DULCOBIS

Package leaflet: Information for the user

Dulcobis, 10 mg, suppositories
Bisacodyl
Please read the 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 any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, contact a doctor.

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 evacuation 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 indicated:

• in adults, adolescents and children for short-term symptomatic treatment of constipation,
• in adults for preparation prior to diagnostic examinations, 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 movement (a condition called "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 accompanied by nausea and vomiting – this may indicate serious disorders,
• 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 take 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 consult a doctor.
• If the patient has impaired 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.

The 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 conditions or ulcers 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 a doctor before using this medicine.
Pregnancy
There is limited data on the use of this medicine in pregnant women.
Dulcobis should not be used during pregnancy unless the doctor considers it absolutely necessary.
Breastfeeding
Studies have shown that the active ingredient of the medicine or its metabolites are not 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, after the doctor has evaluated 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 and operate machinery.
In some individuals, abdominal cramps associated with constipation may cause dizziness and/or fainting during treatment with this medicine. In such cases, the patient should wait until these symptoms subside before driving or operating machinery.

3. How to use Dulcobis

This medicine should always be used exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for short-term use only.
Dulcobis should not be used continuously, on a daily basis, 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 application).
Unless otherwise directed by a physician, 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. The maximum daily dose (1 suppository 10 mg) should not be exceeded.
This medicine should not be used 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 the supervision of medical personnel.
Adults:
To achieve complete emptying of the intestines, adults should initially take Dulcobis orally in another formulation (Dulcobis 5 mg rectal tablets): 2–4 tablets in the evening on the day before the examination.
On the following morning, 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 first.
Use of more Dulcobis than recommended
If more Dulcobis has been used than recommended, consult your 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 diarrhea, abdominal pain, various disorders caused by increased secretion of the hormone that controls blood sodium and potassium levels (secondary hyperaldosteronism), low blood potassium levels, and kidney stones.
Chronic abuse of laxatives may result in renal tubular damage (a form of kidney injury), metabolic alkalosis (a condition in which the body contains more bases than acids), and muscle weakness.
If you forget to use Dulcobis
Do not use a double dose to make up for a forgotten dose of Dulcobis.
If a dose is missed, it should be taken as soon as the patient remembers.
Stopping the use of Dulcobis
Dulcobis should only be used when necessary. Its use without consultation with a doctor should be discontinued once symptoms have resolved, but no later than after 5 days.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Dulcobis may cause adverse reactions, although not everyone experiences them.
If allergic reactions occur, including hives, facial swelling, swelling of the lips, tongue and/or throat, which may cause difficulty 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 (occur in fewer than 1 in 10 patients, but more than 1 in 100 patients):
abdominal cramps, abdominal pain, diarrhoea, nausea
Uncommon (occur in fewer than 1 in 100 patients, but more than 1 in 1000 patients):
abdominal discomfort, vomiting, blood in stool, discomfort around the anus, dizziness
Rare (occur in fewer than 1 in 1000 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), fluid loss (dehydration), inflammation of the intestine (colitis), including ischaemic colitis.
Dizziness and/or fainting have been observed in patients taking 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 symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the Marketing Authorisation Holder or its representative. Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Dulcobis

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after: Expiry/EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Dulcobis contains
The active substance is bisacodyl. Each suppository contains 10 milligrams of bisacodyl.
Other components: hard fat (Witepsol W 45).
What Dulcobis looks like and contents of the pack
Dulcobis is available as suppositories.
Packaging: soft blister Al/PE in a cardboard box.
Pack sizes: 6, 10 or 12 suppositories.
Marketing Authorisation 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 further information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00