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.

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Dulcoease 100 mg Capsules

⚠ 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.

Active substance: Docusate sodium

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What you need to know before you take it

e DulcoEase Capsules

What DulcoEase is DulcoEase contains the active substance docusate sodium. This medicine is a laxative. It belongs to a group of medicines called 'stool softeners'.

  • DulcoEase is used to treat constipation in adults and children 12 years and over

Do not take DulcoEase if:

  • You have stomach pains
  • You feel sick or have been sick in the last 24 hours
  • You have a blockage in your intestine (intestinal obstruction)
  • You are allergic to docusate sodium or any of the other ingredients of this medicine (listed in Section 6)
  • You are intolerant to any sugars such as fructose or sorbitol. DulcoEase contains a small amount of sorbitol
  • You are taking a mineral oil laxative such as liquid paraffin Do not take this medicine if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before taking this medicine.

How DulcoEase works DulcoEase softens the stools (faeces).

  • It does this by increasing the amount of water within the stools (faeces)
  • This makes your bowel movements easier It helps you when:
  • You are constipated
  • You have piles
  • You have a tear in the lining of your anus (anal fissure) What is constipation? Normal and regular bowel movement is important for most people. However, what is 'normal and regular' varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern.

Warnings and precautions As with all laxatives, do not take DulcoEase every day for a long time. Talk to your pharmacist or doctor if:

  • You end up taking DulcoEase every day
  • You get stomach pain which does not go away If any of the above applies to you (or you are not sure), talk to your pharmacist or doctor.

PATLT01-2

Other medicines and DulcoEase Tell your pharmacist or doctor if you are taking, have recently taken or might take any other medicines. Do not take DulcoEase together with a mineral oil laxative such as liquid paraffin. 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 pharmacist or doctor for advice before taking this medicine. DulcoEase contains Sorbitol, Sunset Yellow (E110), Propylene glycol and Sodium

  • This medicine contains approximately 19.3 mg of sorbitol in each 100mg capsule which is equivalent to 1.38mg/kg. 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.
  • DulcoEase contains the colouring Sunset Yellow E110. This may cause an allergic reaction
  • This medicine contains 11.5 mg propylene glycol in each capsule which is equivalent to 0.49mg/kg.
  • This medicine contains less than 1mmol sodium per capsule, that is to say essentially 'sodium free'. 3. How to take DulcoEase Capsules Always take this medicine exactly as described in this leaflet or as your pharmacist or doctor has told you. Check with your pharmacist or doctor if you are not sure. How much to take Adults and children 12 years and over
  • The recommended dose is to start with one capsule 3 times a day. Then take more or less if you need to
  • Do not take more than one capsule 5 times a day Do not give DulcoEase to children under 12 years of age. You should feel more comfortable within 1 to 2 days of treatment. Talk to your pharmacist or doctor if you end up taking DulcoEase every day.

How to take it

Swallow each capsule whole with water. If you take more DulcoEase than you should If you take more DulcoEase than you should, drink lots of water. Then see a doctor or go to the nearest hospital casualty department straight away.

Possible side effects

Like all medicines, DulcoEase can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Talk to your doctor or pharmacist if you get any of the side effects listed below: Rare: affects fewer than 1 in 1,000 people

  • Feeling sick (nausea)
  • Diarrhoea
  • Stomach cramps Not known: frequency cannot be estimated from the available data
  • Skin rash
  • Pruritus (itching) Talk to your doctor or pharmacist if you get any of the side effects listed above. 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.

