Bisacodil Vp

Package Leaflet: Information for the User

Bisacodyl VP, 5 mg, Enteric-Coated Tablets

Bisacodyl

Read the Package Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in the patient information leaflet or as directed by the doctor.

• This 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 the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Bisacodyl VP and What is it Used For
• 2. Important Information Before Using Bisacodyl VP
• 3. How to Use Bisacodyl VP
• 4. Possible Side Effects
• 5. How to Store Bisacodyl VP
• 6. Package Contents and Other Information

1. What is Bisacodyl VP and What is it Used For

Bisacodyl VP is a laxative and carminative.
It acts on the large intestine by:

• increasing intestinal contractions and stimulating peristaltic movements,
• increasing the amount of unabsorbed water and electrolytes in the large intestine. Bisacodyl VP is used for the following indications:
• Constipation of various origins (habitual and chronic constipation in bedridden patients, habitual constipation in the elderly, constipation after dietary changes, constipation in the postoperative period, and others).
• Bowel evacuation before diagnostic tests and surgical procedures (e.g., rectoscopy, cholecystography, urography, abdominal radiodiagnostics, radiological images of the lumbosacral spine).

2. Important Information Before Using Bisacodyl VP

When Not to Use Bisacodyl VP

• If the patient is allergic (hypersensitive) to bisacodyl or any of the other ingredients of this medication (listed in section 6).
• If the patient has an acute abdominal condition requiring surgical intervention (including intestinal obstruction, appendicitis).
• If the patient has Crohn's disease.
• If the patient has ulcerative colitis.
• If the patient has gastrointestinal bleeding.
• If the patient has severe dehydration.

A doctor should be consulted, even if the above warnings refer to past situations.

Warnings and Precautions

Before starting to use Bisacodyl VP, the doctor or pharmacist should be consulted.

• Prolonged and systematic use of bisacodyl should be avoided, as it can lead to increased constipation and inability to defecate without using increasingly stronger laxatives, and may cause water and electrolyte balance disorders (including decreased potassium levels in the blood).
• If the use of laxatives is necessary every day, the cause of constipation should be sought.
• It should not be used for abdominal pain of unknown cause, when nausea or vomiting occurs.
• Dizziness and/or fainting have been reported in patients taking laxatives during defecation.
• In children under 10 years of age with chronic constipation, the medication should not be used without a doctor's recommendation.
• The medication should not be used without a doctor's recommendation in patients of any age for bowel evacuation before diagnostic tests and surgical procedures.

Bisacodyl VP and Other Medications

The doctor or pharmacist should be informed about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Concomitant use of Bisacodyl VP with:

• antacids increases the risk of stomach mucosa irritation. Bisacodyl VP should be taken at least 1 hour after taking an antacid,
• digitalis glycosides may enhance their effect by disrupting water and electrolyte balance, especially if used in high doses,
• diuretics or corticosteroids increases the risk of water and electrolyte balance disorders, although these disorders are mainly observed when Bisacodyl VP is used in doses higher than recommended.

The information in this leaflet may also apply to medications used in the past or those that will be used in the future.

Bisacodyl VP with Food and Drink

Concomitant use of Bisacodyl VP with milk may increase the risk of stomach mucosa irritation. Bisacodyl VP should be taken at least 1 hour after drinking milk.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medication.
Bisacodyl VP should not be used during pregnancy and breastfeeding, unless a doctor recommends otherwise.

Driving and Operating Machines

Bisacodyl VP does not affect the ability to drive vehicles or operate machinery.

Bisacodyl VP Contains Lactose

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medication.

Bisacodyl VP Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

Bisacodyl VP Contains Carmoisine

The medication may cause allergic reactions.

3. How to Use Bisacodyl VP

This medication should always be used exactly as described in the patient information leaflet or as directed by the doctor. In case of doubt, a doctor or pharmacist should be consulted.
Usually, the recommended dose is:
Short-term treatment of constipation:
Adults and children over 10 years old:
Orally, 5 mg to 10 mg (1 to 2 tablets) once a day (usually at night).
Children aged 4 to 10 years:
Orally, 5 mg (1 tablet) once a day (usually at night).
Bowel evacuation before diagnostic tests and surgical procedures:
The medication should be used under medical supervision.
Adults and children over 10 years old:
Orally, 10 mg (2 tablets) in the morning and 10 mg (2 tablets) in the evening on the day before the test or procedure. Usually, on the day of the procedure, it is recommended to use bisacodyl rectally in the form of a suppository.
Children aged 4 to 10 years:
Orally, 5 mg (1 tablet) in the evening on the day before the test or procedure. Usually, on the day of the procedure, it is recommended to use bisacodyl rectally in the form of a suppository.
The elderly, patients with renal or hepatic impairment:
No dose adjustment is necessary.

Tablets should be taken whole (not chewed or crushed), with plenty of water.

Bisacodyl is absorbed from the gastrointestinal tract in minimal amounts. Defecation usually occurs after about 6 hours after oral administration; after 6-12 hours if the medication is taken before sleep.
If the patient feels that the effect of the medication is too strong or too weak, a doctor should be consulted.

Use in Children

In children under 10 years of age with chronic constipation, the medication should not be used without a doctor's recommendation.
The medication should not be used in children under 4 years of age.

Overdose of Bisacodyl VP

In individuals who have overdosed on bisacodyl, the following may occur: diarrhea, abdominal cramps, and water and electrolyte balance disorders that can increase the effect of digitalis glycosides in patients taking them and cause other serious effects.
In case of overdose, a doctor should be consulted.

Missed Dose of Bisacodyl VP

If a dose is missed at the scheduled time, it should be taken as soon as possible.
However, if it is already close to the time for the next dose, the missed dose should be skipped.
A double dose should not be taken to make up for the missed dose.

Stopping Bisacodyl VP

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

4. Possible Side Effects

Like all medications, Bisacodyl VP can cause side effects, although not everybody gets them.
Very rare (less than 1 in 10,000 patients):

• allergic reactions, including isolated cases of angioedema and anaphylactoid reactions.

Frequency not known (frequency cannot be estimated from the available data):

• abdominal pain and diarrhea.

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Drug Reactions, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Bisacodyl VP

The medication should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medication after the expiration date stated on the carton after "EXP". The expiration date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Bisacodyl VP Contains

• The active substance of the medication is bisacodyl.
• Other ingredients are:
• Core: potato starch, lactose monohydrate, talc, magnesium stearate, gelatin.
• Coating: methacrylic acid and ethyl acrylate copolymer (1:1), sodium hydroxide, triethyl citrate, polysorbate 20, talc, titanium dioxide (E171), carmoisine (E124) lake, simethicone.

What Bisacodyl VP Looks Like and What the Package Contains

Bisacodyl VP is available in the form of enteric-coated tablets. The package contains 30 tablets in a blister pack of Al/PVC foil in a cardboard box.

Marketing Authorization Holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów
Date of Last Revision of the Leaflet:April 2025