Bisacodil Vp

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Bisacodyl VP (Fenolax) ,

5 mg, enteric-coated tablets

Bisacodylum
Bisacodyl VP and Fenolax are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
your doctor.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

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. Contents of the packaging 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 a change in diet, constipation in the postoperative period and others).
• Emptying the intestine 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 you are allergic (hypersensitive) to bisacodyl or any of the other ingredients of this medicine (listed in section 6).
• If you have an acute abdominal condition that requires surgical intervention (including intestinal obstruction, appendicitis).
• If you have Crohn's disease.
• If you have ulcerative colitis.
• If you have gastrointestinal bleeding.
• If you have severe dehydration.

You should consult a doctor, even if the above warnings refer to situations that occurred in the past.

Warnings and precautions

Before starting to use Bisacodyl VP, you should discuss it with your doctor or pharmacist.

• You should avoid long-term and systematic use of bisacodyl, as it leads 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, you should 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 medicine should not be used without a doctor's recommendation.
• The medicine should not be used without a doctor's recommendation in patients of any age for the purpose of emptying the intestine before diagnostic tests and surgical procedures.

Bisacodyl VP and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan 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, but these disorders are mainly observed when Bisacodyl VP is used in doses higher than recommended.

The information in this leaflet may also apply to medicines 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child, you should consult a doctor or pharmacist before using this medicine.
Bisacodyl VP should not be used during pregnancy and breastfeeding, unless your doctor recommends otherwise.

Driving and using machines

Bisacodyl VP has no effect on the ability to drive vehicles and operate machinery.

Bisacodyl VP contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.

Bisacodyl VP contains sodium

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

Bisacodyl VP contains carmoisine

The medicine may cause allergic reactions.

3. How to use Bisacodyl VP

This medicine should always be used exactly as described in the patient leaflet or as directed by
your doctor. If you are unsure, you should consult a 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 a day (usually at night).
Children aged 4 to 10 years:
Orally, 5 mg (1 tablet) once a day (usually at night).
Emptying the intestine before diagnostic tests 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 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 medicine is taken before bedtime.
If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Use in children

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

Using a higher dose of Bisacodyl VP than recommended

In people who have overdosed on bisacodyl, the following may occur: diarrhea, abdominal cramps, and water and electrolyte balance disorders that can cause increased potency of digitalis glycosides in patients taking them concomitantly, and other serious consequences. In case of overdose, you should contact a doctor.

Missing a dose of Bisacodyl VP

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

Stopping the use of Bisacodyl VP

If you have any further doubts about the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare (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 the available data):

• abdominal pain and diarrhea.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects, you can help provide more information on the safety of the medicine.

5. How to store Bisacodyl VP

The medicine 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 medicine after the expiry date stated on the carton after "Expiry date (Годен до)". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bisacodyl VP contains

• The active substance of the medicine is bisacodyl.
• The 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 (E 171), carmoisine (E 124) lake, simethicone.

What Bisacodyl VP looks like and what the packaging contains

Bisacodyl VP is available in the form of enteric-coated tablets. The packaging contains 30 tablets in a blister pack with Al/PVC foil in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Number of the marketing authorization in Bulgaria, the country of export: 9800198
Number of the parallel import authorization: 294/22
Date of approval of the leaflet: 28.07.2022
[Information about the trademark]