How to store it

DulcoEase Capsules

  • Keep this medicine out of the sight and reach of children
  • Do not use this medicine after the expiry date which is stated on the carton and blister label after EXP. The expiry date refers to the last date of that month
  • Do not store above 25°C
  • Store in the original package in order to protect from moisture
  • Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

Contents of the pack and other information

What DulcoEase contains

  • The active substance is docusate sodium. Each capsule contains 100 mg of docusate sodium
  • The other ingredients are: macrogol 400, propylene glycol, gelatin, glycerol, sorbitol (E420), titanium dioxide (E171), water, sunset yellow (E110), and quinoline yellow (E104) What DulcoEase Capsules look like and contents of the pack DulcoEase 100 mg Capsules are yellow and white coloured soft, oval capsules. They are available in blister packs of 10, 30 and 60 capsules. The Marketing Authorisation is held by: Sanofi 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom Tel:0800 035 2525 Email: [email protected] DulcoEase Capsules are manufactured at: Patheon Softgels B.V. De Posthoornstraat 7 5048 AS Tilburg, Netherlands. This leaflet was revised in May 2024 ® Registered trade mark For electronic version of this leaflet scan the QR code. This paper leaflet might not be the latest version and thus different to the electronic leaflet which is the last updated version available.

MORE INFO

Frequently asked questions about Dulcoease 100 mg Capsules

How do I take Dulcoease 100 mg Capsules?

Dulcoease 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.

What is the active substance in Dulcoease 100 mg Capsules?

The active substance in Dulcoease 100 mg Capsules is docusate sodium.

Are there equivalent medicines to Dulcoease 100 mg Capsules?

Medicines with the same active substance, strength and form include: Dioctyl 100 mg Capsules. 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 Dulcoease 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.

Can I get Dulcoease 100 mg Capsules 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Docusate sodium (8 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Prevention and treatment of chronic constipation. Prevention of hard, dry stools and reduction of straining at stools in the presence of conditions like haemorrhoids or anal fissures.

4.2. Posology and method of administration

Adults and children 12 years and above:

Up to maximum of 500 mg should be taken daily in divided doses.

Treatment should be commenced with large doses such as 100 mg three times daily, which should be adapted to the treatment response.

Dulcoease is not recommended for use in children under the age of 12 years.

Duration of treatment

The patient should be advised to consult a physician when constipation persists or worsens during treatment or when laxatives are needed for a long period of time.

Method of administration

Oral use. The capsules should be swallowed whole with a glass of water.

Special populations

No specific dose adjustment is necessary for elderly patients.

4.3. Contraindications

Dulcoease is contraindicated in patients with:

- hypersensitivity to docusate or to any of the excipients

- abdominal pain if not constipation-related

- nausea and vomiting

- intestinal obstruction

4.4. Special warnings and precautions for use

Organic disorders should be excluded prior to the administration of any laxative.

Each 100 mg capsule contains approximately 19.3 mg of sorbitol, resulting in 96.5 mg sorbitol per maximum recommended daily dose for adults. Patients with hereditary fructose intolerance (HFI) should not take this medicine.

Dulcoease 100 mg Capsules contain E110 sunset yellow which may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

Dulcoease should not be taken concurrently with mineral oil laxatives such as liquid paraffin.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of the drug in pregnant women. The potential risk for humans is unknown.

Nonclinical studies are insufficient with respect to effects on pregnancy and fetal development. Dulcoease should be used during pregnancy only if the benefits outweigh the risks.

Lactation

Non-clinical studies have shown excretion of docusate sodium and its metabolites into breast milk when administered systemically. Dulcoease should be used with caution in nursing mothers.

Fertility

There is insufficient data on the effect of docusate sodium on fertility.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

The following CIOMS frequency rating is used, when applicable:

Very common ≥ 10 %; Common ≥ 1 and < 10 %; Uncommon ≥ 0.1 and <1%; Rare ≥ 0.01 and < 0.1%; Very rare < 0.01%; Not known (cannot be estimated from available data).

Gastrointestinal disorders

• Rare: Diarrhoea, nausea, abdominal cramps

Skin and subcutaneous tissue disorders

• Frequency unknown: Rash and pruritus

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

Overdose may cause excessive loss of fluid and electrolytes which require replacement.

💬 Ask about this leaflet

Ask anything about Dulcoease 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.

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