Dulcobis

Package Leaflet: Information for the User

Dulcobis, 5 mg, enteric-coated tablets

Bisacodyl
Read this leaflet carefully because it contains important information for you.
This medicine should always be used exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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 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:

• 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 reasons,
• if you experience 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 "Important information about some ingredients of Dulcobis"),
• 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 decreased potassium levels in the blood (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 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

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.

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 foods 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 child, ask your doctor for advice before taking this medicine.

Pregnancy

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

Breastfeeding

Studies have shown that the main ingredient of the medicine and its metabolites are not detected in the milk of healthy breastfeeding women.
The medicine can be used during breastfeeding, but only 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 the medicine 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, you should wait until the feeling passes before driving or operating machinery.

Dulcobis contains lactose 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 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 this leaflet for the patient 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 otherwise directed by your doctor, 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.
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 over 10 years old with chronic or persistent constipation should be treated only 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, 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.
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 surgical procedures.
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 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: 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 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 be taken only when necessary. Its use without consulting a doctor should be stopped after the symptoms disappear, 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, facial, lip, tongue, and/or throat swelling, 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.

The following side effects have been observed during treatment with Dulcobis:
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 region, dizziness
Rare (occurring in more than 1 in 10,000 patients, but less than 1 in 1000 patients):
allergic reaction (hypersensitivity), which may cause skin rash, rapidly progressing, life-threatening anaphylactic reactions, angioedema, fainting (syncope), fluid loss (dehydration), colitis (inflammation of the colon), including ischemic colitis
Patients taking Dulcobis have experienced 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.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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, phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dulcobis

Keep out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiration date stated on the packaging after: Expiration Date/EXP. The expiration date is 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 of the medicine is bisacodyl. One enteric-coated tablet contains 5 milligrams of bisacodyl.
• Other ingredients: lactose monohydrate, corn starch, soluble corn starch, glycerol 85%, magnesium stearate, coating:magnesium stearate, sucrose, talc, arabic gum, titanium dioxide (E171), methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), castor oil, macrogol 6000, yellow iron oxide (E172), 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.
Not all pack sizes may be marketed.

Marketing authorization holder:

Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw

Manufacturer:

Delpharm Reims
10 rue Colonel Charbonneaux
51100 REIMS
France
To obtain more detailed information about this medicine, please contact the marketing authorization holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00

Date of last revision of the leaflet: