PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution

Lactulose

Read all of this leaflet c arefully because it contains important information for you

This medicine is available without prescription. However, you still need to take Lactulose oral 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 3 days.

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

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In this leaflet

1.    What Lactulose oral solution is and what it is used for

2.    Before you take Lactulose oral solution

3.    How to take Lactulose oral solution

4.    Possible side effects

5.    How to store Lactulose oral solution

6.    Further Information

Lactulose oral solution is used for the treatment of chronic constipation and in patients with chronic portal systemic encephalopathy (brain and muscle problems due to liver disease).

2. BEFORE YOU TAKE LACTULOSE ORAL SOLUTION

Do not take Lactulose oral solution

• If you are allergic (hypersensitive) to lactulose

1. WHAT LACTULOSE ORAL SOLUTION IS AND WHAT IT IS USED FOR

•    If you have any blockage in your bowel that is not due to constipation

•    If you suffer from fructose intolerance, lactase insufficiency, galactosaemia

Lactulose oral solution is an aqueous 50 % w/w solution of the sugar lactulose which belongs to a group of medicines known as laxatives, which ease bowel movement.

or glucose/galactose malabsorption syndrome

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Take special care with Lactulose oral solution and speak to your doctor before taking

•    If you have been experiencing constipation for a prolonged period of time (your doctor should examine you before taking Lactulose oral solution).

•    Long-term impairment of bowel movement may be a sign of a more serious illness.

Symptoms like abdominal pains, vomiting and fever could be a sign of such serious illness e.g. gastrointestinal inflammation.

which is used to thin the blood) greater thinning of the blood may occur.

Taking Lactulose oral solution with food and drink

Lactulose oral solution can be diluted with water or other liquids and can be taken with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Lactulose oral solution may be used during pregnancy and breast-feeding.

Taking other medicines

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

With combined use of Lactulose oral solution and coumarins (e.g. like warfarin,

Driving and using machines

Lactulose oral solution has no influence on the ability to drive and use machines.

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Important information about some of the ingredients of Lactulose oral solution

Lactulose oral solution contains fructose, galactose and lactose (all are types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

Chronic Constipation:

Adults

Initially: 15-30 ml daily for first 2-3 days (45 ml may be given in obstinate cases).

Maintenance: 5-15 ml daily or according to the need of the patient.

3. HOW TO TAKE LACTULOSE ORAL SOLUTION

Children

It may take some time before the desired effect is achieved. The laxative effect can be achieved after 2-10 hours, but also 1-2 days can pass until the first motion. The required dose can also be mixed with water or warm drinks e.g. coffee, tea or with yoghurt, cereals and food preparation that is crushed to make it a soft mass.

In children the usual dose for constipation is usually less than that for adults. Usually the child dosage is 2 to 5 x 5 ml for the first 2 to 3 days, followed by 1 to 3 x 5 ml depending on how bad the constipation is and how long it lasts for.

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Chronic portal systemic encephalopathy (brain and muscle problems due to liver disease):

Initially 30-50 ml three times daily according to requirements of the patient for adequate acidification of the colonic response.

Follow these instructions unless your doctor gave you different advice. Because Lactulose oral solution acts naturally to encourage the normal activity of the bowel, it may be 2 or 3 days before the full benefit of the treatment is obtained. Your doctor or pharmacist will tell you how long your treatment with Lactulose oral solution will last.

If you take more Lactulose oral solution than you should

If you have taken too much Lactulose oral solution, diarrhoea and loss of water and electrolytes (mainly potassium and sodium) may occur. Please contact your doctor in case of such complaints.

If you forget to take Lactulose oral solution

If you have forgotten to take a dose, then you should take the dose as soon as you remember. However, if it is almost time for your next dose, do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this product, ask your doctor or

If you have the impression that the effect of Lactulose oral solution is too strong or too weak, talk to your doctor or pharmacist.

pharmacist.

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4. POSSIBLE SIDE EFFECTS

At higher doses, the following side effects have been reported:

Like all medicines, Lactulose oral solution can cause side effects, although not everybody gets them.

Most people benefit from taking Lactulose oral solution, but a few people can be upset by it.

•    nausea

•    vomiting

•    diarrhoea with electrolyte disturbance.

Side-effects that have been reported at the beginning of treatment include:

If any of the side effects gets serious, or if you notice any side effects not listed

• mild abdominal pain

in this leaflet, please tell your doctor or pharmacist.

• flatulence (passing wind).

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5. HOW TO STORE LACTULOSE ORAL SOLUTION

6. FURTHER INFORMATION

Do not store above 25°C.

Keep out of the reach and sight of children.

Do not use Lactulose oral solution after the expiry date which is stated on the label of the bottle (EXP: mm yyyy).

The expiry date refers to the last day of that 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 to protect the environment.

What Lactulose oral solution contains

The active substance is lactulose diluted in water.

What Lactulose oral solution looks like and contents of the pack

Lactulose oral solution is a clear, viscous liquid, colourless or pale brownish-yellow solution and is available in glass, PET and HDPE bottles containing 200 ml, 300 ml, 500 ml and 1000 ml.

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Marketing Authorisation Holder:

Fresenius Kabi Austria GmbH HafnerstraBe 36 8055 Graz, Austria

Tel.: +43 316 249 0, Fax: +43 316 249 1470 Info-atgr@fresenius-kabi.com

Manufacturer:

Fresenius Kabi Austria GmbH EstermannstraBe 17 4020 Linz, Austria

Tel.: +43 732 7651 0, Fax: +43 732 7651 2429 office@fresenius-kabi.com

Distributed by:

Lloyds Pharmacy Limited, Coventry CV2 2TX

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last approved in 08/2010.