Package leaflet: Information for the patient

Duphalac, 667 mg/ml, oral solution
Lactulosum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet. You may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If your symptoms do not improve after a few days or if you feel worse, you should contact your doctor.

Table of contents

What Duphalac is and what it is used for
Important information before taking Duphalac
How to take Duphalac
Possible side effects
How to store Duphalac
Contents of the pack and other information

1. What Duphalac is and what it is used for

What Duphalac is

Duphalac contains a laxative substance called lactulose. It softens the stool and facilitates its passage by drawing water into the intestine. It is not absorbed into the body.

What it is used for

Duphalac is used in the treatment of constipation (slowed intestinal movements, hard and dry stools) and to soften the stool, for example:
- in case of haemorrhoids (piles)
- after surgery in the anal area or in the large intestine
Duphalac is used in the treatment of hepatic encephalopathy (liver disease causing confusion, tremor, reduced level of consciousness, including coma).

2. Important information before taking Duphalac

When not to take Duphalac

If the patient is allergic (hypersensitive) to:
lactulose
or any of the other ingredients of Duphalac (see sections 2 and 6).
If the patient has:
galactosaemia (a serious inherited disorder preventing the digestion of galactose)
intestinal obstruction (other than ordinary constipation)
perforation or risk of perforation of the gastrointestinal tract

If in doubt, consult a doctor or pharmacist before using
Duphalac.
Warnings and precautions
Before starting Duphalac, discuss with a doctor or pharmacist if the
patient has any medical conditions, especially:

unexplained abdominal pain
lactose intolerance (inability to digest milk sugar)
diabetes.

Do not take Duphalac if the following conditions are present:

galactose or fructose intolerance
Lapp-type lactase deficiency
glucose-galactose malabsorption.

In patients with diabetes who are also being treated for hepatic encephalopathy, the dose of
Duphalac will be higher. This higher dose may contain a significant amount of sugar. Therefore,
adjustment of the dose of antidiabetic medications may be necessary.
It should be noted that during treatment, the defecation reflex may be disturbed.
Chronic use of inappropriate doses (resulting in more than 2–3 soft stools per day) or misuse may
lead to diarrhoea and electrolyte disturbances.
When taking laxatives, it is recommended to drink an adequate amount of fluids
(approximately 2 L/day, i.e. 6–8 glasses).
If Duphalac has been taken for several days without improvement or if symptoms worsen,
consult a doctor.
Children
In special cases, a doctor may prescribe Duphalac for use in a child, infant, or newborn. In such
cases, treatment will be closely monitored by a doctor.
Duphalac with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take.
Duphalac with food and drink
Duphalac can be taken with or without food. There are no restrictions regarding food or drink.
Pregnancy, breastfeeding and fertility
Duphalac may be taken during pregnancy and breastfeeding.
No effect on fertility is expected.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Driving and using machines
Duphalac has no effect or a negligible effect on the ability to drive
and operate machinery.
Important information about certain ingredients of Duphalac
Duphalac contains sugars, such as milk sugar (lactose up to 67 mg/mL), galactose (up to 100 mg/mL), fructose
(up to 9 mg/mL).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Duphalac contains sulphites. The medicine may rarely cause severe allergic reactions and bronchospasm.

3. How to take Duphalac

Duphalac should always be taken in accordance with the instructions provided in this leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken at the same time each day.
The medicine should be swallowed quickly. Do not retain the medicine in the mouth.
Duphalac may be taken undiluted or diluted in a certain amount of liquid.
For Duphalac in bottles, the provided measuring cup may be used.
For Duphalac in sachets, tear off the corner of the sachet and immediately take the contents.
Dosage in constipation or cases requiring stool softening for medical reasons
The dose may be administered once daily, e.g. with breakfast, or divided into two doses.
For Duphalac in bottles, the provided measuring cup may be used.
After a few days, the initial dose may be adjusted to a maintenance dose based on the response to treatment. The therapeutic effect may occur after several days (2–3 days) of treatment.
Duphalac in 15 ml bottles or sachets:

	Initial daily dose	Maintenance daily dose
Adults and adolescents	15–45 ml corresponds to 1–3 sachets	15–30 ml corresponds to 1–2 sachets
Children (7–14 years)	15 ml corresponds to 1 sachet	10–15 ml corresponds 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, Duphalac in a bottle should be used.
For precise dosing in infants and children up to 7 years of age, Duphalac in a bottle should be used.
Use in children
Laxatives in children, infants, and newborns should be used only in special cases and under medical supervision, as they may interfere with the natural defecation reflex.
Duphalac should not be administered to children (< 14 years) without consulting a physician, who will prescribe the medicine and supervise treatment.
Dosing in hepatic encephalopathy
Adults
The initial dose in hepatic encephalopathy is 30–45 ml (2–3 sachets) 3–4 times daily.
The dose may be adjusted to a maintenance dose so that the patient has 2–3 soft stools per day.
Use in children
There are no available data on the use of Duphalac in children (up to 18 years) with hepatic encephalopathy.
Elderly population and patients with renal or hepatic impairment
No special dosing recommendations are required.
Overdose of Duphalac
In case of overdose, diarrhea, electrolyte loss, and abdominal pain may occur.
If more than the recommended dose of Duphalac has been taken, contact a physician or pharmacist.
Missed dose of Duphalac
If a dose of Duphalac is missed, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
Discontinuation of Duphalac
Do not stop or change treatment without consulting a physician.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported during treatment with Duphalac:
Very common (may affect more than 1 in 10 people)

diarrhoea
Common (may affect up to 1 in 10 people)
flatulence
nausea
vomiting
abdominal pain
Uncommon (may affect up to 1 in 100 people)
electrolyte imbalance due to diarrhoea
Frequency not known (cannot be estimated from the available data)
allergic reactions, rash, itching, urticaria

During the first few days of treatment, flatulence may occur. These usually resolve after a few days.
If doses higher than recommended are used, abdominal pain and diarrhoea may occur.
In such cases, the dose should be reduced.
When high doses are used for prolonged periods (usually only in the treatment of hepatic encephalopathy), patients may develop electrolyte imbalance due to diarrhoea.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Duphalac

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after: EXP. The expiry date refers to the last day of the stated month.
Partially used sachets should be discarded.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
Medicine packed in HDPE bottles and containers: no special storage instructions required. Medicine packed in sachets: store below 25°C.

6. Contents of the packaging and other information

What Duphalac contains
The active substance is lactulose.
One sachet of Duphalac contains 15 ml of lactulose, equivalent to 10 g of lactulose.
1 ml of Duphalac contains 667 mg of lactulose.
The other ingredient is: purified water.

What Duphalac looks like and contents of the pack
Duphalac is available as an oral solution, a clear, viscous liquid, colourless to brownish-yellow.
Duphalac is available in sachets containing 15 ml of solution (10 sachets per pack), in bottles with a measuring cup in a cardboard box containing 200 ml or 300 ml, and in bottles containing 150 ml, 1,000 ml, and in a 5,000 ml container. The measuring cup has graduations at: 2.5 ml; 5 ml; 10 ml; 15 ml; 20 ml; 25 ml and 30 ml.
Not all pack types and sizes may be marketed.

Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
The Netherlands

Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst, The Netherlands