Summary of Product Characteristics (SmPC) - Docusate Sodium 12.5 mg oral solution in sachets

1 NAME OF THE MEDICINAL PRODUCT

Docusate sodium 12.5 mg oral solution in sachets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Docusate sodium 12.5mg oral solution

Each oral solution sachet (5ml) contains 12.5 mg docusate sodium

Excipient(s) with known effect:

Methyl parahydroxybenzoate (E218): 5.0 mg per 5ml

Propyl parahydroxybenzoate (E216): 2.5 mg per 5ml

Sorbitol 70% (E420): 1200 mg per 5ml (equivalent to sorbitol 840 mg per 5ml)

Sodium 5.6mg per 5ml

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral solution in sachet.

Clear, colourless liquid with strawberry odour.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

a) To prevent and treat chronic constipation.
b) As an adjunct in abdominal radiological procedures.

4.2 Posology and method of administration

Children:

1 – 2 sachets (5ml -10ml / 12.5mg to 25mg) three times daily.

Infants (Over six months):

1 sachet (5ml / 12.5mg) three times daily.

Adults: not appropriate for adults or elderly. For administration to adults use Docusate Sodium 50mg or 100mg oral solution in sachets.

For barium meals: 6 sachets (30ml / 75mg) to be taken with meal.

Method of administration:

For oral administration.

Each sachet contains a single dose and must not be divided

Dilute the medicine in a glass of flavoured drink e.g. fruit juice or milk. Drink the diluted medicine within 30 minutes of preparation.

4.3 Contraindications

Docusate sodium solution should not be taken:

by patients with a known hypersensitivity to docusate sodium or to any of the excipients listed in section 6.1.
in the presence of abdominal pain, intestinal obstruction, nausea or if vomiting occurs.

4.4 Special warnings and precautions for use

Docusate sodium oral solution should not be given to infants under six months. Prolonged use can precipitate the onset of an atonic nonfunctioning colon and hypokalaemia.

Excipients:

Each sachet of Docusate sodium 12.5mg oral solution (5ml) contains 5.0 mg methyl parahydroxybenzoate and 2.5 mg propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).

Docusate sodium 12.5 mg oral solution contains 840mg sorbitol per sachet (5ml). Sorbitol is a source of fructose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. The additive affect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol(or fructose)) should be taken into account. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Docusate sodium 12.5 mg oral solution in sachets contains 33.4mg sodium per 30ml (maximum daily dose), equivalent to 1.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

4.5 Interaction with other medicinal products and other forms of interaction

Docusate sodium solution should not be taken concurrently with mineral oil. Anthraquinone derivatives should be taken in reduced doses, if administered with Docusate sodium as their absorption is increased.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is inadequate evidence of safety of the drug in human pregnancy, nor is there evidence from animal work that it is free from hazard, but it has been in wide use for many years without apparent ill consequence. Use in pregnancy only if the benefits outweigh the potential risks.

Breast-feeding

Docusate sodium is excreted in breast milk and should therefore be used with caution in lactating mothers.

Fertility

Animal studies did not show an effect of docusate sodium on fertility. There are no clinical data available about the effect of docusate sodium on fertility.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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 <1/1,000); 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

In rare cases of overdose excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Softeners, emollients, ATC code: A06AA02

Docusate sodium acts as a faecal softener by increasing the penetration of water and fats.

5.2 Pharmacokinetic properties

Docusate sodium exerts its effects by means of its physical surfactant properties. However, there is some evidence that it is absorbed from the gastrointestinal tract and excreted in bile.

5.3 Preclinical safety data

No relevant information additional to that contained elsewhere in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Sodium dihydrogen phosphate dihydrate (E339i)

Disodium hydrogen phosphate dihydrate (E339ii)

Glycerol (E422)

Povidone (E1201)

Sorbitol 70% (E420)

Sucralose (E955)

Citric acid (E330)

Strawberry flavour

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Docusate sodium oral solution is supplied in:

Single dose sachets made of laminated polyester/ aluminium/ low density polyethylene foil. Each sachet contains 5 ml oral solution. Each pack contains 30 single-dose sachets (strength: 12.5mg per sachet)

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

8 MARKETING AUTHORISATION NUMBER(S)

Lucis Pharma Ltd.,

Rosemont House, Yorkdale Industrial Park,

Braithwaite Street, Leeds,

LS11 9XE, UK.

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

07/08/2026

10 DATE OF REVISION OF THE TEXT