Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for 2. What you need to know before you take Docusate Sodium Adult 50mg/5ml Oral Solution
E DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION Do not take Docusate Sodium Adult 50mg/5ml Oral Solution
Warnings and precautions Talk to your doctor or pharmacist before taking Docusate Sodium Adult 50mg/5ml Oral Solution
This medicine contains 5 mg of methyl p-hydroxybenzoate and 2.5 mg of propyl p-hydroxybenzoate in each dose (5 ml). May cause allergic reactions (possibly delayed).
Docusate Sodium Adult 50mg/5ml Oral Solution contains sorbitol. This medicine contains 1290 mg of sorbitol in each dose (5 ml). Sorbitol is a source of fructose. If your doctor has told you that you (or your child) has an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Docusate Sodium Adult 50mg/5ml Oral Solution 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.
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 two to three 5ml spoonfuls 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 ten 5ml spoonfuls (50ml). Reduce the dose as the condition improves. Use before stomach X-ray: When taken before a stomach X-ray, the dose is eight 5ml spoonfuls, 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 Adult 50mg/5ml Oral Solution than you should If you accidentally take more Docusate Sodium Adult 50mg/5ml 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 Adult 50mg/5ml 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.
4. 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 Adult 50mg/5ml Oral Solution and tell your doctor as soon as possible: Rare: may affect up to 1 in 1,000 people
Docusate Sodium Adult 50mg/5ml Oral Solution 4. Possible side effects 5. How to store Docusate Sodium Adult 50mg/5ml Oral Solution 6. Contents of the pack and other information
1. WHAT DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION IS AND WHAT IT IS USED FOR Docusate Sodium Adult 50mg/5ml Oral Solution is one of a group of medicines called 'laxatives'. They are usually used to prevent and treat constipation. Docusate Sodium Adult 50mg/5ml Oral Solution may also be used before a stomach X-ray.
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.
DOCUSATE SODIUM ADULT 50MG/5ML 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.
What Docusate Sodium Adult 50mg/5ml Oral Solution contains
2/DSA/05/2310/819.v5
Docusate Sodium Adult 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.
The active substance in Docusate Sodium Adult 50mg/5ml Oral Solution is docusate sodium.
Medicines with the same active substance, strength and form include: Docusate sodium 50mg/5ml oral solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Docusate Sodium Adult 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.
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
Posology
Adults: 10ml to 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 50ml.
Treatment should be commenced with large doses which should be decreased as the condition of the patient improves.
For barium meals: 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 Docusol Paediatric Solution 0.25% w/v.
Method of administration
Oral use.
Docusate Sodium Adult 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.
Paediatric population
Docusate Sodium Adult is not recommended for children aged 12 years and under.
Prolonged use can precipitate the onset of an atonic non-functioning colon and hypokalaemia.
Docusate Sodium Adult Solution contains sorbitol. This medicine contains 1290 mg sorbitol in each 5 mL dose. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Docusate Sodium Adult Solution 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 (5 mL). May cause allergic reactions (possibly delayed).
Docusate Sodium Adult Solution contains aspartame. This medicine contains 15 mg aspartame in each 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 Adult Solution contains sodium benzoate. This medicine contains 5 mg sodium benzoate in each dose (5 mL).
Docusate Sodium Adult contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per 5 mL dose, that is to say essentially 'sodium-free'.
Docusate Sodium Adult Solution should not be taken concurrently with mineral oil. Anthraquinone derivatives should be taken in reduced doses, if administered with Docusate Sodium Adult 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.
Breastfeeding
Docusate sodium is excreted in breast milk and should therefore be used with caution in lactating mothers.
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 ≤ 1/1,00); 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.
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 Adult 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.
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