Patient info Open main menu
  1. Patient info
  2. » Patient leaflets
  3. » DOCUSATE SODIUM 12.5 MG / 5ML ORAL SOLUTION - Patient leaflet, side effects, dosage

DOCUSATE SODIUM 12.5 MG / 5ML ORAL SOLUTION - Patient leaflet, side effects, dosage

Dostupné balení:


Sources: Original (products.mhra.gov.uk)

Patient leaflet - DOCUSATE SODIUM 12.5 MG / 5ML ORAL SOLUTION

1. what docusate oral solution is and what it is used for

Docusate sodium 12.5mg/5ml oral solution is one of 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.

2. what you need to know before the patient takes docusate sodium oral solution

Do not give Docusate sodium 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 oral solution

  • Docusate sodium 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 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 oral solution should not be taken if you are already taking mineral oil. Patients already taking other laxatives called anthraquinone laxative such as senna, will need to take reduced doses 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 each dose (5ml). May cause allergic reactions (possibly delayed).

Docusate sodium oral solution contains sorbitol.

This medicine contains 840mg of sorbitol in each dose (5ml). 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.

Sodium content.

This medicinal product contains 29.7mg sodium (main component of cooking/table salt) per 30ml (maximum daily dose). This is equivalent to 1.5% of the recommended maximum daily intake of sodium for an adult.

If the patient takes more Docusate sodium oral solution than you should

If the patient takes more Docusate sodium 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 oral solution

Give the patient their usual 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. Laxatives can increase movement of the intestines and often cause abdominal cramps.

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 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 the Yellow Card Scheme at: 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.

Laetus Pharmacod e Direction


5. how to store docusate sodium 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 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.

6. contents of the pack and other information

What Docusate sodium Oral Solution contains

  • The active substance is docusate sodium (12.5mg/5ml)
  • The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), 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 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

Lucis Pharma Ltd

14 Aston Magna, Moreton in Marsh

Gloucestershire GL56 9QQ

United Kingdom

Manufacturer

LABOMED PHARMACEUTICAL COMPANY S.A.

84 Ioannou Metaxa str.,

19441, Koropi, Athens,

Greece

This leaflet was last revised in February 2022.

3. How to take Docusate sodium 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 5ml three times a day.

The recommended dose for children aged 2–12 years is 5ml to 10 ml 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 30ml, 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.

Product number


Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Docusate Sodium and how does it work?

Docusate Sodium is a stool softener that makes bowel movements easier by increasing the amount of water and fats in the stool.

How should I take Docusate Sodium Oral Solution?

Take Docusate Sodium oral solution as directed by your healthcare provider, usually once or twice a day. Measure the dose with the provided measuring cup.

Can I use Docusate Sodium for constipation relief?

Yes, Docusate Sodium is commonly used to relieve constipation, especially for those who may have difficulty passing stools.

Is Docusate Sodium suitable for children?

Docusate Sodium can be used in children, but you should consult your pediatrician for the appropriate dosage and guidance.

What are some common side effects of Docusate Sodium?

Common side effects may include stomach cramps or mild diarrhea. If symptoms persist or worsen, consult your healthcare provider.

Can I take Docusate Sodium if I'm pregnant or breastfeeding?

Consult your doctor before using Docusate Sodium if you are pregnant or breastfeeding to ensure it’s safe for you.

How long can I take Docusate Sodium?

You should not use Docusate Sodium for more than one week unless directed by a healthcare professional.

Can I mix Docusate Sodium with food or drinks?

Yes, you can mix Docusate Sodium with milk or fruit juice to make it easier to ingest if you find the taste unpleasant.

What should I do if I miss a dose of Docusate Sodium?

If you forget to take a dose, take it as soon as you remember. If it's close to your next scheduled dose, skip the missed dose and continue on your regular schedule.

Is it safe to take other medications while using Docusate Sodium?

Always inform your healthcare provider about all medications you're taking to avoid potential interactions. Generally, it's safe but always check with a professional.

Can I drink alcohol while taking Docusate Sodium?

It's best to limit alcohol consumption while taking any medication. Consult your doctor about alcohol use during treatment with Docusate Sodium.

Will Docusate Sodium help if I have hemorrhoids?

Docusate Sodium may help soften stools and reduce straining during bowel movements, which can be beneficial if you have hemorrhoids.

What should I do if I experience severe side effects from Docusate Sodium?

If you experience severe side effects such as persistent abdominal pain, nausea, or severe diarrhea, seek medical attention immediately.

Can lifestyle changes help improve constipation alongside using Docusate Sodium?

Yes! Drinking plenty of water, eating a high-fiber diet, and exercising regularly can enhance the effectiveness of Docusate Sodium.

Is there a risk of dependency when using stool softeners like Docusate Sodium?

Docusate sodium is generally safe for short-term use; however, prolonged use without medical guidance may lead to dependency for bowel movements.

Are there any dietary restrictions while taking Docusate Sodium?

There are no strict dietary restrictions with Docusate Sodium; however, increasing fiber intake is recommended for better results.

What should I know before starting treatment with Docusate Sodium?

Before starting treatment, inform your healthcare provider about any existing medical conditions or allergies to ensure it's appropriate for you.

How do I store my bottle of Docusate Sodium Oral Solution?

Store at room temperature away from light and moisture. Keep out of reach of children and do not use after the expiration date on the bottle.

Can elderly patients safely use Docusate Sodium?

Yes, elderly patients can generally use Docusate sodium safely; however, they should consult their healthcare provider for personalized advice due to potential coexisting health issues.