DOCUSATE SODIUM PAEDIATRIC

Posology Children: one to two 5ml spoonfuls three times daily. Dilute the medicine in a glass of flavoured drink eg fruit juice or milk. Drink the diluted medicine within 30 minutes of preparation. Infants (Over six months): one 5ml spoonful three times daily.

Dilute the medicine in a glass of flavoured drink eg fruit juice or milk. Drink the diluted medicine within 30 minutes of preparation. Adults: not appropriate for adults or elderly. For administration to adults use Typharm Docusate Sodium Paediatric Adult Solution.

For barium meals: 30 ml to be taken with meal. Method of administration Oral use.

Frequencies are defined as follows:

Very common (≥1/10); common (≥1/100 to ≤ 1/10); uncommon (≥1/1,000 to ≤ 1/100); rare (≥1/10,000 to ≤ 1/1,00); very rare (≤ 1/10,000), not known (cannot be estimated from the available data).

Gastrointestinal disorders:

Rare: diarrhoea, nausea, abdominal cramps.

Skin and subcutaneous tissue disorders:

Not known: skin rash and pruritus. There have been spontaneous reports of burning sensation in mouth and throat following the use of docusate sodium. Patients are advised to drink plenty of water or flavoured drink after taking the solution.

Reporting of suspected adverse reactions Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Docusate Sodium Paediatric should not be given to infants under six months. Prolonged use can precipitate the onset of an atonic non-functioning colon and hypokalaemia. Docusate Sodium Paediatric contains sorbitol. This medicine contains 1290 mg sorbitol in each dose (5 mL).

Sorbitol is a source of fructose so should not be given to patients who have an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Docusate Sodium Paediatric contains methyl p-hydroxybenzoate and propyl p- hydroxybenzoate. 5 mg of propyl p- hydroxybenzoate in each dose (5 ml). May cause allergic reactions (possibly delayed).

Typharm Docusate Sodium Paediatric contains aspartame. This medicine contains 15 mg of aspartame per dose (5 mL). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Docusate Sodium Paediatric contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per 5 mL dose, that is to say essentially ‘sodium-free’.

1. • in the presence of abdominal pain, intestinal obstruction, nausea or if vomiting occurs.