Bisacodyl vp

Package leaflet: Information for the user

Warning! Please keep this leaflet. 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 medicinal product.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 7 days or if your condition worsens, consult your doctor.

Table of contents of the leaflet

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 large intestine.

Bisacodyl VP is indicated for the following uses:

• Constipation of various origins (habitual and chronic constipation in bedridden patients, habitual constipation in the elderly, constipation following dietary changes, postoperative constipation, and others).
• Bowel evacuation prior to diagnostic examinations and surgical procedures (e.g. rectoscopy, cholecystography, urography, abdominal X-ray diagnostics, radiological imaging of the lumbar-sacral spine segment).

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. Page 1 of 5
• If the patient has severe dehydration.

Consult a doctor, even if the above warnings refer to conditions that occurred
in the past.
Warnings and precautions
Before starting to use Bisacodyl VP, discuss it with your doctor or pharmacist.

• Avoid long-term 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 and electrolyte balance (including decreased potassium levels in blood).
• If laxatives are required daily, the underlying cause of constipation should be investigated.
• Do not use in cases of abdominal pain of unknown origin, when nausea or vomiting occur.
• In patients taking laxatives, dizziness and/or fainting during defecation have been reported.
• In children under 10 years of age with chronic constipation, do not use this medicine without a doctor's recommendation.
• Do not use this medicine without a doctor's recommendation 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 the patient plans to 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 effects due to disturbances in water and electrolyte balance, especially when used in high doses,
• diuretics or corticosteroids increases the risk of water and electrolyte imbalance; however, such disturbances are mainly observed when Bisacodyl VP is used in doses higher than recommended.

The 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 have a child, she should consult a doctor or pharmacist before using this medicine.
Bisacodyl VP should not be used during pregnancy and breastfeeding unless otherwise advised by a doctor.
Driving and operating machinery
Bisacodyl VP has no effect on the ability to drive motor vehicles or operate mechanical equipment.
Bisacodyl VP contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Page 2 of 5
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 (E 124)
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 dosage is:
Short-term treatment of constipation:
Adults and children over 10 years of age:
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 of age:
Orally, 10 mg (2 tablets) in the morning and 10 mg (2 tablets) in the evening on the day before the examination or procedure. Usually, on the day of the procedure, additional administration of bisacodyl rectally in the form of a suppository is recommended.
Children aged 4 to 10 years:
Orally, 5 mg (1 tablet) in the evening on the day before the examination or procedure. Usually, on the day of the procedure, additional administration of bisacodyl rectally in the form of a suppository is recommended.

Elderly patients, patients with renal or hepatic impairment:
Dosage adjustment is not required.
Tablets should be swallowed whole (do not chew or crush) and taken with plenty of water.
Bisacodyl is minimally absorbed from the gastrointestinal tract. Defecation usually occurs approximately 6 hours after oral administration; after 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 should not be used in children under 10 years of age with 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 diarrhoea, abdominal cramps, and disturbances in water-electrolyte balance may occur. These disturbances may enhance the effect of cardiac glycosides in patients taking them concomitantly, leading to other 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.
Page 3 of 5

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 they do not occur in everyone.
Very rare (in less than 1 in 10,000 patients):

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

Frequency unknown (frequency cannot be determined 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, please inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse effects enables further information on the safety of the medicine to 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 packaging. 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 in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Bisacodyl VP contains

• The active substance is bisacodyl.
• Other ingredients are:
  Tablet 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), simethicone.

What Bisacodyl VP looks like and contents of the pack
Page 4 of 5
Bisacodyl VP is available as enteric-coated tablets. The pack contains 30 tablets in an Al/PVC foil blister pack within a cardboard box.

For further information, please contact the responsible party or parallel importer:
Responsible party in Bulgaria, country of export:
Mylan EOOD
“Serdika offices” office building
48, Sitnyakovo Blvd., 7th floor
1505 Sofia
Bulgaria
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów
Parallel importer:
Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111 Street
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111 Street
91-222 Łódź
Bulgaria, country of export, marketing authorisation number: 9800198
Parallel import authorisation number: 279/14
Page 5 of 5