1. what duphalac is and what it is used for

What Duphalac is

• Duphalac 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.

What Duphalac is used for

• Duphalac is used to treat constipation (infrequent bowel movements, hard and dry stools).
• Duphalac is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.

2. what you need to know before you take duphalac

Do not take Duphalac if:

• You are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac (see sections 2 and 6).
• You have a rare problem called ‚galactosaemia‘.
• You have a blockage caused by anything else but normal constipation, gastrointestinal perforation or risk of perforation.

Do not take Duphalac if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Duphalac.

Warnings and precautions:

• Talk to your doctor or pharmacist before taking Duphalac if you suffer from any medical conditions or illnesses, in particular: if you suffer from unexplained tummy ache
• if you are unable to digest milk sugar (lactose intolerant)
• if you have diabetes

You should not take Duphalac if you suffer from:

• galactose or fructose intolerance
• total lactase deficiency
• glucose-galactose malabsorption

If you have diabetes and are treated for hepatic encephalopathy, your dose of Duphalac will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your anti-diabetic medicine.

Chronic use of unadjusted dosages (exceeding 2–3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolytes balance.

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

If you take Duphalac for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Children

In special circumstances your doctor may prescribe Duphalac for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Duphalac should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

5

Other medicines and Duphalac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Duphalac with food and drink

Duphalac can be taken with or without food. There are no restrictions on what you can eat or drink.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Duphalac can be used during pregnancy and when breast-feeding if necessary.

No effects on fertility are to be expected.

Driving and using machines

Duphalac has no or negligible influence on your ability to drive safely or use machines.

Important Information about some of the Ingredients of Duphalac Duphalac contains sugars, such as milk sugar (lactose), galactose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Duphalac contains sulphite.

3. how to take duphalac

Always take Duphalac exactly as described in this leaflet or as your doctor or pharmacists have told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take Duphalac from a spoon or measuring cup.
• You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids (approximately 6–8 glasses throughout the day).
• Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Duphalac is taken for long periods.
• Duphalac takes 2 to 3 days to start working.
• After this time you may be able to reduce the dose you take according to your needs.

7

5. how to store duphalac

Keep this medicine out of the sight and reach of children.

Do not use Duphalac after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate or freeze.

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. contents of the pack and other information

:200mi*

1. what duphalac is and what it is used for

What Duphalac is

• Duphalac 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.

What Duphalac is used for

• Duphalac is used to treat constipation (infrequent bowel movements, hard and dry stools).
• Duphalac is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.

2. what you need to know before you take duphalac

Do not take Duphalac if:

• You are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac (see sections 2 and 6).
• You have a rare problem called ‘galactosaemia’.
• You have a blockage caused by anything else but normal constipation, gastrointestinal perforation or risk of perforation.

Do not take Duphalac if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Duphalac.

Warnings and precautions:

• Talk to your doctor or pharmacist before taking Duphalac if you suffer from any medical conditions or illnesses, in particular: if you suffer from unexplained tummy ache
• if you are unable to digest milk sugar (lactose intolerant)
• if you have diabetes

You should not take Duphalac if you suffer from:

• galactose or fructose intolerance
• total lactase deficiency
• glucose-galactose malabsorption

If you have diabetes and are treated for hepatic encephalopathy, your dose of Duphalac will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your anti-diabetic medicine.

Chronic use of unadjusted dosages (exceeding 2–3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolytes balance.

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

If you take Duphalac for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Children

In special circumstances your doctor may prescribe Duphalac for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Duphalac should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

5

Other medicines and Duphalac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Duphalac with food and drink

Duphalac can be taken with or without food. There are no restrictions on what you can eat or drink.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Duphalac can be used during pregnancy and when breast-feeding if necessary.

No effects on fertility are to be expected.

Driving and using machines

Duphalac has no or negligible influence on your ability to drive safely or use machines.

Important Information about some of the Ingredients of

Duphalac

Duphalac contains sugars, such as milk sugar (lactose), galactose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Duphalac contains sulphite.

3. how to take duphalac

Always take Duphalac exactly as described in this leaflet or as your doctor or pharmacists have told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take Duphalac from a spoon or measuring cup.
• You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids (approximately 6–8 glasses throughout the day).
• Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Duphalac is taken for long periods.
• Duphalac takes 2 to 3 days to start working.
• After this time you may be able to reduce the dose you take according to your needs. 7
• diarrhoea
• flatulence (wind)
• nausea (feeling sick)
• vomiting
• abdominal pain

Uncommon (may affect up to 1 in 100 people)

• electrolyte imbalance due to diarrhoea

Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.

