55mm

-J-

O

o

K>

00

K)

O

O

vO

O

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.

180mm

0

Exp:

BN:

• • • •

• •

• •

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 PL 10321/0002

mill

CODE IF NEEDED

UlliU

RESOLUTION

[

85mm

I 10mm

55mm

0 0 ^Outside 0 0

85mm    83mm    81mm    80mm

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

I

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.

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.

@ ^outside    (6)

79mm    78mm

Taking Lactulose Solution with food and drink

Lactulose Solution may be taken with a drink such as water or fruit juice. When you take laxatives you must drink plenty of fluids (1.5-2 l/day, equal to 6-8 glasses).

Pregnancy and breast-feeding

You may take Lactulose Solution during pregnancy and when breast-feeding, as long as you follow the dosage recommendations.

Driving and using machines

There should be no problems when taking Lactulose Solution.

Important information about some of the ingredients of Lactulose Solution

Lactulose Solution contains Lactose and Galactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.

i

I

een told by your doctor

The dose of 30 ml normally used in constipation provides 116 KJ (28 kcals) and should not pose a problem for diabetics. The dose used in the treatment of hepatic encephalopathy is usually much higher and may need to be taken into consideration for diabetics.

3. HOWTO TAKE LACTULOSE SOLUTION

Lactulose Solution is for oral use only

•    Take Lactulose solution from a spoon or measuring cup

•    Lactulose may be taken with water or fruit juice.

The effects of Lactulose may not be seen for up to 48 hours, therefore it is important to continue taking your medicine regularly.

The table below gives the starting doses of Lactulose Solution depending on ■our age. However, the dose may be adjusted by your doctor depending on your needs to have the desired effect.    PTO

Inside

5. HOWTO STORE LACTULOSE SOLUTION

Keep out of the reach and sight of children.

Do not store above 25°C. Do not refrigerate or freeze. Do not use Lactulose Solution after the expiry date which is stated on the bottle label after EXP The expiry date refers to the last day of that month.

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

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.

6. FURTHER INFORMATION What Lactulose Solution contains

The active substance is Lactulose. The other ingredient is Water.

I-------------

What Lactulose Solution looks like and contents of the pack

Lactulose Solution is a clear, colourless or pale brownish yellow liquid.

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 Lactulose Solution is available in 200, 300, 500, 1000ml plastic bottles,

5000 ml plastic containers and also in 200, 300, 500, 1000ml plastic bottles fitted with a measuring cup. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Resolution Chemicals Ltd., Wedgwood Way, Stevenage, Herts., SG1 4QT, UK. Manufacturers

Central Pharma Limited, Caxton Road, Bedford, MK41 0XZ, UK.

Thorpe Laboratories Limited, Enterprise Road, Golf Road Industrial Estate, Mablethorpe, Lincolnshire, LN12 1NB, UK.

This leaflet was last revised in December 2010

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, SG1 4QT, UK PL 10321/0002

Ml

^L Imiul-----