Medine.co.uk

Docusol Adult Solution

Document: leaflet MAH BRAND_PL 00551-0006 change

i

57932 Typharm Docusol Adult leaflet (Doc A PIL 1)_v1r0.ai    1    21/04/2016    12:22

docusol

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:

Laboratorios Basi - Industria Farmaceutica, S.A.

Parque Industrial Manuel Lourenqo Ferreira, Lotes 15 e 16 3450-232 Mortagua, Portugal.

Date of Leaflet Preparation: April 2016