Bisacodil Vp

Leaflet attached to the packaging: information for the user

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 drug.

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

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

• You should keep this leaflet, so that you can read it again if necessary.
• If you need advice or additional information, you should 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 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, radiodiagnosis of the abdominal cavity, 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 drug (listed in section 6).
• If the patient has an acute abdominal disease 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.

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 drug should not be used without a doctor's recommendation.
• The drug 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 drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs 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 contained in this leaflet may also apply to drugs 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 your doctor or pharmacist before using this drug.
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 been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the drug.

Bisacodyl VP contains sodium

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

Bisacodyl VP contains Ponceau 4R (E 124) lake

The drug may cause allergic reactions.

3. How to use Bisacodyl VP

This drug should always be used exactly as described in the patient leaflet or as directed by
the doctor. If you have any doubts, you should consult your 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).

Emptying the intestine before diagnostic tests and surgical procedures

The drug 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 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
about 6 hours after oral administration; after 6-12 hours if the drug is taken before bedtime.
If you feel that the effect of the drug is too strong or too weak, you should consult your doctor.

Use in children

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

Missing a dose of Bisacodyl VP

If you miss a dose of the drug 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 drug, you should consult your doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug 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 side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 gather more information on the safety of the drug.

5. How to store Bisacodyl VP

The drug 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 drug after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Bisacodyl VP contains

• The active substance of the drug 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), Ponceau 4R (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 in a cardboard box.