Medine.co.uk

Lactulose Liquid Ph Eur

Document: label-leaflet MAH GENERIC_PL 00030-0175 change

CARRIER



A


Lactulose Liquid Ph Eur

67% w/v Oral Solution


200ml 0


To be taken by mouth Dosage: (Constipation)

ADULTS: 3 to 6 x 5 ml spoonfuls daily for the first 2 to 3 days of treatment (9 spoonfuls may be given in obstinate cases), followed by 2 to 3 spoonfuls daily as required, or as directed by your doctor.

CHILDREN: 2 to 5 x 5 ml spoonfuls daily for the first 2 to 3 days of treatment, followed by 1 to 3 spoonfuls daily as required, or as directed by your doctor. Dosage: (Liver disease)

Between 6 to 10 x 5 ml spoonfuls, taken three times daily, or as directed by your doctor.

Each 5 ml contains 3.35 g lactulose.

It also contains lactose and galactose.

See leaflet for further information.

Keep out of reach and sight of children.

Do not store above 25°C Novartis Consumer Health,

Horsham, RH12 5AB, UK.

PL 0030/0175 NEWZ4


m


LEAFLET FACE


Laetus code 232


Elderly

No adjustment of the dose is required.

Liver disease

Take 6 to 10 x 5 ml spoonfuls 3 times daily, or as directed by your doctor.


If you take more Lactulose Liquid than you should

If you accidentally take too much Lactulose Liquid, or you suspect that your child has taken extra medicine, contact your doctor or pharmacist.

If you forget to take Lactulose Liquid

Take the next dose as soon as you remember, unless it is nearly time for your next dose. In this case, take your next dose and go on as before. Do not take a


double dose to make up for a forgotten dose.

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


6


4. POSSIBLE SIDE EFFECTS

Like all medicines, Lactulose Liquid can cause side effects, although not everybody gets them.

Mild and short-lasting effects such as abdominal bloatedness, cramps or wind have been reported occasionally. These

7


usually subside after the early stages of treatment.

High doses of Lactulose Liquid may cause nausea in some patients. This can be minimised by taking Lactulose Liquid with water, fruit juice or with meals.

If any of the side effects gets serious, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.


5. HOW TO STORE LACTULOSE LIQUID

Keep out of the reach and sight of children.

Do not store above 25°C. Keep the container tightly closed.

Do not use Lactulose Liquid after the date stated on the bottle. The 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.


6. FURTHER INFORMATION What Lactulose Liquid contains

The active ingredient is lactulose. The other ingredients are lactose, galactose, tagatose and other ketoses, purified water.

What Lactulose Liquid looks like and contents of the pack

Lactulose Liquid is a clear, almost colourless to brownish-yellow syrup.

The following pack sizes are 8 available:


Amber glass bottles or plastic bottles with polyethylene closure containing 200 ml, 300 ml, 500 ml or 1 litre of Lactulose Liquid.

Measuring spoon provided.

Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road Horsham West Sussex RH125AB

9


Manufactured by

BCM Limited, Nottingham,

NG90 2PR, UK.

For any information about this medicinal product, please contact the Marketing Authorisation Holder.

This leaflet was last approved on 24 July 2008


Lactulose Liquid Ph Eur

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To be taken by mouth Dosage: (Constipation)

ADULTS: 3 to 6 x 5 ml


spoonfuls daily for the first 2 to 3 days of treatment (9 spoonfuls may be given in obstinate cases), followed by 2 to 3 spoonfuls daily as required, or as directed by your doctor.


200ml 0


(jKItpRjNtZ t*5® 5(njlgpQ|pfu)s daife fortl® first No^days of treatme* followe*by# to 3(Sp*nfulaJaily,as, required, o o o*a*di«cted t*®ur*®oro O OO OO OO O C> Dosage: (Liver disease)

BbhAeiC* 10x 5 n*s#boi*uls, taken th*e timdldaily!* 0> d*as>difeclltt byybur#naor# • O C) O • C) o • • Each 6 ml contains 3*5 g lactulose. 0> OO •• *0 It also contains lactose and galactose.

Keep out of reach and sight of children.

Do not store above 25°C Novartis Consumer Health,


Horsham, RH12 5AB, UK.


PL 0030/0175


NEWZ24


LEAFLET REVERSE


PACKAGE LEAFLET: INFORMATION FOR THE USER Lactulose Liquid EP

Lactulose 67.0% w/v

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

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

•Keep this leaflet. You may need to read it again.


