Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Docusate sodium 50mg/5ml oral solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Docusate sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Docusate sodium 50mg/5ml oral solution belongs to 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.
What you need to know before you take it
e Docusate sodium oral solution
Use before stomach X-ray: When taken before a stomach X-ray, the dose is 40ml, as a single dose. Docusate sodium may cause an unpleasant aftertaste or burning sensation.This may be minimised by drinking plenty of water after taking the solution. If you take more Docusate sodium Oral Solution than you should If you accidentally take more Docusate sodium oral solution than you should, drink lots of water and contact your nearest hospital casualty department, or tell your doctor immediately. If you forget to take Docusate sodium oral solution As soon as you remember, take a 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.
How to take it
Docusate sodium oral solution Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. Constipation: The recommended dose is 10-15ml three times a day. Take as a single dose followed by plenty of water or flavoured drink e.g. milk or orange juice.The maximum daily dose is 50ml. Reduce the dose as the condition improves. D7P4SRBJ1 V5
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JOB INFORMATION
ARTWORK VERSION:
5
Date:
13.05.2024 Operator:
SBL
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Docusate Sodium 50mg/5mL Oral Solution
Dimensions: 420 x 190mm
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50mg/5mL 300ml Bottle Size: 300ml Design Icon: N/A
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D7P4SRBJ1 CLS-26-00150 CLS-26-00166 CR-00849
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Possible side effects
Do not take Docusate sodium oral solution ■ if you are allergic to docusate sodium or any of the other ingredients of this medicine (listed in section 6). ■ if you are suffering from stomach pains or an obstruction in the gut ■ if you are feeling sick or have been sick in the last 24 hours. Warnings and precautions Talk to your doctor or pharmacist before taking Docusate sodium oral solution ■ This medicine is not suitable for children aged 6 months to 12 years but a suitable alternative, Docusate sodium 12.5mg/5ml oral solution is available. ■ Prolonged use can cause the gut to become lazy and not work properly. ■ If you need to take a laxative everyday. ■ If you have regular or constant stomach pain. Other health conditions should be excluded before taking this medicine.The treatment of constipation with Docusate sodium is only additional to a healthy lifestyle and diet (such as increased intake of fluids, dietary fibre and exercise). Other medicines and Docusate sodium oral solution Tell your doctor or pharmacist if you are 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. If you are taking an anthraquinone laxative such as senna, you will need to reduce the dose 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 5ml oral solution. May cause allergic reactions (possibly delayed). Docusate sodium oral solution contains sorbitol. This medicine contains 840mg of sorbitol in 5ml oral solution. 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. Docusate sodium oral solution contains sodium benzoate. This medicine contains 5 mg sodium benzoate in 5ml oral solution. Sodium content. Docusate sodium 50mg/5ml oral solution contains 57.5 mg sodium (main component of cooking/table salt) per 50 ml dose (maximum daily dose).This is equivalent to 2.9% of the recommended maximum daily dietary intake of sodium for an adult.
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 you need to take a laxative every day, or if you have a persistent stomach ache, see your 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 you notice any side effects not listed in this leaflet, please tell your 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 theYellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRAYellow 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.
How to store it
Docusate sodium Oral Solution 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.
Contents of the pack and other information
What Docusate sodium Oral Solution contains ■ The active substance is docusate sodium ■ The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium benzoate (E211), sodium dihydrogen phosphate dihydrate (E339i), disodium hydrogen phosphate dihydrate (E339ii), glycerol (E422), kollidon 90F (E1201), sorbitol 70% (E420), sucralose (E955), citric acid (E330), strawberry flavor and purified water What Docusate sodium Oral Solution looks like and contents of the pack Docusate sodium 50mg/5ml 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 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 2024.
Frequently asked questions about Docusate sodium 50mg/5ml oral solution
How do I take Docusate sodium 50mg/5ml oral solution?
Docusate sodium 50mg/5ml oral solution comes as oral solution containing 50mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Docusate sodium 50mg/5ml oral solution?
The active substance in Docusate sodium 50mg/5ml oral solution is docusate sodium.
Are there equivalent medicines to Docusate sodium 50mg/5ml oral solution?
Medicines with the same active substance, strength and form include: Docusate Sodium Adult 50mg/5ml Oral Solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Docusate sodium 50mg/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.
Can I get Docusate sodium 50mg/5ml oral solution without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: docusate sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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
Posology
Adults: 100mg (10ml) to 150mg (15ml) 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 (50ml).
Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.
For barium meals: 400mg (40ml) to be taken with the meal.
Elderly: There is no evidence to suggest that an adjustment of the dosage is necessary in the elderly.
Paediatric population
Children: For administration to children and infants over 6 months use Docusate sodium 12.5mg/5ml.
Method of administration
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 50mg/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 non-functioning colon and hypokalaemia.
Docusate sodium oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).
This medicine contains 10.0mg sodium benzoate in each 10ml dose.
This medicine contains 1680.0mg sorbitol in each 10ml 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 57.5 mg sodium per 50 ml dose (maximum daily dose), equivalent to 2.9% 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.
💬 Ask about this leaflet
Ask anything about Docusate sodium 50mg/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.