Bisacodil Vp

Package Leaflet: 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 medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, so you can read it again if you need to.
• 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, pharmacist, or nurse. 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 a change in diet, 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 medicine (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. Page 1 5
• If the patient has severe dehydration.

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

Warnings and precautions

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

• Avoid prolonged 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, 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.
• Do not use the medicine without a doctor's recommendation in patients of any age for bowel evacuation before diagnostic tests and surgical procedures.

Bisacodyl VP and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan 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 large 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 medicines used in the past or those that will be used 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Bisacodyl VP should not be taken during pregnancy and breastfeeding, unless your doctor recommends otherwise.

Driving and using machines

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

Bisacodyl VP contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.
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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 Ponceau 4R (E 124)

The medicine may cause allergic reactions.

3. How to take Bisacodyl VP

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor. If you have any doubts, 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).
Bowel evacuation before diagnostic tests and surgical procedures:
The medicine 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 medicine is taken before bedtime.
If you feel that the effect of the medicine is too strong or too weak, consult your 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.

Overdose of Bisacodyl VP

In people 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 you miss a dose, 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 the missed dose.
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Stopping Bisacodyl VP

If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 (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, tell your doctor, pharmacist, or nurse. 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:
Aleje 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 side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisacodyl VP

Keep the medicine out of the 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 packaging. The expiry date refers to the last day of the month.
Medicines should 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 pack and other information

What Bisacodyl VP contains

• The active substance is bisacodyl.
• The 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), simethicone.

What Bisacodyl VP looks like and contents of the pack

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Bisacodyl VP is available in the form of enteric-coated tablets. The pack contains 30 tablets in a blister pack with an Al/PVC foil in a cardboard box.
For more detailed information, contact 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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 9800198

Parallel import authorization number: 279/14

Date of leaflet approval: 08.07.2024

[information about the trademark]
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