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LACTULOSE 3.3G /5ML ORAL SOLUTION

Active substance(s): LACTULOSE / LACTULOSE SOLUTION

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5 012617 003799

Lactulose 3.3g/5ml Oral Solution
300ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5 ml also contains not more than 0.53g of
Galactose and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way,
Stevenage Herts, SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK
PL 10321/0001

Exp:
BN:

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

3.3g
5ml

AAAG2379

PEEL HERE

For oral use. Dosage for constipation:Adults: 15 ml twice daily.
Children 5 to 10 years: 10 ml twice daily
Children under 5 years: 5 ml twice daily
Babies under 1 year: 2.5 ml twice daily
or as directed by your doctor.
Dosage for other conditions as directed by your doctor.
Take with water or fruit juice if required.
Please read the package leaflet before use.
Keep out of the sight and reach of children.
Storage
Do not store above 25°C. Do not refrigerate or freeze.
Use within 6 months of first opening then discard.

FRONT

Labelxtra 6 Panel
Flat size 494 x 55mm
Folded Size 55 x 83 / 85
79mm

55mm

(Dosage continued) To treat hepatic encephalopathy:
Higher doses of Lactulose Solution are required

Starting dose
Adults
30-50ml three times daily (6-10 x 5ml spoonful)
Elderly
as above
Children
not to be taken (lactulose is not suitable for

children with this condition)
Your doctor may adjust your dose until two or three soft stools are
produced a day.

If you take more Lactulose Solution than you should

Contact your nearest casualty department or tell 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.

83mm
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
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.

82mm

82mm

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. 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 get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in the package 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
Keep out of the sight and reach 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

after EXP. The expiry date refers to the last day of that month.
Use within 6 months of first opening and 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

83mm

85mm

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, 1000, 5000ml plastic
bottles.
Marketing Authorisation Holder
Resolution Chemicals Ltd.,
Wedgwood Way, Stevenage Herts., SG1 4QT.

The active substance is Lactulose
The other ingredients are: Lactose and Galactose

Manufacturer
Central Pharma Limited
Caxton Road, Bedford, MK41 0XZ

What Lactulose Solution looks like and contents of the
pack

This leaflet was last revised in June 2014

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

Lactulose 3.3g/5ml
Oral Solution
300ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5 ml also contains not more than 0.53g of Galactose
and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way, Stevenage Herts,
SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK

AAAG2385

PL 10321/0001

AAAG2385

FRONT PANEL

REVERSE

494mm
85mm
PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution
{Active substance: Lactulose}

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

1 W
 HAT 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:
Chronic (long term) constipation: Constipation is a common
complaint often due to not enough roughage or fibre in the diet,

82mm

82mm

dehydration, immobility, illness or stress. Sometimes constipation
may be due to more serious reasons. You should consult with your
doctor if you suffer from constipation for a period of greater than 4
weeks.

to form acid which stops the formation and absorption of ammonia
from the bowel into the blood stream. In this way it helps to treat
hepatic encephalopathy.

Lactulose can help your bowels to move, and pass a stool if you are
constipated. Lactulose does not enter the bloodstream. It acts by
drawing water into the bowel and so softening the stool or motion. In
this way Lactulose can encourage a normal bowel motion.
Chronic portal systemic encephalopathy (hepatic coma): This is
an uncommon condition where substances such as ammonia go into
the blood stream. It can sometimes occur in patients with severe liver
disease. Your doctor may prescribe Lactulose for you if you suffer from
liver disease and he believes that you may develop or have developed
hepatic encephalopathy.
Lactulose is broken down by the normal bacteria (germs) in the bowel

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).

Taking other medicines

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.

83mm
Taking Lactulose Solution with food and drink

Lactulose Solution may be taken with a drink such as water or fruit
juice.

Pregnancy and breast-feeding

It is always best to avoid the use of medicines during pregnancy
if possible. However, it is safe to 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.

79mm
3 HOW TO TAKE LACTULOSE SOLUTION

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

To treat constipation:

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.

Starting dose
Adults
15ml twice daily (3 x 5ml spoonful)
Children 5 to 10 years 10ml twice daily (2 x 5ml spoonful)
Children under 5 years 5ml twice daily (l x 5ml spoonful
Babies under 1 year
2.5ml twice daily (½ x 5ml spoonful)

PTO

55mm

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.
•  I f 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.

