Patient leaflet - Lactulose solution BP
1. What Lactulose Solution BP is and what it is used for
Lactulose Solution BP contains the active ingredient lactulose.
Lactulose belongs to a group of medicines known as osmotic laxatives which encourage regular bowel movements. It makes the stool softer and easier to pass,
Lactulose Solution BP is used for the treatment of:
- Constipation (infrequent bowel movements, hard and dry stools)
- Hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness including coma). This is also known as ‘hepatic coma’
2. Before you take Lactulose Solution BP
Do not take Lactulose Solution BP
- If you have a rare problem called ‘galactosaemia’ or if you are on a galactose-free diet
- if you are allergic to lactulose or any of the ingredients of this medicine (listed in section 6).
- if you have any obstruction in your stomach or intestine
- If you have undiagnosed stomach problems
- if you have stomach pain or are feeling or being sick, unless your doctor tells you to
- if your bowel habit suddenly changes, and the changes persist for more than two weeks
- if you suffer from rectal bleeding or bleeding from the back passage
- if you fail to have a bowel motion following use of a laxative.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lactulose Solution BP
- if you have diabetes mellitus
- Lactulose Solution BP may contains small amounts of milk sugar (lactose), galactose, epilactose or fructose (milk sugars). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine
- This medicine may take upto 48 hours to become effective
- Excessive and prolonged use is dangerous and could result in diarrhoea with loss of fluid. If this happens, consult your doctor straight away. Prolonged use of this product should be avoided.
Other medicines and Lactulose Solution BP
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
Lactulose Solution BP has no or negligible influence on your ability to drive safely or use machines.
3. How to take Lactulose Solution BP
Always take this medicine exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure exactly how much medicine and how often you must take it will be written on the label. Please read it carefully.
Dosage
For the treatment of constipation:
Adults (including elderly) – 15ml (3 x 5ml spoonful) twice daily.
Children 5 to 10 years: - 10ml (2 x 5ml spoonful) twice daily.
Children 1 to 5 years: - 5ml (1 x 5ml spoonful) twice daily.
Please note that your dosage may vary depending on the condition.
Your dosage may be adjusted by your doctor to meet your individual needs. If after three days, your symptoms continue or have worsened, you should consult your doctor to establish the cause of the constipation.
For treatment of hepatic encephalopathy:
Adults, including the elderly: Initially 6 to 10 x 5ml spoonfuls (30 to 50ml) three times a day. The dosage may be adjusted until you produce 2 or 3 soft stools a day. If you are unsure how to go about this, see your doctor.
Children: No dosage recommendation for this indication.
If you take more Lactulose Solution BP than should
If you accidentally take too much of this medicine you should contact your doctor or nearest hospital casualty department immediately. 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 BP
If you forget to take a dose take it as soon as you remember. If it is almost time for your next dose do not double the dose, just carry on as before.
If you stop taking Lactulose Solution BP
Do not stop or change the treatment before talking to your doctor. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
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 following use of this medicine at a frequency not known: frequency cannot be estimated from the available data:
- Allergic reactions
- Rash
- Itching
- Hives
The following side effects have also been reported following use of this medicine:
- Diarrhoea – in all cases of diarrhoea, the dose should be reduced and fluid intake should be increased
- Flatulence (wind)
- Stomach cramps
- Nausea (feeling sick) and vomiting (being sick) following high doses
- If you are taking large doses of Lactulose Solution BP to treat hepatic encephalopathy or taking Lactulose Solution BP for long time you may also suffer from electrolyte imbalance (dehydration) which may be need to be treated by your doctor.
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 MHRA Yellow Card Scheme. Website www.mhra.gov.uk/yellowcard 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 BP
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month. Store below 25 . Do not refrigerate or freeze.
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 BP contains
The active substance is Lactulose. Each 5ml of solution contains 3.4g of lactulose. The other ingredient is purified water.
What Lactulose Solution BP looks like and contents of the pack
- Lactulose Solution BP is a clear, viscous liquid, colourless to brownish yellow.
- Lactulose Solution BP is available in plastic bottles containing 200ml, 300ml and 500ml. It is also available in glass bottles containing 1000ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Crescent Pharma Ltd., Key House, Sarum Hill, Basingstoke, RG21 8SR, UK
Manufacture
Infra Srl, via Fiorentina, 51100 Pistoia, Italy.
This leaflet was last revised in May 2024.
Title Panel
Lactulose Solution BP
Oral use
5ml of Lactulose Solution contains 3.4g of Lactulose.
Also contains purified water.
See leaflet for further information.
Store below 25°C.
MA Holder: Crescent Pharma Ltd., Key House, Sarum Hill, Basingstoke, RG21 8SR, UK.
PL 20416/0881
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