Dulcobis

Patient Information Leaflet: Information for the User

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Dulcobis (Dulcolax), 10 mg, suppositories
Bisacodyl
Dulcobis and Dulcolax are different brand names for the same medicine.
Please read this 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, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse 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 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 evacuation and softens stool.
As a stimulant laxative acting on the large intestine, Dulcobis promotes the natural bowel movement 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 indicated:

• in adults, adolescents, and children for short-term symptomatic treatment of constipation
• in adults for bowel preparation prior to 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 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 due to other causes,
• if the patient experiences severe abdominal pain associated with nausea and vomiting – this may indicate a more serious condition,
• 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 low blood potassium levels (hypokalaemia),
• if the patient develops excessive 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 using 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 using Dulcobis. These symptoms may be related to constipation (straining during defecation, abdominal pain) and not necessarily to the administration of Dulcobis itself.
Use of suppositories may cause pain and local irritation, especially in patients with anal fissures or proctitis or perianal inflammation with associated ulceration.
Laxatives, including Dulcobis, do not cause weight loss.

Dulcobis and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
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).
Concurrent 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 have a child, 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
Studies on the effect of Dulcobis on the ability to drive and operate machinery have not been conducted.
It should be noted 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.

3. How to use Dulcobis

This medicine should always be used exactly as described in this patient information 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 Dulcobis treatment without consultation with a doctor should not exceed 5 days.
The effect of the suppository occurs on average 20 minutes after administration (range: 10–45 minutes).
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) daily 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:
During preparation for examinations or prior to surgical procedures, Dulcobis should be used under medical supervision.
Adults:
For complete bowel evacuation, 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 Dulcobis rectal suppository is recommended.

Method of administration
Unwrap the suppository and insert into the rectum with the tapered end first.

Use of more than the recommended dose of Dulcobis
If more Dulcobis than recommended has been used, consult your doctor or pharmacist immediately.
Overdose may result in 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 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 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 the patient remembers.

Discontinuation of Dulcobis
Dulcobis should only be used when necessary. Treatment without prior 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 effects

Like all medicines, Dulcobis may cause adverse effects, although they do not occur in everyone.

The following adverse effects have been observed during treatment with Dulcobis:

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

Uncommon (occur less frequently than in 1 in 100 patients, but more frequently than in 1 in 1000 patients):
abdominal discomfort, vomiting, blood in stool, discomfort around the anus, dizziness

Rare (occur less frequently than in 1 in 1000 patients, but more frequently than in 1 in 10,000 patients):
hypersensitivity reactions, fainting, dehydration, angioedema, rapidly progressing, life-threatening anaphylactic reactions, colitis including ischemic colitis

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

In case 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 effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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.

By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Dulcobis

Keep the medicine out of 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 how to dispose of 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 ingredient: 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 contains: 6 or 12 suppositories.
For further information, contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Ireland, the 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 (Fl), Italy

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Ireland, the country of export: PA23180/018/002
Parallel Import Licence Number: 84/24