Dulcobis

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dulcobis (Dulcolax), 10 mg, suppositories
Bisacodyl
Dulcobis and Dulcolax are different trade names for the same medicine.
Please read this entire leaflet carefully, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if the patient feels worse, consult a doctor.

Table of contents of the leaflet:

1. What Dulcobis is and what it is 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 pack and other information

1. What Dulcobis is and what it is used for

Dulcobis is a locally acting laxative that stimulates bowel movements and softens stool.
Dulcobis works by stimulating intestinal peristalsis and promoting water accumulation in the colon (large intestine), thereby accelerating intestinal transit.
As a laxative acting on the large intestine, Dulcobis stimulates the natural defecation process in the lower part of the gastrointestinal tract. Thus, 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 procedures, before and after surgery, and in conditions requiring facilitation of defecation.

2. Important information before using Dulcobis

When not to use Dulcobis

• if the patient is allergic to bisacodyl or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has lost intestinal muscle motility (a condition known as "paralytic ileus"),
• if the patient has intestinal obstruction (mechanical obstruction),
• if the patient has acute abdominal conditions, including appendicitis or acute inflammatory bowel diseases,
• if the patient is dehydrated,
• if the patient is at risk of electrolyte imbalance due to

dehydration or for other reasons,

• if the patient experiences severe abdominal pain associated with nausea and vomiting – this may indicate a more serious condition,
• in children under 10 years of age.

Warnings and precautions

Dulcobis must not be used for longer than 5 days without consulting a doctor.
Laxatives, including Dulcobis, do not cause weight loss.
Before starting to use Dulcobis, discuss with your doctor or pharmacist:

• if the patient feels the need to use laxatives daily or for prolonged periods, they should consult a doctor to investigate the cause of constipation, as prolonged and excessive use may lead to fluid and electrolyte imbalance and low blood potassium levels (hypokalaemia),
• if the patient experiences increased thirst or reduced urine output, which may be signs of dehydration and may occur particularly in elderly patients or patients with kidney disease; the patient should stop using Dulcobis and contact a doctor,
• if the patient has disturbed fluid balance or has lost intestinal fluids (e.g. kidney failure or elderly patients), the medicine should be discontinued and may only be restarted under medical supervision due to increased risk of dehydration,
• if the patient notices blood in the stool,
• if the patient experiences dizziness and/or fainting. These symptoms may be related to constipation (straining during defecation, abdominal pain) and not necessarily to the use of Dulcobis itself. Use of suppositories such as Dulcobis may occasionally cause discomfort and irritation at the site of insertion, especially in patients with skin fissures around the anus (anal fissures) or inflammatory or ulcerative conditions around the anus (ulcerative proctitis).

Dulcobis and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking:

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

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

Breastfeeding
Studies have shown that neither the active substance of the medicine nor its metabolites are detected in the milk of healthy breastfeeding women.
Therefore, the medicine may be used during breastfeeding. However, it should only be used when necessary and under medical supervision, with the doctor evaluating the expected benefits for the patient against the potential risk to the infant.

Fertility
No studies have been conducted on the effect of the medicine on fertility in humans.

Driving and operating machinery
No studies have been conducted on the effect of Dulcobis on the ability to drive or operate machinery.
In some individuals, abdominal cramps associated with constipation may cause dizziness and/or fainting while using this medicine. In such cases, the patient should wait until these symptoms have subsided before driving or operating machinery.

3. How to use Dulcobis

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for short-term use only.
Dulcobis should not be used continuously, daily, or for longer than 5 days without consulting a doctor.
The effect of the suppository occurs on average 20 minutes after administration (10–30 minutes following administration).
Unless otherwise directed by a doctor, the following dosage is recommended:
Short-term treatment of constipation:
Adults, adolescents, and children over 10 years of age: 1 suppository (10 mg) per day for no more than 5 days. Do not exceed the maximum daily dose (1 suppository 10 mg).
Do not use in children under 10 years of age.
Preparation for diagnostic examinations and surgical procedures in adults:
When preparing for examinations or prior to surgical procedures, Dulcobis should be used under medical supervision.
Adults:
To achieve complete bowel evacuation, adults should initially take Dulcobis orally in another formulation (Dulcobis 5 mg enteric-coated tablets): 2–4 tablets in the evening on the day before the examination.
On the following morning, rectal administration of Dulcobis medicinal product in the form of a 10 mg suppository is recommended.
Method of administration
Unwrap the suppository and then insert it into the rectum with the tapered end pointing towards the rectum.
Use of more Dulcobis than recommended
If more Dulcobis has been used than recommended, consult a doctor or pharmacist.
The most common symptoms of overdose are: colicky abdominal pain, vomiting, mucus and diarrheal stools, and loss of fluids, potassium, and other electrolytes.
Long-term use of high doses of Dulcobis may lead to chronic diarrhoea, abdominal pain, various disorders caused by increased secretion of the hormone that controls sodium and potassium levels in the blood (secondary hyperaldosteronism), low blood potassium levels, and kidney stones.
As a result of chronic abuse of laxatives, damage to renal tubules (a form of kidney damage), metabolic alkalosis (a condition occurring when there are more bases than acids in the body), and muscle weakness may occur.
If you forget to use Dulcobis
Do not use a double dose to make up for a missed dose of Dulcobis.
If a dose is missed, use it as soon as the patient remembers.
Stopping Dulcobis
Dulcobis should only be used when necessary. Its use without medical consultation should be discontinued once symptoms have resolved, but no later than after 5 days.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Dulcobis may cause adverse reactions, although not everybody experiences them.
If allergic reactions occur, including hives, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing, stop using Dulcobis immediately and contact your doctor or the Emergency Department of the nearest hospital immediately.

The following adverse reactions have been observed during the use of Dulcobis:

Common (occurs less frequently than in 1 out of 10 patients, but more frequently than in 1 out of 100 patients):
abdominal cramps, abdominal pain, diarrhoea, nausea

Uncommon (occurs less frequently than in 1 out of 100 patients, but more frequently than in 1 out of 1,000 patients):
abdominal discomfort, vomiting, blood in stool, discomfort around the anus, dizziness

Rare (occurs less frequently than in 1 out of 1,000 patients, but more frequently than in 1 out of 10,000 patients):
allergic reaction (hypersensitivity), which may cause skin rash, rapidly progressing, life-threatening anaphylactic reactions, angioedema, fainting (syncope), fluid loss (dehydration), inflammation of the intestine (colitis), including ischaemic colitis.

Dizziness and/or fainting have been observed in patients using Dulcobis. These symptoms may be related to constipation (straining during defecation, abdominal pain), and not necessarily to the administration of Dulcobis itself.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorisation holder or the parallel importer.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dulcobis

Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dulcobis contains
The active substance is bisacodyl. Each suppository contains 10 milligrams of bisacodyl.
Other ingredients: hard fat.

What Dulcobis looks like and contents of the pack
Dulcobis is a suppository.
Pack: soft blister pack made of PVC/Aluminum foil in a cardboard box.
Pack contents: 6 or 12 suppositories.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Ireland, 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 (FI)
Italy

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
Działkowa 56
02-234 Warsaw
Poland

Synoptis Industrial Sp. z o.o.
Forteczna 35-37
87-100 Toruń
Poland

Shiraz Productions Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation Number in Ireland, country of export: PA23180/018/002
Parallel Import Licence Number: 153/25