Duphalac

Leaflet attached to the packaging: patient information

Duphalac, 667 mg/ml, oral solution

Lactulose

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Duphalac and what is it used for
• 2. Important information before taking Duphalac
• 3. How to take Duphalac
• 4. Possible side effects
• 5. How to store Duphalac
• 6. Contents of the pack and other information

1. What is Duphalac and what is it used for

What is Duphalac

• Duphalac contains the laxative substance lactulose. It softens the stool and facilitates its passage by allowing water to penetrate the intestine. It is not absorbed into the body.

What it is used for

• Duphalac is used to treat constipation (slow bowel movements, hard and dry stools) and to soften the stool, for example:
• if hemorrhoids (anal varices) are present
• after surgeries in the anal or large intestine area
• Duphalac is used to treat hepatic encephalopathy (a liver disease that causes confusion, tremors, decreased 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 section 2 and 6).
• If the patient has:
• galactosemia (a severe genetic disorder that prevents the digestion of galactose)
• gastrointestinal obstruction (except for normal constipation)
• perforation or risk of gastrointestinal perforation

In case of doubt, the doctor or pharmacist should be consulted before taking Duphalac.

Warnings and precautions

Before starting to take Duphalac, the doctor or pharmacist should be consulted if the patient has any diseases, especially:

• if the patient has unexplained abdominal pain
• if the patient does not tolerate lactose (milk sugar)
• if the patient has diabetes.

Duphalac should not be taken if:

• there is galactose or fructose intolerance
• there is a lack of lactase type Lapp
• there is poor absorption of glucose-galactose.

In patients with diabetes and also being treated for hepatic encephalopathy, the dose of Duphalac will be higher. This higher dose may contain a large amount of sugar. Therefore, it may be necessary to adjust the dose of antidiabetic drugs.
It should be taken into account that during treatment, the bowel movement reflex may be disturbed.
Chronic intake of unadjusted doses (appearance of more than 2-3 soft stools per day) or abuse may lead to diarrhea and electrolyte disturbances.
During the use of laxatives, it is recommended to drink an adequate amount of fluids (about 2 l/day, i.e. 6-8 glasses).
If Duphalac is taken for several days and there is no improvement or worsening of symptoms, the doctor should be consulted.

Children

In special cases, the doctor may prescribe Duphalac for use in children, infants, or newborns. In such cases, the treatment will be closely monitored by the doctor.

Duphalac and other medicines

The doctor or pharmacist should be told 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 on food or drink intake.

Pregnancy, breastfeeding, and fertility

Duphalac can be taken during pregnancy and breastfeeding.
No effect on fertility is expected.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Duphalac has no influence or negligible influence on the ability to drive and use machines.

Important information about some ingredients of Duphalac

Duphalac contains sugars, such as lactose (up to 67 mg/ml), galactose (up to 100 mg/ml), and fructose (up to 9 mg/ml).
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Duphalac contains sulfites. The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Duphalac

Duphalac should always be taken in accordance with the recommendations in this leaflet or as advised by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The medicine should be taken at the same time of day.
The medicine should be swallowed quickly. The medicine should not be kept in the mouth.
Duphalac can be taken undiluted or diluted in a certain amount of fluid.
In the case of Duphalac in a bottle, the attached measuring cup can be used.
In the case of Duphalac in sachets, the corner of the sachet should be torn off and the contents taken immediately.

Dosage in constipation or medical necessity to soften the stool

The dose can be given once a day, e.g. during breakfast, or in two divided doses.
In the case of Duphalac in a bottle, the attached measuring cup can 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 a few days (2-3 days) of treatment.
Duphalac in bottles or sachets of 15 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, Duphalac in a bottle should be used.

Use in children

Laxatives in children, infants, and newborns should be used in special cases and under medical supervision, as they may disrupt the natural bowel movement reflex.
Duphalac should not be given to children (under 14 years) without consulting a doctor, who will prescribe the medicine and ensure supervision of the treatment.

Dosage in hepatic encephalopathy

Adults

The initial dose in hepatic encephalopathy is 30-45 ml (2-3 sachets) 3-4 times a day.
The dosage may be modified to a maintenance dose so that the patient has 2 to 3 soft stools per day.

Use in children

There are no available data on the use in children (under 18 years) with hepatic encephalopathy.

Population of elderly and patients with renal and hepatic impairment

There are no special dosage recommendations.

Overdose of Duphalac

In case of overdose, diarrhea, electrolyte loss, and abdominal pain may occur. If a higher dose than recommended is taken, the doctor or pharmacist should be consulted.

Missed dose of Duphalac

If a dose of Duphalac is missed, the next dose should be taken at the usual time.
A double dose should not be taken to make up for the missed dose.

Stopping Duphalac treatment

Treatment should not be stopped or changed without consulting a doctor.
In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Duphalac can cause side effects, although not everybody gets them.
The following side effects have been reported during the use of Duphalac:
Very common(may affect more than 1 in 10 people)

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

During the first few days of treatment, bloating may occur. They usually disappear after a few days.
If higher doses than recommended are used, abdominal pain and diarrhea may occur.
In such a case, the dose should be reduced.
If high doses are used for a longer period (usually only in the treatment of hepatic encephalopathy), the patient may experience electrolyte disturbances due to diarrhea.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Duphalac

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the carton or bottle after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
• Partially used sachets should be discarded.
• Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.
• Medicine packaged in bottles and HDPE containers: no special precautions for storage. Medicine packaged in sachets: store below 25°C.

6. Contents of the pack and other information

What Duphalac contains

The active substance of Duphalac 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 ingredients are: purified water.

What Duphalac looks like and contents of the pack

Duphalac is available as an oral solution, which is a clear, viscous, colorless to brownish-yellow liquid.
Duphalac is available in sachets containing 15 ml of solution (10 sachets in a 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 container of 5,000 ml. The measuring cup has the following graduations: 2.5 ml; 5 ml; 10 ml; 15 ml; 20 ml; 25 ml; and 30 ml.
Not all pack sizes and types may be marketed.

Marketing authorization holder

Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
Netherlands

Manufacturer

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst, Netherlands
For more information, please contact:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

Date of last revision of the leaflet: