Dulcobis

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the 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 trade names for the same medicine.
You should carefully read this entire leaflet, 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse after 5 days, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Dulcobis and what is it 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 is Dulcobis and what is it used for

Dulcobis is a locally acting laxative that stimulates bowel movements and softens stools.
Dulcobis is used for the short-term, symptomatic treatment of constipation:

• in patients suffering from constipation,
• to prepare for examinations, before and after surgery, and in conditions requiring facilitated bowel movements.

2. Important information before taking Dulcobis

When not to take Dulcobis

• if you are allergic (hypersensitive) to bisacodyl or any of the other ingredients of Dulcobis (listed in section 6),
• if you have intestinal obstruction,
• if you have acute abdominal conditions, including appendicitis or acute inflammatory bowel diseases,
• if you have lost a lot of water,
• if you have severe abdominal pain accompanied by nausea and vomiting - this may indicate a more serious condition,
• if you have a hereditary intolerance to certain sugars (see also: "Dulcobis contains lactose and sucrose").
• in children under 4 years of age

Warnings and precautions

• if you feel the need to take laxatives every day or for a longer period, you should consult a doctor to investigate the cause of constipation, as prolonged and excessive use can lead to fluid and electrolyte imbalance and potassium deficiency (hypokalemia),
• if you experience 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, you should stop taking Dulcobis and consult a doctor.

Patient may also observe the presence of blood in the stool, but this symptom is usually mild and resolves on its own.
Patients taking Dulcobis may experience dizziness and/or fainting. These symptoms may be related to constipation (straining during bowel movements, abdominal pain) rather than the administration of Dulcobis itself.
Children should not take laxatives without consulting a doctor.
Laxatives, including Dulcobis, do not affect weight loss.

Dulcobis and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Concomitant use of diuretics or steroids may increase the risk of electrolyte imbalance when taking 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.
Dulcobis tablets have a special coating, and to prevent its premature dissolution, you should not take the medicine with 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 its premature dissolution, you should not take the medicine with food products that reduce acidity in the upper gastrointestinal tract, such as milk.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor before taking this medicine.
Dulcobis can be used during pregnancy only after consulting a doctor.
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.
You should remember that due to abdominal cramps associated with constipation, dizziness and/or fainting may occur. If abdominal cramps occur, you should avoid potentially hazardous activities such as driving and operating machinery.

Dulcobis contains lactose and sucrose

The medicine contains 33.2 mg of lactose and 23.4 mg of sucrose in one enteric-coated tablet.
If you have previously been diagnosed with intolerance to certain sugars, you should consult a doctor before taking the medicine.

3. How to take Dulcobis

This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, you 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.
Unless otherwise directed by your doctor, the recommended dosage is:
Short-term treatment of constipation:
Adults (18 years and older): 1-2 enteric-coated tablets (5-10 mg) orally, once a day, before bedtime.
Children and adolescents over 10 years of age:
Children and adolescents over 10 years of age: 1-2 enteric-coated tablets (5-10 mg) orally, once a day, before bedtime.
It is recommended to start treatment with the lowest dose. The dose can be adjusted to the highest recommended dose to achieve regular bowel movements. Do not exceed the maximum daily dose.
Children from 4 to 10 years of age:
1 enteric-coated tablet (5 mg) orally, once a day, before bedtime. Do not exceed the maximum daily dose.
Children aged 10 and under 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 have a bowel movement in the morning. The tablets should be swallowed whole and washed down with a large amount of water (do not wash down with milk - see "Taking Dulcobis with food and drink"). The tablets should not be chewed.
Preparation for diagnostic tests and surgical procedures:
During preparation for tests or before surgery, Dulcobis should be used under medical supervision.
Adults (18 years and older):
to completely empty the intestines, adults should, according to the doctor's instructions, take 2-4 enteric-coated tablets (10-20 mg) orally, in the evening before the test, and then take a laxative with immediate action (e.g., in the form of a suppository) in the morning of the test day.
Children over 4 years of age:
one enteric-coated tablet (5 mg) in the evening, and the next morning, it is recommended to administer a laxative with immediate action (e.g., a suppository).

Taking a higher dose of Dulcobis than recommended

If you take more Dulcobis than recommended, you should consult a doctor or pharmacist.
Symptoms
In case of taking large doses, rare stools, intestinal cramps, abdominal pain, and loss of fluids, potassium, and other electrolytes may occur.
With chronic overdose of Dulcobis, chronic diarrhea, abdominal pain, various conditions caused by increased aldosterone secretion, which controls sodium and potassium levels in the blood (secondary hyperaldosteronism), low potassium levels in the blood, and kidney stones may occur. Chronic abuse of laxatives has also been reported to cause kidney damage (one form of kidney damage), metabolic alkalosis (a condition that occurs when there are more bases than acids in the body), and muscle weakness due to low potassium levels in the blood.

Missing a dose of Dulcobis

You should not take a double dose to make up for a missed dose of Dulcobis. If you miss a dose, you should take it as soon as you remember.

Stopping treatment with Dulcobis

Dulcobis should be taken only when necessary. Its use without consulting a doctor should be stopped after the symptoms have resolved, but no later than after 5 days.

If you have any further doubts about taking the medicine, you 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 treatment with 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)

patients): discomfort in the abdomen, vomiting, blood in the stool, discomfort in the anal area, dizziness
Rare (occurring in less than 1 in 1000 patients, but more than 1 in 10,000 patients):
allergic reactions, fainting, dehydration, angioedema, rapidly progressing, life-threatening anaphylactic reactions, colitis, including ischemic colitis
Dizziness and fainting may be related to constipation (straining during bowel movements, abdominal pain) rather than the administration of bisacodyl.
In case of allergic reactions, including hives, facial, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, you should stop taking Dulcobis and immediately contact a doctor or the Emergency Department of the nearest hospital

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Dulcobis

Keep out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dulcobis contains

• The active substance of the medicine is bisacodyl. One enteric-coated tablet contains 5 milligrams of bisacodyl.
• Other ingredients: lactose monohydrate, corn starch, soluble corn starch, glycerol 85%, magnesium stearate, coating:magnesium stearate, sucrose, talc, arabic gum, titanium dioxide (E 171), methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (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 in the form of enteric-coated tablets.
Packaging: PVC/PVDC/Aluminum blisters in a cardboard box
Packaging contains: 20, 40, or 60 enteric-coated tablets
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Netherlands marketing authorization number: RVG 03843
Parallel import authorization number: 260/24

Date of leaflet approval: 26.06.2024

[Information about the trademark]