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LACTULOSE 3.3G/5 ML ORAL SOLUTION

Active substance(s): LACTULOSE

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BASELABEL

FRONT LABEL

183 mm
133,5 mm

3 mm

Lactulose 3.3g/5ml
Oral Solution

3 mm

3 mm

3 mm

3

4

13

3 mm

3 mm

16

15
3 mm

3 mm

Patients with portal systemic encephalopathy should avoid concomitant
administration of other laxatives, because it hinders the individualization of drug
dose.
Please do not use Lactulose oral solution without medical advice for more than two
weeks.

4. POSSIBLE SIDE EFFECTS

From the route of synthesis Lactulose oral solution may contain traces of sugars.
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

Very common:
• Flatulence (wind), especially during the first few days of treatment. This usually
disappears after a couple of days
• When a higher dose than recommended is used, you may experience abdominal
pain and diarrhoea.

Common:
• Nausea (feeling sick)
• Vomiting

5 mm

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
The following side effects have been reported with Lactulose oral solution:

During the treatment with laxatives you should drink sufficient amounts of fluids
(approx. 2 l/day, equal to 6-8 glasses).

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

3 mm

6

3 mm

3 mm

3 mm

7

8

17

3 mm

3 mm

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
3 mm

18

3 mm

3 mm

Other medicines and Lactulose Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Lactulose oral solution may increase the loss of potassium induced by other drugs
(e.g. thiazides, steroids and amphothericin B). Concomitant use of cardiac glycosides
can increase the effect of the glycosides through potassium deficiency.
With increasing dosage a decrease of pH-value in the colon is found. Therefore drugs

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.

What Lactulose oral solution contains
• The active substance is Lactulose (as lactulose liquid).
5 ml of Lactulose oral solution contains 3.3 g lactulose.
• There are no other ingredients.

19

Marketing Authorisation Holder
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz, Austria
Tel.: +43 316 249 0
Fax: +43 316 249 1470
Info-atgr@fresenius-kabi.com

3 mm

5 mm

During the treatment with laxatives you should drink sufficient amounts of fluids
(approx. 2 l/day, equal to 6-8 glasses).

3 mm

Not all pack sizes may be marketed.

5 mm

You can take Lactulose oral solution undiluted or diluted in some liquid. Use the
measuring cup provided.
3 mm

15 ml of Lactulose oral solution contain 42.7 KJ (10.2 kcals) = 0.21 bu. The dose used
for treatment may need to be taken into considerations for diabetics.

3 mm

Take your doses at the same time each day. The dose may be given once daily, for
example during breakfast, or divided up to three doses a day.
Swallow the medicine quickly. Do not keep it in your mouth.

20

3 mm

Manufacturer
Fresenius Kabi Austria GmbH
Estermannstraße 17
4020 Linz, Austria
Tel.: +43 732 7651 0
Fax: +43 732 7651 2429
office@fresenius-kabi.com

5 mm

10
3 mm

Lactulose oral solution contains milk sugar (lactose), galactose, epilactose,
tagatose or fructose.
Please refer to section “Warnings and precautions”.

3 mm

3 mm

9

3 mm

What Lactulose oral solution looks like and contents of the pack
Lactulose oral solution is a clear, viscous liquid, colourless or pale brownish-yellow
solution and is available in glass, PET bottles or HDPE bottles containing 200 ml, 300
ml, 500 ml and 1000 ml.

3 mm

3 mm

3 mm

Always take Lactulose oral solution exactly as described in this leaflet or as your
doctor or pharmacist has told you. Check with your doctor or pharmacist if you are
not sure.

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.

A measuring cup (polypropylene) with filling marks is added as measuring device.

3 mm

3. HOW TO TAKE LACTULOSE ORAL SOLUTION

Do not use this medicine after the expiry date which is stated on the label of the
bottle (EXP: mm yyyy). The expiry date refers to the last day of that month.

3 mm

Do not store above 25°C. Keep container tightly closed.
Keep this medicine out of the sight and reach of children.

3 mm

Lactulose oral solution with food and drink
Lactulose oral solution can be taken with or without food. There are no restrictions
on what you can eat or drink.
5 mm

6. CONTENTS OF THE PACK AND OTHER INFORMATION

5 mm

5. HOW TO STORE LACTULOSE ORAL SOLUTION

3 mm

which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated.

