml. Infants 6 months - 1 Year: 10ml.
The above doses may be repeated before or after each feed up to six times in 24 hours if needed.
Not recommended for children over 1 year.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
Babies under one month of age or over one year of age.
4.4 Special Warnings And Precautions For Use
Keep all medicines out of the reach of children.
Not to be given to babies under one month of age or over 1 year.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There are no clinically significant interactions.
4.6 Pregnancy And Lactation
The safety of this medicine during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known
4.8 Undesirable Effects
Rarely hypersensitivity reactions
4.9 Overdose
Overdosage with this medicine may give rise to the symptoms of hypernatraemia, which 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 of hypernatraemia includes repair of any dehydration present and the gradual reduction of plasma sodium. The alkalosis, if present, will respond usually to the treatment of Hypernatraemia. At all times, intensive monitoring of electrolytes and patient's circulation and central nervous system is essential.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Sodium Bicarbonate has antacid properties.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lycasin 80/55 Roquette
Glycerol
Sodium citrate
Domiphen bromide
Apple flavour 5112O1E
Purified water
Carbon dioxide
6.2 Incompatibilities
None stated
6.3 Shelf Life
24 months unopened
12 weeks after opening
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
A clear polythene terephthalate bottle with a polypropylene child resistant closure fitted with an expanded polyethylene liner.
Pack size: 100ml, 150ml, 200ml
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
The Boots Company Plc
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL 00014/5236
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of First Authorisation: 24 October 1990
Date of Last Renewal: 20 February 1996
10. Date Of Revision Of The Text
November 2001.
No comments:
Post a Comment