Dulcobis

Package Leaflet: Information for the User

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

Dulcobis (Dulcolax)

5 mg, enteric-coated tablets

Bisacodyl
Dulcobis and Dulcolax are different trade names for the same medicine.
Read this leaflet carefully because it contains important information for you.
This medicine should always be taken exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.
• If after 5 days you have not improved or if you feel worse, you should consult a doctor.

Contents of the pack:

• 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 stool.
Dulcobis works by stimulating intestinal peristalsis and aiding water accumulation 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:

• for short-term, symptomatic treatment of constipation,
• to prepare for diagnostic tests, before and after surgery, and in conditions requiring facilitated bowel movements.

2. Important information before taking Dulcobis

When not to take Dulcobis

• if you are allergic (hypersensitive) to bisacodyl or any of the other ingredients of Dulcobis (listed in section 6),
• if you have lost intestinal motility (a condition called "paralytic ileus"),
• if you have intestinal 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 experience severe abdominal pain accompanied by nausea and vomiting - this may indicate more serious conditions, if you have hereditary intolerance to some sugars (see also: "Dulcobis contains lactose monohydrate and sucrose")

• in children under 4 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 low potassium levels in the blood (hypokalemia).
• If you experience increased thirst or decreased urine production, which may be a sign of dehydration, especially in the elderly or patients with kidney disease, you should stop taking Dulcobis and consult your doctor.
• If you have disturbed fluid balance 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 use of Dulcobis.

Dulcobis and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor about taking:

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

Dulcobis tablets have a special coating, and to prevent its premature dissolution, you should not take the medicine with products that reduce acidity in the upper part of the digestive tract, such as antacids or proton pump inhibitors.

Taking Dulcobis with food and drink

Dulcobis tablets have a special coating, and to prevent its premature dissolution, you should not take the medicine with food products that reduce acidity in the upper part of the digestive tract, such as milk.

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 in the milk of healthy breastfeeding mothers, neither the main ingredient of the medicine nor its metabolites are detected.
The medicine can be used during breastfeeding. However, the medicine should only be used when necessary, under medical supervision, after the doctor has assessed the expected benefits for the mother compared to the possible 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 people, due to abdominal cramps associated with constipation, dizziness and/or fainting may occur when taking this medicine. In such cases, wait until the feeling passes before driving or operating machinery.

Dulcobis contains lactose monohydrate and sucrose

The medicine contains 33.2 mg of lactose and 23.4 mg of sucrose in one enteric-coated tablet.
If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Dulcobis

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, consult 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.
Unless your doctor has told you otherwise, the recommended dosage is:
Short-term treatment of constipation:
Adults (18 years and over): 1-2 enteric-coated tablets (5-10 mg) orally, once a day, before bedtime.
It is recommended to start treatment with the lowest dose. The dose can be adjusted to the highest recommended dose to achieve regular bowel movements.
Do not exceed the maximum daily dose.
Children and adolescents over 10 years old:
1-2 enteric-coated tablets (5-10 mg) orally, once a day, before bedtime.
It is recommended to start treatment with the lowest dose. The dose can be adjusted to the highest recommended dose to achieve regular bowel movements.
Do not exceed the maximum daily dose.
Children from 4 to 10 years old:
1 enteric-coated tablet (5 mg) orally, once a day, before bedtime. Do not exceed the maximum daily dose.
Children aged 10 and under with chronic or persistent constipation should only be treated under medical supervision.
Method of administration:
The enteric-coated tablets should be taken orally, in the evening, to have a bowel movement in the morning.
The tablets should be swallowed whole, with a large amount of water.
Do not take enteric-coated tablets with products that reduce stomach acid secretion, such as milk, antacids, or proton pump inhibitors, as this may cause premature dissolution of the protective coating.
Do not chew the tablets.
Preparation for diagnostic tests and surgical procedures:
When preparing for tests or before surgery, Dulcobis should be used under medical supervision.
Adults (18 years and over):
to completely empty the intestines, adults should, according to the doctor's instructions, take

• 2-4 enteric-coated tablets (10-20 mg) orally, in the evening before the test, and then in the morning of the test, take a laxative with immediate action (e.g., in the form of a suppository).

Children over 4 years old:
one enteric-coated tablet (5 mg) in the evening, and the next morning, it is recommended to administer another, immediately acting laxative (e.g., in the form of a suppository).

Overdose of Dulcobis

In case of overdose, consult your doctor or pharmacist.
The most common symptoms of overdose are: abdominal cramps, 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 can 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.

Missed dose of Dulcobis

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

Stopping treatment with Dulcobis

Dulcobis should only be taken 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 questions about the use of this medicine, ask your 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, face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, stop taking Dulcobis and immediately consult your doctor or the Emergency Department of the nearest hospital.

Side effects observed during treatment with Dulcobis:

Frequent (occurring in more than 1 in 100 patients, but less than 1 in 10 patients):
abdominal cramps, abdominal pain, diarrhea, nausea
Uncommon (occurring in more than 1 in 1000 patients, but less than 1 in 100 patients):
discomfort in the abdomen, vomiting, blood in stool, discomfort in the anal area, dizziness
Rare (occurring in more than 1 in 10,000 patients, but less than 1 in 1000 patients):
allergic reaction (hypersensitivity), which can cause skin rash, rapidly progressing, life-threatening anaphylactic reactions, angioedema, fainting (syncope), fluid loss (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 use of Dulcobis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dulcobis

Keep out of sight and reach of children.
Do not store above 25°C. Store the blister in the outer packaging.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. 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 enteric-coated tablet contains 5 milligrams of bisacodyl.
• Other ingredients: lactose monohydrate, corn starch, modified corn starch (oxidized), glycerol 85%, magnesium stearate, coating:magnesium stearate, sucrose, talc, arabic gum, titanium dioxide (E 171), methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), castor oil, macrogol 6000, yellow iron oxide (E 172), white wax, carnauba wax, shellac.

What Dulcobis looks like and contents of the pack

Dulcobis is in the form of enteric-coated tablets.
Packaging: PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains: 20, 40, or 60 enteric-coated tablets.
For more detailed information, consult 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:

Delpharm Reims S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims
France

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: PA23180/018/003

Parallel import authorization number: 179/25

Date of leaflet approval: 23.05.2025

[Information about the trademark]