Dulcobis

Package Leaflet: Information for the User

Dulcobis, 10 mg, Suppositories

Bisacodyl
Read the package leaflet carefully before taking this medicine. It contains important information for you..
This medicine should always be taken exactly as described in the package leaflet 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, talk to your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse after 5 days, you should contact your doctor.

Contents of the Package 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), speeding up 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 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 to bisacodyl or any of the other ingredients of this medicine (listed in section 6),
• if you have intestinal obstruction (paralytic ileus),
• if you have mechanical intestinal 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,
• 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 may lead to electrolyte and fluid 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 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 administration of Dulcobis itself.

Taking 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Inform your doctor about:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning 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 substance of Dulcobis is not detectable in the milk of healthy breastfeeding women, nor are its metabolites.
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 mother against the possible risk for the baby.

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, you should wait until the feeling passes before driving or operating machinery.

3. How to take Dulcobis

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask 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 insertion).
Unless otherwise directed by your doctor, the recommended dosage is:
Short-term treatment of constipation:
Adults, adolescents, and children over 10 years:1 suppository (10 mg) per day for no more 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 surgery, Dulcobis should be used under medical supervision.
Adults:
To achieve complete bowel emptying, adults should initially take Dulcobis orally (Dulcobis, 5 mg, enteric-coated tablets): 2-4 tablets in the evening before the test.
The next morning, it is recommended to administer Dulcobis rectally in the form of a 10 mg suppository.
Method of administration
Remove the suppository from the packaging and insert it into the anus, with the pointed end directed towards the anus.

Overdose of Dulcobis

If you take more Dulcobis than you should, contact 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.
Prolonged 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.

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 have resolved, 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.
If you experience allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing, stop taking Dulcobis and contact your doctor or the Emergency Department of the nearest hospital immediately.

Rare but serious side effects:

The following side effects have been observed during treatment with Dulcobis:
Common (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 may 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 experience any side effects, including those not listed in this leaflet, tell 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
Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dulcobis

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use the medicine after the expiry date stated on the packaging after: Expiry Date/EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 suppository contains 10 milligrams of bisacodyl.
Other ingredients: solid fat (Witepsol W 45).

What Dulcobis looks like and contents of the pack

Dulcobis is a suppository.
Packaging: soft aluminum/PE blister pack in a cardboard box.
The pack contains: 6, 10, or 12 suppositories.

Marketing authorization holder:

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

Manufacturer:

Istituto De Angeli S.r.l.
Loc. Prulli, 103/C
50066 Reggello (FI)
Italy
For more detailed information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00

Date of revision of the leaflet: