PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution

Lactulose

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 has 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 a doctor if you do not feel better or if you feel worse after 3 days.

2.

3.

What is in this leaflet:

1.    What Lactulose oral solution is and what it is used for

2.    What you need to know before you take Lactulose oral solution

3.    How to take Lactulose oral solution

4.    Possible side effects

5.    How to store Lactulose oral solution

6.    Contents of the pack and other information

•    treat the symptoms of constipation

•    treat a special liver disease (portal systemic encephalopathy)

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE ORAL SOLUTION

1. WHAT LACTULOSE ORAL SOLUTION IS AND WHAT IT IS USED FOR

Lactulose oral solution contains the active substance lactulose. Lactulose is a laxative and it makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body and reaches the colon unchanged.

Lactulose oral solution is used to:

Do not take Lactulose oral solution:

•    if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).

•    if you suffer from

-    galactosaemia (a severe genetic disorder where you cannot digest galactose),

-    acute inflammatory bowel disease (like Crohn's disease or ulcerative colitis), blockage in your bowel (apart from normal constipation), digestive perforation or risk of digestive perforation, abdominal pain of undetermined cause.

4.

5.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lactulose.

Please tell your doctor before taking Lactulose oral solution 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.

From the route of synthesis Lactulose oral solution 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.

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

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 take Lactulose oral solution for more than a 6 month period, your doctor will regularly check your blood electrolytes.

Children

Lactulose oral solution should not normally be given to infants and smaller children as it can disturb the normal reflexes for passing stools. In special circumstances your doctor may prescribe Lactulose oral solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.

Patients with portal systemic encephalopathy should avoid concomitant administration of other laxatives, because it hinders the individualisation of drug dose.

Please do not use Lactulose oral solution without medical advice for more than two weeks.

Other medicines and Lactulose Oral Solution

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

6.

7.

Lactulose oral solution 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.

Driving and using machines

Lactulose oral solution will not affect your ability to drive safely or use machines.

Lactulose oral solution contains milk sugar (lactose), galactose, epilactose, tagatose or fructose.

Please refer to section "Warnings and precautions".

Lactulose oral solution with food and drink

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

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

3. HOW TO TAKE LACTULOSE ORAL SOLUTION

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Always take Lactulose oral solution exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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.

10.

11.

achieved since Lactulose oral solution is not degraded until it reaches the colon.

if you have taken more Lactulose oral solution than you should.

For 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.

If you forget to take Lactulose oral solution

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

If you stop taking Lactulose oral solution

The desired effect of the medicine may not be achieved.

Use in elderly patients and patients with renal or hepatic insufficiency: No special dosage recommendations exist.

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

Use in children and adolescents:

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

4. POSSIBLE SIDE EFFECTS

If you take more Lactulose oral solution than you should

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side

In case of overdosage, you may experience diarrhoea and abdominal pain. Contact your doctor or pharmacist

effects have been reported with Lactulose oral solution:

12.

13.

Very common:

in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

• Flatulence (wind), especially during the first few days of treatment. This usually disappears after a couple of days

Website: www.mhra.gov.uk/yellowcard.

• When a higher dose than recommended is used, you may experience abdominal pain and diarrhoea.

5. HOW TO STORE LACTULOSE ORAL SOLUTION

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

Common:

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

•    Nausea (feeling sick)

•    Vomiting

Do not use this medicine 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.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed

6. CONTENTS OF THE PACK AND OTHER INFORMATION

14.

15.

What Lactulose oral solution contains

•    The active substance is Lactulose (as lactulose liquid).

5 ml of Lactulose oral solution contains 3.3 g lactulose.

•    There are no other ingredients.

Manufacturer

Fresenius Kabi Austria GmbH, Estermannstrahe 17, 4020 Linz, Austria.

Tel.: +43 732 7651 0 Fax: +43 732 7651 2429 office@fresenius-kabi.com

For any information about this medicine, please contact the local representative of the Marketing

What Lactulose oral solution looks like and contents of the pack

Authorisation Holder.

Lactulose oral solution 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.

This leaflet was last revised in January 2016.

A measuring cup (polypropylene) with filling marks is added as a measuring device. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Austria GmbH, Hafnerstrahe 36, 8055 Graz, Austria.

Tel.: +43 316 249 0 Fax: +43 316 249 1470 Info-atgr@fresenius-kabi.com

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution

Lactulose

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 has 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 a doctor if you do not feel better or if you feel worse after 3 days.

2.

3.

