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Lactulose Solution Bp

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Document: document 3 change

Dimensions 123 x 60mm


0

■o


ro

00


Lactulose Solution BP 3.35g

/5ml


3.35g/5ml

300ml


Solution for oral use. Each 5ml of solution contains 3.35g of lactulose. May be mixed with fruit juice, water or milk immediately before use.

Please read the enclosed leaflet.


BN

Exp



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C.

Do not refrigerate or freeze.

Store in the original container.

MA holder: Co-pharma Ltd Watford, Herts, WD1 8SS PL 13606/0084


Lactulose Solution - Co-pharma Ltd 300ml peel and seal label/leaflet Version 1b - Feb 2008

Reason: To support type II variaitons to update clinical particulars

■    Pantone process black

■    Pantone red 185CVC

I Pantone process black 40%


Dimensions 95 x 60mm


Hepatic encephalopathy (disease caused by liver disease):

taking the medicine and ask your doctor or pharmacist for

Adults and the elderly: Initially six to ten 5ml spoonfuls three times daily.

advice.

Dosage should be adjusted to produce 2-3 soft stools daily.

If you notice any side effects not mentioned in this leaflet,

Children: Not recommended.

contact your doctor or pharmacist.

If you take more Lactulose Solution than you should:

Further information

If you take too much Lactulose Solution this may cause diarrhoea or tummy

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

cramps. If you stop taking the solution this will stop and your intestines will

Do not store above 25°C. Do not refrigerate or freeze.

return to normal.

Store in the original container.

If you forget to take a dose:

Do not use the medicine after the expiry date shown on the label.

Take the missed dose as soon as you remember unless it is nearly time for

If crystals appear in the solution they may be removed by gently

your next dose. Do not take a double dose to make up for the missed dose.

warming the solution.

Possible side effects

A pale brownish yellow colour is quite normal for Lactulose Solution. However if the solution darkens or becomes

Like many medicines lactulose may occasionally cause some unwanted

discoloured it should not be used and the remaining solution

effects. As with other laxatives, flatulence or tummy cramps may occur. Too

should be returned to your pharmacist for disposal.

much Lactulose Solution may cause diarrhoea, if diarrhoea occurs during normal dosage ensure you drink plenty of fluids during treatment and reduce

Leaflet revised: February 2008

the dose. If the effects persist, or are causing you a lot of discomfort, stop

COP1034/2


Lactulose Solution BP

3.35g

/5ml

_


3.35g/5ml

300ml


KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C. Do not refrigerate or freeze. Store in the original container.

MA holder: Co-pharma Ltd, Watford, Herts, WD1 8SS PL 13606/0084


Solution for oral use. Each 5ml of solution contains 3.35g of lactulose. May be mixed with fruit juice, water or milk immediately before use.

Dosage: As a laxative for constipation:

Adults and the elderly: Initially three 5ml spoonfuls twice daily. Dosage can often be gradually reduced to two to four 5ml spoonfuls daily or every other day.

Children 5 - 10 years: Two 5ml spoonfuls twice daily. Children under 5 years: One 5ml spoonful twice daily. Babies: Half a 5ml spoonful twice daily.

Hepatic encephalopathy:

Adults and the elderly: Initially six to ten 5ml spoonfuls three times daily. Dosage should be adjusted to produce 2-3 soft stools daily.

Children: Not recommended.


Please read this leaflet carefully before you start to take this medicine. Keep the leaflet, you may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine is for you and should not be given to others, even if their symptoms are the same as yours.

The name is this medicine is LACTULOSE SOLUTION BP

Each 5ml of solution contains 3.35g of the active ingredient lactulose. It also contains other sugars such as lactose (approximately 0.3g/5ml), epilactose, galactose, tagatose and fructose.

MA holder: Co-pharma Ltd, Unit 4 Metro Centre, Tolpits Lane, Watford, Herts, WD1 8SS

Manufacturer: Thorpe Laboratories Ltd, Enterprise Road, Mablethorpe, Lincolnshire, LN12 1NB

What is Lactulose Solution and how does it work?

Lactulose Solution is a pale brownish yellow coloured solution. Lactulose is an osmotic laxative which works by increasing the amount of water in your stools.


Lactulose passes through the intestines with your food and softens your stools, making them easier to pass.

Lactulose Solution is available from your pharmacist in bottles of 200ml, 300ml and 500ml. Not all pack sizes may be marketed.

Lactulose Solution is used for the treatment of constipation or in hepatic encephalpathy (a disease caused by liver failure).

What do you need to know before taking this medicine?

Do not take if:

•    You have previously had a reaction to Lactulose Solution or any of the sugars listed above

•    You have an intestinal blockage

•    You are sensitive to galactose in your diet.

Take special care if:

•    You are taking this medicine over a long period of time

•    You are lactose intolerant

•    You are taking an antibiotic

•    You are diabetic (however a regular dose of 15ml a day provides 58kj (14 cals) and is therefore unlikely to adversely affect diabetics).

Please speak to your doctor or pharmacist before taking, if any of the above statements apply to you.


Pregnancy and breastfeeding - 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, provided that you follow the dosage instructions.

How to take your medicine

Read the dosage instructions carefully. If you are unsure about taking Lactulose Solution, please talk to your pharmacist.

When you first start taking Lactulose Solution it may take 1-2 days to work.

It is important to take this medicine regularly and once it starts to work the amount you can take can be reduced. Lactulose Solution may be mixed with fruit juice, water or milk immediately before taking and can be taken by adults, the elderly and children. The solution should be measured using a 5ml spoon and taken as shown below.

Constipation (as a laxative):

Adults and the elderly: Initially three 5ml spoonfuls twice daily. Dosage can often be gradually reduced to two to four 5ml spoonfuls daily or every other day.

Children 5 - 10 years: Two 5ml spoonfuls twice daily.

Children under 5 years: One 5ml spoonful twice daily.

Babies: Half a 5ml spoonful twice daily.


Dimensions 95 x 60mm


Dimensions 80 x 60mm


Dimensions 80 x 60mm


Dimensions 123 x 60mm


0

■o


ro

GO


Lactulose Solution BP 3.35g

/5ml


3.35g/5ml

500ml


Solution for oral use. Each 5ml of solution contains 3.35g of lactulose. May be mixed with fruit juice, water or milk immediately before use.

Please read the enclosed leaflet.


BN

Exp



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C.

Do not refrigerate or freeze.

Store in the original container.

MA holder: Co-pharma Ltd Watford, Herts, WD1 8SS PL 13606/0084


Lactulose Solution - Co-pharma Ltd 500ml peel and seal label/leaflet Version 1b - Feb 2008

Reason: To support type II variaitons to update clinical particulars

■    Pantone process black

■    Pantone red 185CVC

I Pantone process black 40%


Dimensions 95 x 60mm


Hepatic encephalopathy (disease caused by liver disease):

Adults and the elderly: Initially six to ten 5ml spoonfuls three times daily. Dosage should be adjusted to produce 2-3 soft stools daily.

Children: Not recommended.

If you take more Lactulose Solution than you should:

If you take too much Lactulose Solution this may cause diarrhoea or tummy cramps. If you stop taking the solution this will stop and your intestines will return to normal.

If you forget to take a dose:

Take the missed dose as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for the missed dose.

Possible side effects

Like many medicines lactulose may occasionally cause some unwanted effects. As with other laxatives, flatulence or tummy cramps may occur. Too much Lactulose Solution may cause diarrhoea, if diarrhoea occurs during normal dosage ensure you drink plenty of fluids during treatment and reduce the dose. If the effects persist, or are causing you a lot of discomfort, stop


taking the medicine and ask your doctor or pharmacist for advice.

If you notice any side effects not mentioned in this leaflet, contact your doctor or pharmacist.

Lactulose Solution BP

3.35g

/5ml

Further information

l

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C. Do not refrigerate or freeze. Store in the original container.

3.35g/5ml

500ml


Do not use the medicine after the expiry date shown on the label.

If crystals appear in the solution they may be removed by gently warming the solution.

A pale brownish yellow colour is quite normal for Lactulose Solution. However if the solution darkens or becomes discoloured it should not be used and the remaining solution should be returned to your pharmacist for disposal.


Leaflet revised: February 2008


COP1035/2



Solution for oral use. Each 5ml of solution contains 3.35g of lactulose. May be mixed with fruit juice, water or milk immediately before use.

Dosage: As a laxative for constipation:

Adults and the elderly: Initially three 5ml spoonfuls twice daily. Dosage can often be gradually reduced to two to four 5ml spoonfuls daily or every other day.

Children 5 - 10 years: Two 5ml spoonfuls twice daily. Children under 5 years: One 5ml spoonful twice daily. Babies: Half a 5ml spoonful twice daily.

Hepatic encephalopathy:

Adults and the elderly: Initially six to ten 5ml spoonfuls three times daily. Dosage should be adjusted to produce 2-3 soft stools daily.

Children: Not recommended.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C. Do not refrigerate or freeze.

Store in the original container.

MA holder: Co-pharma Ltd, Watford, Herts, WD1 8SS PL 13606/0084


Please read this leaflet carefully before you start to take this medicine. Keep the leaflet, you may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine is for you and should not be given to others, even if their symptoms are the same as yours.

The name is this medicine is LACTULOSE SOLUTION BP

Each 5ml of solution contains 3.35g of the active ingredient lactulose. It also contains other sugars such as lactose (approximately 0.3g/5ml), epilactose, galactose, tagatose and fructose.

MA holder: Co-pharma Ltd, Unit 4 Metro Centre, Tolpits Lane, Watford, Herts, WD1 8SS

Manufacturer: Thorpe Laboratories Ltd, Enterprise Road, Mablethorpe, Lincolnshire, LN12 1NB

What is Lactulose Solution and how does it work?

Lactulose Solution is a pale brownish yellow coloured solution. Lactulose is an osmotic laxative which works by increasing the amount of water in your stools.


Lactulose passes through the intestines with your food and softens your stools, making them easier to pass.

Lactulose Solution is available from your pharmacist in bottles of 200ml, 300ml and 500ml. Not all pack sizes may be marketed.

Lactulose Solution is used for the treatment of constipation or in hepatic encephalpathy (a disease caused by liver failure).

What do you need to know before taking this medicine?

Do not take if:

•    You have previously had a reaction to Lactulose Solution or any of the sugars listed above

•    You have an intestinal blockage

•    You are sensitive to galactose in your diet.

Take special care if:

•    You are taking this medicine over a long period of time

•    You are lactose intolerant

•    You are taking an antibiotic

•    You are diabetic (however a regular dose of 15ml a day provides 58kj (14 cals) and is therefore unlikely to adversely affect diabetics).

Please speak to your doctor or pharmacist before taking, if any of the above statements apply to you.


Pregnancy and breastfeeding - 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, provided that you follow the dosage instructions

How to take your medicine

Read the dosage instructions carefully. If you are unsure about taking Lactulose Solution, please talk to your pharmacist.

When you first start taking Lactulose Solution it may take 1-2 days to work.

It is important to take this medicine regularly and once it starts to work the amount you can take can be reduced. Lactulose Solution may be mixed with fruit juice, water or milk immediately before taking and can be taken by adults, the elderly and children. The solution should be measured using a 5ml spoon and taken as shown below.

Constipation (as a laxative):

Adults and the elderly: Initially three 5ml spoonfuls twice daily. Dosage can often be gradually reduced to two to four 5ml spoonfuls daily or every other day.

Children 5 - 10 years: Two 5ml spoonfuls twice daily.

Children under 5 years: One 5ml spoonful twice daily.

Babies: Half a 5ml spoonful twice daily.


Dimensions 95 x 60mm


Dimensions 80 x 60mm


Dimensions 80 x 60mm