PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose Solution BP

[Lactulose]

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 their symptoms are the same as yours.

•    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 or any of the other ingredients of Lactulose Solution BP.

•    If you have a gastrointestinal obstruction (obstruction of the gut) or digestive system.

•    If you have a rare problem called ‘Galactosaemia' where your body cannot process a type of sugar called galactose.

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.

•    Taking this medicine over a long period of time. This product should not be taken over a long period of time unless under medical supervision.

•    If you suffer from unexplained tummy ache. Talk to your doctor before taking this medicine.

•    If your symptoms do not improve within a few days you should talk to your doctor.

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.

Children

In special circumstances your doctor may prescribe Lactulose Solution BP for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Lactulose Solution should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

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 breastfeeding

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.

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Constipation

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 - 50ml (6 - 10 x 5ml 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:

Very common (more than 1 in 10 people)

•    Diarrhoea.

Common (more than 1 in 100 but less than 1 in 10 people)

•    Flatulence

•    Abdominal pain

•    Nausea

•    Vomiting.

Uncommon (more than 1 in 1000 but less than 1 in 100 people)

•    Electrolyte imbalances due to diarrhoea. This is normally only seen when using this medicine at high doses and when used long term.

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 Lactulose Solution BP.

Keep out of the sight and reach 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, epilactose, tagatose, laevulose.

What Lactulose Solution BP looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Co-pharma Ltd Unit 4 Metro Centre Tolpits Lane Watford Hertfordshire WD18 9SS

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

N/A

This leaflet was last approved in {04/2015}.

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