What is in this leaflet:

1.    What Lactulose oral solution is and what it is used for

2.    What you need to know before you take Lactulose oral solution

3.    How to take Lactulose oral solution

4.    Possible side effects

5.    How to store Lactulose oral solution

6.    Contents of the pack and other information

•    treat the symptoms of constipation

•    treat a special liver disease (portal systemic encephalopathy)

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE ORAL SOLUTION

1. WHAT LACTULOSE ORAL SOLUTION IS AND WHAT IT IS USED FOR

Lactulose oral solution contains the active substance lactulose. Lactulose is a laxative and it makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body and reaches the colon unchanged.

Lactulose oral solution is used to:

Do not take Lactulose oral solution:

•    if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).

•    if you suffer from

-    galactosaemia (a severe genetic disorder where you cannot digest galactose),

-    acute inflammatory bowel disease (like Crohn's disease or ulcerative colitis), blockage in your bowel (apart from normal constipation), digestive perforation or risk of digestive perforation, abdominal pain of undetermined cause.

4.

5.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lactulose.

Please tell your doctor before taking Lactulose oral solution 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.

From the route of synthesis Lactulose oral solution 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.

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

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 take Lactulose oral solution for more than a 6 month period, your doctor will regularly check your blood electrolytes.

Children

Lactulose oral solution should not normally be given to infants and smaller children as it can disturb the normal reflexes for passing stools. In special circumstances your doctor may prescribe Lactulose oral solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.

Patients with portal systemic encephalopathy should avoid concomitant administration of other laxatives, because it hinders the individualisation of drug dose.

Please do not use Lactulose oral solution without medical advice for more than two weeks.

Other medicines and Lactulose Oral Solution

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

6.

7.

Lactulose oral solution 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.

Driving and using machines

Lactulose oral solution will not affect your ability to drive safely or use machines.

Lactulose oral solution contains milk sugar (lactose), galactose, epilactose, tagatose or fructose.

Please refer to section "Warnings and precautions".

Lactulose oral solution with food and drink

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

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

3. HOW TO TAKE LACTULOSE ORAL SOLUTION

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Always take Lactulose oral solution exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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.

achieved since Lactulose oral solution is not degraded until it reaches the colon.

if you have taken more Lactulose oral solution than you should.

For portal systemic encephalopathy (Liver disease that affects the brain)

If you forget to take Lactulose oral solution

Adults:

If you forget to take a dose of Lactulose oral solution, do not worry. Just take the next dose at the usual time.

Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose). The dosage has to be adopted

Do not take a double dose to make up for a forgotten dose.

to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5.

If you stop taking Lactulose oral solution

Use in elderly patients and patients with renal or hepatic insufficiency:

The desired effect of the medicine may not be achieved.

No special dosage recommendations exist.

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

Use in children and adolescents:

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

4. POSSIBLE SIDE EFFECTS

If you take more Lactulose oral solution than you should

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side

In case of overdosage, you may experience diarrhoea and abdominal pain. Contact your doctor or pharmacist

effects have been reported with Lactulose oral solution:

12.

13.

Very common:

in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

• Flatulence (wind), especially during the first few days of treatment. This usually disappears after a couple of days

Website: www.mhra.gov.uk/yellowcard.

• When a higher dose than recommended is used, you may experience abdominal pain and diarrhoea.

5. HOW TO STORE LACTULOSE ORAL SOLUTION

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

Common:

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

•    Nausea (feeling sick)

•    Vomiting

Do not use this medicine 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.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed

6. CONTENTS OF THE PACK AND OTHER INFORMATION

14.

15.

What Lactulose oral solution contains

•    The active substance is Lactulose (as lactulose liquid).

5 ml of Lactulose oral solution contains 3.3 g lactulose.

•    There are no other ingredients.

Manufacturer

Fresenius Kabi Austria GmbH, Estermannstrahe 17, 4020 Linz, Austria.

Tel.: +43 732 7651 0 Fax: +43 732 7651 2429 office@fresenius-kabi.com

For any information about this medicine, please contact the local representative of the Marketing

What Lactulose oral solution looks like and contents of the pack

Authorisation Holder.

Lactulose oral solution 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.

This leaflet was last revised in January 2016.

A measuring cup (polypropylene) with filling marks is added as a measuring device. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Austria GmbH, Hafnerstrahe 36, 8055 Graz, Austria.

Tel.: +43 316 249 0 Fax: +43 316 249 1470 Info-atgr@fresenius-kabi.com