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Lactulose Liquid Ph Eur

Document: label-leaflet ACTAVIS_PL 44673-0171 change

Lactulose Liquid - PL 44673/0171 - label/leaflet - 1

Front face label - 300ml

Actavis Lactulose Liquid EP

67% w/v Oral Solution

300ml e

To be taken by mouth.

Dosage (constipation):

ADULTS: 3 to 6 x 5ml 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 5ml 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 5ml spoonfuls, taken 3 times daily, or as directed by your doctor.

Each 5ml contains 3.35g lactulose. It also contains lactose and galatose.

Keep out of the reach of children. Lift flap for further information about your medicine.

Do not store above 25°C.

Product Licence Holder: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, UK.

Distributed by: Actavis, Barnstaple, EX32 8NS, UK

P

PL 44673/0171

Braille reads:

Lactulose liquid 300 ml

Leaflet

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 5ml dose of Lactulose Liquid contains 3.35grams 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 minimize 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

may be given in obstinate cases. by your doctor.


Starting dose: 3 to 6 spoonfuls once a day. Up to 9 spoonfuls Maintenance dose: 2 to 3 spoonfuls once a day or as directed

Children

by your doctor.


Starting dose: 2 to 5 spoonfuls once a day Maintenance dose: 1 to 3 spoonfuls once a day or as directed Adjust dose until desired response is seen.

Elderly

No adjustment of the dose is required.

Liver disease

Take 6 to 10 x 5ml 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.

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.

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 available:

Amber glass bottles or plastic bottles with polyethylene closure containing 300ml and 500ml of Lactulose Liquid.

Measuring spoon provided.

Marketing Authorisation holder:

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

Brentford,

TW8 9GS,

U.K.

Manufacturer

BCM Limited, Nottingham,

NG90 2PR, UK

Distributor

Actavis, Barnstaple, EX32 8NS, UK For any information about this

medicinal product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in May 2016.

Actavis Lactulose Liquid Ph Eur

67% w/v Oral Solution

500ml e

To be taken by mouth.

Dosage (constipation):

ADULTS: 3 to 6 x 5ml 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 5ml 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 5ml spoonfuls, taken 3 times daily, or as directed by your doctor.

Each 5ml contains 3.35g lactulose. It also contains lactose and galatose.

Keep out of the reach of children. Lift flap for further information about your medicine.

Do not store above 25°C.

Product Licence Holder: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, UK.

Distributed by: Actavis, Barnstaple, EX32 8NS, UK

P

PL 44673/0171

Braille reads:

Lactulose liquid 500 ml

Leaflet

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 5ml dose of Lactulose Liquid contains 3.35grams 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 minimize 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

may be given in obstinate cases. by your doctor.


Starting dose: 3 to 6 spoonfuls once a day. Up to 9 spoonfuls Maintenance dose: 2 to 3 spoonfuls once a day or as directed

Children

by your doctor.


Starting dose: 2 to 5 spoonfuls once a day Maintenance dose: 1 to 3 spoonfuls once a day or as directed Adjust dose until desired response is seen.

Elderly

No adjustment of the dose is required.

Liver disease

Take 6 to 10 x 5ml 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.

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.

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 available:

Amber glass bottles or plastic bottles with polyethylene closure containing 300ml and 500ml of Lactulose Liquid.

Measuring spoon provided.

Marketing Authorisation holder:

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

Brentford,

TW8 9GS,

U.K.

Manufacturer

BCM Limited, Nottingham,

NG90 2PR, UK

Distributor

Actavis, Barnstaple, EX32 8NS, UK For any information about this medicinal product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in May 2016.