3 mm

Children
Lactulose oral solution should not normally be given to infants and smaller children
as it can disturb the normal reflexes for passing stools. In special circumstances your
doctor may prescribe Lactulose oral solution for a child, infant or baby. In these cases
your doctor will supervise the treatment carefully.

Driving and using machines
Lactulose oral solution will not affect your ability to drive safely or use machines.

5 mm

3 mm

If you take more Lactulose oral solution than you should
In case of overdosage, you may experience diarrhoea and abdominal pain. Contact
your doctor or pharmacist if you have taken more Lactulose oral solution than you
should.

3 mm

3 mm

3 mm

If you stop taking Lactulose oral solution
The desired effect of the medicine may not be achieved.

3 mm

Use in children and adolescents:
The safety and efficacy in children aged 0 - 18 years has not been established.

3 mm

3 mm

3 mm

If you forget to take Lactulose oral solution
If you forget to take a dose of Lactulose oral solution, do not worry. Just take the
next dose at the usual time. Do not take a double dose to make up for a forgotten
dose.

5

Longterm use of unadjusted dosages (exceeding 2-3 soft stools per day) or misuse
can lead to diarrhoea and disturbance of the electrolytes balance.
If you are an elderly patient or a patient in bad general condition and take Lactulose
oral solution for more than a 6 month period, your doctor will regularly check your
blood electrolytes.

14

dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be
between 5.0 to 5.5.
Use in elderly patients and patients with renal or hepatic insufficiency:
No special dosage recommendations exist.

3 mm

Warnings and precautions
Talk to your doctor or pharmacist before taking Lactulose.
Please tell your doctor before taking Lactulose oral solution if you suffer from gastrocardiac syndrome (Roemheld syndrome). If you have symptoms like meteorism or
bloating after using it, stop the treatment and consult your doctor. In these cases
your doctor will supervise the treatment carefully.

3 mm

3 mm

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

5 mm

Lactulose oral solution is used to:
• treat the symptoms of constipation
• treat a special liver disease (portal systemic encephalopathy)

5 mm

Do not take Lactulose oral solution:
• if you are allergic to lactulose or any of the other ingredients of this medicine (listed
in section 6).
• if you suffer from
• galactosaemia (a severe genetic disorder where you cannot digest galactose),
• acute inflammatory bowel disease (like Crohn’s disease or ulcerative colitis),
blockage in your bowel (apart from normal constipation), digestive perforation or
risk of digestive perforation, abdominal pain of undetermined cause.

3 mm

Lactulose oral solution contains the active substance lactulose. Lactulose is a laxative
and it makes the stool softer and easier to pass, by drawing water into the bowel. It is
not absorbed into your body and reaches the colon unchanged.
3 mm

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE ORAL SOLUTION

10-15 ml

corresponding to
10-20 g lactulose
corresponding to
7-10 g lactulose

3 mm

3 mm

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

15-30 ml

Thereafter the dose can be reduced individually.
The daily dose should be taken once during breakfast. It can be taken for 2-3 days
until the desired effect is achieved since Lactulose oral solution is not degraded until
it reaches the colon.
For portal systemic encephalopathy (Liver disease that affects the brain)
Adults:
Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose). The

5 mm

15 ml

corresponding to
10-30 g lactulose
corresponding to
10 g lactulose

corresponding to
3-7 g lactulose
up to 5 ml corresponding to up
to 3 g lactulose

5 mm

15-45 ml

Maintenance dose

5-10 ml

5 mm

Adolescents
over 14 years
Children
(7-14 years)

Children
(1-6 years)
Babies

Maintenance dose
15-30 ml
corresponding to
10-20 g lactulose
3 mm

Starting dose
Adults
15-45 ml
corresponding to
10-30 g lactulose
Use in children and adolescents
Starting dose

3 mm

3 mm

What is in this leaflet:
1. What Lactulose oral solution is and what it is used for
2. What you need to know before you take Lactulose oral solution
3. How to take Lactulose oral solution
4. Possible side effects
5. How to store Lactulose oral solution
6. Contents of the pack and other information

12

3 mm

For constipation:

