Lactulose Solution
Patient Information Leaflet
Lactulose Solution
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
You must talk to your doctor if you do not feel better or if you feel worse after several days.
In this leaflet
1. What Lactulose Solution is and what it is used for.
2. Before taking Lactulose Solution
3. How to take Lactulose Solution
4. Possible side effects
5. Storing Lactulose Solution
6. Further information
1. What Lactulose Solution is and what it is used for
Lactulose is a laxative. 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 including coma). This is also known as a 'hepatic coma'
2. Before taking Lactulose Solution Do not take Lactulose Solution, if
• You are allergic (hypersensitive) to lactulose or any of the other ingredients (listed in Section 6).
• You have a rare problem called 'galactosaemia'.
• You have a blockage caused by anything else but normal constipation, digestive perforation or risk of digestive perforation.
If you are not sure, talk to your doctor or pharmacist before taking Lactulose Oral Solution.
Check with your doctor or pharmacist before taking before taking Lactulose Oral Solution if you suffer from any medical conditions or illnesses, in particular:
• if you suffer from unexplained tummy ache
• if you are unable to digest milk sugar (lactose)
• if you have diabetes
You should not take Lactulose Oral Solution if you suffer from:
• galactose or fructose intolerance
• Lapp lactase deficiency
• glucose-galactose malabsorption
If you have diabetes and are treated for hepatic encephalopathy, your dose of Lactulose Oral Solution will be higher. This high dose contains a large amount of sugar. Therefore, you may need to adjust the dose of your anti-diabetic medicine.
Chronic use of unadjusted dosages (exceeding 2-3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolytes balance.
During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres/day, equal to 6-8 glasses).
If you take Lactulose Oral Solution for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.
Children
In special circumstances your doctor may prescribe Lactulose Oral Solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.
Lactulose Oral Solution should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.
Other medicines and Lactulose Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Lactulose Oral Solution with food and drink
Lactulose Oral Solution can be taken with or without food. There are no restrictions on what you can eat or drink.
Pregnancy, breast-feeding and fertility
Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Lactulose Oral Solution can be used during pregnancy and when breast-feeding if necessary.
No effects on fertility are to be expected.
Driving and using machines
Lactulose has no or negligible influence on your ability to drive safely or use machines.
Important Information about some of the Ingredients of Lactulose
Lactulose may contain small amounts of milk sugar (lactose), galactose, epilactose or fructose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Lactulose Solution
Always take Lactulose exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take Lactulose from a spoon or measuring cup.
• You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids(approximately 6-8 glasses throughout the day)
• Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Lactulose is taken for long periods.
• Lactulose takes 2 to 3 days to start working. After this time you may be able to reduce the dose you take according to your needs.
Constipation
• Adults and adolescents: The starting dose is 15-45ml. After this the dose can be adjusted to 15-30ml daily.
• Children 7 to 14 years: The starting dose is 15ml daily. After this the dose can be adjusted to 10-15ml daily.
• Children 1 to 6 years: The usual dose is 5-10ml daily.
• Infants under 1 year: The usual dose is up to 5ml daily.
Use in Children: Use of laxatives in children, infants, and babies should be exceptional and under medical supervision because it can influence the normal reflexes for passing stools.
Please do not give Lactulose to children (under 14 years) before consulting your doctor for prescription and careful supervision.
Hepatic encephalopathy (adults only)
• Adults: The usual starting dose is 3 to 4 times a day of 30-45ml.
• Use in Children: No information is available for treatment of children (newborn to 18 years of age) with hepatic encephalopathy.
• Use in elderly patients and patients with renal or hepatic insufficiency: No special dosage recommendations exist.
If you forget to take Lactulose Solution
If you forget a dose of Lactulose, do not worry. Just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you take more Lactulose than you should
If you take more Lactulose than you should stop taking this and talk to a doctor or pharmacist.
You may have diarrhoea and abdominal pain.
If you stop taking Lactulose solution
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 or pharmacist.
4. Possible side effects
Like all medicines, Lactulose can cause side effects, although not everybody gets them.
The following side effects have been reported
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing Lactulose Solution
• Keep this medicine out of the reach and sight of children.
• Do not use Lactulose after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month.
• Do not store above 25°C. Do not refrigerate or freeze.
• 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
Each 5ml of Lactulose Oral Solution contains 3.35g of lactulose.
It does not contain any other ingredients. However, it may contain small amounts of other sugars, such as lactose, galactose, epilactose and fructose.
Lactulose Oral Solution is a clear, viscous liquid, colourless to brownish yellow liquid. It is available in plastic bottles containing 300ml or 500ml.
The product licence holder and manufacturer is Crescent Pharma Limited 3&4 Quidhampton Business Units, Polhampton Lane, Overton Hampshire, RG25 3ED, UK.
Leaflet updated: March 2014
Contact us at the above address for information in large print, audio or Braille
PL 20416/0399
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