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THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 165 Fax: +44 (0)1159 592 565 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 29/11/2002

SPC	Boots Gripe Mixture 1 Month Plus

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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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

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient	% Quantity
Sodium Bicarbonate EP	1.0w/v

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3. PHARMACEUTICAL FORM

Liquid

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of wind and griping pains.

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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.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

Babies under one month of age or over one year of age.

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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.

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4.5 Interaction with other medicinal products and other forms of interaction

There are no clinically significant interactions.

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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.

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4.7 Effects on ability to drive and use machines

No adverse effects known

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4.8 Undesirable effects

Rarely hypersensitivity reactions

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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.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Sodium Bicarbonate has antacid properties.

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5.2 Pharmacokinetic properties

None stated.

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5.3 Preclinical safety data

Not applicable.

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