If you use high doses (normally only associated with hepatic encephalopathy, HE) for an extended period of time, you may experience an electrolyte imbalance due to diarrhoea.

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. By reporting side effects you can help provide more information on the safety of this medicine. You can also report side effects directly via the MHRA Yellow Card Scheme. 10

5. how to store duphalac

Keep this medicine out of the sight and reach of children.

Do not use Duphalac after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate or freeze.

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. contents of the pack and other information

What Duphalac contains

• The active substance in Duphalac is lactulose. Each 5ml of Duphalac contains 3.335g of lactulose.
• Duphalac does not contain any excipients.
• Duphalac contains residues from the route of production, see section 2. 11

J.* 300 ml*

CONSTIPATION RELIEF

base label

80 mm

1. what duphalac is and what it is used for

What Duphalac is

• Duphalac 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.

What Duphalac is used for

• Duphalac is used to treat constipation (infrequent bowel movements, hard and dry stools).
• Duphalac is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.

2. what you need to know before you take duphalac

Do not take Duphalac if:

• You are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac (see sections 2 and 6).
• You have a rare problem called ‘galactosaemia’.
• You have a blockage caused by anything else but normal constipation, gastrointestinal perforation or risk of perforation. 3 Do not take Duphalac if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Duphalac.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Duphalac if you suffer from any medical conditions or illnesses, in particular:

• if you suffer from unexplained tummy ache
• if you are unable to digest milk sugar (lactose intolerant)
• if you have diabetes

You should not take Duphalac if you suffer from:

• galactose or fructose intolerance
• total lactase deficiency
• glucose-galactose malabsorption

If you have diabetes and are treated for hepatic encephalopathy, your dose of Duphalac will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your anti-diabetic medicine.

Chronic use of unadjusted dosages (exceeding 2–3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolytes balance.

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

If you take Duphalac for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Children

In special circumstances your doctor may prescribe Duphalac for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Duphalac should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

Other medicines and Duphalac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Duphalac with food and drink

Duphalac can be taken with or without food. There are no restrictions on what you can eat or drink.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Duphalac can be used during pregnancy and when breast-feeding if necessary.

No effects on fertility are to be expected.

5

Driving and using machines

Duphalac has no or negligible influence on your ability to drive safely or use machines.

Important Information about some of the Ingredients of Duphalac

Duphalac contains sugars, such as milk sugar (lactose), galactose and fructose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Duphalac contains sulphite.

3. how to take duphalac

Always take Duphalac exactly as described in this leaflet or as your doctor or pharmacists have told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take Duphalac from a spoon or measuring cup.
• You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids (approximately 6–8 glasses throughout the day).
• Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Duphalac is taken for long periods.
• Duphalac takes 2 to 3 days to start working.
• After this time you may be able to reduce the dose you take according to your needs.

6

Text in braille: duphalac

6. contents of the pack and other information

What Duphalac contains

• The active substance in Duphalac is lactulose. Each 5ml of Duphalac contains 3.335g of lactulose.
• Duphalac does not contain any excipients.
• Duphalac contains residues from the route of production, see section 2.

What Duphalac looks like and contents of the pack

• Duphalac is a clear, viscous liquid, colourless to brownish-yellow liquid.
• Duphalac is available in 15 ml sachets and in plastic bottles containing 200ml, 300ml, 500ml and 1000ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts,

EN6 1TL, UK.

Manufacturer

Abbott Biologicals B.V., 8121 AA, Olst, The Netherlands.

This leaflet was last updated in August 2020. UKMylan

2216578

12

PACKAGE LEAFLET: INFORMATION FOR THE USER

Duphalac

Lactulose

3.335 g/5 ml oral solution

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 have 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 possible side effects not listed in this leaflet. See section 4.
• You must talk to your doctor if you do not feel better or if you feel worse after several days. 2

What is in this leaflet:

• 1. What Duphalac is and what it is used for

• 2. What you need to know before you take Duphalac

• 3. How to take Duphalac

• 4. Possible side effects

• 5. How to store Duphalac

• 6. Contents of the pack and other information

1. what duphalac is and what it is used for

What Duphalac is

• Duphalac 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.

What Duphalac is used for

• Duphalac is used to treat constipation (infrequent bowel movements, hard and dry stools).
• Duphalac is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.

2. what you need to know before you take duphalac

Do not take Duphalac if:

• You are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac (see sections 2 and 6).
• You have a rare problem called ‘galactosaemia’.
• You have a blockage caused by anything else but normal constipation, gastrointestinal perforation or risk of perforation.

