Dulcobis

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dulcobis (Dulcolax), 5 mg, enteric-coated tablets

Bisacodyl
Dulcobis and Dulcolax are different trade names for the same drug.
The entire leaflet should be read carefully, 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 5 days, they should contact their 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 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 disease,
• if the patient has lost a lot of water,
• if the patient experiences severe abdominal pain accompanied by nausea and vomiting - this may indicate a more serious condition,
• 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 a longer period, they should consult a doctor to investigate the cause of constipation,

because prolonged and excessive use can lead to disturbances in fluid and electrolyte balance and a decrease in potassium levels in the blood (hypokalemia),

• if the patient experiences 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, the patient should stop taking Dulcobis and consult a doctor.

Patients may also observe the presence of blood in their 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) and not necessarily to 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

The doctor or pharmacist should be informed 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 taking excessive doses of Dulcobis. Electrolyte imbalance can lead to increased 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, the medicine should not be taken with medicinal 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, 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, thinks they may be pregnant, or plans to have a child, they 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 effects of Dulcobis on the ability to drive and use machines.
It should be remembered that due to abdominal cramps associated with constipation, dizziness and/or fainting may occur. 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 in one enteric-coated tablet.
If the patient has previously been diagnosed with an intolerance to certain sugars, they 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 a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The medicine is intended for short-term use. The treatment period with Dulcobis without consulting a doctor should not exceed 5 days.
Unless otherwise directed by a doctor, the following dosage is recommended:
Short-term treatment of constipation:
Adults (18 years and older): 1-2 enteric-coated tablets (5-10 mg) orally, once a day, before bedtime.
Adolescents and children over 10 years of age:
1-2 enteric-coated tablets (5-10 mg) orally, once a day, before bedtime.
Treatment should be started with the lowest dose. The dose can be adjusted to the highest recommended dose to achieve regular bowel movements.
The maximum daily dose should not be exceeded.
Children between 4 and 10 years of age:
1 enteric-coated tablet (5 mg) orally, once a day, before bedtime.
The maximum daily dose should not be exceeded.
Children under 10 years of age 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 (not milk - see "Taking Dulcobis with food and drink"). The tablets should not be chewed.
Preparation for diagnostic tests and surgical procedures:
Dulcobis should be used under medical supervision during preparation for tests or before surgical procedures.
Adults (18 years and older):
to achieve complete bowel emptying, 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., 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

In case of taking a higher dose of Dulcobis than recommended, a doctor or pharmacist should be consulted.
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), hypokalemia, and kidney stones may occur. Chronic abuse of laxatives has also been reported to cause damage to the renal tubules (a form of kidney damage), metabolic alkalosis (a condition where there is more base than acid in the body), and muscle weakness due to low potassium levels in the blood.

Missing a dose of Dulcobis

A double dose should not be taken to make up for a missed dose of Dulcobis.
In case of missing a dose, it should be taken as soon as the patient remembers.

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.

In case of any further doubts about taking the medicine, a doctor or pharmacist should be consulted.

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):abdominal discomfort, vomiting, blood in stool, anal discomfort, dizziness
Rare (occurring in less than 1 in 1000 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 related to constipation (straining during bowel movements, abdominal pain) and not necessarily to 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, the use of Dulcobis should be stopped and a doctor or the Emergency Department of the nearest hospital should be contacted immediately.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Pharmacovigilance of 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Dulcobis

Keep out of sight and reach of children.
Do not store above 25°C. Store the blister 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 month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. 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 mg of bisacodyl.
• Other ingredients: lactose monohydrate, corn starch, modified starch (corn, oxidized), 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/Al or PVC/Al blisters in a cardboard box.
The pack contains: 20, 40, or 60 enteric-coated tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Ireland, the country of export:

Opella Healthcare France SAS, T/A Sanofi
82 Avenue Raspail
94250 Gentilly
France

Manufacturer:

Delpharm Reims S.A.S., 10 Rue Colonel Charbonneaux, 51100 Reims, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Ireland, the country of export:PA23180/018/003
Parallel import authorization number:108/23

Date of leaflet approval: 07.06.2023

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