•If you have any further questions, ask your doctor or pharmacist.

•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.

•You must contact a doctor if your symptoms worsen or do not improve.

In this leaflet:

1.    What Lactulose Liquid is and

what it is used for

2.    Before you take Lactulose


3.    How to take Lactulose Liquid

4.    Possible side effects

5.    How to store Lactulose Liquid

6.    Further information


1. WHAT LACTULOSE LIQUID IS AND WHAT IT IS USED FOR

Lactulose Liquid belongs to a group of medicines known as laxatives, and is used to treat constipation.

It is also given to patients with liver disease to prevent any damage caused by poisons being released into the blood, which can occur when the liver is 2


not working properly.

Each 5 ml dose of Lactulose Liquid contains 3.35 grams of the sugar, lactulose. It also contains other sugars called lactose, galactose, tagatose and other ketoses.


2. BEFORE YOU TAKE LACTULOSE LIQUID Do not take Lactulose Liquid if you have:

•    an allergy (hypersensitive) to any of the ingredients of Lactulose Liquid (see Section 6),

•    a blockage or obstruction in


the bowel that is not due to constipation,

•    high levels of galactose in your blood (galactosaemia),

•    intolerance to lactose.

Take special care with Lactulose Liquid if you:

•    are pregnant (especially during the first 3 months),

•    Lactulose Liquid contains sugars. You should pay special attention to your dental hygiene while taking Lactulose Liquid, or your child's if taking Lactulose Liquid.


Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription. There are no known interactions between Lactulose Liquid and other medicines.

Taking Lactulose Liquid with food and drink

Taking Lactulose Liquid with water, fruit juice or with meals can help to minimise any 3 feelings of sickness that can


occur after taking high doses.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Lactulose Liquid must be used with caution during the first 3 months of pregnancy.

Driving and using machines

There is no evidence that Lactulose Liquid can affect your ability to drive or operate machinery.


Important information about some of the ingredients of Lactulose Liquid.

This medicine contains the sugars lactose, galactose, tagatose and other ketoses. If you have an intolerance to some sugars, contact your doctor before taking this product.


3. HOW TO TAKE LACTULOSE LIQUID

If this medicine has been prescribed for you,always take Lactulose Liquid exactly as your 4 doctor has told you. You should


check with your doctor or pharmacist if you are not sure. Shake well before use. Swallow the medicine directly from the spoon.

Constipation

Begin with the following starting doses for the first 2-3 days then continue with the daily maintenance doses until your constipation has cleared. Do not dilute your medicine. After use make sure the bottle cap is properly closed.


Adults

Starting dose: 3 to 6 spoonfuls once a day. Up to 9 spoonfuls may be taken in obstinate cases. Maintenance dose: 2 to 3 spoonfuls once a day or as directed by your doctor.

Children

Starting dose: 2 to 5 spoonfuls once a day.

Maintenance dose: 1 to 3 spoonfuls once a day or as directed by your doctor. Adjust dose until desired response is 5 seen.


Lactulose

• ••• • • •• •• • • • •• • • • • • • • • •


r Liquid Ph Eur

CARRIER



Lactulose Liquid Ph Eur

67% w/v Oral Solution


300ml 0


To be taken by mouth Dosage: (Constipation)

ADULTS: 3 to 6 x 5 ml spoonfuls daily for the first 2 to 3 days of treatment (9 spoonfuls may be given in obstinate cases), followed by 2 to 3 spoonfuls daily as required, or as directed by your doctor.

CHILDREN: 2 to 5 x 5 ml spoonfuls daily for the first 2 to 3 days of treatment, followed by 1 to 3 spoonfuls daily as required, or as directed by your doctor. Dosage: (Liver disease)

Between 6 to 10 x 5 ml spoonfuls, taken three times daily, or as directed by your doctor.

Each 5 ml contains 3.35 g lactulose.

It also contains lactose and galactose.

See leaflet for further information.

Keep out of reach and sight of children.

Do not store above 25°C Novartis Consumer Health,

Horsham, RH12 5AB, UK.

PL 0030/0175


LEAFLET FACE


Laetus code 448


Dosage in children should be adjusted until the desired response is seen.

Elderly

No adjustment of the dose is required.

