NOTICE
ANSM - Updated on: 07/29/2019
Name of the drug
BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet
Bisacodyl
Box
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
You should always take this medication by carefully following the information provided in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 10 days.
· Keep this medicine out of the reach of children.
What does this booklet contain ?
1. What is BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet and in which cases is it used?
2. What you need to know before you take BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet?
3. How to take BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet?
4. What are the possible side effects?
5. How to store BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet?
6. Contents of the pack and other information.
1. WHAT IS BISACODYL MYLAN TIP 5 mg, gastro-resistant coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: stimulant laxative - ATC code: A06AB02.
Stimulating laxatives work by stimulating the lower part of the intestine.
This medication is recommended in case of occasional constipation.
BISACODYL MYLAN CONSEIL does not help lose weight; it does not affect the absorption of calories or nutrients.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISACODYL MYLAN ADVICE 5 mg, coated gastro-resistant tablet?
Do not take BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet:
· if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
· severe dehydration,
· in children under 6,
· certain diseases of the intestine and colon (ulcerative colitis and other inflammatory diseases),
· abdominal pain (stomach pain) of unknown origin, which may be a sign of serious illness,
· chronic constipation.
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet .
Special warnings
NO EXTENDED USE (MORE THAN 10 DAYS) WITHOUT MEDICAL ADVICE.
Occasional constipation:
It can be linked to a change in lifestyle (travel). The drug can be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, any constipation accompanied by pain, fever, swelling of the belly must seek the advice of the doctor.
Chronic constipation (long-term constipation):
It should not be treated with a stimulant laxative.
It can be linked to two causes:
· either a disease of the intestine which requires treatment by the doctor,
· or an imbalance of intestinal function due to eating habits and lifestyle.
The treatment includes among others:
· an increase in food intake of products of plant origin (green vegetables, raw vegetables, wholemeal bread, fruit ...),
· increased consumption of water and fruit juice,
· increased physical activity (sports, walking, etc.),
· re-education of the defecation reflex,
· sometimes adding bran to food.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Dizziness and fainting, which can occur during defecation, have been reported.
Precautions for use
This medication can cause potassium loss.
In patients with precarious water balance (for example renal insufficiency or elderly patients), BISACODYL MYLAN CONSEIL must be interrupted and must be reinstated only under medical supervision, because of the increased risk of dehydration by intestinal fluid losses.
Symptoms can be thirsty and a decrease in the amount of urine (oliguria).
Patients may have blood in their stools (rectal bleeding), which is usually mild and self-limiting. In case of rectal bleeding, consult a doctor.
Using other laxatives at the same time as BISACODYL MYLAN CONSEIL may increase the gastrointestinal effects of BISACODYL MYLAN CONSEIL .
This medication should generally NOT be used unless your doctor advises otherwise in combination with: amiodarone, bretylium, disopyramide, quinidinics, sotalol, astemizole, bepridil, erythromycin IV, halofantrine , pentamidine, sultopride, terfenadine, vincamine.
IF IN DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Children and adolescents
In children, the treatment of constipation is based on lifestyle and dietetic measures: in particular the use of the right amount of water with infant milk powders, a diet rich in products of plant origin, the addition of Juice.
Treatment with a stimulant laxative without medical advice is contraindicated (regular use of laxatives at a young age can interfere with the normal functioning of the defecation reflex).
Other medicines and BISACODYL MYLAN CONSEIL 5 mg, gastro-resistant coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
BISACODYL MYLAN TIP 5 mg, gastro-resistant coated tablet with food and drink
Not applicable.
Pregnancy and breast feeding
Pregnancy
The use of this medication is not recommended during pregnancy.
Feeding with milk
The use of this medication is possible during breastfeeding.
Tell your doctor if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
The effects of BISACODYL MYLAN CONSEIL on the ability to drive and use machines have not been studied.
However, dizziness and / or syncope may occur due in particular to abdominal spasms. In case of abdominal spasms, avoid potentially dangerous activities such as driving and using machines.
BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet contains lactose monohydrate, sucrose and sodium.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. that it is essentially "sodium-free".
3. HOW TO TAKE BISACODYL MYLAN TIP 5 mg, gastro-resistant coated tablet?
Always take this medication exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
· In adults : 1 or 2 tablets maximum per day.
· Children up to 12 years of age with chronic or persistent constipation should be treated only under the guidance of a doctor.
In children over 6 years old: the use of a stimulant laxative is exceptional and exclusively on medical prescription: 1 tablet per day for two to ten days.
It is recommended to start treatment with the lowest dose. The dose can then be adjusted up to the dose to obtain regular bowel movements.
Do not exceed the maximum daily dose.
You should avoid taking products that reduce stomach acid at the same time, such as alkaline medicines, antacids, proton pump inhibitors or milk, so as not to dissolve prematurely. coating the tablet.
THIS MEDICATION HAS BEEN PROVIDED TO YOU PERSONALLY IN A SPECIFIC SITUATION: IT MAY NOT BE SUITABLE FOR ANY OTHER CASE.
DO NOT ADVISE IT TO ANOTHER PERSON.
Administration mode
The tablets should be swallowed without being chewed.
Frequency of administration
Take in the evening (effect 10 hours after) or in the morning on an empty stomach (effect 5 hours after).
Duration of treatment
No prolonged use, more than 10 days without medical advice.
If you take more BISACODYL MYLAN CONSEIL 5 mg, gastro-resistant coated tablet than you should:
Immediately consult your doctor or pharmacist.
Correction of hydroelectrolytic disorders in the event of very large fluid loss may be necessary. This is particularly important in the elderly and young people. Administration of antispasmodics may be helpful.
If you forget to take BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet:
Not applicable.
If you stop taking BISACODYL MYLAN CONSEIL 5 mg, coated gastro-resistant tablet:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects reported during treatment are abdominal pain and diarrhea.
The evaluation of adverse reactions is based on the following frequencies:
Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Frequency not known: cannot be estimated from the available data
Immune system disorders
· Rare: anaphylactic reactions, angioedema
Skin and subcutaneous tissue disorder
· Rare: generalized pruritus (allergic reaction)
Metabolism and nutrition disorders
· Rare: dehydration
· Not known: decrease in blood potassium level
Nervous system disorders
· Uncommon: dizziness
· Rare: syncope
Taking bisacodyl can cause abdominal pain related to abdominal spasms and / or defecation which can cause dizziness or fainting.
Gastrointestinal disorders
· Common: abdominal pain, diarrhea, nausea
· Uncommon: blood in stool (rectal bleeding), anorectal discomfort (burning sensation and anorectal pain), vomiting
· Rare: colitis including ischemic colitis (insufficient blood supply to the colon which can cause tissue death)
If you notice any side effects not listed in this leaflet, or if some side effects become serious, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BISACODYL MYLAN TIP 5 mg, gastro-resistant coated tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiration date refers to the last day of this month .
This medication does not require any special storage precautions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What BISACODYL MYLAN CONSEIL 5 mg contains, gastro-resistant coated tablet
· The active substance is:
bisacodyl ................................................. .................................................. ...................... 5 mg
for a coated gastro-resistant tablet.
· The other components are:
lactose monohydrate, microcrystalline cellulose, hyprolose, pregelatinized starch, magnesium stearate.
Coating : hypromellose, triethyl citrate, talc, Eudragit L100, Eudragit S100, sucrose, magnesium stearate, titanium dioxide, yellow iron oxide, carnauba wax.
What is BISACODYL MYLAN CONSEIL 5 mg, gastro-resistant coated tablet and contents of the pack
This medication is in the form of a yellow, round, biconvex, coated gastro-resistant tablet.
Box of 20, 25, 30 tablets in blister packs (PVC / Aluminum) or (white opaque PVC / PVDC / Aluminum).
Not all presentations may be marketed.
Marketing authorization holder
MYLAN SAS
117 Allée des Parcs
69800 Saint Priest
Marketing authorization operator
MYLAN SAS
117 Allée des Parcs
69800 Saint Priest
Maker
MEDIS INTERNATIONAL as
Výrobní závod Bolatice
Prúmyslová 961/16, Bolatice, 747 23,
CZECH REPUBLIC
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this drug is available on the ANSM website (France).