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LACTULOSE 3.3G /5ML ORAL SOLUTION

Active substance(s): LACTULOSE / LACTULOSE SOLUTION / LACTULOSE / LACTULOSE SOLUTION / LACTULOSE / LACTULOSE SOLUTION

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Braille text reads as follows:
lactulose
#3.3 [ls]g
/#5ml
solution
6.0
2.5

12.0

2.5
10.0

P
Exp:
BN:

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 constipationAdults - 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 conditionsas directed by your doctor.

Code

5 060034 830047

(Figures are
in mm)

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, SG1 4QT, UK
Distributed by: Arrow Generics Limited,
Eastman Way, Stevenage, Herts, SG1 4SZ, UK
PL 10321/0002
CODE IF NEEDED

Leaflet section:
Page B shows the leaflet section of the label-leaflet. The leaflet is a double sided strip of
paper that is folded into 6 panels. It is not possible to show all 6 panels side-by-side in the
A3 document, so each panel has been given a number and the diagram below shows the
order of the panels as they will appear in the printed leaflet.
The leaflet section is glued to the carrier label at the left side edge of the title panel.
Outside
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Title Panel

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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.

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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.

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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
consult your doctor who will monitor your treatment and may reduce the dose
or 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)

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.

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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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).

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.

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

3. HOW TO TAKE 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.

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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).

In this leaflet:
1. What Lactulose Solution is and what it is used for
2. Before you take Lactulose Solution
3. How to take Lactulose Solution
4. Possible side effects
5. How to store Lactulose Solution
6. Further information

Outside

Driving and using machines
There should be no problems when taking Lactulose Solution.

Outside

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

Lactulose Solution is for oral use only

If you forget to take Lactulose Solution
If you forget to take a dose of Lactulose Solution, take it as soon as you
remember. If it is almost time for your next dose though do not double the
dose - just carry on as before.
4. POSSIBLE SIDE EFFECTS

Initial dosage for hepatic encephalopathy:
• Adults: 30 to 50ml three times daily.

• Take Lactulose solution from a spoon or measuring cup
• Lactulose may be taken with water or fruit juice.

Your doctor may adjust your dose until two or three soft stools are produced
a day.

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

If you take more Lactulose Solution than you should
Contact your doctor or pharmacist straight away. Take this leaflet and any
remaining solution with you so that the medical staff know exactly what you
have taken.

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

Like all medicines, Lactulose Solution can cause side effects, although not
everybody gets them. If any of these side effects become troublesome, stop
taking the medicine and see your doctor as soon as possible.
The most common side effects probably affecting up to 1 in 10 people are:
bloated stomach, excess wind or stomach cramps. You may suffer from these
in the first few days of taking your medicine. These usually go away on
continuation of your treatment.

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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.

5. HOW TO 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.

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

6. FURTHER INFORMATION

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.

What Lactulose Solution contains
The active substance is Lactulose. The other ingredient is Water.

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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

Inside

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Inside

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
Distributed by: Arrow Generics Limited,
Eastman Way, Stevenage, Herts, SG1 4SZ, UK
PL 10321/0002
CODE IF NEEDED

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11

Title Panel

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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