Duphalac Fruit

Package Leaflet: Information for the Patient

Duphalac Fruit

667 mg/ml, oral solution
Lactulose

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after a few days you don't feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Duphalac Fruit and what is it used for

What is Duphalac Fruit

Duphalac Fruit contains a laxative called lactulose. It softens the stool and makes it easier to pass through the intestines by retaining water in the intestines. It is not absorbed from the gastrointestinal tract.

What is Duphalac Fruit used for

• Duphalac Fruit is used to treat symptomatic constipation (infrequent bowel movements, hard and dry stools) and to soften stools, for example:
• in the case of hemorrhoids (anal varices)
• after anal and large intestine surgeries. If after a few days there is no improvement or worsening, you should consult a doctor.

2. Important information before taking Duphalac Fruit

When not to take Duphalac Fruit

• if you are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac Fruit (see section 2 and 6)
• if you have:
• galactosemia (a severe genetic disorder that prevents the digestion of galactose)
• gastrointestinal obstruction (except for constipation)
• gastrointestinal perforation or risk of its occurrence (e.g., in the case of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis)

In case of doubt, you should consult your doctor or pharmacist before taking Duphalac Fruit.

Warnings and precautions

You should consult your doctor or pharmacist before taking Duphalac Fruit if you have any diseases, especially:

• you have abdominal pain of unknown cause
• you have a gastrocardiac syndrome, i.e., Roemheld syndrome (a disease in which gas accumulated in the gastrointestinal tract or disorders of normal gastric contents passage cause cardiac symptoms)
• you are lactose intolerant
• you have diabetes

You should not take Duphalac Fruit if you have:

• galactose or fructose intolerance
• Lapp lactase deficiency
• glucose-galactose malabsorption

Patient with Roemheld syndrome: if you experience bloating and gas after taking the medicine, you should stop the treatment and consult your doctor.
In such cases, the treatment will be carried out under medical supervision.
Duphalac Fruit may disrupt the normal rhythm of bowel movements.
Chronic use of an inappropriate dose (more than 2-3 bowel movements per day) or inappropriate use may lead to diarrhea and electrolyte imbalance.
You should not use Duphalac Fruit for more than two weeks without consulting a doctor.
During the use of laxatives, it is recommended to drink an adequate amount of fluids (about 2 liters/day, i.e., 6-8 glasses).
If after a few days of taking Duphalac Fruit there is no improvement or worsening of symptoms, you should consult a doctor.

Duphalac Fruit and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Lactulose may increase the loss of potassium caused by other medicines (e.g., thiazides, steroids, and amphotericin B).
Concomitant use of cardiac glycosides (e.g., digoxin) with lactulose may increase their potassium-lowering effect.
If any of the above statements apply to you (or in case of doubt), you should consult your doctor or pharmacist before taking Duphalac Fruit.

Duphalac Fruit with food and drink

Duphalac Fruit can be taken with or without food. There are no restrictions on food and drink intake.

Pregnancy, breastfeeding, and fertility

Duphalac Fruit can be taken during pregnancy and breastfeeding.
No effect on fertility is expected.
Before taking any medicine, you should consult your doctor or pharmacist.

Children

In exceptional cases, a doctor may prescribe Duphalac Fruit for children, infants, and newborns. In such cases, the treatment will be carried out under medical supervision.
This medicine contains 14.37 mg of propylene glycol (E 1520) in each 15 ml dose or 0.96 mg/ml.
Before giving the medicine to a child under 4 weeks of age, you should consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Driving and using machines

Duphalac Fruit has no or negligible influence on the ability to drive and use machines.
Duphalac Fruit contains sugars, such as lactose, galactose, or fructose.
If you have a confirmed intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Duphalac Fruit

Duphalac Fruit should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Doses should be taken daily at the same time.
The medicine should be swallowed quickly. Do not keep it in your mouth.
Duphalac Fruit can be administered diluted in a small amount of liquid or undiluted.
In the case of Duphalac Fruit in bottles, the attached measuring cup can be used.
In the case of Duphalac Fruit in single-dose sachets of 15 ml, you should tear off the corner of the sachet and take the contents immediately.

Dosage

The dose can be given once a day, e.g., during breakfast or in two divided doses.
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, you should use Duphalac in a bottle.

Use in children

For precise dosing in infants and children up to 7 years, you should use Duphalac Fruit in a bottle.
Laxatives can be used in children, infants, and newborns only in exceptional cases and under medical supervision.
Duphalac Fruit should not be given to children under 14 years without consulting a doctor, who will prescribe the medicine and monitor the treatment.

Elderly population and patients with renal and hepatic impairment

There are no special dosage recommendations.

Overdose of Duphalac Fruit

In case of overdose, diarrhea, electrolyte loss, and abdominal pain may occur. If you have taken more Duphalac Fruit than recommended, you should contact your doctor or pharmacist.

Missed dose of Duphalac Fruit

If you miss a dose of Duphalac Fruit, you should take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping Duphalac Fruit treatment

You should not stop or change the treatment without consulting your doctor.
In case of any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people)

• diarrhea

Common(may affect up to 1 in 10 people)

• bloating (abdominal distension)
• nausea (vomiting)
• 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

Bloating may occur within the first few days of treatment. It usually resolves after a few days.
If you experience higher doses than recommended, abdominal pain and diarrhea may occur.
In such a case, you should reduce the dose.
If you experience any side effects, including any possible side effects not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Duphalac Fruit

The medicine should be stored out of sight and reach of children.
Do not use this medicine 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.
Partially used sachets should be discarded.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
The medicine does not require special storage conditions.
After 21 weeks from the first opening of the bottle, the medicine should be discarded.

6. Contents of the pack and other information

What Duphalac Fruit contains

The active substance is lactulose.
One sachet of Duphalac Fruit contains 15 ml of oral solution, equivalent to 10 g lactulose.
One ml of Duphalac Fruit contains 667 mg lactulose.
Duphalac Fruit contains a plum flavor. The flavor contains propylene glycol (E 1520).
Duphalac Fruit contains residues from the manufacturing process, see section 2.

What Duphalac Fruit looks like and contents of the pack

Duphalac Fruit, oral solution is a clear, viscous, colorless to brownish-yellow liquid.
Duphalac Fruit is packaged in 15 ml PET/Aluminum/LDPE sachets in a carton.
1 pack contains 20 sachets in a carton.
Duphalac Fruit is also available in HDPE bottles of 200 ml, 300 ml, 500 ml (in a carton), 800 ml, or 1000 ml, with a PP cap and a PP measuring cup with a scale for: 2.5 ml; 5 ml; 10 ml; 15 ml; 20 ml; 25 ml, and 30 ml.
Not all pack sizes 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

Date of last revision of the package leaflet: