Dulcobis

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language
Dulcobis ( Dulcolax )
5 mg, rectal tablets
Bisacodylum
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 the 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 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.

Table of contents of the leaflet:

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 defecation and softens stool.
Dulcobis is used for short-term, symptomatic treatment of constipation:

• in patients suffering from constipation,
• to prepare for medical examinations, before and after surgery, and in conditions requiring easier 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 disorders,
• if the patient has a hereditary intolerance to certain sugars (see also: "Dulcobis contains 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) and not necessarily to the administration of Dulcobis itself.
Children should not take laxatives without medical advice.
Laxatives, including Dulcobis, do not cause weight loss.

Dulcobis and other medicines
Inform 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.
Concomitant use of diuretics or steroids 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; e.g. digoxin).
Concomitant use of Dulcobis with other laxatives may intensify gastrointestinal adverse effects.
Dulcobis tablets have a special coating, and to prevent premature dissolution of this coating, the medicine should not be taken 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, 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 and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 cause dizziness and/or fainting. If abdominal cramps occur, potentially hazardous activities such as driving and operating machinery should be avoided.

Dulcobis contains lactose and sucrose
The medicine contains 33.2 mg of 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 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.
If your doctor has not advised otherwise, 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.
Treatment should begin 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 under medical supervision only.

Method of administration:
Enteric-coated tablets should be taken orally in the evening to allow for bowel movement in the morning. Swallow the tablets whole with a large amount of water (do not take with milk – see section “Use of Dulcobis with food and drink”). Do not chew the tablets.

Preparation for diagnostic tests and surgical procedures:
When preparing for diagnostic tests 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 a physician, followed by a fast-acting laxative (e.g. 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. suppository) the next morning.

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

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 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 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, but more than 1 in 100 patients):
abdominal cramps, abdominal pain, diarrhoea, nausea
Uncommon (occur in not more than 1 in 100, but more than 1 in 1,000 patients):
abdominal discomfort, vomiting, blood in stool, discomfort around the anus, dizziness
Rare (occur in less than 1 in 1,000, but more than 1 in 10,000 patients):
hypersensitivity reactions, fainting, dehydration, angioedema, rapidly progressing, life-threatening anaphylactic reactions, colitis including ischaemic colitis
Dizziness and fainting may be related to constipation (straining at stool, abdominal pain) and not necessarily to 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 a doctor or the Emergency Department of the nearest hospital immediately.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 the medicine.

5. How to store Dulcobis

Keep the medicine out of 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 specified month.
Medicines should 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, maize starch, soluble maize starch, 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, 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.
Pack: PVC/PVDC/Aluminium blisters in a cardboard carton
Pack contains: 20, 40 or 60 rectal tablets
For further information, please contact the responsible party or the parallel importer.
Responsible party 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:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Marketing Authorization number in the Netherlands, country of export: RVG 03843
Parallel import authorization number: 260/24