NOTICE
ANSM - Last updated: 14/11/2016
Name of the medicinal product
CONTALAX, gastro-resistant tablet
bisacodyl
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed 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 experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 10 days.
Do not use this medication for children.
What is in this leaflet?
1. What is CONTALAX, an enteric-coated tablet and in which cases it is used?
2. What do you need to know before taking CONTALAX Gastro-Resistant Tablets?
3. How to take CONTALAX Gastro-Resistant Tablets?
4. What are the possible side effects?
5. How to store CONTALAX Gastro-resistant tablets?
6. Package contents and other information.
1. WHAT CONTALAX is a gastro-resistant tablet AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - ATC code: A06AB02
STIMULANT LAXATION
(A: digestive system and metabolism)
This medication is indicated in the short-term treatment of occasional constipation.
2. BEFORE YOU TAKE CONTALAX, Gastro-Resistant Tablets?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take CONTALAX, gastro-resistant tablets:
· if you are allergic (hypersensitive) to bisacodyl or to any of the other ingredients of this medication mentioned in section 6.
· if you have bowel and / or colon disease, such as ulcerative colitis, Crohn's disease, intestinal occlusion.
· if you have abdominal pain (stomach pains).
· if you suffer from severe dehydration.
This medication SHOULD NOT BE USED unless your doctor tells you otherwise during pregnancy or in combination with certain medications that cause certain heart problems (peak torsade).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Talk to your doctor or pharmacist before taking CONTALAX, an enteric-coated tablet.
Special warnings
IN THE CONTEXT OF CONSTIPATION, NO EXTENDED USE (ABOVE 8-10 DAYS) WITHOUT MEDICAL ADVICE.
Occasional constipation
It may be related to a recent change in lifestyle (eg travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation)
It can be linked to two causes:
· a bowel disease that requires a physician to take care of;
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);
· increased consumption of water and fruit juices;
· an increase in physical activities (sports, walking, etc.);
· rehabilitation of the defecation reflex;
· sometimes, adding sound to the diet.
Precautions for use
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
children
In children, the treatment of constipation is based on lifestyle and dietary measures: in particular use of the right amount of water with infant milk powders, a diet rich in vegetable products, of fruit juice.
Other drugs and CONTALAX, gastro-resistant tablet
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, especially medicines with certain cardiac disorders (torsade de pointe), INFORM YOUR DOCTOR OR PHARMACIST IF YOU TAKE, HAVE RECENTLY TAKEN OR MAY TAKE ANY OTHER MEDICINE.
CONTALAX, gastro-resistant tablets with food and beverages
Not applicable.
Pregnancy and breast feeding
The use of this medication is not recommended during pregnancy and lactation. If you discover that you are pregnant during treatment, quickly consult your doctor alone will be able to adapt the treatment to your condition.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
CONTALAX, gastro-resistant tablet contains lactose.
3. HOW TO TAKE CONTALAX, Gastro-resistant tablet?
Dosage
Adults : 1 to 2 tablets per day.
If diarrhea occurs, decrease dosage.
Administration mode
Oral use.
The tablets should be swallowed with a little water, without chewing them.
Frequency of Administration
This medication should preferably be given 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.
If diarrhea occurs, decrease dosage.
If you take more CONTALAX, gastric-resistant tablet than you should:
Immediately consult your doctor or pharmacist.
If you forget to take CONTALAX, gastro-resistant tablet:
Not applicable.
If you stop taking CONTALAX, gastro-resistant tablet:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Risk of diarrhea and abdominal pain, especially in subjects suffering from irritable bowel.
· Hypokalemia (decreased potassium in the blood.
· Abnormal staining of urine.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CONTALAX, gastro-resistant tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CONTALAX contains, gastro-resistant tablets
The active substance is:
Bisacodyl ................................................. .................................................. .......................... 5.0 mg
For a gastro-resistant tablet.
The other components are:
Lactose, modified starch (Starx 1500), anhydrous colloidal silica, magnesium stearate, cellulose acetate phthalate, ethyl phthalate.
What is CONTALAX, gastro-resistant tablets and contents of the pack
This medication is in the form of a gastro-resistant tablet. Box of 30.
Marketing Authorization Holder
LABORATOIRES OMEGA PHARMA FRANCE
20 STREET ANDRE GIDE
92320 CHATILLON
Marketing Authorization Operator
LABORATOIRES OMEGA PHARMA FRANCE
20 STREET ANDRE GIDE
92320 CHATILLON
Maker
OPODEX INDUSTRIE LABORATORIES
36-42, AVENUE MARC SANGNIER
92390 VILLENEUVE-LA-GARENNE
or
DELPHARM REIMS
10 RUE COLONEL CHARBONNEAUX
51100 REIMS
Names of the medicinal product 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 medicine is available on the ANSM website (France).