BISACODYL VP

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging in a foreign language!
Bisacodyl VP ( Fenolax) ,
5 mg, enteric-coated tablets
Bisacodylum
Bisacodyl VP and Fenolax are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, 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 physician.

• Keep this leaflet for future reference.
• If advice or additional 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 or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, consult a doctor.

Table of contents

1. What Bisacodyl VP is and what it is 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 Bisacodyl VP is and what it is used for

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

• enhancing intestinal contractions and stimulating peristaltic movements,
• increasing the amount of unabsorbed water and electrolytes in the colon.

Bisacodyl VP is indicated for:

• Constipation of various origins (habitual and chronic constipation in bedridden patients, habitual constipation in elderly individuals, constipation due to dietary changes, postoperative constipation, and others).
• Bowel evacuation prior to diagnostic examinations and surgical procedures (e.g. rectoscopy, cholecystography, urography, abdominal X-ray imaging, radiological imaging of the lumbar-sacral 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 medicine (listed in section 6).
• If the patient has an acute abdominal condition requiring surgical intervention (including, among others, 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 relate to conditions that occurred
in the past.
Warnings and precautions
Before starting to use Bisacodyl VP, discuss this with your doctor or pharmacist.

• Avoid prolonged and regular use of bisacodyl, as it may lead to worsening constipation and inability to defecate without increasingly stronger laxatives, and may cause disturbances in water-electrolyte balance (including decreased blood potassium levels).
• If laxatives are required daily, the underlying cause of constipation should be investigated.
• Do not use in cases of abdominal pain of unknown origin, especially when nausea or vomiting is present.
• In patients taking laxatives, dizziness and/or fainting during defecation have been reported.
• Bisacodyl VP should not be used in children under 10 years of age with chronic constipation without medical advice.
• Do not use Bisacodyl VP without medical advice in patients of any age for bowel cleansing prior to diagnostic examinations or surgical procedures.

Bisacodyl VP and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Concomitant use of Bisacodyl VP with:

• antacids (medicines that neutralize gastric acid) increases the risk of gastric mucosa irritation. Bisacodyl VP should be taken at least 1 hour after taking an antacid,
• cardiac glycosides (digitalis glycosides), may enhance their effect due to disturbances in water-electrolyte balance, especially when used in high doses,
• diuretics or corticosteroids increases the risk of water-electrolyte imbalance; however, such disturbances are mainly observed when Bisacodyl VP is used in doses higher than recommended.

Information contained in this leaflet may also apply to medicines previously used or those to be used in the future.
Bisacodyl VP with food and drink
Concomitant use of Bisacodyl VP with milk may increase the risk of gastric mucosa irritation. Bisacodyl VP should be taken at least 1 hour after drinking milk.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Bisacodyl VP should not be used during pregnancy or breastfeeding unless otherwise advised by a doctor.
Driving and operating machinery
Bisacodyl VP has no influence on the ability to drive motor vehicles or operate mechanical equipment.
Bisacodyl VP contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Bisacodyl VP contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Bisacodyl VP contains carmine (cochineal red)
The medicine may cause allergic reactions.

3. How to use Bisacodyl VP

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist. The usual dose is:

Short-term treatment of constipation:

Adults and children over 10 years: Orally, 5 mg to 10 mg (1 to 2 tablets) once daily (usually at bedtime).

Children aged 4 to 10 years: Orally, 5 mg (1 tablet) once daily (usually at bedtime).

Bowel evacuation prior to diagnostic examinations and surgical procedures: The medicine should be used under medical supervision.

Adults and children over 10 years: Orally, 10 mg (2 tablets) in the morning and 10 mg (2 tablets) in the evening the day before the examination or procedure. Usually, additional administration of bisacodyl as a rectal suppository on the day of the procedure is recommended.

Children aged 4 to 10 years: Orally, 5 mg (1 tablet) in the evening the day before the examination or procedure. Usually, additional administration of bisacodyl as a rectal suppository on the day of the procedure is recommended.

Elderly patients, patients with impaired kidney or liver function:
There is no need to modify the dose.

Tablets should be swallowed whole (do not chew or crush) and taken with plenty of water.

Bisacodyl is minimally absorbed from the gastrointestinal tract. Bowel movement usually occurs approximately 6 hours after oral administration; within 6–12 hours if the medicine is taken before bedtime. If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Use in children

Bisacodyl VP should not be used in children under 10 years of age for chronic constipation without medical advice.
This medicine should not be used in children under 4 years of age.

Use of a higher than recommended dose of Bisacodyl VP

In individuals who have overdosed on bisacodyl, symptoms such as diarrhea, cramp-like abdominal pain, and disturbances in water and electrolyte balance may occur. These disturbances may enhance the effects of cardiac glycosides (e.g. digoxin) in patients taking them concomitantly, leading to potentially serious consequences. In case of overdose, contact your doctor immediately.

Missed dose of Bisacodyl VP

If you miss a dose at the scheduled time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping Bisacodyl VP

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rare (in less than 1 in 10,000 patients):

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

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

• abdominal pain and diarrhoea.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your 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, phone: +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 the medicine can be collected.

5. How to store Bisacodyl VP

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the carton after “Expiry date (Годен до)”. 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 packaging and other information

What Bisacodyl VP contains

• The active substance is bisacodyl.
• The other ingredients are:
• Core: potato starch, monohydrate lactose, talc, magnesium stearate, gelatin.
• Coating: copolymer of methacrylic acid and ethyl acrylate (1:1), sodium hydroxide, triethyl citrate, polysorbate 20, talc, titanium dioxide (E 171), carmine red (E 124) lake, simethicone.

What Bisacodyl VP looks like and contents of the pack
Bisacodyl VP is available as enteric-coated tablets. The pack contains 30 tablets in an Al/PVC blister pack within a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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.
Przemysłowa Street 2
35-959 Rzeszów
Poland
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska Street 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka Street 190
91-610 Łódź
Bulgaria, country of export, Marketing Authorisation Number: 9800198
Parallel Import Licence Number: 294/22