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 )

5 mg, enteric-coated tablets

Bisacodyl
Dulcobis and Dulcolax are different trade names for the same medicine.
You should read this leaflet carefully because it contains important information for you.
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 that you can read it again if you need to.
• If you need advice or further 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 5 days you have not improved or if you 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 you take 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 the 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 you take 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 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,
• if you have a 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 hypokalemia (low potassium levels in the blood).
• 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 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 use of Dulcobis.

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,
• medicines used to treat inflammatory conditions (corticosteroids),
• medicines used to treat heart conditions (cardiac glycosides, such as digoxin),
• other laxatives.

Dulcobis tablets have a special coating, and to prevent it from dissolving too early, 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 it from dissolving too early, 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, you should 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 therefore 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 in relation to the possible risk for the baby.

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.

Dulcobis contains lactose monohydrate and sucrose

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

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.
In case of doubt, you should 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 older): 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.
Young people and children 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:
Enteric-coated tablets should be taken orally, in the evening, to have a bowel movement in the morning.
Tablets should be swallowed whole and washed down with a large amount of water.
Do not take enteric-coated tablets at the same time as products that reduce stomach acid secretion, such as milk, antacids, or proton pump inhibitors, as this may cause the protective coating to dissolve too quickly.
Tablets should not be chewed.
Preparation for diagnostic tests and surgical procedures:
Dulcobis should be used under medical supervision during preparation for tests or before surgery.
Adults (18 years and older):
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 a laxative with immediate action (e.g., in the form of a suppository).

Overdose of Dulcobis

In case of overdose, you should 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 may lead to kidney damage (one form of kidney damage), metabolic alkalosis (a condition that occurs when there are more bases than acids in the body), and muscle weakness.

Missing a 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 taken when necessary. Its use without consulting a doctor should be stopped after the symptoms have passed, but no later than after

5 days.

In case of any further doubts about the use of the medicine, you should consult 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, 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.

During treatment with Dulcobis, the following side effects have been observed:

Common (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, you should 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Dulcobis

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 of Dulcobis is bisacodyl. One enteric-coated tablet contains 5 mg of bisacodyl.
• Other ingredients: lactose monohydrate, corn starch, soluble corn starch, glycerol 85%, 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 blisters in a cardboard box.
The packaging contains: 20, 40, or 60 enteric-coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

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

Manufacturer:

Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Netherlands, the country of export:RVG 03843
Parallel import authorization number:178/25

Date of approval of the leaflet: 23.05.2025

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