LAEVOLAC 3.3G/5ML ORAL SOLUTION

Active substance: LACTULOSE

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Transcript
BASELABEL

FRONT LABEL

183 mm
133,5 mm
3 mm

3 mm

11
3 mm

15
3 mm

5 mm

From the route of synthesis Lactulose 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.

5 mm

During the treatment with laxatives you should drink sufficient amounts of
fluids (approx. 2 l/day, equal to 6-8 glasses).
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently

7

8

3 mm

3 mm

taken any other medicine, including medicines obtained without a
prescription.

17

5 mm

5 mm

3 mm

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

3 mm

9

3 mm

3 mm

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

5 mm

Constipation:

5 mm

3 mm

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

3. How to take LACTULOSE
Always take Lactulose exactly as described in this leaflet or as your doctor or
pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure.

Adults and
adolescents
over 14 years

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

3 mm

For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder.
This leaflet was last approved in September 2012
3 mm

5 mm

20

3 mm

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

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

19

10
3 mm

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

Not all pack sizes may be marketed.

3 mm

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

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 looks like and contents of the pack
Lactulose 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.
As measuring device a measuring cup (polypropylene) with filling marks is
added.

3 mm

3 mm

18
3 mm

6. FURTHER INFORMATION
What Lactulose contains
•  he active substance is Lactulose (as lactulose liquid) 5 ml of Lactulose
T
contain 3.3 g lactulose.
•  There are no other ingredients

Important information about some of the ingredients of Lactulose
Lactulose may contain milk sugar (lactose), galactose , epilactose, tagatose or
fructose. Please refer to section “Take special care with Lactulose”.

Taking Lactulose with food and drink
Lactulose can be taken with or without food. There are no restrictions on what

3 mm

3 mm

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before you use Lactulose if you are pregnant
or breastfeeding.
3 mm

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

you can eat or drink.

5. HOW TO StorE LACTULOSE
Do not store above 25°C.
Keep container tightly closed.
Keep out of the sight and reach of children.
Do not use Lactulose 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.
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.

3 mm

3 mm

3 mm

3 mm

3 mm

Children
Lactulose should not normally be given to infants and smaller children as it can

3 mm

The following side effects have been reported with Lactulose
Very common:
•  latulence (wind), especially during the first few days of treatment. This
F
usually disappears after a couple of days
•  hen a higher dose than recommended is used, you may experience
W
abdominal pain and diarrhoe.
Common:
•  ausea (feeling sick)
N
•  omiting
V
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.

3 mm

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 without medical advice for more than two weeks.

disturb the normal reflexes for passing stools.
In special circumstances your doctor may prescribe Lactulose for a child, infant
or baby. In these cases your doctor will supervise the treatment carefully.

3 mm

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 who take
Lactulose for a more than 6 months period, your doctor will regularly check
your blood electrolytes.

16

3 mm

6
3 mm

3 mm

5
3 mm

5 mm

4. Possible side effects
Like all medicines, Lactulose can cause side effects, although not everybody
gets them.
3 mm

3 mm

3 mm

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

5 mm

If you take more Lactulose 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 than you
should.

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

5 mm

5 mm

Take special care with Lactulose
Please tell your doctor before taking Lactulose if you suffer from gastro-cardiac
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.

If you forget to take Lactulose
If you forget to take a dose of Lactulose, 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.

In elderly patients and patients with renal or hepatic insufficiency no special
dosage recommendations exist.
5 mm

3 mm

3 mm

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

3 mm

5 mm

3 mm

cannot digest galactose)
•  cute inflammatory bowel disease (like Crohn’s disease or ulcerative
a
colitis), blockage in your bowel (apart from normal constipation), digestive
perforation or risk of digestive perforation, abdominal pain of undetermined
cause.

2. before you take LaCTULOSE
Do not take Lactulose
• f you are allergic (hypersensitive) to any of the components of Lactulose.
i
• f you suffer from galactosaemia (a severe genetic disorder where you
i

5 mm

14

3 mm

3 mm

1. What LACTULOSE is and what it is used for
Lactulose contains a laxative called lactulose. It makes the stool softer and
easier to pass, by drawing water into the bowel. It is not absorbed into your
body.

