Patient leaflet - Lactulose 3.335 g/5 ml oral solution
1. What Lactulose Medley is and what it is used for
The name of this medicine is Lactulose Medley 3.335 g/5 ml oral solution. It contains a laxative called lactulose.
It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body.
Lactulose Medley is used to treat constipation (infrequent bowel movements, hard and dry stools). It is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, and decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.
2. What you need to know before you take Lactulose Medley
Do not take Lactulose Medley if:
- You are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
- You have a rare problem called ‘galactosaemia’.
- You have a blockage caused by anything else but normal constipation, gastrointestinal perforation or risk of perforation.
Do not take Lactulose Medley if any of the above applies to you. 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 Medley 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 intolerant)
- if you have diabetes
You should not take Lactulose Medley if you suffer from:
- galactose or fructose intolerance
- total lactase deficiency
- glucose-galactose malabsorption (condition in which the body cannot absorb the sugars glucose and galactose)
If you have diabetes and are treated for hepatic encephalopathy, your dose of Lactulose Medley 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.
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 (approximately 2 liters per day, equal to
6-8 glasses).
If you take this medicine for several days and there is no improvement in your condition or if your symptoms worsen, contact your doctor.
Children
In special circumstances your doctor may prescribe Lactulose Medley for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Lactulose 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 Medley
Tell your doctor or pharmacist if you are taking or have recently taken 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. Lactulose Medley can be used during pregnancy and when breast-feeding if necessary. No effects on fertility are to be expected.
Driving and using machines
This medicine has no or negligible influence on your ability to drive safely or use machines.
Lactulose Medley contains lactose, galactose and fructose
This medicine contains sugars, such as milk sugar (lactose), galactose and fructose.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Lactulose Medley contains sulphite
May rarely cause severe hypersensitivity reactions and bronchospasm.
3. How to take Lactulose Medley
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Take Lactulose Medley from a 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).
You can take this medicine with or without food.
- Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if this medicine is taken for long periods.
- Lactulose Medley 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 15-45 ml daily. After this the dose can be adjusted to 15-30 ml daily.
Children 7 to 14 years: The starting dose is 15 ml daily. After this the dose can be adjusted to 10-15 ml daily.
Children 1-6 years: The usual dose is 5-10 ml daily.
Infants under 1 year: The usual dose is up to 5 ml 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. Do not give Lactulose Medley to children (under 14 years) before consulting your doctor for prescription and careful supervision.
Hepatic encephalopathy
Adults: The usual starting dose is 3 to 4 times a day of 30-45 ml.
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 kidney or liver problems: No special dosage recommendations exist.
If you take more Lactulose Medley than you should
If you take more medicine than you should stop taking Lactulose Medley and talk to a doctor or pharmacist. You may have diarrhoea, loss of electrolytes and abdominal pain.
If you forget to take Lactulose Medley
If you forget a dose of this medicine, 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 stop taking Lactulose Medley
Do not stop or change the treatment before talking to your doctor.
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 Medley:
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 (being sick)
- 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 Medley
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 and carton. This expiry date refers to the last day of that month.
Do not use after 90 days of first opening of the bottle.
Do not store above 25°C. 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 Medley contains
Each 5 ml of Lactulose Medley contains 3.335 g of lactulose.
It does not contain any excipients.
Lactulose contains residues from the route of production, see section 2.
What Lactulose Medley looks like and contents of the pack
Lactulose is a clear, viscous liquid, colorless to pale brownish-yellow.
Lactulose Medley is available in round amber PET bottles containing 200, 300 and 500 ml.
Each carton contains one bottle and a 30 ml graduated measuring cup with intermediate graduations of 5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Medley Pharma Ltd
Unit 2A, Olympic Way,
Sefton Business Park,
Bootle, Merseyside, L30 1RD,
United Kingdom
PL Number: PL 43870/0047
This leaflet was last revised in 03/2021
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