Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Lactulose 10 g / 15 ml oral solution sachets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lactulose may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR Lactulose 10 g/15 ml oral solution sachets contain 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 is indicated in adults and in children and adolescents aged 7 to 18 years. For children below 7 years, other dosage forms are available. Lactulose is used to treat the symptoms of constipation.
If you forget to take Lactulose If you forget to take 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 have any further questions on the use of this medicine, ask your doctor or pharmacist. If you stop taking Lactulose The desired effect of the medicine may not be achieved.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
How to take it
LACTULOSE
Starting dose
The following side effects have been reported with Lactulose: Very common (may affect more than 1 in 10 people):
- Flatulence (wind), especially during the first few days of treatment. This usually disappears after a couple of days.
- When a higher dose than recommended is used, you may experience abdominal pain.
Maintenance dose 15-30 ml daily
Marketing Authorisation Holder Fresenius Kabi Austria GmbH Hafnerstraße 36 8055 Graz, Austria Manufacturer Fresenius Kabi Austria GmbH Estermannstraße 17 4020 Linz, Austria Distributed by: Esteve Pharmaceuticals Ltd. The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berks SL6 6PT. United Kingdom This leaflet was last revised in 11/2022.
1-2 sachets, corresponding to 10-20 g lactulose
Thereafter the dose can be reduced individually. In elderly patients and patients with kidney or liver disease no special dosage recommendations exist.
V0056218/08
V0056218/08
Possible side effects
Do not take Lactulose:
- if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from galactosaemia (a severe genetic disorder where you cannot digest galactose), acute inflammatory bowel disease (like Crohn's disease or ulcerative colitis), blockage in your bowel (apart from normal constipation), digestive perforation or risk of digestive perforation or unexplained abdominal pain.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Warnings and precautions Talk to your doctor or pharmacist before taking Lactulose. Please tell your doctor before taking Lactulose if you suffer from gastro-cardiac syndrome (Roemheld syndrome). If you have symptoms like excess gas in your bowels or bloating after using it, stop the treatment and consult your doctor. In these cases your doctor will supervise the treatment carefully. 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. If you are an elderly patient or a patient in bad general condition and take lactulose for a more than 6 months period, your doctor will regularly check your blood electrolytes. During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres per day, equal to 6-8 glasses). Children and adolescents Lactulose should not normally be given to infants and smaller children as it can disturb the normal reflexes for passing stools. In special circumstances your doctor may prescribe Lactulose for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Other medicines and Lactulose Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Lactulose may increase the loss of potassium caused by other drugs (e.g. thiazides, steroids and amphothericin B). Use of cardiac glycosides (e.g. digoxin) along with Lactulose can increase the effect of the glycosides by decreasing potassium in the blood. With increasing dosage a decrease of pH-value in the colon is found. Therefore drugs which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated. Lactulose 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 Lactulose will not affect your ability to drive safely or use machines. 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 contain 42.7 KJ (10.2 kcals) = 0.21 BU.
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 your doses at the 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. You can take Lactulose oral solution undiluted or diluted in some liquid. During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres per day, equal to 6-8 glasses). It can take 2-3 days until the desired effect has been achieved since Lactulose is not degraded until it reaches the colon. The recommended dose is:
Adults
15-45 ml daily
1-3 sachets, corresponding to 10-30 g lactulose
Common (may affect up to 1 in 10 people):
- Nausea (feeling sick)
- Vomiting
- When a higher dose than recommended is used, you may experience diarrhoea (sometimes including electrolyte imbalance). Not Known (frequency cannot be estimated from the available data):
- Allergic reactions
- Rash
- Itching
- Hives 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 national reporting system: For patients in the United Kingdom 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.
How to store it
LACTULOSE Do not store above 25 °C. 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 outer carton and sachets after "EXP". The expiry date refers to the last day of that month. Partially used sachets have to be discarded. 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.
Contents of the pack and other information
What Lactulose contains
- The active substance is Lactulose (as lactulose liquid).
- One sachet (15 ml) of Lactulose oral solution contains 10 g lactulose.
- There are no other ingredients. What Lactulose looks like and contents of the pack Lactulose 10 g/15 ml oral solution is a clear, viscous liquid, colourless or pale brownish-yellow solution and is available in the following pack sizes: 10, 20, 30, 50 and 100 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
Frequently asked questions about Lactulose 10 g / 15 ml oral solution sachets
How do I take Lactulose 10 g / 15 ml oral solution sachets?
Lactulose 10 g / 15 ml oral solution sachets comes as oral solution containing 10g / 15ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Lactulose 10 g / 15 ml oral solution sachets?
The active substance in Lactulose 10 g / 15 ml oral solution sachets is lactulose.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lactulose 10 g / 15 ml oral solution sachets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Lactulose 10 g / 15 ml oral solution sachets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: lactulose
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
• Symptomatic treatment of constipation
Laevolac is indicated in adults and in children and adolescents aged 7 to 18 years. For children below 7 years, other dosage forms are available.
4.2. Posology and method of administration
Posology
Laevolac may be administered diluted or undiluted. The dose should be titrated according to the clinical response. Lactulose may be given as a single daily dose or in two to three divided doses.
