Document: document 0 change

• document 0
• document 1
• document 2
• document 3

---

SUMMARY OF PRODUCT CHARACTERISTICS

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

Active ingredient    % Quantity

Sodium Bicarbonate EP    1.0 w/v

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

For oral administration.

Babies up to 1 month: Not Recommended.

Infants 1 - 6 months: 5 ml.

Infants 6 months - 1 year: 10 ml.

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.

4.3    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

Hypertension/Eclampsia

Impaired renal function

Cirrhosis of the liver

Aldosteronism

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

4.4    Special warnings and precautions for use

Do not exceed the recommended dose as excess use may lead to alkalosis.

The medicine should be given to the child to swallow before or after feeds. Inclusion of this medicine in feeds or bottles has not been studied and should be avoided.

Keep all medicines out of the reach of children.

4.5    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 renal clearance of acidic drugs such as salicylates, tetracyclines and barbiturates. Conversely, it prolongs the half life of basic drugs.

Sodium bicarbonate enhances lithium excretion.

4.6 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.

4.7 Effects on ability to drive and use machines

No adverse effects known

4.8    Undesirable effects

Immune system disorders: Rarely hypersensitivity reactions including skin rash

Gastrointestinal disorders: Stomach cramps, belching, flatulence, vomiting

General disorders and administration site conditions: Malaise

Metabolism and nutrition disorders: Excessive use may lead to hypernatraemia and hyperosmolality, hypokalaemia and metabolic acidosis, especially in patients with impaired renal function.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

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 in the plasma, bicarbonate ions are excreted in the urine that is rendered alkaline and there is an accompanying diuresis.

5.3    Preclinical safety data

Not applicable.

6.1    List of excipients

Maltitol liquid 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: 150 ml.

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

The Boots Company Plc 1 Thane Road West