Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language
Dulcobis (Dulcolax)
5 mg, rectal tablets
Bisacodyl
Dulcobis and Dulcolax are different trade names for the same medicine.
Please read the entire leaflet carefully as it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician 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 physician or pharmacist. See section 4.
If there is no improvement after 5 days, or if the patient feels worse, consult a physician.

Table of contents of the leaflet:

What Dulcobis is and what it is used for
Important information before using Dulcobis
How to use Dulcobis
Possible side effects
How to store Dulcobis
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 indicated:

for short-term, symptomatic treatment of constipation,
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 (hypersensitive) to bisacodyl or any of the other ingredients of Dulcobis (listed in section 6),
if the patient has loss of intestinal muscle motility (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 associated with nausea and vomiting – this may indicate a more serious condition,
if the patient has a hereditary intolerance to certain sugars (see also: "Dulcobis contains monohydrate lactose and sucrose"),
in children under 4 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 taking 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.

Dulcobis with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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.

Dulcobis tablets have a special coating, and to prevent premature dissolution of this coating,
the medicine should not be taken together with medicinal products that reduce acidity in the upper
gastrointestinal tract, such as antacids or proton pump inhibitors.
Taking Dulcobis with food and drink
Dulcobis tablets have a special coating, and to prevent premature dissolution of this coating,
the medicine should not be taken with food products that reduce acidity in the upper
gastrointestinal tract, such as milk.
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 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 ingredient of Dulcobis nor its metabolites are detected
in the milk of healthy breastfeeding mothers.
Therefore, the medicine may be used during breastfeeding. However, it should only be used when
necessary, under medical supervision, and only after the doctor has evaluated the expected benefits
for the patient against the possible risks for the infant.
Fertility
No studies have been conducted on the effect of Dulcobis 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 related to 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.
Dulcobis contains monohydrate lactose and sucrose
The medicine contains 33.2 mg of lactose and 23.4 mg of sucrose in one enteric-coated tablet.
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

3. How to use Dulcobis

This medicine should always be taken 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 taken continuously, on a daily basis, or for longer than 5 days without consulting a doctor.
Unless otherwise prescribed by a doctor, the following dosage is recommended:

Short-term treatment of constipation:
Adults (aged 18 years and over): 1–2 enteric-coated tablets (5–10 mg) orally, once daily, taken in the evening before bedtime.
It is recommended to start treatment with the lowest dose. The dose may be adjusted up to the maximum recommended dose to achieve regular bowel movements.
Do not exceed the maximum daily dose.

Children and adolescents over 10 years of age:
1–2 enteric-coated tablets (5–10 mg) orally, once daily, taken in the evening before bedtime.
It is recommended to start treatment with the lowest dose. The dose may be adjusted up to the maximum recommended dose to achieve regular bowel movements.
Do not exceed the maximum daily dose.

Children aged 4 to 10 years:
1 enteric-coated tablet (5 mg) orally, once daily, taken in the evening before bedtime. Do not exceed the maximum daily dose.
Children aged 10 years and younger with chronic or persistent constipation should be treated under medical supervision only.

Administration method:
Enteric-coated tablets should be taken orally in the evening to ensure bowel movement in the morning.
The tablets should be swallowed whole with a large amount of water.
Do not take the enteric-coated tablets simultaneously with products that reduce gastric acid secretion, such as milk, antacids, or proton pump inhibitors, as this may cause premature dissolution of the protective coating.
The tablets must not be chewed.

Preparation for diagnostic examinations and surgical procedures:
During preparation for diagnostic tests or prior to surgical procedures, Dulcobis should be used under the supervision of medical personnel.

Adults (aged 18 years and over):
To achieve complete bowel evacuation, adults should take 2–4 enteric-coated tablets (10–20 mg) orally in the evening the day before the examination, as directed by a physician, followed by a fast-acting laxative (e.g., in suppository form) on the morning of the examination.

Children aged over 4 years:
One enteric-coated tablet (5 mg) should be taken in the evening, followed the next morning by administration of another fast-acting laxative (e.g., in suppository form).

Overdose of Dulcobis
If more Dulcobis has been taken than recommended, consult a doctor or pharmacist immediately.
The most common symptoms of overdose are: colicky abdominal pain, vomiting, slimy 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 regulating blood sodium and potassium levels (secondary hyperaldosteronism), low blood potassium levels (hypokalaemia), and kidney stones.
Chronic abuse of laxatives may result in renal tubular damage (a type of kidney injury), metabolic alkalosis (a condition in which the body contains more bases than acids), and muscle weakness.

Missed dose of Dulcobis
Do not take a double dose to make up for a missed dose of Dulcobis.
If a dose is missed, take it as soon as remembered.

Discontinuation of Dulcobis
Dulcobis should be taken only when necessary. Its use without medical consultation should be discontinued once symptoms resolve, but no later than after 5 days.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Dulcobis may cause adverse effects, although not everyone 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 taking Dulcobis immediately and seek immediate medical attention at the nearest hospital Emergency Department.
The following adverse effects have been observed during treatment with Dulcobis:
Common (occur in more than 1 in 100 patients, but less than 1 in 10 patients):
abdominal cramps, abdominal pain, diarrhoea, nausea
Uncommon (occur in more than 1 in 1,000 patients, but less than 1 in 100 patients):
abdominal discomfort, vomiting, blood in stool, discomfort around the anus, dizziness
Rare (occur in more than 1 in 10,000 patients, but less than 1 in 1,000 patients):
allergic reaction (hypersensitivity) which may cause skin rash, rapidly progressing, life-threatening anaphylactic reactions, angioedema, fainting (syncope), fluid loss (dehydration), intestinal inflammation (colitis), including ischaemic colitis
Dizziness and/or fainting have been observed in patients treated with Dulcobis. These symptoms may be related to constipation (straining during defecation, abdominal pain) and not necessarily to the use of Dulcobis.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 adverse effects 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. Keep the blister in the outer packaging.
Do not use the medicine after the expiry date stated on the packaging. 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 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. One rectal tablet contains 5 milligrams of bisacodyl.
Other ingredients: lactose monohydrate, corn starch, modified starch (corn, oxidized), glycerol 85%, magnesium stearate, coating: magnesium stearate, sucrose, talc, gum arabic, titanium dioxide (E 171), copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and methyl methacrylate (1:2), castor oil, macrogol 6000, iron oxide yellow (E 172), white wax, carnauba wax, shellac.

What Dulcobis looks like and contents of the pack
Dulcobis is available as rectal tablets.
Pack: PVC/PVDC/Aluminium blisters in a cardboard box.
Pack contains: 20, 40 or 60 rectal tablets.
For further information, please contact the Marketing Authorisation Holder 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:
Delpharm Reims S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims
France
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Ireland, country of export: PA23180/018/003
Parallel Import Licence number: 179/25