Dulcobis

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dulcobis (Dulcolax), 10 mg, suppositories

Bisacodyl
Dulcobis and Dulcolax are different trade names for the same drug.
The entire leaflet should be read 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Dulcobis and what is it used for
• 2. Important information before using Dulcobis
• 3. How to use Dulcobis
• 4. Possible side effects
• 5. How to store Dulcobis
• 6. Package contents 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 the 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 diagnostic tests, before and after surgery, and in conditions requiring facilitated bowel movements.

2. Important information before using Dulcobis

When not to use Dulcobis

• if the patient is allergic to bisacodyl or any of the other ingredients of this medicine (listed in section 6),
• if the patient has lost intestinal motility (a condition called "paralytic ileus"),
• if the patient has intestinal obstruction (mechanical obstruction),
• if the patient has acute abdominal conditions, including appendicitis or acute inflammatory bowel diseases,
• if the patient is dehydrated,
• if the patient is at risk of electrolyte imbalance due to dehydration or other causes,

if the patient has severe abdominal pain accompanied by nausea and vomiting - this may indicate a more serious condition,

Warnings and precautions

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

• if the patient feels the need to use laxatives daily or for a longer period, they should contact their doctor to investigate the cause of constipation, as prolonged and excessive use can lead to fluid and electrolyte imbalance and low potassium levels in the blood (hypokalemia),
• if the patient experiences increased thirst or decreased urine production, which may be a sign of dehydration and may occur in elderly patients or those with kidney disease, the patient should stop using Dulcobis and consult their doctor,
• if the patient has impaired fluid balance or has 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 the patient notices blood in their stool,
• if the patient experiences dizziness and/or fainting. These symptoms may be related to constipation (straining during bowel movements, abdominal pain) and not necessarily to the use of Dulcobis itself. The use of suppositories like 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor about taking:

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor before using this medicine.

Pregnancy

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

Breastfeeding

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

Fertility

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

Driving and using machines

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

3. How to use Dulcobis

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for short-term use.
Dulcobis should not be used 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 insertion).
Unless otherwise directed by the doctor, 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. The maximum daily dose (1 suppository 10 mg) should not be exceeded.
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 Dulcobis as a 10 mg suppository.
Method of administration
Remove the suppository from the packaging, then insert it into the anus, with the tapered end pointing towards the anus.

Using more than the recommended dose of Dulcobis

In case of using more than the recommended dose of Dulcobis, the patient should consult their doctor or pharmacist.
The most common symptoms of overdose are: crampy 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 conditions 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 where there are more bases than acids in the body), and muscle weakness.

Missing a dose of Dulcobis

A double dose should not be used to make up for a missed dose of Dulcobis.
If a dose is missed, it should be used as soon as the patient remembers.

Stopping the use of Dulcobis

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

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dulcobis can cause side effects, although not everybody gets them.
In case of allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing, the patient should stop using Dulcobis and immediately contact their doctor or the Emergency Department of the nearest hospital.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product 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 or parallel importer.
Reporting side effects can help gather more information on the safety of the 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 refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Dulcobis contains

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

What Dulcobis looks like and what the package contains

Dulcobis is in the form of suppositories.
Packaging: soft PVC/Al foil blister in a cardboard box.
The package contains: 6 or 12 suppositories.
For more detailed information, the patient 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.l.
Località Prulli n. 103/c
50066 Reggello (FI)
Italy

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
02-234 Warsaw
Authorization number in Ireland, the country of export:PA23180/018/002

Parallel import authorization number: 153/25

Date of leaflet approval: 29.04.2025

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