Liver disease

Take 6 to 10 x 5 ml spoonfuls 3 times daily, or as directed by your doctor.

If you take more Lactulose Liquid than you should

If you accidentally take too much Lactulose Liquid, or you suspect that your child has taken extra medicine, contact you doctor or pharmacist.    5


If you forget to take Lactulose Liquid

Take the next dose as soon as you remember, unless it is nearly time for your next dose. In this case, take your next dose and go on as before. Do not take a double dose to make up for a forgotten dose.

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

occasionally. These usually subside Do not use Lactulose Liquid after after the early stages of treatment. the date stated on the bottle. The High doses of Lactulose Liquid may date refers to the last day of that cause nausea in some patients. This month.

can be minimised by taking Medicines should not be disposed Lactulose Liquid with water, fruit of via wastewater or household juice or with meals. waste. Ask your pharmacist how to If any of the side effects gets dispose of medicines no longer serious, or if you experience any required. These measures will help side effects not listed in this leaflet, to protect the environment. please tell your doctor or pharma-

cist. 6. FURTHER INFORMATION

What Lactulose Liquid contains

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lactulose Liquid can cause side effects, although not everybody gets them.

Mild and short-lasting effects such as abdominal bloatedness, cramps or wind have been reported

5. HOW TO STORE LACTULOSE The active ingredient is lactulose. LIQUID The other ingredients are lactose,

Keep out of the reach and sight of galactose, tagatose and other children. ketoses, purified water.

Do not store above 25°C. Keep the container tightly closed. 6


What Lactulose Liquid looks like and contents of the pack

Lactulose Liquid is a clear, almost colourless to brownish-yellow syrup. The following pack sizes are available:

Amber glass bottles or plastic bottles with polyethylene closure containing 200 ml, 300 ml, 500 ml or 1 litre of Lactulose Liquid.

Measuring spoon provided.

Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road Horsham West Sussex RH125AB

7


Manufactured by

BCM Limited, Nottingham,

NG90 2PR, UK.

For any information about this medicinal product, please contact the Marketing Authorisation Holder.

This leaflet was last approved on 24 July 2008


Lactulose Liquid Ph Eur

^ mo mo mm o


67% w/v Oral) Solution

o

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oo

o

o

• o

om

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o

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oo

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300ml e


To be taken by mouth Dosage: (Constipation)

ADULTS: 3to6x5 ml

spoonfuls daily for the first 2 to 3 days of treatment (9 spoonfuls may be given in obstinate cases), followed by 2 to 3 spoonfuls daily as required, or as directed by your doctor.

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Dosage: (Liver disease)    I

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• Easts m) contain® 3«5a lasjtoiosai ci o o • • • o It also contains lactose and galactose.

Keep out of reach and sight of children.

Do not store above 25°C Novartis Consumer Health,

Horsham, RH12 5AB, UK.

LVBE6


LEAFLET REVERSE


PACKAGE LEAFLET:

INFORMATION FOR THE USER Lactulose Liquid EP

Lactulose 67.0% w/v

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

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

•Keep this leaflet. You may need to read it again.

•If you have any further questions, ask your doctor or pharmacist.

•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.

•You must contact a doctor if your symptoms worsen or do not improve.

In this leaflet:

1.    What Lactulose Liquid is and

what it is used for

2.    Before you take Lactulose Liquid

3.    How to take Lactulose Liquid

4.    Possible side effects

5.    How to store Lactulose Liquid

6.    Further information


1. WHAT LACTULOSE LIQUID IS AND WHAT IT IS USED FOR

Lactulose Liquid belongs to a group of medicines known as laxatives, and is used to treat constipation.


It is also given to patients with liver disease to prevent any damage caused by poisons being released into the blood, which can occur when the liver is not working properly.

Each 5 ml dose of Lactulose Liquid contains 3.35 grams of the sugar, lactulose. It also contains other sugars called lactose, galactose, tagatose and other ketoses.


2. BEFORE YOU TAKE LACTULOSE LIQUID Do not take Lactulose Liquid if you have:

• an allergy (hypersensitive) to any of the ingredients of Lactulose Liquid (see Section 6),


•    a blockage or obstruction in the bowel that is not due to constipation,

•    high levels of galactose in your blood (galactosaemia),

•    intolerance to lactose.