3 mm

13

4

3

Lactulose is used to:
•  reat the symptoms of constipation
t
•  reat a special liver disease (portal systemic encephalopathy)
t

3 mm

3 mm

3 mm

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

3 mm

Babies

Maintenance dose
10-15 ml corresponding to
7-10 g
lactulose

3 mm

•  eep this leaflet. You may need to read it again.
K

Children
(1-6 years)

Starting dose
corresponding to
10 g
lactulose
5-10 ml
corresponding to
3-7 g
lactulose
up to 5 ml
corresponding to
up to 3 g
lactulose
15 ml

3 mm

This medicine is available without prescription. However, you still need to take
Lactulose carefully to get the best results from it.

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

5 mm

3 mm

Read all of this leaflet carefully because it contains important information
for you

3 mm

Lactulose 3.3 g/5 ml Oral Solution
Lactulose

Children
(7-14 years)

3 mm

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

5 mm

3 mm

• Ask your pharmacist if you need more information or advice.
•  ou must contact a doctor if your symptoms worsen or do not improve after
Y
3 days.
•  f any of the side effects gets serious, or if you notice any side effect not
I
listed in this leaflet, please tell your doctor or pharmacist.

AAAD9537

12

3 mm

5 mm

2

3 mm

5 mm

3 mm

3 mm

1

5 mm

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)
300ml e
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 recommendations exist.
Exp:
Marketing Authorisation Holder:
Keep out of the sight and reach of children.
Lot:
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
AAAD9537 PL 05061/0001
V0055129/03

LC 661

3 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

3.3g
5ml

Lactulose

55 mm

3 mm

3 mm

3 mm

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)
300ml e
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 recommendations exist.
Marketing Authorisation Holder:
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
AAAD9537 PL 05061/0001

55 mm

3.3g
5ml

Lactulose

3 mm

Lactulose 3.3g/5ml Oral Solution

3 mm

Lactulose 3.3g/5ml Oral Solution

3 mm

3 mm

15 mm

138 mm

15 mm

5 mm

30 mm

AAAD9537

3 mm



BASELABEL

FRONT LABEL

183 mm
133,5 mm
3 mm

3 mm

11
3 mm

If you take more Lactulose 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 than you
should.

In elderly patients and patients with renal or hepatic insufficiency no special
dosage recommendations exist.

15
3 mm

5 mm

From the route of synthesis Lactulose 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.

5 mm

During the treatment with laxatives you should drink sufficient amounts of
fluids (approx. 2 l/day, equal to 6-8 glasses).
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently

7

8

3 mm

3 mm

taken any other medicine, including medicines obtained without a
prescription.

17

5 mm

5 mm

3 mm

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

3 mm

9

3 mm

3 mm

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

5 mm

Constipation:

5 mm

3 mm

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

3. How to take LACTULOSE
Always take Lactulose exactly as described in this leaflet or as your doctor or
pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure.

Adults and
adolescents
over 14 years

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

3 mm

For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder.
This leaflet was last approved in September 2012
3 mm

5 mm

20

3 mm

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

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

19

10
3 mm

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

Not all pack sizes may be marketed.

3 mm

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

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 looks like and contents of the pack
Lactulose 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.
As measuring device a measuring cup (polypropylene) with filling marks is
added.

3 mm

3 mm

18
3 mm

6. FURTHER INFORMATION
What Lactulose contains
•  he active substance is Lactulose (as lactulose liquid) 5 ml of Lactulose
T
contain 3.3 g lactulose.
•  There are no other ingredients

Important information about some of the ingredients of Lactulose
Lactulose may contain milk sugar (lactose), galactose , epilactose, tagatose or
fructose. Please refer to section “Take special care with Lactulose”.

Taking Lactulose with food and drink
Lactulose can be taken with or without food. There are no restrictions on what

3 mm

3 mm

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before you use Lactulose if you are pregnant
or breastfeeding.
3 mm

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

you can eat or drink.

5. HOW TO StorE LACTULOSE
Do not store above 25°C.
Keep container tightly closed.
Keep out of the sight and reach of children.
Do not use Lactulose 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.
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.

