Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Dulcobis (Dulcolax)
5 mg, enteric-coated tablets
Bisacodyl
Dulcobis and Dulcolax are different brand names of the same medicine.
Please read the entire leaflet carefully, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

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

Table of Contents:

What is Dulcobis and what is it used for?
Important information before taking Dulcobis
How to take Dulcobis
Possible side effects
How to store Dulcobis
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 stool.
Dulcobis is used for short-term, symptomatic treatment of constipation:

in patients suffering from constipation,
for bowel preparation before and after medical procedures or surgeries, and in conditions requiring facilitated 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 intestinal obstruction,
if the patient has acute abdominal conditions, including appendicitis or acute inflammatory bowel diseases,
if the patient has lost a significant amount of fluid,
if the patient experiences severe abdominal pain associated with nausea and vomiting – this may indicate serious underlying conditions,
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

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 disturbances in fluid and electrolyte balance and to low blood potassium levels (hypokalaemia),
if the patient experiences increased thirst or reduced urine output, which may be signs of dehydration and may be dangerous in elderly patients or patients with kidney disease, the patient should stop taking Dulcobis and consult a doctor.

Patients may also notice the presence of blood in the stool, but this symptom is usually mild and resolves spontaneously.
Dizziness and/or fainting have been observed in patients taking Dulcobis. These symptoms may be related to constipation (straining during defecation, abdominal pain) rather than to the administration of Dulcobis itself.
Children should not take laxatives without medical advice.
Laxatives, including Dulcobis, do not cause weight loss.

Dulcobis with other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance when excessive doses of Dulcobis are taken. Electrolyte imbalance may increase sensitivity to cardiac glycosides (medicines used in the treatment of heart failure and cardiac arrhythmias; for example, digoxin).
Concomitant use of Dulcobis with other laxatives may intensify gastrointestinal adverse effects.
Dulcobis tablets have a special coating, and to prevent premature dissolution, the medicine should not be taken together with medicinal products that reduce gastric acidity, such as antacids or proton pump inhibitors.

Taking Dulcobis with food and drink
Dulcobis tablets have a special coating, and to prevent premature dissolution, the medicine should not be taken with food products that reduce gastric acidity, such as milk.

Pregnancy and breastfeeding
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.
Dulcobis may be used during pregnancy only after consultation with a doctor.
Dulcobis may be used during breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of Dulcobis on the ability to drive or operate machinery.
It should be remembered that abdominal cramps associated with constipation may lead to dizziness and/or fainting. If abdominal cramps occur, potentially hazardous activities such as driving or operating machinery should be avoided.

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 a sugar intolerance has previously been diagnosed in the patient, the patient should consult a doctor before taking the medicine.

3. How to use Dulcobis

This medicine should always be taken 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. The duration of using Dulcobis without consulting a doctor should not exceed 5 days.
Unless otherwise advised by a doctor, the following dosage is recommended:

Short-term treatment of constipation:
Adults (aged 18 years and above):
1–2 enteric-coated tablets (5–10 mg) orally, once daily, before bedtime.
Children and adolescents above 10 years of age:
Children and adolescents above 10 years of age: 1–2 enteric-coated tablets (5–10 mg) orally, once daily, 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, 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 must be swallowed whole and taken with a large amount of water (do not take with milk – see section “Taking Dulcobis with food and drink”). Do not chew the tablets.

Preparation for diagnostic tests and surgical procedures:
During preparation for examinations or prior to surgical procedures, Dulcobis should be used under medical supervision.
Adults (aged 18 years and above):
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 the doctor, followed by a fast-acting laxative (e.g. 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. a suppository) the next morning.

Overdose of Dulcobis
If more Dulcobis has been taken than recommended, consult your doctor or pharmacist immediately.
Symptoms
After taking large doses, rare stools, intestinal cramps, abdominal pain, and loss of fluids, potassium, and other electrolytes may occur.
With chronic overdose, Dulcobis may cause chronic diarrhoea, abdominal pain, various medical conditions caused by increased aldosterone secretion, which regulates sodium and potassium levels in the blood (secondary hyperaldosteronism), low blood potassium levels, and kidney stones. Chronic abuse of laxatives has also been associated with renal tubular damage (a type of kidney injury), metabolic alkalosis (a condition in which the body contains more bases than acids), and muscle weakness due to low potassium levels in the blood.

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 only be taken when necessary. Treatment without consulting a doctor should be discontinued after symptoms resolve, 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 can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed during the use of Dulcobis:
Common (occur in not more than 1 in 10 patients, but more than 1 in 100 patients):
abdominal cramps, abdominal pain, diarrhoea, nausea.
Uncommon (occur in not more than 1 in 100 patients, but more than 1 in 1,000 patients):
abdominal discomfort, vomiting, blood in stool, anal discomfort, dizziness.
Rare (occur in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):
hypersensitivity reactions, fainting, dehydration, angioedema, rapidly progressing, life-threatening
anaphylactic reactions, colitis including ischemic colitis.
Dizziness and fainting may be associated with constipation (straining at stool, abdominal pain) and
not necessarily with the use of bisacodyl.
If allergic reactions occur, including urticaria, facial swelling, swelling of lips, tongue and/or throat,
which may cause difficulty in breathing or swallowing, stop using Dulcobis and contact your doctor or the Emergency Department of your nearest hospital immediately.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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 reactions helps to provide more information on the safety of this medicine.

5. How to store Dulcobis

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store the blister pack 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 enteric-coated 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 an enteric-coated tablet.
Pack: PVC/PVDC/Al blisters in a cardboard box.
Pack contains: 20, 40 or 60 enteric-coated tablets.
For further information, contact the responsible party or the 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Irish Marketing Authorisation number, country of export: PA23180/018/003
Parallel import authorisation number: 245/24