Take special care with Lactulose Liquid if you:

•    are pregnant (especially during the first 3 months),

•    Lactulose Liquid contains sugars. You should pay special attention to your dental hygiene while taking Lactulose Liquid, or that of your child if you are giving Lactulose Liquid to him or her.


Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

There are no known interactions between Lactulose Liquid and other medicines.

Taking Lactulose Liquid with food and drink

Taking Lactulose Liquid with water, fruit juice or with meals can help to minimise any feelings of sickness that can occur after taking high doses.


Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Lactulose Liquid must be used with caution during the first 3 months of pregnancy.

Driving and using machines

There is no evidence that Lactulose Liquid can affect your ability to drive or operate machinery.

Important information about some of the ingredients of Lactulose Liquid.

This medicine contains the sugars lactose, galactose, tagatose and other ketoses. If you have an intolerance to some sugars, contact


your doctor before taking this product.


3. HOW TO TAKE LACTULOSE LIQUID

If this medicine has been prescribed for you,always take Lactulose Liquid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Shake well before use. Swallow the medicine directly from the spoon.

Constipation

Begin with the following starting doses for the first 2-3 days then continue with the daily maintenance doses until your constipation has cleared.


Do not dilute your medicine. After use make sure the bottle cap is properly closed.

Adults

Starting dose: 3 to 6 spoonfuls once a day. Up to 9 spoonfuls may be taken in obstinate cases. Maintenance dose: 2 to 3 spoonfuls once a day or as directed by your doctor.

Children

Starting dose: 2 to 5 spoonfuls once a day.

Maintenance dose: 1 to 3 spoonfuls once a day or as directed by your doctor.

4


Lactulose

• • •• • • •• •• • • • •• • • • • • • • • •


r Liquid Ph Eur

139mm


CARRIER



A

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ro

o

o

r\j


o

ro


Lactulose Liquid Ph Eur

67% w/v Oral Solution


To be taken by mouth Dosage: (Constipation)

ADULTS: 3 to 6 x 5 ml spoonfuls daily for the first 2 to 3 days of treatment (9 spoonfuls may be given in obstinate cases), followed by 2 to 3 spoonfuls daily as required, or as directed by your doctor.

CHILDREN: 2 to 5 x 5 ml spoonfuls daily for the first 2 to 3 days of treatment, followed by f to 3 spoonfuls daily as required, or as directed by your doctor. Dosage: (Liver disease)

Between 6 to 10 x 5 ml spoonfuls, taken three times daily, or as directed by your doctor.

Each 5 ml contains 3.35 g lactulose.

It also contains lactose and galactose.

See leaflet for further information.

Keep out of reach and sight of children.

Do not store above 25°C Novartis Consumer Health,

Horsham, RH12 5AB, UK.

XJJJ9


500ml e


Laetus code 248

LEAFLET FACE


Laetus code 248


Dosage in children should be adjusted until the desired response is seen.

Elderly

No adjustment of the dose is required.

Liver disease

Take 6 to 10 x 5 ml spoonfuls 3 times daily, or as directed by your doctor.

If you take more Lactulose Liquid than you should

If you accidentally take too much Lactulose Liquid, or you suspect that your child has taken extra medicine, contact you doctor or pharmacist.    5


If you forget to take Lactulose Liquid

Take the next dose as soon as you remember, unless it is nearly time for your next dose. In this case, take your next dose and go on as before. Do not take a double dose to make up for a forgotten dose.

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 Liquid can cause side effects, although not everybody gets them.

Mild and short-lasting effects such as abdominal bloatedness, cramps or wind have been reported


occasionally. These usually subside after the early stages of treatment.

High doses of Lactulose Liquid may cause nausea in some patients. This can be minimised by taking Lactulose Liquid with water, fruit juice or with meals.

If any of the side effects gets serious, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Do not use Lactulose Liquid after the date stated on the bottle. The 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.


5. HOW TO STORE LACTULOSE LIQUID

Keep out of the reach and sight of children.

Do not store above 25°C. Keep the container tightly closed.    6


6. FURTHER INFORMATION What Lactulose Liquid contains

The active ingredient is lactulose. The other ingredients are lactose, galactose, tagatose and other ketoses, purified water.


What Lactulose Liquid looks like and contents of the pack

Lactulose Liquid is a clear, almost colourless to brownish-yellow syrup.