83mm

5 012617 002693
Exp:
BN:

Lactulose 3.3g/5ml Oral Solution
500ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5 ml also contains not more than 0.53g of
Galactose and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way,
Stevenage Herts, SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK
PL 10321/0001

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

3.3g
5ml

AAAG2384

PEEL HERE

For oral use. Dosage for constipation:Adults: 15 ml twice daily.
Children 5 to 10 years: 10 ml twice daily
Children under 5 years: 5 ml twice daily
Babies under 1 year: 2.5 ml twice daily
or as directed by your doctor.
Dosage for other conditions as directed by your doctor.
Take with water or fruit juice if required.
Please read the package leaflet before use.
Keep out of the sight and reach of children.
Storage
Do not store above 25°C. Do not refrigerate or freeze.
Use within 6 months of first opening then discard.

FRONT

Labelxtra 6 Panel
Flat size 494 x 55mm
Folded Size 55 x 83 / 85
79mm

55mm

(Dosage continued) To treat hepatic encephalopathy:
Higher doses of Lactulose Solution are required

Starting dose
Adults
30-50ml three times daily (6-10 x 5ml spoonful)
Elderly
as above
Children
not to be taken (lactulose is not suitable for

children with this condition)
Your doctor may adjust your dose until two or three soft stools are
produced a day.

If you take more Lactulose Solution than you should

Contact your nearest casualty department or tell 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.

83mm
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
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.

82mm

82mm

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. 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 get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in the package 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
Keep out of the sight and reach 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

after EXP. The expiry date refers to the last day of that month.
Use within 6 months of first opening and 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

83mm

85mm

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, 1000, 5000ml plastic
bottles.
Marketing Authorisation Holder
Resolution Chemicals Ltd.,
Wedgwood Way, Stevenage Herts., SG1 4QT.

The active substance is Lactulose
The other ingredients are: Lactose and Galactose

Manufacturer
Central Pharma Limited
Caxton Road, Bedford, MK41 0XZ

What Lactulose Solution looks like and contents of the
pack

This leaflet was last revised in June 2014

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

Lactulose 3.3g/5ml
Oral Solution
500ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5 ml also contains not more than 0.53g of Galactose
and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way, Stevenage Herts,
SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK

AAAG2392

PL 10321/0001

AAAG2392

FRONT PANEL

REVERSE

494mm
85mm
PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution
{Active substance: Lactulose}

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

1 W
 HAT 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:
Chronic (long term) constipation: Constipation is a common
complaint often due to not enough roughage or fibre in the diet,

82mm

82mm

dehydration, immobility, illness or stress. Sometimes constipation
may be due to more serious reasons. You should consult with your
doctor if you suffer from constipation for a period of greater than 4
weeks.

to form acid which stops the formation and absorption of ammonia
from the bowel into the blood stream. In this way it helps to treat
hepatic encephalopathy.

Lactulose can help your bowels to move, and pass a stool if you are
constipated. Lactulose does not enter the bloodstream. It acts by
drawing water into the bowel and so softening the stool or motion. In
this way Lactulose can encourage a normal bowel motion.
Chronic portal systemic encephalopathy (hepatic coma): This is
an uncommon condition where substances such as ammonia go into
the blood stream. It can sometimes occur in patients with severe liver
disease. Your doctor may prescribe Lactulose for you if you suffer from
liver disease and he believes that you may develop or have developed
hepatic encephalopathy.
Lactulose is broken down by the normal bacteria (germs) in the bowel

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).

Taking other medicines

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.

83mm
Taking Lactulose Solution with food and drink

Lactulose Solution may be taken with a drink such as water or fruit
juice.

Pregnancy and breast-feeding

It is always best to avoid the use of medicines during pregnancy
if possible. However, it is safe to 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.

79mm
3 HOW TO TAKE LACTULOSE SOLUTION

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

To treat constipation:

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.

Starting dose
Adults
15ml twice daily (3 x 5ml spoonful)
Children 5 to 10 years 10ml twice daily (2 x 5ml spoonful)
Children under 5 years 5ml twice daily (l x 5ml spoonful)
Babies under 1 year
2.5ml twice daily (½ x 5ml spoonful) PTO

55mm

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.
•  I f 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.

83mm

Expand view ⇕

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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