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DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL SOLUTION

Active substance(s): DOCUSATE SODIUM

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Docusol Paediatric Solution
Docusate Sodium
Information for the Patient
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription.
However, the patient still needs to take Docusol Paediatric Solution
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask the patient's pharmacist if you need more information or advice.
- Contact a doctor if the patient’s symptoms worsen or do not
improve after a few days.
- 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.
In this leaflet:
1. What Docusol Paediatric Solution is and what it is used for
2. Before the patient takes Docusol Paediatric Solution
3. How to take Docusol Paediatric Solution
4. Possible side effects
5. How to store Docusol Paediatric Solution
6. Further information

1. WHAT DOCUSOL PAEDIATRIC SOLUTION IS AND WHAT IT IS USED FOR
Docusol Paediatric Solution is one of a group of medicines called
'laxatives'. They are usually used to prevent and treat constipation.
Docusol Paediatric Solution may also be used before a stomach X-ray.

2. BEFORE THE PATIENT TAKES DOCUSOL PAEDIATRIC SOLUTION
Do not give Docusol Paediatric Solution
• if the patient is allergic (hypersensitive) to docusate sodium or any of the
other ingredients of Docusol Paediatric Solution (see 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.
Take special care with Docusol Paediatric Solution
• Docusol Paediatric 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.
Taking other medicines
Docusol Paediatric Solution should not be taken if the patient is already
taking mineral oil. Patients already taking other laxatives called
anthraquinone laxatives such as senna, will need to take reduced doses as
Docusol Paediatric Solution increases their effects.
Please tell the doctor or pharmacist if the patient is taking or has recently
taken any other medicines, including medicines obtained without a
prescription.
Taking Docusol Paediatric Solution with food and drink
Docusol Paediatric Solution can be taken with food and drink.
Pregnancy and breast-feeding
The patient should not take this medicine if they are pregnant, thinking of
becoming pregnant or if the patient is breast feeding. Please ask the
doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Docusol
Paediatric Solution
Docusol Paediatric Solution contains methyl p-hydroxybenzoate and propyl
p-hydroxybenzoate which may cause allergic reactions, possibly delayed.
Docusol Paediatric Solution contains glycerol. It may cause headache,
stomach upset and diarrhoea.
Docusol Paediatric Solution contains sorbitol. Each 5ml dose contains 0.9g
of sorbitol. If the patient has been told by their doctor that they have an
intolerance to sorbitol, contact their doctor before they take this medicine.
Docusol Paediatric Solution contains aspartame which is a source of
phenylalanine. May be harmful for people with phenylketonuria.

3. HOW TO TAKE DOCUSOL PAEDIATRIC SOLUTION
Docusol Paediatric Solution should always be taken exactly as the doctor or
pharmacist has instructed. You should check with your pharmacist if you
are not sure.

Constipation:
The usual dose for infants aged over 6 months is one 5ml spoonful three
times a day.
The usual dose for children aged 2-12 years is one to two 5ml spoonfuls
three times a day.
Dilute the medicine in a glass of flavoured drink such as fruit juice or milk
and give to your child/infant 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 six 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 the patient takes more Docusol Paediatric Solution than they should
If the patient takes more Docusol Paediatric 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 Docusol Paediatric Solution
Give the patient their usual dose and then continue the normal course of
treatment. Do not give 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, Docusol Paediatric Solution 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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE DOCUSOL PAEDIATRIC SOLUTION
Keep out of the sight and reach of children. Do not use Docusol Paediatric
Solution after the expiry date that is stated on the bottle label and carton
after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste.
Always return any left over medicine to a pharmacist for safe disposal.
These measures will help to protect the environment.

6. FURTHER INFORMATION
What Docusol Paediatric Solution contains
- The active substance is Docusate sodium, (12.5mg/5ml)
- The other ingredients are sorbitol (E420), glycerol (E422), povidone,
sodium acid phosphate (E339), sodium phosphate (E339), methyl-phydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), strawberry
flavour, aspartame (E951) and purified water.
What Docusol Paediatric Solution looks like and contents of the pack
Docusol Paediatric Solution is a clear liquid available in amber glass bottles
of 125ml and 300ml with a plastic screw cap.
Marketing Authorisation Holder:
Typharm Ltd., 14D Wendover Road, Rackheath Industrial Estate,
Norwich, NR13 6LH.
Manufacturer:
Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 15 e 16
3450-232 Mortágua, Portugal.
Date of Leaflet Preparation: August 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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