Dulcobis

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Dulcobis(Dulcolax)

10 mg, suppositories

Bisacodyl
Dulcobis and Dulcolax are different trade names for the same medicine.

You should read this leaflet carefully, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information 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 a pharmacist.
• If you get any side effects, talk to your doctor or pharmacist or nurse. See section 4.
• If after 5 days you have not improved or feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Dulcobis and what is it used for

Dulcobis is a locally acting laxative that stimulates bowel movements and softens stools.
Dulcobis works by stimulating intestinal peristalsis and helping to accumulate water in the colon (large intestine), accelerating the passage of intestinal contents.
As a laxative acting on the large intestine, Dulcobis stimulates the natural process of bowel movements in the lower part of the digestive tract. Therefore, Dulcobis does not affect digestion or absorption of calories and nutrients in the small intestine.
Dulcobis is used:

• in adults, adolescents, and children for short-term, symptomatic treatment of constipation,
• in adults to prepare for examinations, before operations, and after operations, as well as in conditions requiring facilitated bowel movements.

2. Important information before taking Dulcobis

When not to take Dulcobis

• if you are allergic to bisacodyl or any of the other ingredients of this medicine (listed in section 6),
• if you have lost the mobility of the intestinal muscles (a condition called "paralytic ileus"),
• if you have a bowel obstruction (mechanical obstruction),
• if you have acute abdominal conditions, including appendicitis or acute inflammatory bowel diseases,
• if you are dehydrated,
• if you have a risk of electrolyte imbalance due to dehydration or other causes,
• if you have severe abdominal pain accompanied by nausea and vomiting - this may indicate more serious conditions,
• in children under 10 years of age.

Warnings and precautions

Dulcobis should not be taken for more than 5 days without consulting a doctor.
Laxatives, including Dulcobis, do not affect weight loss.
Before taking Dulcobis, you should discuss it with your doctor or pharmacist:

• if you feel the need to take laxatives every day or for a longer period, you should contact your doctor to investigate the cause of constipation, as prolonged and excessive use can lead to fluid and electrolyte imbalance and potassium deficiency (hypokalemia),
• if you experience increased thirst or decreased urine production, which may be a sign of dehydration and may occur especially in the elderly or patients with kidney disease, you should stop taking Dulcobis and contact your doctor.
• if you have impaired fluid management or have lost intestinal fluids (e.g., kidney failure or elderly patients), the medicine should be discontinued and can only be resumed under medical supervision, due to the increased risk of dehydration.
• if you notice blood in your stool.
• if you experience dizziness and/or fainting. These symptoms may be related to constipation (straining during bowel movements, abdominal pain), and not necessarily to the administration of Dulcobis itself. The use of suppositories, such as Dulcobis, may sometimes cause discomfort and irritation at the site of administration, especially in patients with anal fissures or inflammatory conditions around the anus (ulcerative proctitis).

Dulcobis and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor about taking:

• diuretics,
• corticosteroids,
• heart medicines (cardiac glycosides, such as digoxin),
• other laxatives.

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.

Pregnancy

There is limited data on the use of Dulcobis in pregnant women.
Dulcobis should not be used during pregnancy, unless your doctor considers it absolutely necessary.

Breastfeeding

Studies have shown that the active ingredient of the medicine or its metabolites are not detected in the milk of healthy breastfeeding women.
The medicine can be used during breastfeeding. However, the medicine should only be used when necessary and under medical supervision, after the doctor has assessed the expected benefits for the patient in relation to the possible risk to the infant.

Fertility

No studies have been conducted on the effect of Dulcobis on fertility in humans.

Driving and using machines

No studies have been conducted on the effect of Dulcobis on the ability to drive and use machines.
In some people, due to abdominal cramps associated with constipation, dizziness and/or fainting may occur when taking this medicine. In such cases, you should wait until the feeling passes before driving or operating machinery.

3. How to take Dulcobis

This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, you should speak to your doctor or pharmacist.
The medicine is intended for short-term use.
Dulcobis should not be taken continuously, daily, or for more than 5 days without consulting a doctor.
The effect of the suppository occurs on average 20 minutes after administration (10-30 minutes after administration).
If your doctor does not advise otherwise, the following dosage is recommended:
Short-term treatment of constipation:
Adults, adolescents, and children over 10 years:1 suppository (10 mg) per day for no longer than 5 days. Do not exceed the maximum daily dose (1 suppository 10 mg).
The medicine should not be used in children under 10 years of age.
Preparation for diagnostic tests and surgical procedures in adults:
During preparation for tests or before surgical procedures, Dulcobis should be used under medical supervision.
Adults:
To completely empty the intestines, adults should initially take Dulcobis orally in a different form (Dulcobis, 5 mg, enteric-coated tablets): 2-4 tablets in the evening before the test.
The next morning, it is recommended to use the rectal form of the medicinal product Dulcobis in the form of a 10 mg suppository.
Method of administration
Unpack the suppository and then insert it into the anus, with the tapered end directed towards the anus.

Overdose of Dulcobis

If you have taken more than the recommended dose of Dulcobis, you should speak to a doctor or pharmacist.
The most common symptoms of overdose are: colicky abdominal pain, vomiting, mucous and diarrhea stools, and loss of fluids, potassium, and other electrolytes.
Long-term use of high doses of Dulcobis may cause chronic diarrhea, abdominal pain, various diseases caused by increased hormone secretion that controls sodium and potassium levels in the blood (secondary hyperaldosteronism), low potassium levels in the blood, and kidney stones.
Chronic abuse of laxatives may lead to kidney damage (one form of kidney damage), metabolic alkalosis (a condition in which there are more bases than acids in the body), and muscle weakness.

Missed dose of Dulcobis

You should not take a double dose to make up for a missed dose of Dulcobis.
If you miss a dose, you should take it as soon as you remember.

Stopping treatment with Dulcobis

Dulcobis should only be used when necessary. Its use without consulting a doctor should be stopped after the symptoms have passed, but no later than after 5 days.

If you have any further doubts about the use of this medicine, you should speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dulcobis can cause side effects, although not everybody gets them.
If you experience an allergic reaction, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing, you should stop taking Dulcobis and immediately contact your doctor or the Emergency Department of the nearest hospital.

Frequent (occurring in less than 1 in 10 patients, but more than 1 in 100 patients):

abdominal cramps, abdominal pain, diarrhea, nausea.

Uncommon (occurring in less than 1 in 100 patients, but more than 1 in 1,000 patients):

discomfort in the abdomen, vomiting, blood in stool, discomfort around the anus, dizziness.

Rare (occurring in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):

allergic reaction (hypersensitivity), which can cause skin rash, rapidly progressing, life-threatening anaphylactic reactions, angioedema, fainting (syncope), dehydration, colitis (inflammation of the colon), including ischemic colitis.
In patients taking Dulcobis, dizziness and/or fainting have been observed. These symptoms may be related to constipation (straining during bowel movements, abdominal pain), and not necessarily to the administration of Dulcobis itself.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dulcobis

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store the blister in the outer packaging to protect from light.
Do not use the medicine after the expiry date stated on the packaging. The expiry date is the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dulcobis contains

The active substance is bisacodyl. One suppository contains 10 milligrams of bisacodyl.
Other ingredients: solid fat.

What Dulcobis looks like and contents of the pack

Dulcobis is a suppository.
Packaging: soft PVC/Al foil blister in a cardboard box.
Packaging contains: 6 or 12 suppositories.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

Opella Healthcare France SAS
157 avenue Charles de Gaulle
92200 Neuilly-sur-Seine
France

Manufacturer:

Istituto De Angeli S.r.I.
Località Prulli n. 103/c
50066 Reggello (FI)
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing authorization number in Ireland, the country of export:

PA23180/018/002

Parallel import authorization number: 183/25

Date of approval of the leaflet: 23.05.2025

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