Laevolac 3.3g/5ml Oral Solution
o
co
o
SZ83203LL03A V0054403/04
• •
• • • • • • •
a Novartis company
tulose A
Oral use. lift flap for further information about your medicine. Read the package leaflet before use. Lactulose oral solution is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).
Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose). Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose). Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose). Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose). Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3-7 g lactulose). Babies: Starting dose: up to 5 ml (corresponding to up to 3 g lactulose).
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. Children: The safety and efficacy in children aged 0 - 18 years has not been established. In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist.
Do not store above 25°C. Keep out of the sight and reach of children. Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose).
PL 05061/0001. Marketing Authorisation Holder: Fresenius Kabi Austria GmbH, HafnerstraOe 36, 8055 Graz, Austria. Distributed by: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. ryi
>mU
300 mlo 0000
5 ml contains 3.3 ^O^tulose O O
Braille:
• • •
O O Novartis company
Oral use. Lift flap for further information about your medicine. Read the package leaflet before use. Lactulose oral solution is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy). Constipation: jWu/fe and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose). Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose). Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose). Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose). Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3-7 g lactulose). Babies: Starting dose: up to 5 ml (corresponding to up to 3 g lactulose).
Portal systemic encephalopathy (Liver disease that affects the brain): ^du/ts: 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. Children: The safety and efficacy in children aged 0 - 18 years has not been established. In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist. ODo not store above 25°C. Keep out of the sight and reach of children. Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose). PL 05061/0001.
Marketing Authorisation Holder: Fresenius Kabi Austria Lot:
GmbH, HafnerstraOe 36, 8055 Gra^st^ EXP:
Distributed by: Sandoz Ltd, Frimley Bu^ss Park, _
Frimle©C©iberley, Surrey, GU10SR. O Lu
Open
|
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.Website: |
|
• Flatulence (wind), especially during the first few days of treatment. This usually disappears after a couple of days | |
|
• 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 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 |
Manufacturer |
|
• The active substance is Lactulose (as lactulose liquid). |
Fresenius Kabi Austria GmbH, Estermannstrahe 17, 4020 Linz, Austria. |
|
5 ml of Lactulose oral solution contains 3.3 g lactulose. |
Tel.: +43 732 7651 0 Fax: +43 732 7651 2429 office@fresenius-kabi.com |
|
• There are no other ingredients. |
Distributed by: |
|
What Lactulose oral solution looks like and contents of the pack Lactulose oral solution is a clear, viscous liquid, colourless or pale brownish-yellow solution and is available |
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. |
|
in glass, PET bottles or HDPE bottles containing 200 ml, 300 ml, 500 ml and 1000 ml. |
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. |
|
A measuring cup (polypropylene) with filling marks is added as a measuring device. Not all pack sizes may be marketed. |
This leaflet was last revised in September 2015. |
|
Marketing Authorisation Holder Fresenius Kabi Austria GmbH, HafnerstraBe 36, 8055 Graz, Austria. Tel.: +43 316 249 0 Fax: +43 316 249 1470 Info-atgr@fresenius-kahi.com |
For constipation:
|
Starting dose |
Maintenance dose | |||
|
Adults |
15-45 ml |
corresponding to 10-30 g lactulose |
15-30 ml |
corresponding to 10-20 g lactulose |
Use in children and adolescents
|
Starting dose |
Maintenance dose | |||
|
Adolescents over 14 years |
15-45 ml |
corresponding to 10-30 g lactulose |
15-30 ml |
corresponding to 10-20 g lactulose |
|
Children (7-14 years) |
15 ml |
corresponding to 10 g lactulose |
10-15 ml |
corresponding to 7-10 g lactulose |
|
Children (1-6 years) |
5-10 ml |
corresponding to 3-7 g lactulose | ||
|
Babies |
up to 5 ml |
corresponding to up to 3 g lactulose | ||
Thereafter the dose can be reduced individually.
The daily dose should be taken once during breakfast. It can be taken for 2-3 days until the desired effect is
8. 9.
Swallow the medicine quickly. Do not keep it in your mouth.
You can take Lactulose oral solution undiluted or diluted in some liquid. Use the measuring cup provided.
During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 l/day, equal to 6-8
glasses).
The recommended dose is:
SZ83204LL03A V0054411/04
• •
• • • • • • •
A
5 ml contains 3.3 g lactulose
a Novartis company
Oral use. lift flap for further information about your medicine. Read the package leaflet before use. Lactulose oral solution is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).
Constipation: j4dute and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose). Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose). Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose). Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose). Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3-7 g lactulose). Babies: Starting dose: up to 5 ml (corresponding to up to 3 g lactulose).
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. Children: The safety and efficacy in children aged 0 - 18 years has not been established. In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist.
Do not store above 25°C. Keep out of the sight and reach of children. Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose).
PL 05061/0001. Marketing Authorisation Holder: Fresenius Kabi Austria GmbH, HafnerstraOe 36, 8055 Graz, Austria. Distributed by: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. j~p~j
ml
Braille:
• • •
_ o o o o
O-oo oA o o
Q ml contains 3.3 gDactuQs© O
^DO±
O 0° Novartis company
Oral use. Lift flap for further information about your medicine. Read the package leaflet before use. Lactulose oral solution is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy). Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose). Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose). Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose). Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose). Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3-7 g lactulose). Babies: Starting dose: up to 5 ml (corresponding to up to 3 g lactulose).
Portal systemic encephalopathy (Liver disease that affects the brain): ^du/ts: 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. Children: The safety and efficacy in children aged 0 - 18 years has not been established. In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist. ODo not store above 25°C. Keep out of the sight and reach of children. Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose). PL 05061/0001.
Marketing Authorisation Holder: Fresenius Kabi Austria Lot:
GmbH, Haf^r^fie 36, 8055 GrU^s^ EXP:
Distributed by: Sandoz Ltd, Frimley Bu0ess Park, _
Frirnle0Cfijmberley, Surrey, GU10SR. Q Lu
Open
|
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) |
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.Website: |
|
• Flatulence (wind), especially during the first few days of treatment. This usually disappears after a couple of days | |
|
• 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 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 |
Manufacturer |
|
• The active substance is Lactulose (as lactulose liquid). |
Fresenius Kabi Austria GmbH, Estermannstrahe 17, 4020 Linz, Austria. |
|
5 ml of Lactulose oral solution contains 3.3 g lactulose. |
Tel.: +43 732 7651 0 Fax: +43 732 7651 2429 office@fresenius-kabi.com |
|
• There are no other ingredients. |
Distributed by: |
|
What Lactulose oral solution looks like and contents of the pack Lactulose oral solution is a clear, viscous liquid, colourless or pale brownish-yellow solution and is available |
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. |
|
in glass, PET bottles or HDPE bottles containing 200 ml, 300 ml, 500 ml and 1000 ml. |
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. |
|
A measuring cup (polypropylene) with filling marks is added as a measuring device. Not all pack sizes may be marketed. |
This leaflet was last revised in September 2015. |
|
Marketing Authorisation Holder Fresenius Kabi Austria GmbH, HafnerstraBe 36, 8055 Graz, Austria. Tel.: +43 316 249 0 Fax: +43 316 249 1470 Info-atgr@fresenius-kahi.com |
For constipation:
|
Starting dose |
Maintenance dose | |||
|
Adults |
15-45 ml |
corresponding to 10-30 g lactulose |
15-30 ml |
corresponding to 10-20 g lactulose |
Use in children and adolescents
|
Starting dose |
Maintenance dose | |||
|
Adolescents over 14 years |
15-45 ml |
corresponding to 10-30 g lactulose |
15-30 ml |
corresponding to 10-20 g lactulose |
|
Children (7-14 years) |
15 ml |
corresponding to 10 g lactulose |
10-15 ml |
corresponding to 7-10 g lactulose |
|
Children (1-6 years) |
5-10 ml |
corresponding to 3-7 g lactulose | ||
|
Babies |
up to 5 ml |
corresponding to up to 3 g lactulose | ||
Thereafter the dose can be reduced individually.
The daily dose should be taken once during breakfast. It can be taken for 2-3 days until the desired effect is
8. 9.
Swallow the medicine quickly. Do not keep it in your mouth.
You can take Lactulose oral solution undiluted or diluted in some liquid. Use the measuring cup provided.
During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 l/day, equal to 6-8
glasses).
The recommended dose is: