DOCUSOL PAEDIATRIC

Posology Children: one to two 5ml spoonfuls three times daily. g. fruit juice or milk. Drink the diluted medicine within 30 minutes of preparation. Infants (Over six months): one 5ml spoonful three times daily. g. 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 Docusol Adult Solution. For barium meals: 30ml 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.

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

Sorbitol is a source of fructose. If the patient has an intolerance to some sugars or has herediatary fructose intolerance (HFI), a rare genetic disorder, the patient must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 5 mg propyl p- hydroxybenzoate in each 5 mL dose. May cause allergic reactions (possibly delayed). Docusol Paediatric contains aspartame. This medicine contains 15 mg of aspartame per dose (5 mL).

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Docusol 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.