Bisacodil Vp

Package Leaflet: Information for the User

Warning: Immediate Packaging in a Foreign Language! Keep the Leaflet!

Bisacodyl VP (Fenolax)

5 mg, enteric-coated tablets
Bisacodylum
Bisacodyl VP and Fenolax are different trade names for the same drug.

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This medication should always be taken exactly as described in the patient leaflet or as directed by the doctor.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Bisacodyl VP and what is it used for
• 2. Important information before taking Bisacodyl VP
• 3. How to take Bisacodyl VP
• 4. Possible side effects
• 5. How to store Bisacodyl VP
• 6. Contents of the pack 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 taking Bisacodyl VP

When not to take 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. Consult a doctor, even if the above warnings apply to past situations.

Warnings and precautions

Before starting Bisacodyl VP, discuss it with your doctor or pharmacist.

• Avoid long-term and systematic use of bisacodyl, 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 daily, try to determine the cause of constipation.
• Do not use in abdominal pain of unknown cause, when nausea or vomiting occurs.
• In patients taking laxatives, dizziness and/or fainting have been reported 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

Tell your doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Taking 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 taken in high doses,
• diuretics or corticosteroids increases the risk of water and electrolyte balance disorders, but these disorders are mainly observed when Bisacodyl VP is taken in doses higher than recommended.

The information in this leaflet may also apply to medications taken in the past or to be taken in the future.

Bisacodyl VP with food and drink

Taking 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 they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Bisacodyl VP should not be taken during pregnancy and breastfeeding, unless a doctor recommends otherwise.

Driving and using 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, they should consult their doctor before taking the medication.

Bisacodyl VP contains sodium

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

Bisacodyl VP contains carmoisine

The medication may cause allergic reactions.

3. How to take Bisacodyl VP

This medication should always be taken exactly as described in the patient leaflet or as directed by the doctor. In case of doubt, consult a doctor or pharmacist.
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 old:
Orally, 5 mg (1 tablet) once a day (usually at night).
Bowel evacuation before diagnostic tests and surgical procedures:
The medication should be taken 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 old:
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.
Elderly patients, 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 bedtime.
If the patient feels that the medication is too strong or too weak, they should consult their doctor.

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 cause increased effects of digitalis glycosides in patients taking them concurrently, and other serious consequences. In case of overdose, consult a doctor.

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 close to the time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Bisacodyl VP

In case of further doubts about taking the medication, consult a doctor or pharmacist.

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, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 side effects can help gather more information on the safety of the medication.

5. How to store Bisacodyl VP

Keep the medication 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 expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bisacodyl VP contains

• The active substance is bisacodyl.
• Other ingredients are:
• Tablet 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 (E 171), carmoisine (E 124) lake, simethicone.

What Bisacodyl VP looks like and contents of the pack

Bisacodyl VP is available in the form of enteric-coated tablets. The pack contains 30 tablets in a blister pack with an aluminum/PVC foil in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Mylan EOOD, "Serdika offices" office building, 48 Sitnyakovo Blvd., 7 floor, 1505 Sofia, Bulgaria

Manufacturer

ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów, Poland

Parallel importer:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Cesky Tesin, Czech Republic

Repackaged by:

Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY, ul. Wł. Żeleńskiego 45, 31-353 Kraków, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Marketing authorization number in Bulgaria, the country of export: 9800198

Parallel import authorization number: 440/19

Date of leaflet approval: 13.11.2024

[Information about the registered trademark]