Quoted from the official patient leaflet (emc). Always follow your doctor or pharmacist.
Docusate sodium 12.5mg/5ml oral solution is one of a group of medicines called ‘laxatives’. They are usually used to prevent and treat constipation. They may also be used before a stomach X-ray.
Do not give Docusate sodium oral solution • if the patient is allergic to docusate sodium or any of the other ingredients of this medicine (listed in section 6).
• if the patient is suffering from stomach pains or an obstruction in the gut.
• if the patient is feeling sick or has been sick in the last 24 hours.
Warnings and precautions Talk to the patient’s doctor or pharmacist before the patient starts taking Docusate sodium oral solution
• Docusate sodium oral solution should not be given to infants under the age of 6 months.
• Prolonged use can cause the gut to become lazy and not work properly.
Other medicines and Docusate sodium oral solution Tell the patient’s doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines.
Docusate sodium oral solution should not be taken if you are already taking mineral oil. Patients already taking other laxatives called anthraquinone laxative such as senna, will need to take reduced doses as Docusate sodium oral solution increases their effects.
Taking Docusate sodium oral solution with food and drink Docusate sodium oral solution can be taken with food and drink.
Pregnancy and breast-feeding Do not use Docusate sodium oral solution if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Important information about some of the ingredients of Docusate sodium oral solution Docusate sodium oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
This medicine contains 5mg of methyl p-hydroxybenzoate and 2.5 mg of propyl p-hydroxybenzoate in each dose (5ml). May cause allergic reactions (possibly delayed).
Docusate sodium oral solution contains sorbitol.
This medicine contains 840mg of sorbitol in each dose (5ml). Sorbitol is a source of fructose. If the patient’s doctor has told you that the patient has an intolerance to some sugars or if the patient has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to a doctor before the patient takes this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Sodium content.
This medicinal product contains 29.7mg sodium (main component of cooking/table salt) per 30ml (maximum daily dose).This is equivalent to 1.5% of the recommended maximum daily intake of sodium for an adult.
Docusate sodium oral solution contains propylene glycol.
This medicine contains 3.7 mg propylene glycol in each 5ml dose. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Always take this medicine exactly as described in this leaflet or as the patient’s doctor or pharmacist have told you. Check with the patient’s doctor or pharmacist if you are not sure.
Constipation: The recommended dose for infants aged over 6 months is 5ml three times a day.
The recommended dose for children aged 2-12 years is 5ml to 10 ml three times a day.
Dilute the medicine in a glass of flavoured drink such as fruit juice or milk and give to the patient to drink within 30 minutes of preparation. This medicine should not be given to infants under the age of 6 months. Reduce the dose as the condition improves.
Use before stomach X-ray: When taken before a stomach X-ray the dose is 30ml, as a single dose. Docusate sodium may cause an unpleasant aftertaste or burning sensation. This may be minimised by drinking plenty after taking the solution.
If the patient takes more Docusate sodium oral solution than you should If the patient takes more Docusate sodium oral solution than they should, the patient should drink lots of water.
The nearest hospital casualty department should be contacted or the patient’s doctor must be informed immediately.
If the patient forgets to take Docusate sodium oral solution Give the patient their usual dose and then continue the normal course of treatment. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask the doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following happen, stop taking Docusate sodium and tell your doctor as soon as possible:
Rare: may affect up to 1 in 1,000 people
• Diarrhoea
• Feel sick
• Stomach cramps
Not known: frequency cannot be estimated from the available data
• Skin rash
• Pruritus (Itching)
If the patient needs to take a laxative every day, or if the patient has a persistent stomach ache, they must see their doctor.
Docusate sodium may cause an unpleasant aftertaste or burning sensation. This may be minimised by drinking plenty of water after taking the solution. If any of the side effects gets serious, or if the patient notices any side effects not listed in this leaflet, please tell the patient’s doctor or pharmacist.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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.
By reporting side effects you can help provide more information on the safety of this medicine.
This medicinal product does not require any special storage condition. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date that is stated on the bottle label and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Docusate sodium Oral Solution contains • The active substance is docusate sodium (12.5mg/5ml)
• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium dihydrogen phosphate dihydrate (E339i), disodium hydrogen phosphate dihydrate (E339ii), glycerol (E422), kollidon 90F (E1201), sorbitol 70% (E420), sucralose (E955), citric acid (E330), strawberry flavour (contains propylene glycol) and purified water
What Docusate sodium Oral Solution looks like and contents of the pack Docusate sodium oral solution is a clear, colorless to pale yellow, viscous solution with strawberry odor available in an amber glass bottle of 300ml with a plastic screw cap. It comes with a dosing cup with 2.5 / 5 / 10 / 15 ml graduations.
Marketing Authorisation Holder Rosemont Pharmaceuticals Ltd.
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
United Kingdom
Manufacturer LABOMED PHARMACEUTICAL COMPANY S.A.
84 Ioannou Metaxa str.
19441
Koropi
Athens
Greece
This leaflet was last revised in May 2026
D2H4SRBJ1
V4
CLS-26-00172
Docusate Sodium 12.5mg/5mL Oral Solution comes as solution containing 12.5mg/5mL. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Docusate Sodium 12.5mg/5mL Oral Solution is docusate sodium.
This leaflet reproduces the patient information leaflet approved for Docusate Sodium 12.5mg/5mL Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
a) To prevent and treat chronic constipation b) As an adjunct in abdominal radiological procedures
For oral administration Children: 12.5mg (5ml) to 25mg (10ml) 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): 12.5mg (5ml) 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 Docusate Sodium 50mg/5ml or 100mg/5ml oral solution. For barium meals: 75mg (30ml) to be taken with meal.
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.
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. Docusate sodium oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed). This medicine contains 840.0mg sorbitol in each 5ml dose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not be given this medicinal product. This medicinal product contains 29.7mg sodium per 30ml (maximum daily dose), equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Docusate sodium oral solution contains propylene glycol. This medicine contains 3.7 mg propylene glycol in each 5ml dose. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
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.
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. Lactation 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.
None known
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.
In rare cases of overdose excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid.
Ask anything about Docusate Sodium 12.5mg/5mL Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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