A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of the patient. The starting dose can be adjusted after adequate treatment effect individually (maintenance dose). Several days (2-3 days) of treatment may be needed in some patients before adequate treatment effect occurs. In case of single daily dose, this should be taken at the same time of the day, e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses).
If diarrhoea occurs, the dosing regimen should be reduced.
The duration of treatment has to be adopted according to the symptoms.
Starting dose
Maintenance dose
Adults
15-45 ml daily
1-3 sachets, corresponding to 10-30 g lactulose
15-30 ml daily
1-2 sachets, corresponding to 10-20 g lactulose
Older people
In elderly patients no special dosage recommendations exist.
Patients with renal or hepatic impairment
In patients with renal or hepatic insufficiency no special dosage recommendations exist.
Paediatric population
Starting dose
Maintenance dose
Adolescents over 14 years
15-45 ml daily
1-3 sachets, corresponding to 10-30 g lactulose
15-30 ml daily
1-2 sachets, corresponding to 10-20 g lactulose
Children(7-14 years)
15 ml daily
1 sachet, corresponding to 10 g lactulose
15 ml daily
1 sachet, corresponding to 10 g lactulose
For a precise dosing for infants, toddlers and children up to 6 years, lactulose is available in bottles.
Method of administration
Oral use.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Use in patients with galactosaemia.
- Acute inflammatory bowel disease (ulcerative colitis, Crohn's disease), gastrointestinal obstruction or subocclusive syndromes, digestive perforation or risk of digestive perforation, painful abdominal syndromes of undetermined cause.
4.4. Special warnings and precautions for use
In case of insufficient therapeutic effect after several days consultation of a physician is advised.
From the route of synthesis Laevolac may contain small amounts of sugars
(Not more than 67 mg/ml lactose, 100 mg/ml galactose, 67 mg/ml epilactose, 27 mg/ml tagatose and 7 mg/ml fructose).
Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose mal-absorption should not take this medicine.
Lactulose should be administered with care to patients who are intolerant to lactose.
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 contain 42.7 KJ (10.2 kcals) = 0.21 BU.
For patients with gastro-cardiac syndrome (Roemheld syndrome) lactulose should only be taken after consultation of a physician. If symptoms like meteorism or bloating occur in such patients after lactulose intake, the dose should be reduced or the treatment should be discontinued.
Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.
For elderly patients or patients that are in bad general condition and take lactulose for a more than 6 months period, periodic control of electrolytes is indicated.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses).
Paediatric population
Use of laxatives in children should be exceptional and under medical supervision.
Lactulose should be administrated with caution in infants and small children with autosomal recessive hereditary fructose intolerance.
The defecation reflex may be altered during the treatment with lactulose.
4.5. Interaction with other medicinal products and other forms of interaction
Lactulose may increase the loss of potassium induced by other drugs (e.g. thiazides, steroids and amphotericin B). Concomitant use of cardiac glycosides can increase the effect of the glycosides through potassium deficiency.
With increasing dosage a decrease of pH-value in the colon is found. Therefore drugs which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated.
4.6. Fertility, pregnancy and lactation
Pregnancy
Limited data on pregnant patients indicate neither malformative nor foeto/neonatal toxicity. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
The use of Laevolac may be considered during pregnancy if necessary.
Breast-feeding
Laevolac can be used during breastfeeding.
Fertility
For Laevolac no clinical data on the effects on fertility are available.
4.7. Effects on ability to drive and use machines
Laevolac has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Very common
≥ 1/10
Common
≥1/100 to < 1/10
Uncommon
≥1/1,000 to <1/100
Rare
≥1/10,000 to < 1/1,000
Very rare
< 1/10,000
Not known
cannot be estimated from the available data
Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.
Gastrointestinal disorders
Very common (≥ 1/10):
Flatulence, abdominal pain,
Common (≥ 1/100 < 1/10):
Nausea and vomiting; if dosed too high, diarrhoea (sometimes including electrolyte imbalance).
Immune system disorders:
Not known (cannot be estimated from the available data): Hypersensitivity reactions
Skin and subcutaneous tissue disorders
Not known (cannot be estimated from the available data): Rash, pruritus, urticaria
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms:
If the dose is too high, the following may occur: diarrhoea and abdominal pain.
Management: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- DUPHALAC FRUIT 667 mg/ml over the counterLACTULOSUM · taken by mouth
- LACTECON 667 g/l prescriptionLACTULOSUM · taken by mouth
- LACTULOSE-MIP 650 mg/ml prescriptionLACTULOSUM · taken by mouth
- LACTULOSE EIPICO 650 mg/ml prescriptionLACTULOSUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Lactulosum OrifarmLactulosum · taken by mouth
- NormalacLactulosum · taken by mouth
- Lactulosum PolfarmexLactulosum · taken by mouth
- Lactulose-MIPLactulosum · taken by mouth
- Lactulosum HascoLactulosum · taken by mouth
- DuphalacLactulosum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Lactulose 10 g / 15 ml oral solution sachets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.