The following pack sizes are available:

Amber glass bottles or plastic bottles with polyethylene closure containing 200 ml, 300 ml, 500 ml or 1 litre of Lactulose Liquid. Measuring spoon provided.

Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH125AB    7


Manufactured by

BCM Limited, Nottingham,

NG90 2PR, UK.

For any information about this medicinal product, please contact the Marketing Authorisation Holder.

This leaflet was last approved on 24 July 2008


Lactulose Liquid Ph Eur

67% w/v orabSaluJion. o.

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500ml 0


To be taken by mouth Dosage: (Constipation)

ADULTS: 3to6x5 ml

spoonfuls daily for the first 2 to 3 days of treatment (9 spoonfuls may be given in obstinate cases), followed by 2 to 3 spoonfuls daily as required, or as directed by your doctor.

CHILDREN: 2 to 5 x 5 ml spoonfuls daily for the first 2 to 3 days of treatment, followed by 1 to 3 spoonfuls daily as required, •rtisdlfddeiftyyr^fbdlrp    uu    uu    uO

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Keep out of reach and sight of children.

Do not store above 25°C Novartis Consumer Health,

Horsham, RH12 5AB, UK.

PL 0030/0175    e |

XJJJ9


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m


LEAFLET REVERSE


PACKAGE LEAFLET: INFORMATION FOR THE USER Lactulose Liquid EP

Lactulose 67.0% w/v

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

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

•Keep this leaflet. You may need to read it again.

•If you have any further questions, ask your doctor or pharmacist.

•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.

•You must contact a doctor if your symptoms worsen or do not improve.

In this leaflet:

1.    What Lactulose Liquid is and

what it is used for

2.    Before you take Lactulose

Liquid

3.    How to take Lactulose Liquid

4.    Possible side effects

5.    How to store Lactulose Liquid

6.    Further information


1. WHAT LACTULOSE LIQUID IS AND WHAT IT IS USED FOR

Lactulose Liquid belongs to a 1 group of medicines known as


laxatives, and is used to treat constipation.

It is also given to patients with liver disease to prevent any damage caused by poisons being released into the blood, which can occur when the liver is not working properly.

Each 5 ml dose of Lactulose Liquid contains 3.35 grams of the sugar, lactulose. It also contains other sugars called lactose, galactose, tagatose and other ketoses.


2. BEFORE YOU TAKE LACTULOSE LIQUID Do not take Lactulose Liquid if you have:

• an allergy (hypersensitive) to


any of the ingredients of Lactulose Liquid (see Section 6),

•    a blockage or obstruction in the bowel that is not due to constipation,

•    high levels of galactose in your blood (galactosaemia),

•    intolerance to lactose.

Take special care with Lactulose Liquid if you:

•    are pregnant (especially during the first 3 months),

•    Lactulose Liquid contains sugars. You should pay special attention to your dental hygiene while taking Lactulose Liquid, or that of your child if you are giving Lactulose Liquid to him or her.

2


Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription. There are no known interactions between Lactulose Liquid and other medicines.

Taking Lactulose Liquid with food and drink

Taking Lactulose Liquid with water, fruit juice or with meals can help to minimise any feelings of sickness that can occur after taking high doses.


Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Lactulose Liquid must be used with caution during the first 3 months of pregnancy.

Driving and using machines

There is no evidence that Lactulose Liquid can affect your ability to drive or operate machinery.

Important information about some of the ingredients of Lactulose Liquid.

This medicine contains the sugars lactose, galactose, tagatose and 3 other ketoses. If you have an


intolerance to some sugars, contact your doctor before taking this product.


3. HOW TO TAKE LACTULOSE LIQUID

If this medicine has been prescribed for you,always take Lactulose Liquid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Shake well before use. Swallow the medicine directly from the spoon.

Constipation

Begin with the following starting doses for the first 2-3 days then continue with the daily

4


maintenance doses until your constipation has cleared.

Do not dilute your medicine. After use make sure the bottle cap is properly closed.

Adults

Starting dose: 3 to 6 spoonfuls once a day. Up to 9 spoonfuls may be taken in obstinate cases. Maintenance dose: 2 to 3 spoonfuls once a day or as directed by your doctor.

Children

Starting dose: 2 to 5 spoonfuls once a day.

Maintenance dose: 1 to 3 spoonfuls once a day or as directed by your doctor.


Lactulose

• • •• • • •• •• • • • •• • • • • • • • • •


r Liquid Ph Eur