5 mm

3 mm

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any

3 mm

5 mm

5 mm
3 mm

3 mm

5 mm

11

possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

AAAI3361

Lactulose 3.3 g/5 ml Oral Solution
Lactulose

5 mm

3 mm

2

3 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

5 mm

LC 662

3 mm

1

5 mm

55 mm

3 mm

Lactulose

5 ml contain 3.3 g lactulose. Oral use. Lift flap for further information about your medicine. Read the package leaflet before use.
Lactulose is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).
Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose)
Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose)
Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose)
Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose)
Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3–7g lactulose)
Babies: Starting dose: up to 5 ml (corresponding to up to 3g lactulose)
Portal systemic encephalopathy (Liver disease that affects the brain)
Adults: Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose). The dosage has to be adopted to get
2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5. Children: The safety and efficacy in children aged 0 - 18
years has not been established. In elderly patients and patients with renal or
Exp:
hepatic insufficiency no special dosage recommendations exist.
Marketing Authorisation Holder:
Lot:
Keep out of the sight and reach of children.
Fresenius Kabi Austria GmbH
Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose).
Hafnerstraße 36
Do not store above 25°C.
8055 Graz, Austria
V0055137/05
AAAI3361 PL 05061/0001

5 mm

3 mm

3 mm

3 mm

3 mm

Lactulose

5 ml contain 3.3 g lactulose. Oral use. Lift flap for further information about your medicine. Read the package leaflet before use.
Lactulose is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).
Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose)
Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose)
Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose)
Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose)
Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3–7g lactulose)
Babies: Starting dose: up to 5 ml (corresponding to up to 3g lactulose)
Portal systemic encephalopathy (Liver disease that affects the brain)
Adults: Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose).
The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5.
Children: The safety and efficacy in children aged 0 - 18 years has not been established.
In elderly patients and patients with renal or hepatic insufficiency no special dosage
Marketing Authorisation Holder:
recommendations exist. Keep out of the sight and reach of children.
Fresenius Kabi Austria GmbH
Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose).
Hafnerstraße 36
Do not store above 25°C.
8055 Graz, Austria
AAAI3361 PL 05061/0001

Lactulose 3.3g/5ml
Oral Solution
55 mm

3 mm

3 mm

3 mm

15 mm

138 mm

15 mm

5 mm

30 mm

For any information about this medicine, please contact the local representative of
the Marketing Authorisation Holder.

The recommended dose is:

This leaflet was last revised in September 2015.
3 mm

3 mm

AAAI3361

3 mm

Digitally signed by
emma.cornforth@mhra.gov.u
k
DN:
cn=emma.cornforth@mhra.g
ov.uk
Date: 2015.11.25 13:00:03 Z

BASELABEL

FRONT LABEL

183 mm
133,5 mm

3 mm

Lactulose 3.3g/5ml
Oral Solution

3 mm

3

4

13

3 mm

Use in children and adolescents:
The safety and efficacy in children aged 0 - 18 years has not been established.

3 mm

16

From the route of synthesis Lactulose oral solution may contain traces of sugars.
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
The following side effects have been reported with Lactulose oral solution:

Common:
• Nausea (feeling sick)
• Vomiting

Very common:
• Flatulence (wind), especially during the first few days of treatment. This usually
disappears after a couple of days

3 mm

3 mm

7

8

17

3 mm

3 mm

5 mm

5 mm

3 mm

3 mm

Do not use this medicine after the expiry date which is stated on the label of the
bottle (EXP: mm yyyy). The expiry date refers to the last day of that month.

3 mm

3 mm

You can take Lactulose oral solution undiluted or diluted in some liquid. Use the
measuring cup provided.

3 mm

15 ml of Lactulose oral solution contain 42.7 KJ (10.2 kcals) = 0.21 bu. The dose used
for treatment may need to be taken into considerations for diabetics.

During the treatment with laxatives you should drink sufficient amounts of fluids
(approx. 2 l/day, equal to 6-8 glasses).
The recommended dose is:

20

3 mm

3 mm

A measuring cup (polypropylene) with filling marks is added as measuring device.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz, Austria
Tel.: +43 316 249 0
Fax: +43 316 249 1470
Info-atgr@fresenius-kabi.com

Manufacturer
Fresenius Kabi Austria GmbH
Estermannstraße 17
4020 Linz, Austria
Tel.: +43 732 7651 0
Fax: +43 732 7651 2429
office@fresenius-kabi.com
For any information about this medicine, please contact the local representative of
the Marketing Authorisation Holder.
This leaflet was last revised in September 2015.

3 mm

3 mm

5 mm

3 mm

19

10
Take your doses at the same time each day. The dose may be given once daily, for
example during breakfast, or divided up to three doses a day.
Swallow the medicine quickly. Do not keep it in your mouth.

