DULCOBIS

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Dulcobis (Dulcolax)
10 mg, suppositories
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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for possible 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, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if the patient feels worse, consult a doctor.

Table of contents of the leaflet:

1. What Dulcobis is and what it is used for
2. Important information before using Dulcobis
3. How to use 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.
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 used:

• in adults, adolescents, and children for short-term, symptomatic treatment of constipation
• in adults 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 to bisacodyl or to any of the other ingredients of this medicine (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 or is at risk of electrolyte imbalance for other reasons,
• if the patient experiences severe abdominal pain associated with nausea and vomiting – this may indicate more serious conditions,
• in children under 10 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 develops increased thirst or reduced urine output, which may be signs of dehydration and may be dangerous for elderly patients or patients with kidney disease, the patient should stop using Dulcobis and consult a doctor.

Patients may also notice the presence of blood in the stool, but usually this symptom is mild and resolves spontaneously.
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 administration of Dulcobis itself.
The use of suppositories may cause pain and local irritation, especially in patients with anal fissures or proctitis and anal inflammation with accompanying ulceration.
Laxatives, including Dulcobis, do not cause weight loss.

Dulcobis and other medicines

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance when excessive doses of Dulcobis are used. 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.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Dulcobis may be used during pregnancy only after consultation with a doctor and if the doctor considers it absolutely necessary.
Dulcobis may be used during breastfeeding.

Driving and operating machinery

No studies on the effect of Dulcobis on the ability to drive vehicles or operate machinery have been conducted.
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 vehicles or operating machinery should be avoided.

3. How to use Dulcobis

This medicine should always be used 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.
The duration of Dulcobis treatment without consulting a doctor should not exceed 5 days.
The effect of the suppository occurs on average after 20 minutes (10–45 minutes after administration).
Unless otherwise advised by a doctor, the following dosage is recommended:

Short-term treatment of constipation:
Adults, adolescents and children above 10 years of age: 1 suppository (10 mg) per day for no longer than 5 days. Do not exceed the maximum daily dose.
This medicine should not be used in children under 10 years of age.

Preparation for diagnostic examinations and surgical procedures in adults:
When preparing for diagnostic tests or prior to surgical procedures, Dulcobis should be used under medical supervision.
Adults:
To achieve complete emptying of the intestines, adults should initially take Dulcobis orally in another formulation (Dulcobis 5 mg enteric-coated tablets): 2–4 tablets in the evening on the day before the examination.
On the following morning, a 10 mg rectal suppository of Dulcobis is recommended.

Instructions for use
Unwrap the suppository and insert it into the rectum with the tapered end first.

Overdose of Dulcobis
If more Dulcobis has been used than recommended, consult a doctor or pharmacist immediately.
Symptoms of overdose may include: diarrhoea, intestinal cramps, abdominal pain, and loss of fluids, potassium, and other electrolytes.
Long-term use of high doses of Dulcobis may lead to chronic diarrhoea, abdominal pain, various medical conditions 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 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 use a double dose to make up for a missed dose.
If a dose is missed, it should be taken as soon as remembered.

Discontinuation of Dulcobis
Dulcobis should only be used when necessary. Treatment without prior consultation with a doctor should be discontinued once 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 may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed during the use of Dulcobis:

Common (occur in fewer than 1 in 10 patients but more than 1 in 100 patients):
abdominal cramps, abdominal pain, diarrhoea, nausea.

Uncommon (occur in fewer than 1 in 100 patients but more than 1 in 1,000 patients):
abdominal discomfort, vomiting, blood in stool, discomfort around the anus, dizziness.

Rare (occur in fewer 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, inflammation of the large intestine, including ischemic colitis.

Dizziness and/or fainting have been observed in patients taking Dulcobis. These symptoms may be related to constipation (straining during bowel movements, abdominal pain) and not necessarily to the administration of Dulcobis itself.

In the event of allergic reactions, including urticaria, facial swelling, swelling of the lips, tongue and/or throat, which may cause difficulty in breathing or swallowing, treatment with Dulcobis must be discontinued and immediate contact must be made with a doctor or the Emergency Department of the nearest hospital.

Reporting of adverse reactions
If any adverse reactions occur, including those 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Dulcobis

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Keep the blister in the outer packaging to protect from light.
Do not use the 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 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. Each suppository contains 10 milligrams of bisacodyl.
Other ingredients: hard fat.

What Dulcobis looks like and contents of the pack
Dulcobis is a suppository.
Pack: soft blister made of PVC/Al foil in a cardboard box.
Pack contents: 6 or 12 suppositories.

For further information, please contact the responsible party or the parallel importer.

Responsible party in Ireland, country of export:
Opella Healthcare France SAS
157 avenue Charles de Gaulle
92200 Neuilly-sur-Seine, France

Manufacturer:
Istituto De Angeli S.r.l.
Località Prulli n. 103/c
50066 Reggello (FI)
Italy

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Irish licence number, country of export: PA23180/018/002
Parallel import licence number: 357/24