Lactulose 3.3g /5ml Oral Solution
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For oral use. Dosage for constipation:-Adults: 15 ml twice daily.
Children 5 to 10 year.: 10 ml twice daily Children under 5 years: 5 ml twice daily Babies under 1 year: 2.5 ml 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 o, the sight and reach of children.
Storage
Do not store above 25°C. Do not refrigerate or freeze. Use within 6 months of first opening then discard.
Exp:
BN:
Lactulose 3.3g/5ml Oral Solution 300ml
5ml of Lactulose Solution contains 3.3g of Lactulose. Each 5 ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way,
Stevenage Herts, SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK
PL 10321/0001
AAAG2379
PEEL HERE
Braille text reads as follows:
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lactulose | |||||
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solution
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83mm
82mm
82mm
(Dosage continued) To treat hepatic encephalopathy:
55mm
Higher doses of Lactulose Solution are required Starting dose
Adults 30-50ml three times daily (6-10 x 5ml spoonful)
Elderly as above
Children not to be taken (lactulose is not suitable for
children with this condition)
Your doctor may adjust your dose until two or three soft stools are produced a day.
If you take more Lactulose Solution than you should
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.
0 POSSIBLE SIDE EFFECTS
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.
The most common side effects probably affecting up to 1 in 10 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 stomach 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.
0 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 stated on the bottle
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.
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.
494mm
85mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
83mm
◄-►
In this leaflet:
_l| What Lactulose Solution is and what it is used for
_2| Before you take Lactulose Solution
^3| How to take Lactulose Solution
4 Possible side effects
_5| How to store Lactulose Solution
16 Further information
0 WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR
Lactulose Solution belongs to a group of medicines called laxatives. 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,
82mm
82mm
dehydration, immobility, illness or stress. Sometimes constipation may be due to more serious reasons. You should consult with your doctor if you suffer from 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.
Chronic portal systemic encephalopathy (hepatic coma): This 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.
Lactulose is broken down by the normal bacteria (germs) in 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.
0 BEFORE YOU TAKE LACTULOSE SOLUTION
Do not take Lactulose Solution if:
• you know that you are allergic (causing itching, reddening of the skin or difficulty in breathing) to Lactulose Solution or any of the other ingredients of Lactulose Solution listed at the 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 called galactosaemia (an increase in a sugar called galactose in the blood).
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.
t
f
83mm
85mm
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
AAAG2385
Lactulose 3.3g/5ml Oral Solution
300ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5 ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way, Stevenage Herts,
SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK
PL 10321/0001 @ AAAG2385
FRONT PANEL
5ml
83mm
79mm
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 ingredients of 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.
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 desired effect.
Adults
Children 5 to 10 years Children under 5 years Babies under 1 year
Starting dose
15ml twice daily (3 x 5ml spoonful)
10ml twice daily (2 x 5ml spoonful)
5ml twice daily (l x 5ml spoonful 2.5ml twice daily (/ x 5ml spoonful) pto
A
55mm
For oral use. Dosage for constipation:-Adults: 15 ml twice daily. *#
children 5 to 10 years: 10 ml twice d'ily Children under 5 years: 5 ml twice daily Babies under 1 year: 2.5 ml twice daily or as directed by your doctor.
Dosage for other conditions -as directed by your doctoi.
Take with water or fruit juice if required.
Please read the package leaflet before use.
Keep out of the sight and reach of children. storage
Do not store above 25°C. Do not refrigerate or freeze. Use within 6 months of first opening then discard.
0
Lactulose 3.3g/5ml Oral Solution 500ml
PEEL HERE
Exp:
BN:
5ml of Lactulose Solution contains 3.3g of Lactulose. Each 5 ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way,
Stevenage Herts, SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK
PL 10321/0001
AAAG2384
Braille text reads as follows:
|
• |
• • |
• |
• |
• | |
|
• |
• |
• • |
• |
• |
• |
|
lactulose | |||||
|
• •• |
• • |
• • | |||
|
• • |
• |
• • | |||
|
• • |
• | ||||
|
#3.3 [ls]g | |||||
|
• • • |
• |
• • |
• | ||
|
• • |
• |
• | |||
|
• • •• |
• |
• | |||
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/#5ml | |||||
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• • • |
• |
• |
• |
• |
• • |
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• • • |
• • |
• |
• |
• | |
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• • • |
• • |
• |
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• |
solution
t
f
79mm
83mm
82mm
82mm
83mm
85mm
55mm
(Dosage continued) To treat hepatic encephalopathy:
Higher doses of Lactulose Solution are required Starting dose
Adults 30-50ml three times daily (6-10 x 5ml spoonful)
Elderly as above
Children not to be taken (lactulose is not suitable for
children with this condition)
Your doctor may adjust your dose until two or three soft stools are produced a day.
If you take more Lactulose Solution than you should
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.
0 POSSIBLE SIDE EFFECTS
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.
The most common side effects probably affecting up to 1 in 10 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 stomach 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.
0 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 stated on the bottle
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.
0 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.
494mm
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
AAAG2392
Lactulose 3.3g/5ml Oral Solution
500ml
5ml
5ml of Lactulose Solution contains 3.3g of Lactulose.
Each 5 ml also contains not more than 0.53g of Galactose and not more than 0.40g of Lactose
MA Holder
Resolution Chemicals Ltd., Wedgwood Way, Stevenage Herts, SG1 4QT
Distributed by: Actavis, Barnstaple, EX32 8NS, UK
PL 10321/0001
0
AAAG2392
FRONT PANEL
85mm
83mm
82mm
82mm
83mm
79mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
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:
_l| What Lactulose Solution is and what it is used for
_2| Before you take Lactulose Solution
^3| How to take Lactulose Solution
4 Possible side effects
_5| How to store Lactulose Solution
16 Further information
0 WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR
Lactulose Solution belongs to a group of medicines called laxatives. 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. You should consult with your doctor if you suffer from 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.
Chronic portal systemic encephalopathy (hepatic coma): This 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.
Lactulose is broken down by the normal bacteria (germs) in 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.
0 BEFORE YOU TAKE LACTULOSE SOLUTION
Do not take Lactulose Solution if:
• you know that you are allergic (causing itching, reddening of the skin or difficulty in breathing) to Lactulose Solution or any of the other ingredients of Lactulose Solution listed at the 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 called galactosaemia (an increase in a sugar called galactose in the blood).
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 ingredients of 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.
0 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 desired effect.
Starting dose
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 (l x 5ml spoonful)
Babies under 1 year 2.5ml twice daily (/ x 5ml spoonful) PTO
55mm