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KEEP OUT OF THE REACH AND SIGHT OF CHILDREN For oral use. Take with water or fruit juice if required. Read the package leaflet before use.

Initial dosage for constipation-

Adults - 15ml twice daily ••

Children 5 to 10 years - 10ml twice daily

Children 2 to 5 years - 5ml twice daily    "§

Babies 1 to 2 year - 2.5-5ml twice daily

Babies 1 month to 1 year - 2.5ml twice daily.

Dosage for other conditions- ¹ as directed by your doctor.

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Storage: Do not store above 25 C. Do not refrigerate or freeze.

After the first opening do not store longer than 6 months. Discard any remaining solution.

Lactulose 3.3g/5ml Oral Solution

Lactulose    500 ml

5ml of Lactulose Solution contains 3.3g of Lactulose.

Each 5ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose. See leaflet for further information. Oral solution. Also contains water.

MA Holder: Resolution Chemicals Ltd.,

Wedgwood Way, Stevenage, Herts, SGI 4QT, UK Distributed by: Arrow Generics Limited,

Eastman Way, Stevenage, Herts, SGI 4SZ, UK PL 10321/0002

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution

{Lactulose}

Read all of this leaflet carefully before you start using 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 is and what it is used for Before you take Lactulose Solution How to take Lactulose Solution

4.    Possible side effects

5.    How to store Lactulose Solution

6.    Further information

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

Lactulose Solution belongs to a group of medicines called laxatives. It is used in the treatment of constipation. It is also used to treat a liver problem called hepatic encephalopathy. This is also known as a hepatic coma.

2. BEFORE YOU TAKE LACTULOSE SOLUTION

Do not take Lactulose Solution if:

-    you know that you are allergic (causing itching, reddening of the skin or difficulty in breathing) to Lactulose Solution or any of the other ingredients of Lactulose Solution listed at the end of this leaflet;

- you are suffering from a blockage in your gut or intestine;

- you suffer from a rare inherited condition of the metabolism called galactosaemia (an increase in a sugar called galactose in the blood).

Children, especially young children should be seen by a doctor before use of the medication.

Take special care with Lactulose Solution

If you suffer from Glucose/galactose malabsorption syndrome or a lactase

insufficiency (lactose intolerance).

If you suffer from Hereditary Fructose-Intolerance.

If you know that you suffer from Roemheld syndrome (a condition which causes stomach symptoms and heart symptoms such as chest pain and changes in the heart rate) you should consult your doctor before taking lactulose. If you develop bloating or a build up of gas in the bowel or stomach onsult your doctor who will monitor your treatment and may reduce the dose r stop the treatment.

If the constipation does not respond to treatment after a couple of days or reoccurs after treatment, a physician should be consulted.

Taking other medicines

Lactulose may interact with other medicines you may be taking by enhancing their activity (cardiac glycocides), inactivating them (e.g. 5-ASA) or may cause increased loss of potassium (e.g. diuretics, corticosteroids and amphotericin B) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that you have obtained without a prescription.

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If you are taking large doses of Lactulose Solution to treat hepatic encephalopathy you may also suffer from diarrhoea, nausea (feeling sick), vomiting (being sick), flatulence and stomach pain. These side effects are common, probably affecting between 1 in 100 up to 1 in 10 people. If this is the case, tell your doctor as he can adjust your dose to obtain just two or three soft stools a day.

If you are taking large doses of Lactulose Solution to treat hepatic encephalopathy or are taking Lactulose solution for a long time you may also suffer from an electrolyte imbalance also known as hypernatraemia (dehydration) which may need to be treated by your Doctor. This side effect is rare, probably affecting between 1 in 10000 up to 1 in 1000 people.

The urge to open your bowels may change during treatment with lactulose.

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.

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5ml of Lactulose Solution contains 3.3g of Lactulose. Each 5ml also contains not more than 0.53g of Galactose

MA Holder: Resolution Chemicals Ltd., Wedgwood Way, Stevenage, Herts, SG1 4QT, UK Distributed by: Arrow Generics Limited,

Eastman Way, Stevenage, Herts, SG1 4SZ, UK PL 10321/0002

GENERICS