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DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION

Active substance(s): DOCUSATE SODIUM

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57932 Typharm Docusol Adult leaflet (Doc A PIL 1)_v1r0.ai

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21/04/2016

12:22

Docusol Adult 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, you still need to take Docusol Adult Solution carefully to get
the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not
improve after a few days.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Docusol Adult Solution is and what it is used for
2. Before you take Docusol Adult Solution
3. How to take Docusol Adult Solution
4. Possible side effects
5. How to store Docusol Adult Solution
6. Further information

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

2. BEFORE YOU TAKE DOCUSOL ADULT SOLUTION
Do not take Docusol Adult Solution
• if you are allergic (hypersensitive) to docusate sodium or any of the
other ingredients of Docusol Adult Solution (see section 6).
• if you are suffering from stomach pains or an obstruction in the gut.
• if you are feeling sick or have been sick in the last 24 hours.
Take special care with Docusol Adult Solution
• This medicine is not suitable for children aged 6 months to 12 years but a
suitable alternative, Docusate Paediatric Solution is available.
• Prolonged use can cause the gut to become lazy and not work properly.
Taking other medicines
Docusol Adult Solution should not be taken if you are already taking mineral
oil. If you are taking an anthraquinone laxative such as senna, you will need
to reduce the dose as Docusol Adult Solution increases their effects.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Taking Docusol Adult Solution with food and drink
Docusol Adult Solution can be taken with food and drink.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant, thinking of becoming
pregnant or if you are breast feeding. Please ask the doctor or pharmacist
for advice before taking any medicine.
Important information about some of the ingredients of Docusol Adult
Solution
Docusol Adult Solution contains methyl p-hydroxybenzoate and propyl
p-hydroxybenzoate which may cause allergic reactions, possibly delayed.
Docusol Adult Solution contains glycerol. It may cause headache, stomach
upset and diarrhoea.
Docusol Adult Solution contains sorbitol. Each 5ml dose contains 0.9g of
sorbitol. If you have been told by your doctor that you have an intolerance
to sorbitol, contact your doctor before you take this medicine.
Docusol Adult Solution contains aspartame which is a source of
phenylalanine. May be harmful for people with phenylketonuria.
Docusol Adult Solution contains propylene glycol which may cause
alcohol-like symptoms.

3. HOW TO TAKE DOCUSOL ADULT SOLUTION
Docusol Adult 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 is two to three 5ml spoonfuls three times a day. Take as
a single dose followed by plenty of water or flavoured drink e.g. milk or
orange juice. The maximum daily dose is ten 5ml doses (50ml).
Reduce the dose as the condition improves.

If you have been told to take Docusol during a stomach X-ray, you should
take eight 5ml spoonfuls. Your doctor will tell you exactly when to take
the 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 you take more Docusol Adult Solution than you should
If you accidentally take more Docusol Adult Solution than you should,
drink lots of water, and contact your nearest hospital casualty department,
or tell your doctor immediately.
If you forget to take Docusol Adult Solution
As soon as you remember, take a 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 your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Docusol Adult Solution can cause side effects,
although not everybody gets them. Laxatives can increase movement of
the intestines and often cause abdominal cramps.
If you need 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 your 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 ADULT SOLUTION
Keep out of the sight and reach of children. Do not use Docusol Adult
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 Adult Solution contains
- The active substance is Docusate sodium, (50mg/5ml)
- The other ingredients are sorbitol (E420), glycerol (E422), povidone,
sodium acid phosphate (E339), sodium phosphate (E339),
methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216),
strawberry flavour, propylene glycol (E1520), aspartame (E951), sodium
benzoate (E212), citric acid anhydrous (E330) and purified water.
What Docusol Adult Solution looks like and contents of the pack
Docusol Adult Solution is a clear liquid available in a amber glass bottle of
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: April 2016

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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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