NOTICE
ANSM - Updated on : 25/12/2023
Product name
BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet
Bisacodyl
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 10 days.
What does this leaflet contain?
1. What is BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet and what is it used for?
2. What do I need to know before taking BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet?
3. How should BISACODYL BIOGARAN CONSEIL 5 mg gastro-resistant tablet be taken?
4. What are the possible side effects?
5. How should BISACODYL BIOGARAN CONSEIL 5 mg gastro-resistant tablet be stored?
6. Package contents and other information.
1. WHAT IS BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: stimulant laxatives - ATC code: A06AB02.
This medicine is indicated for the short-term treatment of occasional constipation.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet?
Never take BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet
- if you are allergic to bisacodyl or to any of the other ingredients listed in section 6,
- if you have bowel and/or colon disease, such as ulcerative colitis, Crohn's disease, intestinal obstruction,
- if you have acute abdominal pain such as appendicitis,
- if you have severe abdominal pain associated with nausea and vomiting, which may be a sign of the above-mentioned severe diseases,
- if you suffer from severe dehydration,
- in children under 6 years of age.
If in doubt, ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking BISACODYL BIOGARAN CONSEIL.
Unless otherwise advised by your doctor, this medicine should not be used during pregnancy, or in association with medicines that cause certain heart problems (torsade de pointes).
For constipation, do not use for longer than 8-10 days without medical advice.
Occasional constipation
This may be due to a recent change in lifestyle (e.g., travel). The drug can be used as a short-term treatment. Any recent constipation unexplained by a change in lifestyle, or any constipation accompanied by pain, fever or swelling of the abdomen, should be referred to a doctor.
Chronic constipation (long-term constipation)
There are two possible causes of chronic constipation:
- or an intestinal disease requiring medical attention;
- or an imbalance in bowel function due to dietary and lifestyle habits.
Treatment includes:
- increasing dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit, etc.);
- increased consumption of water and fruit juices;
- increased physical activity (sports, walking, etc.);
- reeducation of the defecation reflex;
- sometimes adding bran to the diet.
Children and adolescents
BISACODYL BIOGARAN CONSEIL should not be used in children under 6 years of age.
BISACODYL BIOGARAN CONSEIL should not be used in children under 12 years of age without medical advice.
The treatment of constipation in children is based on healthy lifestyle and dietary measures, in particular the use of the right amount of water with infant milk powders, a diet rich in plant-based products, and the addition of fruit juices.
Intestinal fluid loss can lead to dehydration. Symptoms may include thirst and reduced urine output (oliguria). If you feel dehydrated, or if dehydration could be dangerous for you (e.g. in cases of kidney failure or in the elderly), bisacodyl should be stopped and only resumed under medical supervision.
Other medicines and BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet
To avoid possible interactions between several medicines, in particular medicines causing certain cardiac disorders (torsade de pointes), inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
If you are taking milk, antacids or proton pump inhibitors, the acidity of the upper gastrointestinal tract may be reduced, and the gastro-resistant coating may dissolve prematurely. When taking drugs from the digitalis family, an imbalance in electrolyte levels may be observed, leading to increased sensitivity to digitalis.
Concomitant use of diuretics and corticosteroids may increase the risk of electrolyte imbalance if excessive doses of BISACODYL BIOGARAN CONSEIL are taken, with an increased risk of hypokalemia (additive effect).
BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The use of this medicine is not recommended during pregnancy or while breast-feeding.
If you discover that you are pregnant during treatment, consult your doctor immediately; only he/she will be able to adapt the treatment to your condition.
No human fertility studies have been performed.
Driving and use of machinery
BISACODYL BIOGARAN CONSEIL has a minor effect on the ability to drive and use machines.
BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet contains lactose and sodium.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
Adults : 1 to 2 tablets a day.
If diarrhea occurs, reduce dosage.
Method of administration
Take by mouth.
Tablets should be swallowed with a little water, without chewing.
Frequency of administration
Preferably in the evening, at bedtime.
Duration of treatment
The duration of treatment is limited to 8-10 days.
Use in children
Children over 6 years: 1 tablet per day. Children under 12 years of age should only be treated on the advice of a doctor.
If diarrhea occurs, reduce dosage.
If you have taken more BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet than you should have
Prolonged use or overdosage may lead to diarrhoea with excessive loss of water and electrolytes, particularly potassium.
Laxatives, when taken in chronic overdose, can lead to chronic diarrhea, abdominal pain, hypokalemia and kidney stones. Metabolic alkalosis and muscle weakness following hypokalemia have also been described when laxatives are taken chronically in excess.
Consult your doctor or pharmacist immediately.
If you forget to take BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
- Risk of diarrhoea and abdominal pain, particularly in patients suffering from irritable bowel syndrome.
- Hypokalemia (decrease in potassium levels in the blood).
- Abnormal coloring of urine.
- Severe allergic reactions, angioedema, hypersensitivity.
- Abdominal cramps, intestinal inflammation, nausea, vomiting.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What BISACODYL BIOGARAN CONSEIL 5 mg gastro-resistant tablet contains
- The active substance is :
Bisacodyl......................................................................................................................... 5 mg
For one gastro-resistant tablet.
- The other components are :
Lactose monohydrate, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.
Gastro-resistant coating: Triacetin, OPADRY 03K19229 (triacetin, hypromellose, talc), Acryl-Eze 93A18597 (methacrylic acid, talc, titanium dioxide (E171), sodium bicarbonate, colloidal anhydrous silica, sodium lauryl sulfate).
What is BISACODYL BIOGARAN CONSEIL 5 mg, gastro-resistant tablet and what does it contain?
This medicine comes in the form of a round, white, biconvex, gastro-resistant tablet.
Box of 30 gastro-resistant tablets in blister packs (PVC/Aluminium).
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
LABORATOIRES MACORS
RUE DES CAILLOTTES
ZI PLAINE DES ISLES
89000 AUXERRE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.