Do not take Duphalac if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Duphalac.

Warnings and precautions:

• Talk to your doctor or pharmacist before taking Duphalac if you suffer from any medical conditions or illnesses, in particular: if you suffer from unexplained tummy ache
• if you are unable to digest milk sugar (lactose intolerant)
• if you have diabetes

You should not take Duphalac if you suffer from:

• galactose or fructose intolerance
• total lactase deficiency
• glucose-galactose malabsorption

If you have diabetes and are treated for hepatic encephalopathy, your dose of Duphalac will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your anti-diabetic medicine.

Chronic use of unadjusted dosages (exceeding 2–3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolytes balance.

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

If you take Duphalac for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Children

In special circumstances your doctor may prescribe Duphalac for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Duphalac should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

5

Other medicines and Duphalac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Duphalac with food and drink

Duphalac can be taken with or without food. There are no restrictions on what you can eat or drink.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Duphalac can be used during pregnancy and when breast-feeding if necessary.

No effects on fertility are to be expected.

Driving and using machines

Duphalac has no or negligible influence on your ability to drive safely or use machines.

Important Information about some of the Ingredients of

Duphalac

Duphalac contains sugars, such as milk sugar (lactose), galactose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Duphalac contains sulphite.

3. how to take duphalac

Always take Duphalac exactly as described in this leaflet or as your doctor or pharmacists have told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take Duphalac from a spoon or measuring cup.
• You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids (approximately 6–8 glasses throughout the day).
• Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Duphalac is taken for long periods.
• Duphalac takes 2 to 3 days to start working.
• After this time you may be able to reduce the dose you take according to your needs. 7
• diarrhoea
• flatulence (wind)
• nausea (feeling sick)
• vomiting
• abdominal pain

Uncommon (may affect up to 1 in 100 people)

• electrolyte imbalance due to diarrhoea

Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.

If you use high doses (normally only associated with hepatic encephalopathy, HE) for an extended period of time, you may experience an electrolyte imbalance due to diarrhoea.

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. By reporting side effects you can help provide more information on the safety of this medicine. You can also report side effects directly via the MHRA Yellow Card Scheme. 10

PACKAGE LEAFLET: INFORMATION FOR THE USER

Duphalac

Lactulose

3.335 g/5 ml oral solution

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

What is in this leaflet:

• 1. What Duphalac is and what it is used for

• 2. What you need to know before you take Duphalac

• 3. How to take Duphalac

• 4. Possible side effects

• 5. How to store Duphalac

• 6. Contents of the pack and other information

1. what duphalac is and what it is used for

What Duphalac is

• Duphalac 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.

What Duphalac is used for

• Duphalac is used to treat constipation (infrequent bowel movements, hard and dry stools).
• Duphalac is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.

2. what you need to know before you take duphalac

Do not take Duphalac if:

• You are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac (see sections 2 and 6).
• You have a rare problem called ‘galactosaemia’.
• You have a blockage caused by anything else but normal constipation, gastrointestinal perforation or risk of perforation. 3 Do not take Duphalac if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Duphalac.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Duphalac if you suffer from any medical conditions or illnesses, in particular:

• if you suffer from unexplained tummy ache
• if you are unable to digest milk sugar (lactose intolerant)
• if you have diabetes

You should not take Duphalac if you suffer from:

• galactose or fructose intolerance
• total lactase deficiency
• glucose-galactose malabsorption

If you have diabetes and are treated for hepatic encephalopathy, your dose of Duphalac will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your anti-diabetic medicine.

Chronic use of unadjusted dosages (exceeding 2–3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolytes balance.

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

If you take Duphalac for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Children

In special circumstances your doctor may prescribe Duphalac for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Duphalac should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

Other medicines and Duphalac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Duphalac with food and drink

Duphalac can be taken with or without food. There are no restrictions on what you can eat or drink.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Duphalac can be used during pregnancy and when breast-feeding if necessary.

No effects on fertility are to be expected.

5

Driving and using machines

Duphalac has no or negligible influence on your ability to drive safely or use machines.

Important Information about some of the Ingredients of Duphalac

Duphalac contains sugars, such as milk sugar (lactose), galactose and fructose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Duphalac contains sulphite.

3. how to take duphalac

Always take Duphalac exactly as described in this leaflet or as your doctor or pharmacists have told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take Duphalac from a spoon or measuring cup.
• You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids (approximately 6–8 glasses throughout the day).
• Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Duphalac is taken for long periods.
• Duphalac takes 2 to 3 days to start working.
• After this time you may be able to reduce the dose you take according to your needs.

6

v3/July 2017