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
Dioctyl contains the active substance docusate sodium, it is one of a group of medicines called 'laxatives'. They are usually taken to prevent and treat constipation that has lasted for a long time. It may also be taken during certain types of stomach X-rays, or to help you go to the toilet if you have piles (haemorrhoids).
2.
e Dioctyl
Do not take Dioctyl: • 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 • if you are feeling sick, or have been sick in the last 24 hours • if you have a blocked bowel (intestinal obstruction) • if you have been told you are unable to take a sugar called fructose. Dioctyl contains sorbitol and is therefore unsuitable for you. Warnings and precautions Talk to your doctor or pharmacist before taking Dioctyl: • if you need to take a laxative every day • if you have regular or constant stomach pain. Other health conditions should be excluded before taking this medicine. The treatment of constipation with Dioctyl is only additional to a healthy lifestyle and diet (such as increased intake of fluids, dietary fibre and exercise). Other medicines and Dioctyl:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are taking any of the following medicines: • Mineral oil • Any other medicine, including medicines obtained without a prescription.
Dioctyl with food and drink Dioctyl can be taken with or without food. Pregnancy and breast-feeding 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. Pregnancy The safety of Dioctyl during pregnancy has not yet been proven. Breast-feeding Docusate sodium is excreted in breast milk and should therefore, be used with caution in breastfeeding mothers. Dioctyl contains sorbitol, sunset yellow (E110) and Propylene glycol
Dioctyl
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose in adults and adolescents (12 years and older) is: • Maximum dose is 5 capsules although you may need less • Take your capsules one at a time at regular intervals throughout the day • Swallow Dioctyl capsules whole with a drink of water • Reduce the dose as your condition gets better • If you have been told to take Dioctyl during a stomach X-ray, you should take four capsules. Your doctor will tell you exactly when to take the capsules. Use in children aged 0 to 11 years: Dioctyl is not suitable for children under 12 years of age. If you take more Dioctyl than you should: If you take more Dioctyl than you should, drink lots of water and immediately go to your doctor or the nearest hospital casualty department. If you forget to take Dioctyl: Do not take a double dose to make up for a forgotten dose. If you stop taking Dioctyl: If you have any further questions on the use of this medicines, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Dioctyl 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) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.
5.
Dioctyl
Keep this medicine out of the sight and reach of children. Do not use after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Store below 25°C. Store in the original package in order to protect from moisture. 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 protect the environment.
6.
What Dioctyl contains Each capsule contains 100 mg docusate sodium. The other ingredients are: macrogol 400, propylene glycol, gelatin 175 bloom, purified water, glycerol, sorbitol, titanium dioxide (E171), quinoline yellow (E104), sunset yellow (E110), lecithin, isopropyl alcohol and medium-chain triglycerides. What Dioctyl looks like and contents of the pack Dioctyl are yellow and white soft, oval capsules. Dioctyl is available in blister packs containing 10, 20, 30, 40 or 50 capsules and in plastic containers with 30 or 100 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Teofarma S.r.l. Via Fratelli Cervi 8. Valle Salimbene. PV. 27010. Italy This leaflet was last revised in August 2023. If this leaflet is difficult to read and you would like it in a different format, please contact Teofarma S.r.l. Via Fratelli Cervi 8. Valle Salimbene. PV. 27010. Italy.
Dioctyl 100 mg Capsules comes as capsule containing 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Dioctyl 100 mg Capsules is docusate sodium.
Medicines with the same active substance, strength and form include: Dulcoease 100 mg Capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Dioctyl 100 mg Capsules, 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.
(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and
(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.
b) As an adjunct in abdominal radiological procedures.
Posology
Adults:
Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.
For use with barium meals:
400 mg to be taken with the meal.
Elderly:
As for adults.
Paediatric population:
The safety and efficacy of Dioctyl in children aged 0 to 11 years have not yet been established. No data are available.
Method of administration
For oral use.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Dioctyl should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.
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.
Excipients
Fructose intolerance:
This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Excipients which may cause allergic reactions:
This product contains sunset yellow (E110) which may cause allergic reactions.
Dioctyl should not be taken concurrently with mineral oil.
Pregnancy
There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported.
Use in pregnancy only if the benefits outweigh the risks.
Breast-feeding
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 <1/1,000); 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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions 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. Electrolyte loss should be replenished where appropriate.
Ask anything about Dioctyl 100 mg Capsules. 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.