Lactulose 3.3g /5ml Oral Solution
Out of date information, search another180mm
55mm
For oral use. Dosage for constipation Adults: 15ml twice daily.
Children 5 to 10 years: 10ml twice daily Children under 5 years: 5ml twice daily Babies under 1 year: 2.5ml twice daily or as directed by your doctor.
Dosage for other conditions - as directed by your doctor. Take with water or fruit juice if required.
Please read the package leaflet before use.
Keep out of the sight and reach of children.
• GO •
Storage: • • •
Do not store above 25°C. Do not refrigerate or freeze. Use within 6 months of firsj oijejiing then discard. •••••• ••
• •
• •
300 ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose.
PL 10321/0001
MA Holder: Resolution Chemicals Ltd.,
Wedgwood Way, Stevenage,
Herts, SG1 4QT, UK.
Distributed by: Kent Pharmaceuticals Limited, Repton Road, Measham,
DE12 7DT, U.K.
CFAF.LAC.3.3-50S.300.V1 P2 LAC300/KPUK/LL02
85mm
I 10mm]
BATCH/EXPIRY DETAILS WILL BE PRINTED/EMBOSSED IN THE SPACE HIGHLIGHTED
Customer: Kent Originated by: TC (AWG)
Product: Lactulose 3.3mg/5ml Oral Solution x 300ml
Dimensions: 55 x 180 mm
Item Code: CFAF.LAC.3.3-50S.300.V1 P2
Proof No and Date: 2 23/02/2015
Revision:
ARTWORK FOR SUBMISSION Supersedes: n/a
Colours
Pantone 327 C
Braille text reads as follows:
• • • • • • • • ••••••
• • • • • • • • • • • • • • •
# 3 • 3 G
• • • • • • •
• • • •
• • •• • •
• •• ••• •• • ••••• ••
S 0 L U T ION
Leaflet section:
Page B shows the leaflet section of the label-leaflet. The leaflet is a double sided strip of paper that is folded into 6 panels. It is not possible to show all 6 panels side-by-side in the A3 document, so each panel has been given a number and the diagram below shows the order of the panels as they will appear in the printed leaflet.
The leaflet section is glued to the carrier label at the left side edge of the title panel.
Outside
486mm
|
85 mm |
83 mm |
81mm |
80mm |
79 mm |
78mm | |
|
3 3 |
® |
© |
Q |
0 |
j © |
| © |
85mm
83mm
Outside
81mm
80mm
55mm
'ACKAGEDEAFLETTTNFDRMATIONTORTHEDSER^ 1
LACTULOSE 3.3g/5ml ORAL SOLUTION (Active substance: Lactulose)
Read all of this leaflet carefully before you start using this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
In this leaflet: “|
1. What Lactulose Solution is and what it is used for . Before you take Lactulose Solution . How to take Lactulose Solution
4. Possible side effects
5. How to store Lactulose Solution
6. Further information
1. WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR_
Lactulose Solution belongs to a group of medicines called axatives. It is used in the treatment of:
Chronic (long term) constipation: Constipation is a common complaint often due to not enough roughage or fibre in the diet, dehydration, immobility, illness or stress. Sometimes constipation may be due to more serious reasons._ _ _ _ _ J
YouShouldconsult with your doctor ifyou sufferfrom 1
constipation for a period of greater than 4 weeks.
|Lactulose can help your bowels to move, and pass a stool if you are constipated. Lactulose does not enter the bloodstream. It acts by drawing water into the bowel and so softening the stool or motion. In this way Lactulose can encourage a normal bowel motion.
hronic portal systemic encephalopathy (hepatic coma):
his is an uncommon condition where substances such as ammonia go into the blood stream. It can sometimes occur in patients with severe liver disease. Your doctor may prescribe Lactulose for you if you suffer from liver disease and he believes that you may develop or have developed hepatic encephalopathy.
Lactulosels" broken downSy thdnormal bacteria~(germs) in~ 1 the bowel to form acid which stops the formation and absorption of ammonia from the bowel into the blood stream.
In this way it helps to treat hepatic encephalopathy.
2. BEFORE YOU TAKE LACTULOSE SOLUTION
Do not take Lactulose Solution if:
- you know that you are allergic (causing itching, reddening of
I the skin or difficulty in breathing) to Lactulose Solution or any of the other ingredients of Lactulose Solution listed at the I end of this leaflet;
- you are suffering from a blockage in your gut or intestine;
- you suffer from a rare inherited condition of the metabolism I called galactosaemia (an increase in a sugar called
galactose in the blood).
(5) Outside (6)
79mm 78mm
4. POSSIBLE SIDE EFFECTS
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that you have obtained without a prescription.
Taking Lactulose Solution with food and drink: Lactulose Solution may be taken with a drink such as water or fruit juice. Pregnancy and breast-feeding 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, as long as you follow the dosage recommendations.
Driving and using machines
There should be no problems when taking Lactulose Solution.
Important information about some of the ingredienfsof Lactulose Solution: Lactulose Solution contains Lactose and Galactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
I 3. HOW TO TAKE LACTULOSE SOLUTION |Lactulose Solution is for oral use only. The effects of Lactulose may not be seen for up to 48 hours, therefore it is important to continue taking your medicine regularly.
To treat constipation:
The table below gives the starting doses of Lactulose Solution depending on your age. However, the dose may be adjusted by your doctor depending on your needs to have the p-j-g (desired effect.
_ Starting dose H
Adults 15ml twice daily (3 x 5ml spoonful)
Children 5 to 10 years 10ml twice daily (2 x 5ml spoonful) Children under 5 years 5ml twice daily (1 x 5ml spoonful) Babies under 1 year 2.5ml twice daily (% x 5ml spoonful)
To treat hepatic encephalopathy:
Higher doses of Lactulose Solution are required. i Starting dose
Adults 30-50ml three times daily (6-10 x
5ml spoonful)
Elderly as above
Children not to be taken (lactulose is not
I suitable for children with this
condition)
Your doctor may adjust your dose until two or three soft gtools are produced a day.
If you take more Lactulose Solution than you should 1
Contact your nearest casualty department or tell your doctor or pharmacist straight away. Take this leaflet and any remaining solution with you so that the medical staff know exactly what you have taken.
If you forget to take Lactulose Solution
If you forget to take a dose of Lactulose Solution, take it as soon as you remember. If it is almost time for your next dose though do not double the dose - just carry on as before.
Like all medicines, Lactulose Solution can cause side effects, although not everybody gets them. If any of these side effects become troublesome, stop taking the medicine and see your doctor as soon as possible.
|
78mm |
79mm |
Inside
The“mosfcommdn side effects“probabfy affectingupTd 1 ind0 people are: bloated stomach, excess wind or stomach cramps You may suffer from these in the first few days of taking your medicine. These usually go away on continuation of your treatment.
If you are taking large doses of Lactulose Solution to treat hepatic encephalopathy you may also suffer from diarrhoea, nausea (feeling sick), vomiting (being sick), flatulence and Istomach pain. If this is the case, tell your doctor as he can adjust your dose to obtain just two or three soft stools a day.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.'
5. HOW TO STORE LACTULOSE SOLUTION
Keep out of the sight and reach of children.
Do not store above 25°C. Do not refrigerate or freeze.
Do not use Lactulose Solution after the expiry date which is jstated on the bottle label after EXP. The expiry date refers to the last day of that month.
Use within 6 months of first opening and discard any remaining (solution.
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.
I 6. FURTHER INFORMATION
What Lactulose Solution contains
The active substance is Lactulose
The other ingredients are: Lactose and Galactose
What Lactulose Solution looks like and contents of the pack
Lactulose Solution is a clear, colourless or pale brownish yellow liquid. 5ml of Lactulose Solution contains 3.3g of Lactulose. Each 5ml also contains not more than 0.53g of Galactose and not more than 0.40g of lactose. Lactulose Solution is available in 200, 300, 500, 1000, 5000ml plastic bottles.
Marketing Authorisation Holder
Resolution Chemicals Ltd., Wedgwood Way, Stevenage, Herts., SG1 4QT.
Manufacturer
Central Pharma Limited, Caxton Road, Bedford, MK41 0XZ.
This leaflet was last revised in June 2014
Lactulose Oral Solution 300 ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose.
PL 10321/0001
MA Holder: Resolution Chemicals Ltd.,
Wedgwood Way, Stevenage,
Herts, SG1 4QT, UK.
Distributed by: Kent Pharmaceuticals Limited, Repton Road, Measham,
DE12 7DT, U.K.
CFAF.LAC.3.3-5OS.300.V1P2 LAC300/KPUK/LL02
|
80mm |
81mm |
83mm |
85mm | |
|
10 |
Inside |
© |
Title Panel |
55mm
For oral use. Dosage for constipation Adults: 15ml twice daily.
Children 5 to 10 years: 10ml twice daily Children under 5 years: 5ml twice daily Babies under 1 year: 2.5ml twice daily or as directed by your doctor.
Dosage for other conditions - as directed by your doctor. Take with water or fruit juice if required.
Please read the package leaflet before use.
Keep out of the sight and reach of children.
• GO •
Storage: • • •
Do not store above 25°C. Do not refrigerate or freeze. Use within 6 months of firsj oijejiing then discard. •••••• ••
0
• •
• •
500 ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose.
PL 10321/0001
MA Holder: Resolution Chemicals Ltd.,
Wedgwood Way, Stevenage,
Herts, SG1 4QT, UK.
Distributed by: Kent Pharmaceuticals Limited, Repton Road, Measham,
DE12 7DT, U.K.
CFAF.LAC.3.3-50S.500.V1 P2 LAC500/KPUK/LL02
85mm
I 10mm]
BATCH/EXPIRY DETAILS WILL BE PRINTED/EMBOSSED IN THE SPACE HIGHLIGHTED
Customer: Kent Originated by: TC (AWG)
Product: Lactulose 3.3mg/5ml Oral Solution x 500ml
Dimensions: 55 x 180 mm
Item Code: CFAF.LAC.3.3-50S.500.V1 P2
Proof No and Date: 2 23/02/2015
Revision:
ARTWORK FOR SUBMISSION Supersedes: n/a
Colours
Pantone 327 C
Braille text reads as follows:
• • • • • • • • ••••••
• • • • • • • • • • • • • • •
# 3 • 3 G
• • • • • • •
• • • •
• • •• • •
• •• ••• •• • ••••• ••
S 0 L U T ION
Leaflet section:
Page B shows the leaflet section of the label-leaflet. The leaflet is a double sided strip of paper that is folded into 6 panels. It is not possible to show all 6 panels side-by-side in the A3 document, so each panel has been given a number and the diagram below shows the order of the panels as they will appear in the printed leaflet.
The leaflet section is glued to the carrier label at the left side edge of the title panel.
Outside
486mm
|
85 mm |
83 mm |
81mm |
80mm |
79 mm |
78mm | |
|
3 3 |
® |
© |
Q |
0 |
j © |
| © |
85mm
83mm
Outside
81mm
80mm
55mm
'ACKAGEDEAFLETTTNFDRMATIONTORTHEDSER^ 1
LACTULOSE 3.3g/5ml ORAL SOLUTION (Active substance: Lactulose)
Read all of this leaflet carefully before you start using this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
In this leaflet: “|
1. What Lactulose Solution is and what it is used for . Before you take Lactulose Solution . How to take Lactulose Solution
4. Possible side effects
5. How to store Lactulose Solution
6. Further information
1. WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR_
Lactulose Solution belongs to a group of medicines called axatives. It is used in the treatment of:
Chronic (long term) constipation: Constipation is a common complaint often due to not enough roughage or fibre in the diet, dehydration, immobility, illness or stress. Sometimes constipation may be due to more serious reasons._ _ _ _ _ J
YouShouldconsult with your doctor ifyou sufferfrom 1
constipation for a period of greater than 4 weeks.
|Lactulose can help your bowels to move, and pass a stool if you are constipated. Lactulose does not enter the bloodstream. It acts by drawing water into the bowel and so softening the stool or motion. In this way Lactulose can encourage a normal bowel motion.
hronic portal systemic encephalopathy (hepatic coma):
his is an uncommon condition where substances such as ammonia go into the blood stream. It can sometimes occur in patients with severe liver disease. Your doctor may prescribe Lactulose for you if you suffer from liver disease and he believes that you may develop or have developed hepatic encephalopathy.
Lactulosels" broken downSy thdnormal bacteria~(germs) in~ 1 the bowel to form acid which stops the formation and absorption of ammonia from the bowel into the blood stream.
In this way it helps to treat hepatic encephalopathy.
2. BEFORE YOU TAKE LACTULOSE SOLUTION
Do not take Lactulose Solution if:
- you know that you are allergic (causing itching, reddening of
I the skin or difficulty in breathing) to Lactulose Solution or any of the other ingredients of Lactulose Solution listed at the I end of this leaflet;
- you are suffering from a blockage in your gut or intestine;
- you suffer from a rare inherited condition of the metabolism I called galactosaemia (an increase in a sugar called
galactose in the blood).
(5) Outside (6)
79mm 78mm
4. POSSIBLE SIDE EFFECTS
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that you have obtained without a prescription.
Taking Lactulose Solution with food and drink: Lactulose Solution may be taken with a drink such as water or fruit juice. Pregnancy and breast-feeding 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, as long as you follow the dosage recommendations.
Driving and using machines
There should be no problems when taking Lactulose Solution.
Important information about some of the ingredienfsof Lactulose Solution: Lactulose Solution contains Lactose and Galactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
I 3. HOW TO TAKE LACTULOSE SOLUTION |Lactulose Solution is for oral use only. The effects of Lactulose may not be seen for up to 48 hours, therefore it is important to continue taking your medicine regularly.
To treat constipation:
The table below gives the starting doses of Lactulose Solution depending on your age. However, the dose may be adjusted by your doctor depending on your needs to have the p-j-g (desired effect.
_ Starting dose H
Adults 15ml twice daily (3 x 5ml spoonful)
Children 5 to 10 years 10ml twice daily (2 x 5ml spoonful) Children under 5 years 5ml twice daily (1 x 5ml spoonful) Babies under 1 year 2.5ml twice daily (% x 5ml spoonful)
To treat hepatic encephalopathy:
Higher doses of Lactulose Solution are required. i Starting dose
Adults 30-50ml three times daily (6-10 x
5ml spoonful)
Elderly as above
Children not to be taken (lactulose is not
I suitable for children with this
condition)
Your doctor may adjust your dose until two or three soft gtools are produced a day.
If you take more Lactulose Solution than you should 1
Contact your nearest casualty department or tell your doctor or pharmacist straight away. Take this leaflet and any remaining solution with you so that the medical staff know exactly what you have taken.
If you forget to take Lactulose Solution
If you forget to take a dose of Lactulose Solution, take it as soon as you remember. If it is almost time for your next dose though do not double the dose - just carry on as before.
Like all medicines, Lactulose Solution can cause side effects, although not everybody gets them. If any of these side effects become troublesome, stop taking the medicine and see your doctor as soon as possible.
|
78mm |
79mm |
Inside
The“mosfcommdn side effects“probabfy affectingupTd 1 ind0 people are: bloated stomach, excess wind or stomach cramps You may suffer from these in the first few days of taking your medicine. These usually go away on continuation of your treatment.
If you are taking large doses of Lactulose Solution to treat hepatic encephalopathy you may also suffer from diarrhoea, nausea (feeling sick), vomiting (being sick), flatulence and Istomach pain. If this is the case, tell your doctor as he can adjust your dose to obtain just two or three soft stools a day.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.'
5. HOW TO STORE LACTULOSE SOLUTION
Keep out of the sight and reach of children.
Do not store above 25°C. Do not refrigerate or freeze.
Do not use Lactulose Solution after the expiry date which is jstated on the bottle label after EXP. The expiry date refers to the last day of that month.
Use within 6 months of first opening and discard any remaining (solution.
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.
I 6. FURTHER INFORMATION
What Lactulose Solution contains
The active substance is Lactulose
The other ingredients are: Lactose and Galactose
What Lactulose Solution looks like and contents of the pack
Lactulose Solution is a clear, colourless or pale brownish yellow liquid. 5ml of Lactulose Solution contains 3.3g of Lactulose. Each 5ml also contains not more than 0.53g of Galactose and not more than 0.40g of lactose. Lactulose Solution is available in 200, 300, 500, 1000, 5000ml plastic bottles.
Marketing Authorisation Holder
Resolution Chemicals Ltd., Wedgwood Way, Stevenage, Herts., SG1 4QT.
Manufacturer
Central Pharma Limited, Caxton Road, Bedford, MK41 0XZ.
This leaflet was last revised in June 2014
Lactulose Oral Solution 500 ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose.
PL 10321/0001
MA Holder: Resolution Chemicals Ltd.,
Wedgwood Way, Stevenage,
Herts, SG1 4QT, UK.
Distributed by: Kent Pharmaceuticals Limited, Repton Road, Measham,
DE12 7DT, U.K.
CFAF.LAC.3.3-5OS.500.V1P2 LAC500/KPUK/LL02
|
80mm |
81mm |
83mm |
85mm | |
|
10 |
Inside |
© |
Title Panel |