Summary of Product Characteristics (SmPC) - Docusate Sodium 50 mg oral solution in sachet

1 NAME OF THE MEDICINAL PRODUCT

Docusate sodium 50mg oral solution in sachet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each oral solution sachet (5ml) contains 50mg docusate sodium

Excipient(s) with known effect:

Methyl parahydroxybenzoate (E218): 5.0mg per 5ml

Propyl parahydroxybenzoate (E216): 2.5 mg per 5ml

Sodium benzoate (E211): 5.0mg per 5ml

Sorbitol 70% (E420): 1200mg per 5ml

Sodium 8.3mg 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

Adults:

2-3 sachets (10ml – 15ml / 100mg-150mg) three times a day. Take as a single dose followed by plenty of water or flavoured drink e.g. milk or orange juice. Maximum daily dose 500mg.

Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.

For barium meals: 8 sachets (400mg) to be taken with the meal.

Elderly:

There is no evidence to suggest that an adjustment of the dosage is necessary in the elderly.

Children:

For administration to children and infants over 6 months use Docusate sodium 12.5mg oral solution.

Method of administration

For oral use.

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 50 mg (5ml) oral solution is not recommended for children aged 12 years and under.

Organic disorders should be excluded prior to the administration of any laxative.

The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example:

increased intake of fluids and dietary fibre
advice on appropriate physical activity.

If laxatives are needed every day, or if there is persistent abdominal pain, consult your doctor.

Prolonged use can precipitate the onset of an atonic nonfunctioning colon and hypokalaemia.

Excipients:

Each sachet of Docusate sodium 50 mg oral solution contains 5.0 mg methyl parahydroxybenzoate and 2.5 mg propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).

Docusate sodium 50mg oral solution contains 5.0mg sodium benzoate per sachet (5ml).

This medicine contains 1200mg sorbitol per sachet. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Docusate sodium 50mg oral solution contains 83.0mg sodium per 50ml dose (maximum daily dose), equivalent to 4.2% of the WHO recommended maximum daily intake of 2g 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 benzoate (E211)

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: 50mg 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

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park, Braithwaite Street

Leeds

LS11 9XE

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00427/0326

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

24/10/2025

10 DATE OF REVISION OF THE TEXT