BOOTS GRIPE MIXTURE Liquid (2014)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Childrens Gripe Mixture or Gripe Mixture or Infant Sugar Free Gripe Mixture or Childrens 1 Month Plus Gripe Mixture or Boots Gripe Mixture 1 Month Plus.
Qualitative and quantitative composition
Active ingredient % Quantity Sodium Bicarbonate EP 1.0 w/v
Pharmaceutical form
Liquid.
Therapeutic indications
For the relief of wind and griping pains.
Posology and method of administration
For oral administration. <u>Babies up to 1 month:</u> Not Recommended. <u>Infants 1-6 months:</u> 5ml. <u>Infants 6 months-1 Year:</u> 10ml. The above doses may be repeated before or after each feed up ...
Contraindications
Hypersensitivity to sodium bicarbonate, or any of the ingredients. Metabolic or respiratory alkalosis Hypocalcaemia Hypochlorhydria Patients on low sodium diets Congestive heart failure Oedema/fluid retention ...
Special warnings and precautions for use
Do not exceed the recommended dose as excess use may lead to alkalosis. This medicine should be given to the child to swallow before or after feeds. Inclusion of this medicine in feeds or bottles has not ...
Interaction with other medicinal products and other forms of interaction
The effect of oral bicarbonate compounds in raising intra-gastric pH may reduce or increase the rate and/or extent of absorption of a number of medicines. Alkalinisation of the urine leads to increased ...
Pregnancy and lactation
The safety of sodium bicarbonate during pregnancy and lactation has not been established but its use during these periods is not considered to constitute a hazard.
Effects on ability to drive and use machines
No adverse effects known.
Undesirable effects
Immune system disorders: Rarely hypersensitivity reactions including skin rash Gastrointestinal disorders: Stomach cramps, belching, flatulence, vomiting General disorders and administration site conditions: ...
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 ...
Pharmacodynamic properties
Sodium Bicarbonate has antacid properties.
Pharmacokinetic properties
Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. Any bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate ...
Preclinical safety data
Not applicable.
List of excipients
Maltitol liquid Glycerol Sodium citrate Domiphen bromide Apple flavour 5112O1E Purified water Carbon dioxide
Incompatibilities
None stated.
Shelf life
24 months unopened. 12 weeks after opening.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
A clear polythene terephthalate bottle with a polypropylene child resistant closure fitted with an expanded polyethylene liner. Pack size: 150ml
Special precautions for disposal and other handling
None.
Marketing authorization holder
The Boots Company Plc, 1 Thane Road West, Nottingham NG2 3AA
Marketing authorization number(s)
PL 00014/5236R
Date of first authorization / renewal of the authorization
Date of First Authorisation: 24 October 1990 Date of Last Renewal: 20 February 1996
Date of revision of the text
February 2014
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