3 mm

3 mm

3 mm

3 mm

3 mm

Children
Lactulose should not normally be given to infants and smaller children as it can

3 mm

The following side effects have been reported with Lactulose
Very common:
•  latulence (wind), especially during the first few days of treatment. This
F
usually disappears after a couple of days
•  hen a higher dose than recommended is used, you may experience
W
abdominal pain and diarrhoe.
Common:
•  ausea (feeling sick)
N
•  omiting
V
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.

3 mm

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 without medical advice for more than two weeks.

disturb the normal reflexes for passing stools.
In special circumstances your doctor may prescribe Lactulose for a child, infant
or baby. In these cases your doctor will supervise the treatment carefully.

3 mm

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 who take
Lactulose for a more than 6 months period, your doctor will regularly check
your blood electrolytes.

16

3 mm

6
3 mm

3 mm

5

If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Lactulose can cause side effects, although not everybody
gets them.
3 mm

3 mm

3 mm

3 mm

5 mm

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

5 mm

Take special care with Lactulose
Please tell your doctor before taking Lactulose if you suffer from gastro-cardiac
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.

If you forget to take Lactulose
If you forget to take a dose of Lactulose, 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 mm

3 mm

3 mm

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

3 mm

5 mm

3 mm

cannot digest galactose)
•  cute inflammatory bowel disease (like Crohn’s disease or ulcerative
a
colitis), blockage in your bowel (apart from normal constipation), digestive
perforation or risk of digestive perforation, abdominal pain of undetermined
cause.

2. before you take LaCTULOSE
Do not take Lactulose
• f you are allergic (hypersensitive) to any of the components of Lactulose.
i
• f you suffer from galactosaemia (a severe genetic disorder where you
i

5 mm

14

3 mm

3 mm

1. What LACTULOSE is and what it is used for
Lactulose contains a laxative called lactulose. It makes the stool softer and
easier to pass, by drawing water into the bowel. It is not absorbed into your
body.

3 mm

13

4

3

Lactulose is used to:
•  reat the symptoms of constipation
t
•  reat a special liver disease (portal systemic encephalopathy)
t

3 mm

3 mm

3 mm

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

3 mm

Babies

Maintenance dose
10-15 ml corresponding to
7-10 g
lactulose

3 mm

•  eep this leaflet. You may need to read it again.
K

Children
(1-6 years)

Starting dose
corresponding to
10 g
lactulose
5-10 ml
corresponding to
3-7 g
lactulose
up to 5 ml
corresponding to
up to 3 g
lactulose
15 ml

3 mm

This medicine is available without prescription. However, you still need to take
Lactulose carefully to get the best results from it.

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

5 mm

3 mm

Read all of this leaflet carefully because it contains important information
for you

3 mm

Lactulose 3.3 g/5 ml Oral Solution
Lactulose

Children
(7-14 years)

3 mm

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

3 mm

• Ask your pharmacist if you need more information or advice.
•  ou must contact a doctor if your symptoms worsen or do not improve after
Y
3 days.
•  f any of the side effects gets serious, or if you notice any side effect not
I
listed in this leaflet, please tell your doctor or pharmacist.

AAAD9536

12

5 mm

2

3 mm

5 mm

3 mm

3 mm

1

5 mm

5 mm

55 mm

LC 662

3 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

3.3g
5ml

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).
500ml e
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
recommendations exist. Keep out of the sight and reach of children.
Exp:
Marketing Authorisation Holder:
Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose)
Lot:
Fresenius Kabi Austria GmbH
Do not store above 25°C.
Hafnerstraße 36
8055 Graz, Austria
V0055137/03 AAAD9536 PL 05061/0001

55 mm

3.3g
5ml

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)
500ml e
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
AAAD9536 PL 05061/0001

5 mm

3 mm

3 mm

3 mm

3 mm

Lactulose

Lactulose 3.3g/5ml Oral Solution

3 mm

Lactulose 3.3g/5ml Oral Solution

3 mm

3 mm

15 mm

138 mm

15 mm

5 mm

30 mm

AAAD9536

3 mm

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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