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 Paediatric 12.5mg/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 2. What you need to know before the patient takes Docusate Sodium Paediatric 12.5mg/5ml Oral Solution 3. How to take Docusate Sodium Paediatric 12.5mg/5ml Oral Solution 4. Possible side effects 5. How to store Docusate Sodium Paediatric 12.5mg/5ml Oral Solution 6. Contents of the pack and other information
1. WHAT DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL SOLUTION IS AND WHAT IT IS USED FOR Docusate Sodium Paediatric 12.5mg/5ml Oral Solution is one of a group of medicines called 'laxatives'. They are usually used to prevent and treat constipation. Docusate Sodium Paediatric 12.5mg/5ml Oral Solution may also be used before a stomach X ray.
2. WHAT YOU NEED TO KNOW BEFORE THE PATIENT TAKES DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL SOLUTION Do not give Docusate Sodium Paediatric 12.5mg/5ml 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 Paediatric 12.5mg/5ml Oral Solution.
- Docusate Sodium Paediatric 12.5mg/5ml 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 Paediatric 12.5mg/5ml 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 Paediatric 12.5mg/5ml Oral Solution should not be taken if the patient is already taking mineral oil. Patients already taking other laxatives called anthraquinone laxatives such as senna, will need to take reduced doses as Docusate Sodium Paediatric 12.5mg/5ml Oral Solution increases their effects. Taking Docusate Sodium Paediatric 12.5mg/5ml Oral Solution with food and drink Docusate Sodium Paediatric 12.5mg/5ml Oral Solution can be taken with food and drink. Important information about some of the ingredients of Docusate Sodium Paediatric Docusate Sodium Paediatric contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate. This medicine contains 5 mg of methyl p-hydroxybenzoate and 2.5 mg of propyl p-hydroxybenzoate in each dose (5ml). May cause allergic reactions (possibly delayed). Docusate Sodium Paediatric contains sorbitol. This medicine contains 1290 mg of sorbitol in each dose (5 ml). 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. Docusate Sodium Paediatric contains aspartame. This medicine contains 15 mg of aspartame per dose (5 ml). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Docusate Sodium Paediatric contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 5 mL dose, that is to say essentially 'sodium-free'.
How to take it
DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL SOLUTION 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 one 5ml spoonful three times a day. The recommended dose for children aged 2-12 years is one to two 5ml spoonfuls 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 six 5ml spoonfuls, 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 Paediatric 12.5mg/5ml Oral Solution than they should If the patient takes more Docusate Sodium Paediatric 12.5mg/5ml 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 Paediatric 12.5mg/5ml Oral Solution Give the patient their usual dose and then continue the normal course of treatment. Do not give 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following happen, stop taking Docusate Sodium Paediatric Oral Solution 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 the patient gets any side effects, talk to the patient's 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.
How to store it
DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL SOLUTION 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 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 Paediatric 12.5mg/5ml Oral Solution contains
- The active substance is docusate sodium (12.5mg/5ml)
- The other ingredients are sorbitol (E420), glycerol (E422), povidone, monosodium phosphate dihydrate, disodium phosphate dodecahydrate, methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), strawberry flavour, aspartame (E951) and purified water.
What Docusate Sodium Paediatric 12.5mg/5ml Oral Solution looks like and contents of the pack Docusate Sodium Paediatric 12.5mg/5ml Oral Solution is a clear liquid available in amber glass bottles of 125ml and 300ml with a plastic screw cap. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: Typharm Ltd., Unit 1, 39 Mahoney Green, Rackheath, Norwich, NR13 6JY. Manufacturer Laboratórios Basi – Industria Farmacêutica, S.A., Parque Industrial Manuel Lourenco Ferreira, Lotes 8, 15 e 16 3450-232 Mortágua, Portugal This leaflet was last revised in October 2023
2/DSP/05/2310/821.v4
Frequently asked questions about Docusate Sodium Paediatric 12.5mg/5ml Oral Solution
How do I take Docusate Sodium Paediatric 12.5mg/5ml Oral Solution?
Docusate Sodium Paediatric 12.5mg/5ml Oral Solution comes as oral 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.
What is the active substance in Docusate Sodium Paediatric 12.5mg/5ml Oral Solution?
The active substance in Docusate Sodium Paediatric 12.5mg/5ml Oral Solution is docusate sodium.
Are there equivalent medicines to Docusate Sodium Paediatric 12.5mg/5ml Oral Solution?
Medicines with the same active substance, strength and form include: Docusol Paediatric 12.5 mg/5 ml 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 Paediatric 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.
Can I get Docusate Sodium Paediatric 12.5mg/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
Children: one to two 5ml spoonfuls three times daily. Dilute the medicine in a glass of flavoured drink e.g. fruit juice or milk. Drink the diluted medicine within 30 minutes of preparation.
Infants (Over six months): one 5ml spoonful three times daily. Dilute the medicine in a glass of flavoured drink e.g. 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 Docusol Adult Solution.
For barium meals: 30ml to be taken with meal.
Method of administration
Oral use.
4.3. Contraindications
Docusol 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
Docusol Paediatric should not be given to infants under six months. Prolonged use can precipitate the onset of an atonic non-functioning colon and hypokalaemia.
Docusol Paediatric contains sorbitol.
This medicine contains 1290 mg sorbitol in each dose (5 mL). Sorbitol is a source of fructose. If the patient has an intolerance to some sugars or has herediatary fructose intolerance (HFI), a rare genetic disorder, the patient must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Docusol Paediatric contains 5 mg methyl p-hydroxybenzoate and 2.5 mg propyl p-hydroxybenzoate in each 5 mL dose.
May cause allergic reactions (possibly delayed).
Docusol Paediatric contains aspartame.
This medicine contains 15 mg of aspartame per dose (5 mL). Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Docusol Paediatric contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per 5 mL dose, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Docusol solution should not be taken concurrently with mineral oil. Anthraquinone derivatives should be taken in reduced doses, if administered with Docusol 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.
Breastfeeding
Docusate sodium is excreted in breast milk and should therefore be used with caution in lactating mothers.
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 ≤ 1/1,00); 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 Paediatric 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.