Dulcobis

Leaflet accompanying 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.

Read the leaflet 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 or pharmacist. See section 4.
• If there is no improvement after 5 days or 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. Contents of the packaging 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.
As a laxative that acts 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 examinations, before and after surgery, and in conditions that require facilitated bowel movements

2. Important information before using Dulcobis

When not to use Dulcobis

• if the patient is allergic to bisacodyl or any other ingredient of this medicine (listed in section 6),
• if the patient has intestinal obstruction,
• if the patient has acute abdominal conditions, including appendicitis or acute inflammatory bowel diseases,
• if the patient has lost a lot of water or there is a risk of electrolyte imbalance for other reasons
• if the patient experiences severe abdominal pain accompanied by nausea and vomiting - this may indicate more serious conditions,
• in children under 10 years of age

Warnings and precautions

• if the patient feels the need to use laxatives daily or for a longer period, they should consult a doctor to investigate the cause of constipation, as prolonged and excessive use can lead to electrolyte imbalance and decreased 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 be dangerous for the elderly or patients with kidney disease, the patient should stop using Dulcobis and consult a doctor.

Patients may also observe the presence of blood in the stool, but this symptom is usually mild and resolves on its own.
Patients using Dulcobis may 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 itself.
The use of suppositories may cause discomfort and local irritation, especially in patients with anal fissures and proctitis or rectal ulcers.
Laxatives, including Dulcobis, do not affect weight loss.

Dulcobis and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of diuretics or steroids may increase the risk of electrolyte imbalance when using excessive doses of Dulcobis. Electrolyte imbalance can increase sensitivity to cardiac glycosides (medicines used to treat heart failure and arrhythmias; examples include digoxin).
Concomitant use of Dulcobis with other laxatives may enhance gastrointestinal side effects.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor before using this medicine.
Dulcobis can be used during pregnancy only after consulting a doctor and if the doctor considers it absolutely necessary.
Dulcobis can be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of Dulcobis on the ability to drive and use machines.
It should be remembered that due to abdominal cramps associated with constipation, dizziness and/or fainting may occur. If abdominal cramps occur, the patient should avoid potentially hazardous activities such as driving and using machines.

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. If in doubt, the patient should consult a doctor or pharmacist.
The medicine is intended for short-term use.
The duration of use of Dulcobis, without consulting a doctor, should not exceed 5 days.
The effect of the suppository occurs on average after 20 minutes (10-45 minutes after administration).
If the doctor does not recommend otherwise, 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 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 surgery, Dulcobis should be used under medical supervision.
Adults:
To achieve complete bowel emptying, adults should initially take Dulcobis orally in a different form (Dulcobis, 5 mg, enteric-coated tablets): 2-4 tablets in the evening on the day before the test.
The next morning, it is recommended to use Dulcobis rectally in the form of a 10 mg suppository.
Method of administration
Unpack the suppository and insert it into the rectum with the pointed end first.

Using a higher dose of Dulcobis than recommended

In case of using a higher dose of Dulcobis than recommended, the patient should consult a doctor or pharmacist.
As a result of overdosing, the following may occur: diarrhea, intestinal cramps, abdominal pain, 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 in which 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.
In case of missing a dose, the patient should use it as soon as they remember.

Stopping the use of Dulcobis

Dulcobis should be used only 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 a doctor or pharmacist.

4. Possible side effects

Like all medicines, Dulcobis can cause side effects, although not everybody gets them.
The following side effects have been observed during the use of 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 1000 patients):
abdominal discomfort, vomiting, blood in the stool, anal discomfort, dizziness
Rare (occurring in less than 1 in 1000 patients, but more than 1 in 10,000 patients):
allergic reactions, fainting, dehydration, angioedema, severe, life-threatening anaphylactic reactions, colitis, including ischemic colitis
Patients using Dulcobis may 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 itself.
In case of allergic reactions, including hives, facial, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, the patient should stop using Dulcobis and immediately contact a 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
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 given 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. Contents of the packaging and other information

What Dulcobis contains

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

What Dulcobis looks like and what the packaging contains

Dulcobis is in the form of suppositories.
Packaging: soft PVC/Al foil blister in a cardboard box.
The packaging 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 (Fl), Italy

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
Authorization number in Ireland, the country of export:PA23180/018/002
Parallel import authorization number:84/24

Date of leaflet approval: 05.03.2024

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