Bisacodyl vp

Patient Information Leaflet

Warning! Keep this leaflet! The packaging label is in a foreign language.
Bisacodyl VP (Fenolax)
5 mg, enteric-coated tablets
Bisacodylum
Bisacodyl VP and Fenolax are different brand names for the same medicine.
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 doctor.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, contact your 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 water and electrolytes not absorbed in the large intestine.

Bisacodyl VP is indicated for:

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

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 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 any of the above warnings relate to conditions that occurred in the past.

Warnings and precautions

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

• Avoid long-term and regular use of bisacodyl, as this 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.
• In children under 10 years of age with chronic constipation, do not use this medicine without medical advice.
• Do not use this medicine without medical advice in patients of any age for bowel cleansing prior to diagnostic examinations or surgical procedures.

Bisacodyl VP and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Concomitant use of Bisacodyl VP with:

• antacids (medicines that neutralize gastric acid) increases the risk of gastric mucosal irritation. Bisacodyl VP should be taken at least 1 hour after taking an antacid,
• cardiac glycosides (e.g. digoxin), may enhance their effects due to disturbances in water-electrolyte balance, especially when bisacodyl is 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.

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 mucosal 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 or breastfeeding unless otherwise advised by a doctor.

Driving and operating machinery

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

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 (E 124) lake

The medicine may cause allergic reactions.

3. How to use Bisacodyl VP

This medicine should always be taken exactly as described in this 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 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 impaired kidney or liver function
Dose adjustment is not required.
Tablets should be swallowed whole (do not chew or crush) and taken with plenty of water.
Bisacodyl is absorbed from the gastrointestinal tract in minimal amounts. Bowel movement usually occurs about 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
In children under 10 years of age with chronic constipation, this medicine must not be used without medical advice.
This medicine must 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, cramp-like abdominal pain and disturbances in water-electrolyte balance may occur. These disturbances may enhance the effects of cardiac glycosides (e.g. digoxin) in patients taking them concomitantly, leading to other serious adverse effects.
In case of overdose, contact your doctor immediately.
Missed dose of Bisacodyl VP
If you have missed 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 treatment with 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 unknown (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 the leaflet, inform a 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, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects enables more 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 required. Such measures 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: Tablet core: potato starch, monohydrate lactose, talc, magnesium stearate, gelatin.

Coating: methacrylic acid and ethyl acrylate copolymer (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 responsible party or the parallel importer.

Responsible party in Bulgaria, country of export:
Mylan EOOD
Office building “Serdika Offices”
Sitnyakovo Blvd. 48, fl. 7
1505 Sofia
Bulgaria

Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa Street 2
35-959 Rzeszów
Poland

Parallel importer:
InPharm Sp. z o.o.
Strumykowa Street 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska Street 249
04-458 Warsaw
Poland

Marketing authorization number in Bulgaria, country of export: 9800198
Parallel import authorization number: 283/15