BOOTS GRIPE MIXTURE Liquid Ref.[8233] Active ingredients: Sodium bicarbonate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: The Boots Company Plc, 1 Thane Road West, Nottingham NG2 3AA

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.

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 been studied and should be avoided.

Keep all medicines out of the reach of children.

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.

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: 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.

Incompatibilities

None stated.

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