Lactulose 3.3g/5ml Oral Solution
Each 5ml contains:
Lactulose 33 g. May also contain Galactose, Lactose, Epi lactose, Tagatose and Fructose.
Lactulose 3.3g/5ml Oral Solution
An effective laxative for constipation and in hepatic encephalopathy
Lactulose, Galactose, Lactose and Tagatose act as purgatives (laxatives).
500 ml e
KEEP THE CONTAINER TIGHTLY CLOSED STORE IN A COOL DRY PLACE, BELOW ifc
MA Holder:
Sterling Pharmaceuticals Ltd 288 Upper Balsall Heath Rd Birmingham, B12 9DR, UK
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(a condition which occurs In association with advanced liver disease)
PL 32515/0055
Date of last revision: March 2016
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Note to customer: This braille translation must be verified to confirm it is how you require it before giving artwork approval.
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Lactulose 3.3g/5ml O.al Solution
An ef.'etJve taxaJve fc.
cnnstioatinn and in hepatic encephalopathy
(a condition which occurs In association with advanced liver disease)
Each 5ml contains:
Lactulose 33 g. May also contain Galactose, Lactose, Epi lactose, Tagal||eandFructp. q LactulosejalaQse, Lactose Qd Tagate act asrjrgatives (laxatives).
IfOOml e[p|
n • '-'
KEEPTHtCOI
STORE IN AC
WINER I DRY
[HTLY CLOSED IE, BELOW 25°C
MA Holder:
Sterling Pharmaceuticals Ltd 288 Upper Balsall Heath Rd Birmingham, B12 9DR, UK • • ••
PL 32515/0055
Date of last revision: March 2016
RECOMMENDED FOR: Constipation^ Hepatic Encephalopathy^
For oral administration only. Lactulose may be taken with water or fruit juice. HOW TO TAKE IT in Constipation:
AGE DOSAGE
ADULTS AND THE ELDERLY 15 ml twice daily (3x5 ml spoonfuls),
& CHILDREN OVER 12 YEARS gradually reduced.
CHILDREN 5 TO 12 YEARS 10 ml twice daily (2x5 ml spoonfuls),
gradually reduced.
CHILDREN 1 TO 5 YEARS 5 ml twice daily (1 x 5 ml spoonful).
CHILDREN UNDER 1 YEAR_2.5 ml twice daily QA x 5 ml spoonful).
HOWTO TAKE IT In Hepatic Encephalopathy:
30 to 50 ml three times daily (6 -10 x 5 ml spoonfuls), then, adjusted to produce 2 to 3 soft stools daily.
DO NOT TAKE MORE MEDICINE THAN THE LABELTELLSYOUTO. _IF YOU DO NOT GET BETTER, TALK TO YOUR DOCTOR.
Do not take Lactulose Solution:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Warnings & Precautions:
If you suffer from diabetes or blockages of the intestine or are sensitive to any of the ingredients, consult your doctor or pharmacist before taking this medicine. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
combined label
a
To treat Hepatic Encephalopathy Higher doses of Lactulose are required. Starting dose is 30 to 50 ml three times daily (6 -10 x 5ml spoonfuls), then adjusted to produce 2 or 3 soft stools daily.
If you take more Lactulose solution than you should, contact your doctor or nearest hospital emergency department immediately. Take any remaining solution with you so that the 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 unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten one.
4. POSSIBLE SIDE EFFECTS
Like all medicines. Lactulose solution can cause side effects, although not everybody gets them.
If the following happens, stop using this medicine and tell your doctor immediately or go to the nearest hospital emergency department:
• allergic reactions such as difficulty in breathing, swelling of your face, lips, throat or tongue, skin rash, itching and hives.
Other side effects:
• gas
• stomach or intestine discomfort
• stomach cramps
• bloated stomach
If you are taking large doses of Lactulose solution to treat hepatic encephalopathy, you may also suffer from:
• feeling sick (nausea)
• vomiting
• diarrhoea
• low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm.
In such a case, please tell your doctor as he can adjust your dose to obtain two to three stools a day.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in the leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the safety of this medicine.
Do not use Lactulose solution after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicines via the waste-water or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Keep all medicines out of the sight and reach of children.
Do not store above 25 °C.
Store in a cool dry place.
What Lactulose Solution contains:
5ml of Lactulose Solution contains 3.3g of Lactulose. May also contain Galactose, Lactose, Epilactose, Tagatose and Fructose.
What Lactulose Solution looks like and contents of the pack:
Lactulose solution is a clear viscous liquid, colourless or pale brownish-yellow.
Lactulose solution is available in 200ml, 300ml, 500ml & 1000ml plastic bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer:
Sterling Pharmaceuticals Ltd 288 Upper Balsall Heath Road Moseley, Birmingham B12 9DR United Kingdom
This leaflet was last revised in March 2016
RECOMMENDED FOR: Constipation-/' Hepatic Encephalopathy/1
For oral administration only. Lactulose may be taken with water or fruit juice.
HOW TO TAKE IT In Constipation:
AGE
ADULTS AND THE ELDERLY & CHILDREN OVER 12 YEARS CHILDREN 5TO 12 YEARS
CHILDREN 1 TO 5 YEARS CHILDREN UNDER 1 YEAR
DOSAGE
15 ml twice daily (3 x 5 ml spoonfuls), gradually reduced.
10 ml twice daily (2x5 ml spoonfuls), gradually reduced.
5 ml twice daily (1 x 5 ml spoonful). 2.5 ml twice daily (!A x 5 ml spoonful).
HOW TO TAKE IT in Hepatic Encephalopathy:
30 to 50 ml three times daily (6 -10 x 5 ml spoonfuls), then, adjusted to produce 2 to 3 soft stools daily.
DO NOT TAKE MORE MEDICINE THAN THE LABEL TELLS YOU TO. _IF YOU DO NOT GET BETTER, TALK TO YOUR DOCTOR.
Do not take Lactulose Solution:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Warnings & Precautions:
If you suffer from diabetes or blockages of the intestine or are sensitive to any of the ingredients, consult your doctor or pharmacist before taking this medicine.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
What is in this leaflet:
1. What Lactulose Solution is and what it is used for
2. What you need to know before you take Lactulose Solution
3. How to take Lactulose Solution
4. Possible side effects
5. How to store Lactulose Solution
6. Contents of the pack and other information
Package leaflet: Information for the user Lactulose 33g/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because It contains important information for you.
■ 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 only. Do not pass on to others. It may harm them, even if their signs of illness are the same as yours.
■ 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.
1. WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Lactulose Solution, it belongs to a group of medicines called laxatives.
It is used in:
• 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. Lactulose can help the bowel move, and pass a stool if you are constipated. It acts by drawing water into the bowel and softening the stool or motion. In this way, Lactulose can encourage a normal bowel motion.
• Advanced liver disease marked by a disturbance of mental functioning (hepatic encephalopathy).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE SOLUTION
Do not take Lactulose Solution if you:
• Are allergic (hypersensitive) to Lactulose, Galactose, Lactose, Epilactose, Tagatose and Fructose (see section 6).
• Suffer from a rare inherited condition of metabolism, called galactosaemia (an increase in sugar called galactose in the blood).
• Are suffering from a blockage in your gut or intestine.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Lactulose Solution:
• If you are diabetic
Other medicines and Lactuose Solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.
Driving and using machines:
There should be no problems when taking Lactulose solution.
Lactulose Solution contains Lactose, Galactose and Fructose. If you have been told by your doctor that you have an intolerance to some sugars, please ask your doctor before taking this medicine.
3. HOWTO TAKE LACTULOSE SOLUTION
Lactulose Solution is for oral use only. Lactulose Solution may be taken with a drink such as water or juice.
To treat constipation
The details mentioned below give the starting dose 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, the elderly and children over 12 years:
15 ml twice daily (3 x 5 ml spoonfuls), gradually reduced.
Children 5 to 12 years:
10 ml twice daily (2 x 5 ml spoonfuls), gradually reduced.
Children 1 to 5 years: 5 ml twice daily (1 x 5ml spoonful).
Babies under 1 year: 2.S ml twice daily C/2 x 5ml spoonful).