What Lactulose oral solution contains
• The active substance is Lactulose (as lactulose liquid).
5 ml of Lactulose oral solution contains 3.3 g lactulose.
• There are no other ingredients.
What Lactulose oral solution looks like and contents of the pack
Lactulose oral solution is a clear, viscous liquid, colourless or pale brownish-yellow
solution and is available in glass, PET bottles or HDPE bottles containing 200 ml, 300
ml, 500 ml and 1000 ml.

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will

3 mm

Lactulose oral solution contains milk sugar (lactose), galactose, epilactose,
tagatose or fructose.
Please refer to section “Warnings and precautions”.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Do not store above 25°C. Keep container tightly closed.
Keep this medicine out of the sight and reach of children.

3 mm

9

help to protect the environment.

5. HOW TO STORE LACTULOSE ORAL SOLUTION

Driving and using machines
Lactulose oral solution will not affect your ability to drive safely or use machines.

3 mm

3 mm

via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.

Lactulose oral solution with food and drink
Lactulose oral solution can be taken with or without food. There are no restrictions
on what you can eat or drink.

3 mm

18

3 mm

3 mm

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3 mm

3 mm

Other medicines and Lactulose Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Lactulose oral solution may increase the loss of potassium induced by other drugs
(e.g. thiazides, steroids and amphothericin B). Concomitant use of cardiac glycosides
can increase the effect of the glycosides through potassium deficiency.
With increasing dosage a decrease of pH-value in the colon is found. Therefore drugs

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly

3 mm

which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated.

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.

5 mm

During the treatment with laxatives you should drink sufficient amounts of fluids
(approx. 2 l/day, equal to 6-8 glasses).

Children
Lactulose oral solution should not normally be given to infants and smaller children
as it can disturb the normal reflexes for passing stools. In special circumstances your
doctor may prescribe Lactulose oral solution for a child, infant or baby. In these cases
your doctor will supervise the treatment carefully.

3 mm

4. POSSIBLE SIDE EFFECTS

3 mm

• When a higher dose than recommended is used, you may experience abdominal
pain and diarrhoea.

5 mm

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

3 mm

3 mm

3 mm

administration of other laxatives, because it hinders the individualization of drug
dose.
Please do not use Lactulose oral solution without medical advice for more than two
weeks.
5 mm

3 mm

15
3 mm

3 mm

6

Always take Lactulose oral solution exactly as described in this leaflet or as your
doctor or pharmacist has told you. Check with your doctor or pharmacist if you are
not sure.

If you stop taking Lactulose oral solution
The desired effect of the medicine may not be achieved.
3 mm

3 mm

3. HOW TO TAKE LACTULOSE ORAL SOLUTION

If you forget to take Lactulose oral solution
If you forget to take a dose of Lactulose oral solution, do not worry. Just take the
next dose at the usual time. Do not take a double dose to make up for a forgotten
dose.

3 mm

5

Longterm use of unadjusted dosages (exceeding 2-3 soft stools per day) or misuse
can lead to diarrhoea and disturbance of the electrolytes balance.
If you are an elderly patient or a patient in bad general condition and take Lactulose
oral solution for more than a 6 month period, your doctor will regularly check your
blood electrolytes.
Patients with portal systemic encephalopathy should avoid concomitant

3 mm

If you take more Lactulose oral solution than you should
In case of overdosage, you may experience diarrhoea and abdominal pain. Contact
your doctor or pharmacist if you have taken more Lactulose oral solution than you
should.
3 mm

Use in elderly patients and patients with renal or hepatic insufficiency:
No special dosage recommendations exist.

3 mm

Warnings and precautions
Talk to your doctor or pharmacist before taking Lactulose.
Please tell your doctor before taking Lactulose oral solution if you suffer from gastrocardiac syndrome (Roemheld syndrome). If you have symptoms like meteorism or
bloating after using it, stop the treatment and consult your doctor. In these cases
your doctor will supervise the treatment carefully.

14

3 mm

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

5 mm

Lactulose oral solution is used to:
• treat the symptoms of constipation
• treat a special liver disease (portal systemic encephalopathy)

3 mm

For portal systemic encephalopathy (Liver disease that affects the brain)
Adults:
Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose). The
dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be
between 5.0 to 5.5.
5 mm

Do not take Lactulose oral solution:
• if you are allergic to lactulose or any of the other ingredients of this medicine (listed
in section 6).
• if you suffer from
• galactosaemia (a severe genetic disorder where you cannot digest galactose),
• acute inflammatory bowel disease (like Crohn’s disease or ulcerative colitis),
blockage in your bowel (apart from normal constipation), digestive perforation or
risk of digestive perforation, abdominal pain of undetermined cause.

3 mm

Lactulose oral solution contains the active substance lactulose. Lactulose is a laxative
and it makes the stool softer and easier to pass, by drawing water into the bowel. It is
not absorbed into your body and reaches the colon unchanged.
3 mm

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE ORAL SOLUTION

corresponding to
7-10 g lactulose

Thereafter the dose can be reduced individually.
The daily dose should be taken once during breakfast. It can be taken for 2-3 days
until the desired effect is achieved since Lactulose oral solution is not degraded until
it reaches the colon.

Maintenance dose
15-30 ml corresponding to
10-20 g lactulose

3 mm

3 mm

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

up to 5 ml

10-15 ml

5 mm

3 mm

5-10 ml

corresponding to
10 g lactulose
corresponding to
3-7 g lactulose
corresponding to up
to 3 g lactulose

5 mm

3 mm

15 ml

5 mm

Use in children and adolescents
Starting dose
Adolescents
15-45 ml
corresponding to
over 14 years
10-30 g lactulose

3 mm

Children
(7-14 years)
Children
(1-6 years)
Babies

Maintenance dose
15-30 ml
corresponding to
10-20 g lactulose
3 mm

Starting dose
15-45 ml
corresponding to
10-30 g lactulose

3 mm

3 mm

Adults

12

3 mm

What is in this leaflet:
1. What Lactulose oral solution is and what it is used for
2. What you need to know before you take Lactulose oral solution
3. How to take Lactulose oral solution
4. Possible side effects
5. How to store Lactulose oral solution
6. Contents of the pack and other information

For constipation:

5 mm

3 mm

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any

3 mm

5 mm

5 mm
3 mm

3 mm

5 mm

11

possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

AAAI3358

Lactulose 3.3 g/5 ml Oral Solution
Lactulose

5 mm

3 mm

2

3 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

5 mm

LC 661

3 mm

1

5 mm

55 mm

3 mm

Lactulose

5 ml contain 3.3 g lactulose. Oral use. Lift flap for further information about your medicine. Read the package leaflet before use.
Lactulose is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).
Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose)
Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose)
Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose)
Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose)
Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3–7g lactulose)
Babies: Starting dose: up to 5 ml (corresponding to up to 3g lactulose)
Portal systemic encephalopathy (Liver disease that affects the brain)
Adults: Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose). The dosage has to be adopted to get
2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5. Children: The safety and efficacy in children aged 0 - 18
years has not been established. In elderly patients and patients with renal or
Exp:
hepatic insufficiency no special dosage recommendations exist.
Marketing Authorisation Holder:
Lot:
Keep out of the sight and reach of children.
Fresenius Kabi Austria GmbH
Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose).
Hafnerstraße 36
Do not store above 25°C.
8055 Graz, Austria
AAAI3358
PL
05061/0001
V0055129/05

5 mm

3 mm

3 mm

3 mm

3 mm

Lactulose

5 ml contain 3.3 g lactulose. Oral use. Lift flap for further information about your medicine. Read the package leaflet before use.
Lactulose is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).
Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose)
Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose)
Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose)
Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose)
Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3–7g lactulose)
Babies: Starting dose: up to 5 ml (corresponding to up to 3g lactulose)
Portal systemic encephalopathy (Liver disease that affects the brain)
Adults: Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose).
The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5.
Children: The safety and efficacy in children aged 0 - 18 years has not been established.
In elderly patients and patients with renal or hepatic insufficiency no special dosage
Marketing Authorisation Holder:
recommendations exist. Keep out of the sight and reach of children.
Fresenius Kabi Austria GmbH
Hafnerstraße 36
Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose).
8055 Graz, Austria
AAAI3358 PL 05061/0001
Do not store above 25°C.

Lactulose 3.3g/5ml
Oral Solution
55 mm

3 mm

3 mm

3 mm

15 mm

138 mm

15 mm

5 mm

30 mm

5 mm

emma.cornf
orth@mhra.
gov.uk

AAAI3358

3 mm

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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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