Docusate sodium 12.5mg oral solution in sachets – patient leaflet, side effects, dosage

1. What Docusate sodium oral solution is and what it is used for

Docusate sodium 12.5 mg oral solution belongs to 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 you take Docusate sodium oral solution

Do not take 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 have been sick in the last 24 hours.

Warnings and precautions

Talk to the patient’s doctor, nurse or pharmacist before taking Docusate sodium oral solution.

• This medicine 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, nurse or pharmacist if the patient is taking, has recently taken or might take any other medicines.

Docusate sodium oral solution should not be taken if the patient is already taking mineral oil. Patients already taking an anthraquinone laxative such as senna, will need to reduce the dose as Docusate sodium oral solution increases their effects.

Docusate sodium oral solution with food and drink

Docusate sodium oral solution can be taken with food and drink.

Docusate sodium 12.5mg oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medicine contains 5.0 mg of methyl p-hydroxybenzoate and 2.5 mg of propyl p-hydroxybenzoate in each sachet (5 ml). May cause allergic reactions (possibly delayed).

Docusate sodium 12.5mg oral solution contains sorbitol.

Docusate sodium 12.5 mg oral solution contains 840 mg of sorbitol in each sachet (5 ml). Sorbitol is a source of fructose. If your doctor has told you that your child have an intolerance to some sugars or if your child 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 your child takes or receives this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Docusate sodium 12.5mg oral solution contains sodium.

Docusate sodium 12.5 mg oral solution contains 33.4 mg sodium (main component of cooking/table salt) per 30 ml (maximum daily dose). This is equivalent to 1.7% of the recommended maximum daily intake of sodium for an adult.

3. How to take Docusate sodium oral solution

Always take this medicine exactly as described in this leaflet or as the patient’s doctor, nurse or pharmacist has told you. Check with the patient’s doctor, nurse or pharmacist if you are not sure.

Each sachet contains a single dose and must not be divided.

Constipation:

Children (2-12 years):

1 – 2 sachets (5 ml -10 ml / 12.5 mg to 25 mg) three times daily.

Infants (Over six months):

1 sachet (5 ml / 12.5 mg) three times daily.

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 (barium meal):

Take 6 sachets (75 mg) as a single dose before the meal.

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 oral solution than you should

If the patient accidentally takes more Docusate sodium oral solution than they should, the patient should drink lots of water and contact your nearest hospital casualty department, or tell the patient’s doctor immediately.

If you forget to take Docusate sodium oral solution

Do not take a double dose to make up for a forgotten dose. Give the patient their usual dose and then continue the normal course of treatment. If you have any further questions on the use of this product, ask the doctor, nurse 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 and tell the patient’s 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 you have a persistent stomach ache, see your 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 you notice any side effects not listed in this leaflet, please tell the patient’s doctor, nurse 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.

E6ES2RBJ1

V9

CLS-26-00203

0 10 20 30 40 50 60 70 80 90 100

JOB IN

Produc

Strengt

Dimensions: EAN Code:

Folded Size: No. of Colours:

Page Number: Tabbed:

Pack Si

Bottle S

Design

COLOU

Operator: Operator:

PREFLIGHT VERSION:

MAIN BODY TEXT

Univers LT Std Roman Univers LT Std Bold

UKL527 N/A 420 x 190mm N/A N/A 1

9pt

N/A

Docu

14/09/2026 -

JSC (IH) -9 -

Sign:

Sign:

5. How to store Docusate sodium oral solution

This medicinal product does not require any special storage conditions.

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 sachet 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 protect the environment.

6. Contents of the pack and other information

What Docusate sodium oral solution in sachets contains

• The active substance is docusate sodium
• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium dihydrogen phosphate dehydrate (E339i), disodium hydrogen phosphate dehydrate (E339ii), glycerol (E422), povidone (E1201), sorbitol 70% (E420), sucralose (E955), citric acid (E330), strawberry flavor and purified water.

What Docusate sodium oral solution in sachets looks like and contents of the pack

Docusate sodium oral solution is supplied in:

• Single dose sachets made of laminated polyester/ aluminium/ low density polyethylene foil. Each sachet contains

  5ml oral solution. Each pack contains 30 single-dose sachets (strength: 12.5mg per sachet).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd.,

Rosemont House,

Yorkdale Industrial Park, Braithwaite Street,

Leeds, LS11 9XE,

United Kingdom

Manufacturer

LABOMED PHARMACEUTICAL INDUSTRY S.A.

84 Ioannou Metaxa str.,

19441, Koropi,

Athens,

Greece

This leaflet was last revised in August 2026

E6ES2RBJ1

V9

CLS-26-00203

0 10 20 30 40 50 60 70 80 90 100

JOB INFORM

Product Name

Strength:

Dimensions: EAN Code:

Folded Size: No. of Colours:

Page Number: Tabbed:

Pack Size:

Bottle Size:

Design Icon:

Operator: Operator:

PREFLIGHT VERSION:

MAIN BODY TEXT

Univers LT Std Roman Univers LT Std Bold

UKL527 N/A 420 x 190mm N/A N/A 1

9pt

N/A

Docusate

14/09/2026 -

JSC (IH) -9 -

Sign:

Sign: