Patient leaflet - LACTULOSE SOLUTION BP
1. what lactulose solution is and what it is used for
Lactulose Solution belongs to a group of medicines which are called Iaxatives. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body. It is used to treat;
- constipation (infrequent bowel movements, hard and dry stools)
- hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness).
2. what you need to know before you take lactulose solution
Do not Take Lactulose Solution if:
- you are allergic to lactulose or any of the other ingredients of this medicine (listed in Section 6)
- you have a gastrointestinal obstruction (obstruction of the gut) or digestive system
- you have a rare problem called galactosaemia (a severe genetic disorder where you cannot digest galactose), acute inflammatory bowel disease (like ulcerative colitis or Crohn's disease), digestive perforation or risk of digestive perforation or unexplained abdominal pain.
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lactulose Solution if you suffer from any medical conditions or illnesses, in particular:
- if you are unable to digest milk sugar (lactose intolerant)
- if you have diabetes
- if you suffer from unexplained tummy ache
- if you suffer from gastro-cardiac syndrome (Roemheld syndrome).
You should not take Lactulose Solution if you suffer from:
- galactose or fructose intolerance
- total lactase deficiency
- glucose-galactose malabsorption.
If you have diabetes and are treated for hepatic encephalopathy, your dose of Lactulose Solution will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your anti-diabetic medicine.
Long-term use of unadjusted dosages (exceeding 2–3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolyte balance.
During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres per day, equal to 6–8 glasses).
If you are an elderly patient or a patient in bad general condition and take lactulose for more than a 6 months period, your doctor will regularly check your blood electrolytes.
If you take this medicine for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.
Stop the medicine and consult your doctor if:
- you have symptoms like excess gas in your bowels or bloating after using this medicine
- there is no improvement in your condition or if your symptoms worsen after taking this medicine for several days.
Children and adolescents
In special circumstances your doctor may prescribe Lactulose Solution for a child, infant or baby.
In these cases your doctor will supervise the treatment carefully.
Lactulose Solution should not normally be given to infants and smaller children as it can influence the normal reflexes for passing stools.
Other medicines and Lactulose Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Lactulose may decrease potassium levels caused by other drugs (e.g. glycosides, thiazides, steroids and amphotericin B). Decrease in colon pH-value is found when dosage is increased. Therefore drugs which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated.
Lactulose Solution with food and drink
Lactulose can be taken with or without food. There are no restrictions on what you can eat or drink.
Pregnancy, breast-feeding and fertility
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 is no evidence that Lactulose Solution affects your ability to drive or operate machinery.
Important information about some of the ingredients of Lactulose
Lactulose may contain small amounts of sugars (lactose, galactose or epilactose).
If you have been told by your doctorthat you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Lactulose may contain more than 5 g lactose/galactose/epilactose depending upon the dose taken. This should be taken into account in patients with diabetes mellitus.
15 ml of Lactulose contains 42.7 KJ (1O.2 kcals) = O.21 BU.
3. how to take lactulose solution
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Take the dose at same time each day. The dose may be given once daily, for example during breakfast, or divided into two or three doses a day.
Swallow the medicine quickly. Do not keep it in your mouth.
Lactulose Solution may be taken undiluted or diluted with some liquid (fruit juice, water or milk).
Constipation
Adults and adolescents: Starting dose is 15 ml twice daily.
Children 5 to 10 years: Starting dose is 1O ml twice daily.
Children under 5years: Starting dose is 5 ml twice daily.
Infants under 1 year: 2.5 ml twice daily.
Dosage to be gradually reduced on the advice of your doctor.
Hepatic encephalopathy
Adults: Starting dose is 3O-5O ml 3 to 4 times a day.
Elderly: Standard adult dose is recommended.
Use in Children: Not recommended for treatment of children (newborn to 18 years of age). Use in elderly patients and patients with renal or hepatic insufficiency: No special dosage recommendations exist.
If you take more Lactulose Solution than you should
If you take more medicine than you should contact your doctor or pharmacist.
Symptoms of overdose include diarrhoea, loss of electrolytes and abdominal pain.
If you forget to take Lactulose Solution
If you forget to take one or more doses, 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 Solution
Do not stop or change the treatment before talking to your doctor as desired effect of the medicine may not be achieved.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Lactulose Solution:
Very common: may affect more than 1 in 10 people
- diarrhoea.
Common: may affect up to 1 in 10 people
- flatulence (wind)
- nausea (feeling sick)
- vomiting
- abdominal pain.
Uncommon: may affect up to 1 in 100 people
- electrolyte imbalance due to diarrhoea.
Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur.
In such a case the dosage should be decreased. If you use high doses (normally only associated with hepatic encephalopathy, HE) for an extended period of time, you may experience an electrolyte imbalance due to diarrhoea.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store lactulose solution
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze. Store in the original container.
Dilution and subsequent storage not recommended.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
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 protect the environment.
6. contents of the pack and other information
What Lactulose Solution contains
The active substance is lactulose. Each 5 ml of Lactulose Solution contains 3.335 g of lactulose. Lactulose Solution does not contain any excipients. It may also contain the following related substances: galactose, lactose, epilactose, tagatose, laevulose.
What Lactulose Solution looks like and contents of the pack
Amber glass bottles with plastic screw caps of 2OO ml, 3OO ml and 5OO ml or HDPE bottles with plastic screw caps of 2OO ml, 3OO ml, 5OO ml, 1OOO ml and 5OOO ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited,
Cheshire House,
Gorsey Lane,
Widnes,
Cheshire, WA8ORP, UK.
PL 2O395/O287.
This leaflet was last revised in April 2021.
Lactulose
1. what lactulose solution is and what it is used for
Lactulose Solution belongs to a group of medicines which are called laxatives. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body. It is used to treat;
- constipation (infrequent bowel movements, hard and dry stools)
- hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness).
2. what you need to know before you take lactulose solutiondo not take lactulose solution if: you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6)
- you have a gastrointestinal obstruction (obstruction of the gut) or digestive system
- you have a rare problem called galactosaemia (a severe genetic disorder where you cannot digest galactose), acute inflammatory bowel disease (like ulcerative colitis or Crohn's disease), digestive perforation or risk of digestive perforation or unexplained abdominal pain.
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lactulose Solution if you suffer from any medical conditions or illnesses, in particular:
- if you are unable to digest milk sugar (lactose intolerant)
- if you have diabetes
- if you suffer from unexplained tummy ache
- if you suffer from gastro-cardiac syndrome (Roemheld syndrome).
You should not take Lactulose Solution if you suffer from:
- galactose or fructose intolerance
- total lactase deficiency
- glucose-galactose malabsorption.
If you have diabetes and are treated for hepatic encephalopathy, your dose of Lactulose Solution will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your anti-diabetic medicine.
Long-term use of unadjusted dosages (exceeding 2–3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolyte balance.
During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres per day, equal to 6–8 glasses).
If you are an elderly patient or a patient in bad general condition and take lactulose for more than a 6 months period, your doctor will regularly check your blood electrolytes.
If you take this medicine for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.
Stop the medicine and consult your doctor if:
- you have symptoms like excess gas in your bowels or bloating after using this medicine
- there is no improvement in your condition or if your symptoms worsen after taking this medicine for several days.
Children and adolescents
In special circumstances your doctor may prescribe Lactulose Solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.
Lactulose Solution should not normally be given to infants and smaller children as it can influence the normal reflexes for passing stools.
Other medicines and Lactulose Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Lactulose may decrease potassium levels caused by other drugs (e.g. glycosides, thiazide steroids and amphotericin B). Decrease in colon pH-value is found when dosage is increased. Therefore drugs which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated.
Lactulose Solution with food and drink
Lactulose can be taken with or without food. There are no restrictions on what you can eat or drink.
Pregnancy, breast-feeding and fertility
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 is no evidence that Lactulose Solution affects your ability to drive or operate machinery.
Important information about some of the ingredients of Lactulose
Lactulose may contain small amounts of sugars (lactose, galactose or epilactose).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Lactulose may contain more than 5 g lactose/galactose/epilactose depending upon the dose taken.
This should be taken into account in patients with diabetes mellitus.
15 ml of Lactulose contains 42.7 KJ (10.2 kcals) = 0.21 BU.
3. how to take lactulose solution
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Take the dose at same time each day. The dose may be given once daily, for example during breakfast, or divided into two or three doses a day.
Swallow the medicine quickly. Do not keep it in your mouth.
Lactulose Solution may be taken undiluted or diluted with some liquid (fruit juice, water or milk).
Constipation
Adults and adolescents: Starting dose is 15 ml twice daily.
Children 5 to 10 years: Starting dose is 10 ml twice daily.
Children under 5years: Starting dose is 5 ml twice daily.
Infants under 1 year: 2.5 ml twice daily.
Dosage to be gradually reduced on the advice of your doctor.
Hepatic encephalopathy
Adults: Starting dose is 30–50 ml 3 to 4 times a day.
Elderly: Standard adult dose is recommended.
Use in Children: Not recommended for treatment of children (newborn to 18 years of age). Use in elderly patients and patients with renal or hepatic insufficiency: No special dosage recommendations exist.
If you take more Lactulose Solution than you should
If you take more medicine than you should contact your doctor or pharmacist. Symptoms of overdose include, loss of electrolytes and abdominal pain.
If you forget to take Lactulose Solution
If you forget to take one or more doses, 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 Solution
Do not stop or change the treatment before talking to your doctor as desired effect of the medicine may not be achieved.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Lactulose Solution:
Very common: may affect more than 1 in 10 people
- diarrhoea.
- flatulence (wind)
- nausea (feeling sick)
- vomiting
- abdominal pain.
- electrolyte imbalance due to diarrhoea.
5. how to store lactulose solution
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze. Store in the original container.
Dilution and subsequent storage not recommended.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
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 protect the environment.
6. contents of the pack and other informationwhat lactulose solution containsthe active substance is lactulose.
Each 5 ml of Lactulose Solution contains 3.335 g of lactulose.
Lactulose Solution does not contain any excipients. It may also contain the following related substances: galactose, lactose, epilactose, tagatose, laevulose.
What Lactulose Solution looks like and contents of the pack
Amber glass bottles with plastic screw caps of 200 ml, 300 ml and 500 ml or HDPE bottles with plastic screw caps of 200 ml, 300 ml, 500 ml, 1000 ml and 5000 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited,
Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.
PL 20395/0287.
This leaflet was last revised in April 2021.