Dulcobis

Patient Information Leaflet: Information for the User

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dulcobis ( Dulcolax )
5 mg, enteric-coated tablets
Bisacodyl
Dulcobis and Dulcolax are different brand 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 this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Table of Contents:

1. What Dulcobis is and what it is 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 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 stimulant laxative acting on the large intestine, Dulcobis enhances the natural defecation process in the lower gastrointestinal tract. Thus, Dulcobis does not affect digestion or absorption of calories and nutrients in the small intestine.
Dulcobis is used:

• for short-term, symptomatic treatment of constipation,
• to prepare for 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 accompanied by 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 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 excessive and prolonged use may lead to disturbances in fluid and electrolyte balance 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 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.

Dulcobis with other medicines
Tell your doctor or pharmacist about any other 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 designed to prevent premature dissolution. Therefore, the medicine should not be taken together with medicinal products that reduce gastric 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 designed to prevent premature dissolution. Therefore, the medicine should not be taken with food products that reduce gastric acidity in the upper gastrointestinal tract, such as milk.
Pregnancy and breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her 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 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, 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 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 associated with constipation may lead to dizziness and/or fainting while taking 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 monohydrate lactose and 23.4 mg of sucrose per enteric-coated tablet.
If the patient has previously been diagnosed with 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 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, before bedtime.
Treatment should be started 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.

Adolescents and children above 10 years of age:
Adolescents and children above 10 years of age: 1–2 enteric-coated tablets (5–10 mg) orally, once daily, before bedtime.
Treatment should be started 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, before bedtime.
Do not exceed the maximum daily dose.
Children aged 10 years and younger with chronic or persistent constipation should be treated only under medical supervision.

Method of administration:
Enteric-coated tablets should be taken orally in the evening to induce bowel movement in the morning.
The tablets should be swallowed whole with a large amount of water.
Do not take 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 medical supervision.
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 before the examination, as directed by a doctor, followed by a fast-acting laxative (e.g. in the form of a suppository) on the morning of the examination.

Children above 4 years of age:
One enteric-coated tablet (5 mg) in the evening, followed by administration of a fast-acting laxative (e.g. in the form of a suppository) the next morning.

Use of a higher than recommended dose of Dulcobis
If more Dulcobis has been taken than recommended, seek advice from a doctor or pharmacist immediately.
The most common symptoms of overdose are: colicky abdominal pain, vomiting, mucus and diarrhoeal stools, and fluid loss, potassium loss, and loss of 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 regulating blood sodium and potassium levels (secondary hyperaldosteronism), low blood potassium levels, and kidney stones.
Chronic abuse of laxatives may result in damage to renal tubules (a form of kidney damage), 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 prior consultation with a doctor, should be discontinued once symptoms have resolved, 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 breathing or swallowing, immediately discontinue use of Dulcobis and contact a doctor or the Emergency Department of the nearest hospital immediately.

The following adverse effects have been observed during use of 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 using 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 out of the sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use this 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 how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Dulcobis contains

• The active substance is bisacodyl. Each rectal tablet contains 5 mg of bisacodyl.
• Other ingredients: monohydrate lactose, corn starch, soluble corn starch, glycerol 85%, magnesium stearate, sucrose, talc, arabic gum, 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, yellow iron oxide (E 172), white wax, carnauba wax, shellac.

What Dulcobis looks like and contents of the pack
Dulcobis is available as rectal tablets.
Packaging: PVC/PVDC blisters in a cardboard box.
Pack sizes: 20, 40 or 60 rectal tablets.
For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
Opella Healthcare France SAS
157 avenue Charles de Gaulle
92200 Neuilly-sur-Seine
France
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in the Netherlands, country of export: RVG 03843
Parallel import authorisation number: 178/25