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PACKAGE LEAFLET: INFORMATION FOR THE USER Lactulose Solution

Lactulose

Read all of this leaflet carefully before

you start to take this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Lactulose Solution is and what it is used for

2.    Before you take Lactulose Solution

3.    How to take Lactulose Solution

4.    Possible side effects

5.    How to store Lactulose Solution

6.    Further information

1. What Lactulose Solution is and what it is used for

The name of your medicine is Lactulose Solution. Lactulose belongs to a group of medicines called laxatives. These help prevent and treat constipation by softening your stools.

Lactulose is also used in a condition called hepatic encephalopathy, which is a disease of the brain caused by the accumulation of toxins in the blood in patients with liver failure.

2. Before you take Lactulose Solution

You should not take Lactulose Solution if you:

•    are allergic (hypersensitive) to lactulose

•    suffer from galactosaemia (a rare enzyme disease that causes accumulation of the sugar galactose in the blood)

•    suffer from obstruction of your bowel

•    are on a low galactose diet.

Talk to your doctor before taking Lactulose Solution if you:

•    suffer from lactose intolerance

•    suffer from diabetes.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines can be affected by treatment with Lactulose Solution:

• coumarins - these are medicines used to thin the blood (e.g. warfarin). Lactulose can increase the effects of these medicines, making you bleed more easily.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding you should discuss with your doctor before you use Lactulose Solution.

Driving and using machinery

This medicine does not affect your ability to drive.

Important information about some of the ingredients in Lactulose Solution

This medicine contains lactose, fructose and galactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

3. How to take Lactulose Solution

Always take Lactulose Solution as your doctor has told you.Your doctor will decide the right dose for you. This will be on the pharmacist's label. This medicine can be swallowed by itself or with water or fruit juice.

In Constipation:

Adults and the elderly

•    the starting dose is usually 15 to 30ml in divided doses, each day for two to three days

•    this can be continued, according to response, with 10 to 15ml per day in divided doses.

Children

•    for children under one year: 2.5ml twice daily

•    for children 1 to 5 years: 5ml twice daily

•    for children 5-10 years: 10ml twice daily.

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Please be ready to give the following information:

Product name

Reference number

Lactulose Solution

PL 29831/0269


In Hepatic Encephalopathy:

•    the starting dose is usually 30 to 50ml, three times a day

•    this is adjusted until the patient produces two to three soft stools a day.

If you take more Lactulose Solution than you should

If you (or anybody else, including a child), takes more Lactulose Solution than you should it is unlikely to cause you any harm. Symptoms associated with taking too much of this medicine are nausea, vomiting and diarrhoea. If you are concerned at all then speak to your doctor or pharmacist.

If you forget to take Lactulose Solution

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Lactulose Solution can cause side effects, although not everybody gets them. As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:

•    rash, itching, difficulty breathing.

Side effects that have been reported with Lactulose Solution    are:

•    stomach pains    •    wind

•    nausea    •    vomiting

•    diarrhoea    •    salt imbalances.

Using this medicine over a long period or in excessively large doses can cause loss of water and salts from your gut. This may cause dehydration or fatigue.

If you experience any side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

5. How to store Lactulose Solution

Keep out the reach and sight of children.

•    Lactulose Solution should be stored below 20°C. Store in the original container to protect it from light and do not transfer to another container.

•    Lactulose Solution should not be taken after the expiry date on the label or if the solution shows signs of deterioration such as discoloration; the expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What Lactulose Solution contains

The active ingredient is: lactulose. Each 5ml of Lactulose Solution contains not less than 3.1g of lactulose.

The other ingredient is: water.

What Lactulose Solution looks like and the contents of the pack

Lactulose Solution is a clear, colourless to brownish yellow liquid. It is supplied in glass or plastic bottles in sizes of 300ml, 500ml or 1000ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Wockhardt UK Ltd,

Ash Road North,

Wrexham,

LL13 9UF, UK.

Manufacturer:

CP Pharmaceuticals Ltd,

Ash Road North,

Wrexham,

LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

This is a service provided by the Royal National Institute of Blind People.

Leaflet Prepared: May 2009.

WOCKHARDT

Lactulose-11May09-v2.2

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