Docusol Paediatric Solution
•A.
docusol
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-p-hydroxybenzoate (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:
Laboratorios Basi - Industria Farmaceutica, S.A.
Parque Industrial Manuel Lourengo Ferreira, Lotes 15 e 16 3450-232 Mortagua, Portugal.
Date of Leaflet Preparation: August 2015