Summary of Product Characteristics (SmPC) - Docusate Sodium 100 mg oral solution in sachets
1 NAME OF THE MEDICINAL PRODUCT
Docusate sodium 100mg oral solution in sachets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral solution sachet (5ml) contains 100mg 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 (equivalent to sorbitol 840 mg per 5ml)
Sodium 10.9mg per 5ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution in sachets.
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:
100 mg (1 sachet) should be taken three times a day..
A maximum single dose of150mg may also be administered using other suitable available strengths. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.
Maximum daily dose, 5 sachets (500mg).
For barium meals: 4 sachets (400mg) to be taken before 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 in sachets.
Method of administration
For oral use. Each sachet contains a single dose and must not be divided. Take as a single dose followed by plenty of water or flavoured drink e.g. milk or orange juice.
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 100mg 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 100 mg oral solution contains 5.0 mg methyl parahydroxybenzoate and 2.5 mg propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).
Docusate sodium 100mg oral solution contains 50 mg sodium benzoate per sachet (5 ml).
This medicine contains 840 mg sorbitol per sachet (5 ml). 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 100mg oral solution (5 ml) contains 54.4 mg sodium per 25 ml dose (maximum daily dose), equivalent to 2.7% 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 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: 100mg 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, UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00427/0348
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/08/2026
10 DATE OF REVISION OF THE TEXT
21/09/2026