Duphagol

Package Leaflet: Information for the User

Duphagol

13,125 g + 350,7 mg + 46,6 mg + 178,5 mg, powder for oral solution
Macrogol 3350 + sodium chloride + potassium chloride + sodium bicarbonate

Read the package leaflet carefully before using the medicine, as it contains

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

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 weeks of experiencing constipation there is no improvement or you feel worse, you should contact your doctor. If the medicine is used to treat severe constipation (so-called spastic constipation or fecal impaction), follow your doctor's advice.

Table of Contents of the Package Leaflet

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

1. What is Duphagol and what is it used for

Duphagol helps maintain normal bowel movement, even when constipation lasts for a long time. After consulting a doctor, Duphagol can also be used in the case of severe constipation (so-called spastic constipation or fecal impaction).
Macrogol 3350 increases the volume of stool mass by retaining water in the intestine, leading to normalization of colon motility. As a result, there is increased transport of softened stool and facilitation of bowel movements. The salts contained in the medicine help maintain proper levels of salts and water in the body.
If after 2 weeks of experiencing constipation there is no improvement or you feel worse, you should contact your doctor. If the medicine is used to treat severe constipation (so-called spastic constipation or fecal impaction), follow your doctor's advice.

2. Important information before taking Duphagol

When not to use Duphagol:

• if you are allergic to macrogol 3350, sodium chloride, potassium chloride, sodium bicarbonate, or any of the other ingredients of this medicine (listed in section 6),
• if you have intestinal obstruction, perforation, or severe inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon or intestinal obstruction.

Warnings and precautions

Before starting to use Duphagol, discuss it with your doctor.
While taking Duphagol, continue to drink plenty of fluids. The fluid taken with Duphagol should not replace regular fluid intake.
If you experience side effects such as swelling, shortness of breath, fatigue, dehydration (symptoms include increased thirst, dry mouth, and weakness) or heart problems, stop using Duphagol and contact your doctor immediately.
Duphagol should not be used for a longer period than advised by your doctor, e.g., if you are taking medicines that may cause constipation or if you have a disease that causes constipation, such as Parkinson's disease or multiple sclerosis.

Children

This medicine should not be given to children under 12 years of age.

Duphagol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Some medicines, such as antiepileptic drugs, may not be fully effective when taken with Duphagol. Therefore, do not take other oral medicines 1 hour before, during, or 1 hour after taking Duphagol.
Duphagol may interact with food thickeners based on starch, causing products that must remain thick for people with swallowing problems to become liquid. Duphagol should be used with caution in combination with starch-based thickeners.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Duphagol can be used during pregnancy and breastfeeding.

Driving and using machines

Duphagol has no effect on the ability to drive and use machines.
Duphagol contains sodium.This medicine contains 187 mg of sodium (the main component of common salt) per sachet, which corresponds to 9.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Duphagol

This medicine should always be used exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Recommended dose in case of constipation:
1 sachet 1 to 3 times a day. The usual dose for most patients is 1-2 sachets per day. Depending on the individual response to the medicine, it may be necessary to use 3 sachets per day. The dose depends on the severity of constipation. It can be reduced after a few days of use to the smallest effective dose. The normal duration of treatment is 2 weeks. You should contact your doctor if symptoms do not improve after 2 weeks.
The contents of the sachet should be poured into half a glass of water (about 125 ml). Stir until the powder dissolves and drink. You can add juice or fruit syrup to taste just before drinking the medicine.
Children (under 12 years of age): the medicine is not recommended.
Recommended dose in case of fecal impaction:
Adults: usually 8 sachets per day are used. The contents of these sachets should be taken within 6 hours each day for up to 3 days if necessary. Treatment for fecal impaction should not last longer than 3 days.
When using Duphagol for fecal impaction, the contents of 8 sachets can be dissolved in 1 liter of water. After dissolution, the solution should be stored in the refrigerator.
Patients with cardiovascular disorders:
In the treatment of fecal impaction, the dose should be divided so as not to take more than 2 sachets within 1 hour.
Patients with renal impairment:
There is no need to modify the dose of the medicine for both constipation and fecal impaction treatment.

Using a higher dose of Duphagol than recommended

In case of taking a higher dose of Duphagol than recommended and experiencing severe diarrhea or vomiting, stop the treatment, and then, after the symptoms have subsided, continue the treatment using a reduced dose. If you are concerned, contact your doctor or pharmacist.

Missing a dose of Duphagol

Do not take a double dose to make up for a missed dose.
This medicine should always be used exactly as described in this package leaflet for the patient or as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Duphagol can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):stomach pain and cramps, diarrhea, vomiting, nausea, rumbling in the stomach, and gas-related discomfort.
Common (may affect up to 1 in 10 people):itching, headache, swelling of hands, feet, or ankles.
Uncommon (may affect up to 1 in 100 people):rash, indigestion, and abdominal bloating.
Rare (may affect up to 1 in 10,000 people):severe allergic reactions causing breathing problems or swelling of the face, lips, tongue, or throat. If you experience any of these symptoms, tell your doctor immediately and stop taking Duphagol. Allergic reactions (e.g., skin reactions and hay fever), elevated and decreased potassium levels in the blood, and discomfort in the anal area.
Frequency not known (frequency cannot be estimated from the available data):changes in fluid or electrolyte levels in the body (low sodium levels).

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Duphagol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton. The expiry date refers to the last day of that month.
There are no special precautions for storage temperature.
Store in the original package to protect from moisture. After dissolving the contents of the sachet, the solution should be stored in the refrigerator (2°C – 8°C). After 6 hours, any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Duphagol contains

• The active substances of Duphagol are macrogol 3350 (also known as polyethylene glycol 3350) 13,125 g, sodium chloride 350,7 mg, potassium chloride 46,6 mg, sodium bicarbonate 178,5 mg.
• The other ingredients (excipients) are acesulfame potassium (E 950) (sweetener) and lemon flavor (flavor).

What Duphagol looks like and contents of the pack

White powder for oral solution.
The sachets contain 13.8 g of powder. The pack contains 10, 20, 30, 40, 50, 60, and 100 or 2x50 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer

Klocke Pharma-Service GmbH
Strassburger Strasse 77
D-777 67 Appenweier
Germany
Lamp San Prospero S.p.A.
Via Della Pace 25/a
San Prospero, 41030
Italy

For further information, please contact:

Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet:04/2025