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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose Solution BP

[Lactu lose]

Read all of this leaflet carefully before you

start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, 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 theirsymptoms are the same as you rs.

•    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 Lactulose Solution BP is and what it is used for

2.    Before you take Lactulose Solution BP

3.    How to take Lactulose Solution BP

4.    Possible side effects

5.    How to store Lactulose Solution BP

6.    Further information

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

Lactulose belongs to a group of medicines which

are called laxatives.

It is used to treat

•    constipation

•    hepatic encephalopathy (psychiatric issues associated with liver disease)

2.    Before you take Lactulose Solution BP

Do not take Lactulose Solution BP

•    If you are allergic (hypersensitive) to Lactulose

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or any of the other ingredients of Lactulose Solution BP.

•    if you have a Gastrointestinal obstruction (obstruction of the gut).

•    If you require a low-galactose diet, (found in dairy and milk products)

If in doubt, ask your pharmacist or doctor for advice.

Take special care with Lactulose Solution BP if you are

•    Lactose intolerant (found in dairy and milk products). This product contains lactose. If you have an intolerance to this sugar, speak to your doctor before taking this medicinal product.

•    Diabetic    _H,

•    taking this medicine over a long period of time.

This product should not be taken over a long HI period of time unless under medical supervision.

Taking other medicines

•    If you are taking any medicines to treat infections you should tell your doctor before taking lactulose.

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

Taking Lactulose Solution BP with food and drink

Lactulose may be mixed with fruit juice, water or milk to improve the taste

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast feeding.

Driving and using machines

There is no evidence that Lactulose Solution BP affects your ability to drive or operate machinery.

You should check with your doctor or pharmacist if you are not sure.

3.    How to take Lactulose Solution BP

Always take Lactulose Solution BP exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Consti pation

Adults and Elderly: initially 15ml twice daily. Dosage can often be gradually reduced on the advice of your doctor

Children Starting dose

Children 5 to 10 years: 10ml twice daily Children under 5 years: 5ml twice daily Babies: 2.5ml twice daily

Hepatic encephalopathy

Adults: initially 30 - 50m! (6 - 10 x 5m! spoonfuls) three times daily

Elderly: the standard adult dose is recommended Children: not recommended

If you take more Lactulose Solution BP than you should

If you take more than prescribed please contact your doctor or pharmacist. Symptoms of overdose include diarrhoea and stomach cramps.

If you forget to take Lactulose Solution BP.

If you forget to take one or more doses, take another as soon as you remember and then go on as prescribed.

Do not take a double dose to make up for a forgotten dose.

4.    Possible side effects

Like all medicines, Lactulose Solution BP can cause side effects, although not everybody gets them. These include:

•    Flatulence

•    Stomach cramps

•    Diarrhoea

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.

5.    How to store Lactulose Solution BP.

Keep out of the reach and sight of children.

Do not store above 25°C

Do not refrigerate or freeze. Store in the original

container.

Dilution and subsequent storage not recommended Do not use Lactulose Solution BP after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use Lactulose Solution BP if you notice visible signs of deterioration.

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

6.    Further Information

What Lactulose Solution BP contains

Lactulose solution BP contains 3.35g lactulose in each 5ml. It may also contain the following related substances: galactose, lactose, epiiactose, tagatose, iaevulose.

What Lactulose Solution BP looks like and contents of the pack

Amber glass bottles with plastic screw caps of 200mi, 300m! and 500ml or HDPE bottles with plastic screw caps of 200ml, 300mi, 500ml, 1000mi and 5000ml

Marketing Authorisation Holder and Manufacturer    hi

Co-pharma Ltd Unit4 Metro Centre Tolpits Lane Watford Hertfordshire WD189SS

This medicinal product is authorised in the Member States of the EEA under the following names:

^N/A    fe

This leaflet was last approved in {MM/YYYY}. §

Not applicable

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