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.
Duphalac 3.335 g/5 ml Oral Solution
⚠ 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 What Lactulose is Lactulose 3.335 g/5 ml oral solution 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. What Lactulose is used for Lactulose is used to treat constipation (infrequent bowel movements, hard and dry stools). Lactulose is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.
What you need to know before you take it
e Lactulose Do not take Lactulose if: You are allergic (hypersensitive) to lactulose or any of the other ingredients of Lactulose (see sections 2 and 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 if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lactulose. Warnings and precautions: Talk to your doctor or pharmacist before taking Lactulose 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 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 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 (approx. 2 litres/day, equal to 6-8 glasses). If you take Lactulose 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 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 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking 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 Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Lactulose 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 contains sugars, such as milk sugar (lactose), galactose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Lactulose contains sulphite.
How to take it
Lactulose Always take Lactulose exactly as described in this leaflet or as your doctor or pharmacists have 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 or 1-3 sachets per day. After this the dose can be adjusted to 15-30ml or 1-2 sachets daily. Children 7 to 14 years: The starting dose is 15ml or 1 sachet daily. After this the dose can be adjusted to 10-15ml or 1 sachet daily. Children 1-6 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: The usual starting dose is 3 to 4 times a day of 30-45ml or 2-3 sachets. 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 take more Lactulose than you should If you take more Lactulose than you should stop taking Lactulose and talk to a doctor or pharmacist. You may have diarrhoea, loss of electrolytes and abdominal pain. If you forget to take Lactulose 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 stop taking Lactulose 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
Possible side effects
have been reported with Lactulose: 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 Not known (frequency cannot be estimated from the available data) allergic reactions, rash, itching, hives. 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. By reporting side effects you can help provide more information on the safety of this medicine. 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.
How to store it
Lactulose Keep this medicine out of the sight and reach 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.
Contents of the pack and other information
What Lactulose contains The active substance in Lactulose 3.335 g/5 ml oral solution is lactulose. Each 5ml of Lactulose contains 3.335g of lactulose. Lactulose does not contain any excipients. Lactulose contains residues from the route of production, see section 2. What Lactulose looks like and contents of the pack Lactulose is a clear, viscous liquid, colourless to brownish- yellow liquid. Lactulose is available in 15 ml sachets and in plastic bottles containing 200ml, 300ml, 500ml and 1000ml. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK. Manufacturer Abbott Biologicals B.V., 8121 AA, Olst, The Netherlands. This leaflet was last updated in April 2022.
Braille text: Lactulose 3.335 g/5 ml oral solution
Frequently asked questions about Duphalac 3.335 g/5 ml Oral Solution
How do I take Duphalac 3.335 g/5 ml Oral Solution?
Duphalac 3.335 g/5 ml Oral Solution comes as oral solution containing 3.335g / 5ml. 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 Duphalac 3.335 g/5 ml Oral Solution?
The active substance in Duphalac 3.335 g/5 ml Oral Solution is lactulose.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Duphalac 3.335 g/5 ml Oral Solution, 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 Duphalac 3.335 g/5 ml Oral Solution 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
1. For the treatment of constipation.
2. For the treatment of hepatic encephalopathy (HE); hepatic coma.
4.2. Posology and method of administration
The lactulose solution may be administered diluted or undiluted. Each dose may if necessary be taken with water or fruit juices, etc.
Each 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.
In case of single daily dose, this should be taken at the same time, e.g. during breakfast.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5–2 litres, equal to 6-8 glasses) during the day.
Dosing in constipation:
Lactulose may be given as a single daily dose or in two divided doses.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs.
Lactulose oral solution in bottles or 15 ml single dose sachets:
Starting dose daily
Maintenance dose daily
Adults and adolescents
15-45 ml, corresponding to 1-3 sachets
15-30 ml, corresponding to 1-2 sachets
Children(7-14 years)
15 ml, corresponding to 1 sachet
10-15 ml, corresponding to 1 sachet*
Children(1-6 years)
5-10 ml
5-10 ml
Infants under 1 year
up to 5 ml
up to 5 ml
* If the maintenance dose is below 15 ml, lactulose in bottles should be used.
Dosing in Hepatic Encephalopathy
Adults
Starting dose: 3 to 4 times daily 30-45 ml (6-9 x 5 ml spoonfuls) or 2-3 sachets. This dose may be adjusted to the maintenance dose to achieve two or three soft stools each day.
Method of Administration
Oral use
For lactulose in bottles the measuring cup may be used.
For lactulose in 15 ml single dose sachets the corner of the sachet should be torn off and contents taken immediately.
Special populations
Paediatric population
The safety and efficacy in children (newborn to 18 years of age) with HE have not been established. No data are available.
For a precise dosing for infants and children up to 7 years lactulose in bottles should be used.
Elderly patients and patients with renal or hepatic insufficiency
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.
4.3. Contraindications
• Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
• Galactosaemia.
• Gastro-intestinal obstruction, -perforation or risk of perforation.
4.4. Special warnings and precautions for use
Painful abdominal symptoms of undetermined cause should be evaluated to exclude undiagnosed perforation or obstruction or undiagnosed disease/condition that predisposes to either before the treatment is started.
In case of insufficient therapeutic effect after several days the dose and/or additional measures should be re-considered.
Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.
It should be taken into account that the defaecation reflex could be disturbed during the treatment.
The dose normally used in constipation should not pose a problem for diabetics.
The dose used in the treatment of HE is usually much higher and may need to be taken into consideration for diabetics.
Information on residues from manufacturing with known effect:
This product contains lactose, galactose and fructose from the route of production. Therefore, patients with rare hereditary problems of galactose or fructose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Lactulose should be administered with care to patients who are intolerant to lactose.
This product contains sulphite from the route of production.
Paediatric population
Use of laxatives in children should be exceptional and under medical supervision.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
Duphalac can be used during pregnancy.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Duphalac can be used during breast-feeding.
Fertility
No effects are to be expected, since systemic exposure to lactulose is negligible.
4.7. Effects on ability to drive and use machines
Lactulose has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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. See also overdose section 4.9.
If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea. Dosage should then be adjusted to obtain two or three formed stools per day.
Tabulated list of adverse reactions
The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients in placebo-controlled clinical trials:
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 (frequency cannot be estimated from the available data)
MedDRA SOC
Frequency category
Very common
Common
Uncommon
Not known
Gastrointestinal disorders
Diarrhoea
Flatulence, abdominal pain, nausea, vomiting
Investigations
Electrolyte imbalance due to diarrhoea
Immune system disorders
Hypersensitvity reactions
Skin and subcutaneous tissue disorders
Rash*, pruritis*, urticaria*
*Post-marketing experience
Paediatric population
The safety profile in children is expected to be similar as in adults.
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 MHRA Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
If the dose is too high, the following may occur:
Symptom: diarrhoea, loss of electrolytes and abdominal pain.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
No specific antidote. Symptomatic treatment should be given.
🇷🇴 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 Duphalac 3.335 g/5 ml Oral Solution. 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.